The important work of Yu,et al.[1]who presented one of the first randomized controlled trials(RCTs)to directly compare robot-assisted and manual percutaneous coronary intervention(PCI),is commendable;offering importan...The important work of Yu,et al.[1]who presented one of the first randomized controlled trials(RCTs)to directly compare robot-assisted and manual percutaneous coronary intervention(PCI),is commendable;offering important insights into the feasibility and outcomes of this emerging technology.While the analysis is timely,several issues warrant further consideration.展开更多
Background:Risk-adapted colorectal cancer(CRC)screening has the potential to balance effectiveness with resource demands,yet evidence comparing it with established methods remains limited.This study aims to compare ou...Background:Risk-adapted colorectal cancer(CRC)screening has the potential to balance effectiveness with resource demands,yet evidence comparing it with established methods remains limited.This study aims to compare outcomes of risk-adapted CRC screening with colonoscopy and fecal immunochemical test(FIT)strategies.Methods:We adopted a hybrid methodology combining real-world data from a population-based CRC screening randomized controlled trial(TARGET-C)with projections from a validated Markov-based microsimulation model(MIMIC-CRC).The TARGET-C trial enrolled 19,582 participants aged 50-74 years from 6 centers in China,randomized in a 1:2:2 ratio into three groups.After applying the exclusion criteria,the final analysis included 3883 participants in the one-time colonoscopy group,7793 in the annual FIT group,and 7697 in the risk-adapted screening group.In the latter group,screening allocation was determined by a composite risk score incorporating age,sex,family history of CRC,smoking status,and body mass index,with high-risk participants referred for colonoscopy and low-risk participants for FIT.The primary outcome was detection rates of advanced neoplasm(CRC and advanced adenoma)over 4 rounds.Secondary outcomes included screening participation,colonoscopy demand,and costs from a societal perspective.Long-term effectiveness and cost-effectiveness were modeled over 15 years using MIMIC-CRC.Results:Across 4 rounds,overall participation rates(attending at least one screening round)were 42.3%(colonoscopy),99.8%(FIT),and 92.5%(risk-adapted).Detection rates of advanced neoplasms were 2.8%,2.3%,and 2.6%,respectively,with no significant differences(P>0.05).Colonoscopies needed to detect 1 advanced neoplasm were 15.4,7.9,and 9.3,respectively.From a societal perspective,the cost for detecting 1 advanced neoplasm was 15,341,21,754,and 24,300 Chinese Yuan,respectively.Over 15 years,risk-adapted screening reduced incidence by 16.7%and mortality by 21.5%compared with no screening,slightly less effective than colonoscopy(24.6%and 24.8%,respectively).Under observed real-world adherence,colonoscopy was the most cost-effective;under perfect full adherence,risk-adapted screening was the most cost-effective.Conclusions:In this population-based CRC screening trial,risk-adapted screening,colonoscopy,and FIT demonstrated comparable effectiveness,but differed in participation rates,resource utilization,and cost-effectiveness.Risk-adapted screening could serve as a complementary approach to established strategies,particularly when health resources are limited.Trial registration:Chinese Clinical Trial Registry(ChiCTR1800015506).展开更多
OBJECTIVE:To investigate the efficacy and safety of electro-thumbtack needles(ETN)compared with sham acupuncture(SA)on symptoms during high-altitude exposure.METHODS:In this pilot,single-blind,randomized,controlled st...OBJECTIVE:To investigate the efficacy and safety of electro-thumbtack needles(ETN)compared with sham acupuncture(SA)on symptoms during high-altitude exposure.METHODS:In this pilot,single-blind,randomized,controlled study,we assessed the impact of ETN acupuncture on symptoms associated with high-altitude exposure.Participants were randomized into two groups:an ETN group and a SA group.The intervention involved routine skin disinfection and stimulation of seven acupuncture points:bilateral Neiguan(PC6),bilateral Hegu(LI4),bilateral Taiyang(EX-HN5),and Zhongwan(CV12),with pressure for approximately 1 min on each point.The primary outcome was the Lake Louise Score after intervention.Secondary outcome measures were heart rate,blood pressure,blood oxygen saturation,headache visual analogue scale score,clinical function score,and sleep scale scores after the intervention.RESULTS:We enrolled 125 patients with high-altitude exposure;59 in the ETN group and 66 in the SA group.AMS was present in 37.90%of the 125 patients.The Lake Louise Score in the ETN group was significantly lower than that in the SA group 6 h postintervention[P=0.05;adjusted mean difference:0.56;95%confidence interval(CI)(0.01,1.11)].The changes in blood pressure,blood oxygen saturation,and Groningen Sleep Quality Survey,Stanford Sleepiness Scale,visual analog scale,and clinical functioning scores 48 h postintervention showed no significant differences between the groups.Decreases in cerebral oxygen saturation postintervention differed significantly between the ETN and SA groups[P<0.05;t=-1.39;95%CI(3.50,0.59)].CONCLUSIONS:This study assessed the feasibility of ETN to address AMS and was a preliminary evaluation of its efficacy.This study provides a basis for the development of intervention programs and scale implementation.ETN is a possible intervention in AMS for special populations,such as those with drug contraindications or pregnant women.This study may guide future research by presenting novel insights,strategic directions,and foundational evidence.展开更多
Background:Auriculotherapy is a simple,convenient,nonpharmacological option that has shown positive effects for insomnia patients,but its efficacy and safety remain unknown.Objective:The aim of this study is to evalua...Background:Auriculotherapy is a simple,convenient,nonpharmacological option that has shown positive effects for insomnia patients,but its efficacy and safety remain unknown.Objective:The aim of this study is to evaluate the efficacy and safety of auricular therapy for insomnia.Design,setting,participants and intervention:An 18-week(2-week screening,4-week treatment,and 12-week follow-up),recruiter-and assessor-blinded,randomized,sham-controlled trial was performed.Patients were recruited from outpatient settings at three clinical centers in China from 2 February 2023 to 26 January 2024.Participants had insomnia for more than 3 months and met the criteria classified in the Diagnostic and Statistical Manual of Mental Disorders(Fifth Edition).Patients were randomly assigned in a 1:1 ratio to receive auricular therapy(AT)or sham AT(SAT)for 4 consecutive weeks,twice a week,and once every 3 days.Main outcome measures:Primary outcome was the response rate at week 4 after treatment,defined as the percentage of patients with at least a 50%reduction in Pittsburgh Sleep Quality Index(PSQI)from baseline.Secondary outcomes consisted of response rates at other time points,PSQI and 4 related scales,actigraphy-recorded sleep efficiency,sleep arousal frequency,and total sleep time.Results:A total of 234 participants were screened,and 156 patients(122 female[78.2%];mean[standard deviation]age,37.2[13.5]years)were included in the intention-to-treat analysis,with 78 participants randomized to each group.A total of 117 participants(75%)were followed up for 3 months.The AT group had a higher response rate at week 4 than the SAT group(39.73%[29/73]vs 23.29%[17/73],P=0.03),and the response rates for the AT and SAT groups at week 2 were 28.38%(21/74)and 13.33%(10/75),respectively(P=0.02).The differences between the two groups in the PSQI at each time point(P<0.05)and the Insomnia Severity Index at weeks 4 and 12(both P=0.03)were also statistically significant.The other partial outcomes also showed statistically significant differences.Adverse events occurred in 2 cases in the AT group(2.60%).Conclusion:Four-week AT treatment was an effective and safe alternative therapy for insomnia,although the difference with the SAT treatment did not reach the minimal clinically important difference.Adverse events were mild or transient.展开更多
OBJECTIVE:To observe the clinical efficacy and safety of Chinese herbal medicine Jiawei Simiao Yongan granules(加味四妙勇安颗粒,JWSMYAG)in the treatment of non-infectious anterior uveitis(NIAU).METHODS:We conducted a ...OBJECTIVE:To observe the clinical efficacy and safety of Chinese herbal medicine Jiawei Simiao Yongan granules(加味四妙勇安颗粒,JWSMYAG)in the treatment of non-infectious anterior uveitis(NIAU).METHODS:We conducted a single-center,randomized,open-labeled clinical trial in adults with NIAU.Patients received standard treatment or a combination of JWSMYAG(twice daily)for three months,with a 3-month withdrawal period for observation.The primary endpoint was the recurrence rate within six months.RESULTS:A total of 98 patients were included in the intention-to-treat analysis,including 49 patients in the Traditional Chinese Medicine(TCM)group and 49 patients in the control group.Compared with the control group,the number of relapses was significantly lower in the TCM group[24.5%vs 6.1%,P=0.0224;Hazard Ratio=0.208,95%Confidence Interval(0.059,0.737)];in addition,patients in the TCM group had lower symptom scores of eye pain,insomnia,and bitter taste within two weeks(all P10 mm Hg,the scoring of anterior chamber cells,the number of patients with keratic precipitates(+)after 1/2 weeks of treatment,and the scores of conjunctival hyperemia,headache,photophobia,and lacrimation.The difference in the number of adverse events between the two groups over six months was not statistically significant.CONCLUSION:JWSMYAG can reduce the recurrence rate of NIAU,alleviate ocular pain,insomnia,and bitter taste symptoms in patients with NIAU,and have a favorable safety profile.展开更多
Objectives This study aimed to design and evaluate a detection system for the accidental dislodgement of head-and-neck medical supplies through hand position recognition and tracking in Intensive Care Unit(ICU)patient...Objectives This study aimed to design and evaluate a detection system for the accidental dislodgement of head-and-neck medical supplies through hand position recognition and tracking in Intensive Care Unit(ICU)patients.Methods We conducted a single-center,prospective,parallel-group feasibility randomized controlled trial.We recruited 80 participants using convenience sampling from the ICU of a hospital in Ningbo City,Zhejiang Province,between March 2025 and June 2025,and they were randomly assigned to either the control group(routine care)or the intervention group(routine care plus image recognition-based detection system).The system continuously tracked patients’hand positions via bedside cameras and generated real-time alarms when hands entered predefined risk zones,notifying on-duty nurses to enable early intervention.System stability was assessed by continuous system uptime;system performance and clinical feasibility were evaluated by the frequencies of risk actions and accidental dislodgement of medical supplies(ADMS).Results All 80 participants completed the intervention,with 40 patients in each group.The baseline characteristics and median observation time of the two groups were balanced(intervention group:48 h/patient vs.control group:49 h/patient).Compared with the control group,the intervention group showed fewer ADMS(2/40 vs.9/40)and detected more risk actions per 100 h(36 vs.25);all system-detected events had corroborating images with complete concordance on manual review,and all nurse-recorded hand-contact events were accurately captured.Conclusions The study demonstrated that the image recognition-based detection system can function stably in clinical settings,providing accurate and continuous surveillance while supporting the early detection of risk actions.By reducing the observation burden and offering real-time cognitive support,the system complements routine nursing care and serves as an additional safety measure in ICU practice.With further optimization and larger multicenter validation,this approach could have the potential to make a significant contribution to the development of smart ICUs and the broader digital transformation of nursing care.展开更多
OBJECTIVE:To evaluate the efficacy of Traditional Chinese Medicine(TCM)psychosomatic integration therapy in treating subthreshold depression(SD).METHODS:A multicenter randomized controlled trial was conducted.Eligible...OBJECTIVE:To evaluate the efficacy of Traditional Chinese Medicine(TCM)psychosomatic integration therapy in treating subthreshold depression(SD).METHODS:A multicenter randomized controlled trial was conducted.Eligible participants were evaluated by physicians and randomly assigned to either the intervention or control group.The intervention group received group psychotherapy,Jue tune music therapy,and Yuleyin oral formula(郁乐饮).The control group received only group psychotherapy.The intervention period lasted 12 weeks,followed by a 12-week follow-up.The primary outcome was the Center for Epidemiologic Studies Depression Scale(CES-D)score at week 12.Secondary outcomes included dropout rate,scores of the Hamilton Anxiety Scale(HAMA)and the Hamilton Depression Rating Scale(HAMD-17)at week 12,and CES-D scores at weeks 4,8,16,20,and 24.RESULTS:A total of 505 patients were randomly allocated to the two groups,and 496 participants[77%female;(38±16)years]were included in the final analysis.The primary outcome showed no statistically significant difference in CES-D scores between the intervention and control groups at week 12(P>0.05).However,the intervention group exhibited significant reductions in CES-D scores at weeks 4,8,12,16,20,and 24 compared to baseline,and at week 24 compared to week 12(P<0.0001).The control group also showed significant reductions in CES-D scores at weeks 4 and 8 during the intervention period(P<0.0001).Although no significant differences were observed between groups at each specific time point,the intervention group showed a more consistent downward trend.Additionally,both HAMD and HAMA scores significantly decreased from baseline to week 12 in both groups(P<0.0001).CONCLUSIONS:TCM psychosomatic integration therapy,which includes group psychotherapy,Jue tune music therapy,and Yuleyin oral formula,may be effective in improving symptoms of SD,with good safety and feasibility.The complete TCM intervention demonstrated better long-term effectiveness than group psychotherapy alone.Further high-quality studies are needed to validate these findings.展开更多
Background:The optimal sequencing of surgery and chemotherapy in advanced epithelial ovarian cancer remains debated.While primary debulking surgery(PDS)has been considered the standard approach,recent randomized trial...Background:The optimal sequencing of surgery and chemotherapy in advanced epithelial ovarian cancer remains debated.While primary debulking surgery(PDS)has been considered the standard approach,recent randomized trials have questioned its survival advantage over neoadjuvant chemotherapy(NACT)followed by interval debulking surgery(IDS).The study aimed to systematically evaluate phase Ⅲ randomized controlled trials comparing PDS and NACT.Methods:Following PRISMA guidelines(PROSPERO ID 1169057),PubMed and Scopus were systematically searched in October 2025 for phase Ⅲ randomized clinical trials evaluating cytoreductive strategies in ovarian carcinoma.Only full-text English studies reporting overall survival(OS)or disease-free survival(DFS)were included.Risk ratios(RR)with 95%confidence intervals(CI)were calculated.Results:Five phase Ⅲ trials(EORTC 55971,CHORUS,JCOG0602,SCORPION,TRUST)comprising 2296 patients met the inclusion criteria.PDS(n=1139)and NACT(n=1157)showed comparable OS(RR 0.99,95%CI 0.94-1.03,p=0.55,I2=0%)and DFS(PDS RR 0.98,95%CI 0.95-1.02,p=0.27,I2=0%).Subgroup analyses confirmed the absence of significant differences for patients with CC0(RR 0.96,95%CI 0.87-1.05,p=0.35,I2=0%),FIGO stage Ⅲ disease(RR 0.97,95%CI 0.92-1.03,p=0.34,I2=0%),or age under 70 years(RR 1.03,95%CI 0.97-1.09,p=0.38,I2=0%).Conclusions:PDS and NACT provide no significant survival outcomes in advanced ovarian cancer.No clear survival benefit for PDS was observed.Refinement of patient selection,integration of predictive biomarkers,and re-evaluation of PDS in the context of HIPEC and Poly-ADP-Ribose Polymerase(PARP)inhibitor use are warranted to guide individualized treatment strategies.展开更多
Objective:This study aimed to compare the efficacy of Traditional Chinese Medicine(TCM)Five-Element Music Therapy(FEMT)versus Western Art Music Therapy(WAMT)in reducing negative emotions and improving sleep quality am...Objective:This study aimed to compare the efficacy of Traditional Chinese Medicine(TCM)Five-Element Music Therapy(FEMT)versus Western Art Music Therapy(WAMT)in reducing negative emotions and improving sleep quality among clinical nurses and to inform future psychological support strategies.Methods:This randomized controlled trial was conducted at the Department of Nursing,Xiyuan Hospital Jining Branch.Sixty nurses were randomized to receive either personalized FEMT based on TCM pattern differentiation or standardized WAMT.The intervention lasted 4 weeks.The outcomes were measured using the Hospital Anxiety and Depression Scale(HADS)and the Pittsburgh Sleep Quality Index(PSQI)at baseline,postintervention,and at 1-week follow-up.Results:Fifty-seven participants completed the study,29 in the FEMT group and 28 in the WAMT group.At the 4th week,both groups showed significant within-group improvements in HADS scores(FEMT:P=0.002;WAMT:P0.05).The WAMT group reported significantly higher scores on music acceptability and familiarity than the FEMT group(mean acceptability:9.39 vs.8.28,P=0.013;mean familiarity:9.29 vs.8.10,P<0.001).Conclusion:Both FEMT and WAMT were effective.FEMT was more effective than WAMT in reducing anxiety and depression symptoms,while WAMT was more familiar and acceptable.Music therapy is a viable intervention for improving nurses’well-being.展开更多
Objective:Conventional total hip arthroplasty(cTHA)may be technically challenging in some scenarios.Robotic-assisted THA(rTHA)was introduced in the 1980s with an active ROBODOC system.Considering the miscellaneous dra...Objective:Conventional total hip arthroplasty(cTHA)may be technically challenging in some scenarios.Robotic-assisted THA(rTHA)was introduced in the 1980s with an active ROBODOC system.Considering the miscellaneous drawbacks of this early system,more recent semi-active systems were subsequently introduced.The present meta-analysis aimed to compare the operative and clinical outcomes of rTHA assisted by semi-active systems with those of cTHA in randomized controlled trials(RCTs).Methods:The present study was conducted in line with the recommendations of the Preferred Reporting Items for Systematic Review and Meta-Analyses 2020 expanded statement.Three databases were searched for relevant studies(July 2025)in English,including PubMed,Web of Science Core Collection and Scopus.The outcome data included the operative time,amount of intraoperative and total blood loss,duration of hospital stay,number of patients in the Lewinnek or Callanan safe zones,postoperative Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC)score,postoperative Harris hip score and leg length discrepancy(LLD).The risk of bias in the included studies was assessed via the risk of bias assessment tool.Results:Eleven RCTs with 834 patients were included in this study.No significantdifferences were found between rTHA and cTHA regarding blood loss,hospital stay,WOMAC score or Harris hip score.While cTHA had a significantlyshorter operative duration(MD:22.12;95%CI:9.75,34.48),rTHA was associated with a significantlygreater frequency of patients in the Lewinnek(OR:4.11;95%CI:2.04,8.31)and Callanan(OR:3.93;95%CI:1.15,13.57)safe zones and a significantly lower LLD(SMD:-0.45;95%CI:-0.60,-0.30).Conclusion:Compared with cTHA,rTHA is a more accurate surgical technique with comparable blood loss,hospital stay and clinical scores.展开更多
Background:Research on the benefits of mobilization-focused manual therapy for whiplash syndrome is needed.Objective:This study evaluated the effectiveness of manual therapy as an adjunct to integrative Korean medicin...Background:Research on the benefits of mobilization-focused manual therapy for whiplash syndrome is needed.Objective:This study evaluated the effectiveness of manual therapy as an adjunct to integrative Korean medicine treatment(IKMT)for acute neck pain following traffic accidents.Design,setting,participants and interventions:A single-center,two-arm,assessor-blinded,randomized clinical trial was conducted between 20 November 2020 and 26 July 2022.This study included 120patients with acute neck pain after a traffic accident.IKMT was performed in the intervention and control groups during hospitalization.The intervention group also underwent four mobilization-focused manual therapy sessions.Main outcome measures:The primary outcome was a change from the baseline in the numeric rating scale of neck pain on day 5 of hospitalization.Results:A total of 120 participants were allocated to two groups(60 patients each),and the modified intention-to-treat analysis set included 60 and 59 patients in the intervention and control groups,respectively.On day 5,the intervention group showed more improvement in numeric rating(by 0.97[0.38,1.57])and visual analogue(by 9.84[4.15,15.54])scale scores,compared to the control group.The area under the curve of cumulative values up to day 5 was smaller in the intervention group than in the control group,with numeric rating and visual analogue scale scores of 2.81(1.33,4.29)and 31.02(15.81,46.22),respectively.Conclusion:Administration of manual therapy as an adjunct to IKMT among patients with traffic accident-induced acute neck pain resulted in faster and better improvement in neck pain up to day 5compared to IKMT alone.However,the outcomes showed no significant differences at the 12-week follow-up.Trial registration:Clinical Trials.gov(NCT04660175).展开更多
Superconducting qubits are compelling platforms for charge-parity detection and,due to their theoretical sensitivity on the meV energy scale,hold promise for rare event searches.In this work,we realize high-fidelity m...Superconducting qubits are compelling platforms for charge-parity detection and,due to their theoretical sensitivity on the meV energy scale,hold promise for rare event searches.In this work,we realize high-fidelity mapping of charge-parity states onto qubit states using an offset-charge-tunable transmon qubit and efficiently characterize the fidelity of the charge-parity detection via randomized benchmarking.Specifically,a gate control line is applied to control offset charge,allowing us to achieve the single-qubit gate fidelity up to 99.96%.We combine a net-zero-based pulse on the gate line with a spin-echo-based sequence to realize charge-parity mapping,achieving a fidelity of 99.37%.Then,we demonstrate continuous monitoring of the charge-parity state with over 93.4%fidelity at a 4-μs sampling interval.Finally,an error analysis of charge-parity detection is performed,and it is found that qubit readout is currently the largest source of error.We believe this work lays the foundation for future exploration of ultra-low energy particles.展开更多
This work presents a cracked template and vacuum metal evaporation strategy for fabricating structurally randomized copper(Cu)mesh films.Regulating the internal stress distribution within the coating during template c...This work presents a cracked template and vacuum metal evaporation strategy for fabricating structurally randomized copper(Cu)mesh films.Regulating the internal stress distribution within the coating during template cracking enables the controlled fabrication of Cu mesh films with varying discrete degrees of mesh aperture area and distinct probability distributions of metal line inclination.The influence of structural parameter randomization within the Cu mesh films on properties has been systematically investigated,encompassing higher-order diffraction energy homogenization,optoelectronic performance,and electromagnetic interference shielding effectiveness(EMI SE).Results demonstrate that increasing structural randomization effectively suppresses higher-order diffraction energy,achieving a reduction to-3.93 dB in normalized higher-order diffraction energy.Furthermore,the Cu mesh film exhibited minimal degradation on imaging system performance,with resolution decreasing only marginally from 80.6 to 71.8 lp/mm.Simultaneously,the most randomized Cu mesh film demonstrates an ultra-low sheet resistance(3.31Ω/sq),high visible light transmittance(88.7%at 550 nm),an exceptional figure of merit(FoM=913.69),and robust EMI SE within the X-band(average SE of 33.18 dB).These findings underscore that metal mesh films incorporating structural randomization offer an effective strategy for enhancing EMI shielding in high-performance optoelectronic imaging systems.展开更多
OBJECTIVE:To assess the efficacy of point application therapy(PAT)in alleviating the exacerbation of chronic respiratory diseases represented by bronchial asthma.METHODS:In this multicenter randomized placebocontrolle...OBJECTIVE:To assess the efficacy of point application therapy(PAT)in alleviating the exacerbation of chronic respiratory diseases represented by bronchial asthma.METHODS:In this multicenter randomized placebocontrolled trial,eligible bronchial asthma patients received placebo PAT on the dog days of the first summer to establish a baseline,and then patients who continued to participate in the trial and repassed the eligibility review were randomized to receive regular or placebo PAT in the next two consecutive summers.The primary outcome was the change from baseline in the number of asthma exacerbations at 24 months.Secondary outcomes included severity of asthma exacerbation,asthma control test(ACT)score,percentage of forced expiratory volume in 1 s(FEV1)to the predicated value(FEV1%pred),peak expiratory flow(PEF),ratio of FEV1 to forced vital capacity(FEV1/FVC),and use of palliative drugs during bronchial asthma exacerbations at 12 and 24 months.The adverse events(AEs)were also assessed.RESULTS:A total of 835 patients with bronchial asthma were randomized in this trial.Compared with the placebo control,the PAT significantly decreased the mean number of asthma exacerbations(1.42;95%confidence interval,0.69 to 2.14;P<0.001),and increased the FEV1%pred at 24 months(P=0.039)and FEV1/FVC at 12 months(P=0.01)and 24 months(P=0.01).There were no significant differences between the groups in PEF or ACT score at 12 and 24 months,or in FEV1%pred at 12 months.Treatment-related AEs were mild and more common in the PAT group than in the placebo PAT group.No serious AEs were reported.CONCLUSION:PAT conducted on dog days could reduce asthma exacerbations in patients with bronchial asthma.展开更多
OBJECTIVE:To evaluate the efficacy and safety of Yi'anning pills(益安宁丸)for the treatment of stable angina pectoris in coronary heart disease with Qi-blood deficiency syndrome and liver-kidney deficiency syndrom...OBJECTIVE:To evaluate the efficacy and safety of Yi'anning pills(益安宁丸)for the treatment of stable angina pectoris in coronary heart disease with Qi-blood deficiency syndrome and liver-kidney deficiency syndrome.METHODS:This study was a multicenter,randomized,double-blind,double-dummy,positive-controlled clinical trial.Participants were randomly divided into the experimental group and the control group(3∶1)using the randomized block method.All participants received guideline-standardized treatment for stable angina pectoris associated with coronary heart disease,among whom the first 64 participants underwent the treadmill exercise test.The experimental group was also treated with Yi'anning pills and Xinyuan capsules(心元胶囊)simulant,while the control group received Yi'anning pills simulant and Xinyuan capsules,both for 8 weeks.The primary clinical outcome was the total Seattle Angina Questionnaire(SAQ)score,and the secondary clinical outcomes were the individual SAQ scores,treadmill exercise test results,rate of nitroglycerin cessation or reduction,classification of angina pectoris severity,and therapeutic effect against Traditional Chinese Medicine syndrome.RESULTS:Overall,158 participants were included from nine sub-centers,including 119 in the experimental group and 39 in the control group.After 8 weeks of treatment,the experimental intervention was superior to the control intervention in terms of the increase in total SAQ score(P0.05)and improving the angina-free rate after treatment(P>0.05),but the differences were not statistically significant.The rate of nitroglycerin cessation or reduction was higher in the experimental group than in the control group(P0.05).CONCLUSION:Based on the standardized treatment of stable angina pectoris in coronary heart disease,Yi'anning pills outperformed Xinyuan capsules in terms of the total SAQ score,demonstrating a good clinical effect and safe application.展开更多
Objective:To evaluate the efficacy and safety of Ruyi Zhenbao tablet(RYZBT),a traditional Tibetan medicinal formula,for the treatment of lumbar disc herniation(LDH),that is frequently associated with lower back pain(L...Objective:To evaluate the efficacy and safety of Ruyi Zhenbao tablet(RYZBT),a traditional Tibetan medicinal formula,for the treatment of lumbar disc herniation(LDH),that is frequently associated with lower back pain(LBP),through rigorous randomized controlled trials(RCTs).Methods:This multicenter,randomized,positive-controlled trial study will include 400 participants diagnosed with LDH,and include an enrollment period,a 4-week treatment period,and a 4-week follow-up period.Participants will be randomly assigned at a 1:1 ratio for treatment with either RYZBT or diclofenac sodium sustained-release tablet(DSSRT)for 4 weeks.The time points of visits are set at baseline,during treatment(weeks 1,2,and 4),and during follow-up(weeks 2 and 4 post-treatment).The relevant outcome will be recorded at each timepoint.The primary outcomes include the Visual Analog Scale(VAS)scores for LBP and leg pain,as well as the Japanese Orthopaedic Association scores for functional assessment.Secondary outcomes comprise the VAS scores for numbness,Oswestry Disability Index,rescue treatments,patient health education,and safety assessments.Discussion:This study has been designed to provide robust and reliable evidence of the efficacy and safety of RYZBT in alleviating LDH symptoms,with the goal of supporting evidence-based clinical applications.By using DSSRT as a positive control,the placebo effect will be effectively minimized,enabling a more accurate assessment of RYZBT efficacy.展开更多
Objective:To assess the efficacy and safety of Qixuekang oral liquid in the treatment of leukopenia during chemotherapy and radiotherapy.Methods:This randomized,double-blind,placebo-controlled,multicenter clinical tri...Objective:To assess the efficacy and safety of Qixuekang oral liquid in the treatment of leukopenia during chemotherapy and radiotherapy.Methods:This randomized,double-blind,placebo-controlled,multicenter clinical trial was conducted between July 2018 and May 2021.A total of 234 patients with malignant tumors were enrolled from 12 medical centers.They were randomly assigned to receive either Qixuekang oral liquid or placebo in addition to standard chemotherapy and radiotherapy,with a treatment duration≤42 days.The primary outcome was defined as the change in peripheral white blood cell(WBC)count,determined by routine laboratory hematology tests,from baseline(D-7 to D0)to Day 42(±2 days)of dosing(D42).Results:In the full analysis set comprising 227 patients(113 and 114 in the experimental and control groups,respectively),a significant reduction in WBC count was observed after treatment(P.05).Conclusion:Qixuekang oral liquid may exert a therapeutic effect in mitigating leukopenia induced by chemotherapy and radiotherapy,while exhibiting favorable safety profiles.展开更多
Objective To systematically evaluate the clinical efficacy of topical preparations of Mongolian medicine Manggari hot compress therapy(hereafter referred to as Manggari hot compress therapy)in treating cervical spondy...Objective To systematically evaluate the clinical efficacy of topical preparations of Mongolian medicine Manggari hot compress therapy(hereafter referred to as Manggari hot compress therapy)in treating cervical spondylotic radiculopathy(CSR)and explore the possible pharmacological material basis in the formula,providing evidence for the clinical application of Mongolian medicine in the treatment of CSR.Methods The clinical trial employed a randomized,controlled,open-label,and outcome-assessor-blinded design.The CSR patients who were treated at the Department of Traditional Therapeutics Outpatient Clinic,Xilinguole Meng Mongolian General Hospital between July 1,2024 and August 31,2025,were enrolled.They were randomly assigned to three groups:an oral control group(administration of oral administration of mecobalamin tablets combined with cervical electric traction),an experimental group(Manggari external hot compress),and a patch control group(flurbiprofen gel plaster).The intervention lasted two weeks.Before and after treatment,the following subjective indicators were recorded:Mongolian Medicine Syndrome(MMS)score,Visual Analog Scale(VAS)score,Northwick Park Neck Pain Questionnaire(NPQ)score,and tongue morphology.Serum levels of inflammatory markers[tumor necrosis factor(TNF)-α,interleukin(IL)-6,and IL-1β)]and oxidative stress markers[malondialdehyde(MDA)content,superoxide dismutase(SOD)activity,and glutathione peroxidase(GSH-Px)activity]were measured using enzyme-linked immunosorbent assay(ELISA).Overall therapeutic efficacy was evaluated.One month after treatment completion,a follow-up assessment was conducted,and the MMS,VAS,and NPQ scores were recorded again for all patients.For the pharmacological substance exploration,ultra-high-performance liquid chromatography-Q-exactive orbitrap-mass(UHPLC-QE-MS)was employed to analyze blood-absorbed prototype components of Manggari,under both positive and negative ion modes.The targeting relationship between the core active compounds and the target protein was validated using molecular docking.Results This study ultimately included 90 patients with CSR for analysis.Baseline characteristics showed no statistically significant differences among the three groups(P>0.05).(i)Symptom scores.After treatment,the MMS,VAS,and NPQ scores decreased significantly from baseline in all three groups(P0.05).After treatment,the experimental group showed significantly greater reductions in MMS,VAS,and NPQ scores than oral control and patch control groups(P<0.001).At follow-up,these differences remained significant(P<0.001).(ii)Inflammatory and oxidative stress markers.After treatment,serum levels of TNF-α,IL-6,and IL-1β,and MDA activity decreased significantly from baseline in all three groups(P<0.001),and SOD content and GSH-Px activity increased significantly from baseline(P<0.05).After treatment,the experimental group had significantly lower serum levels of TNF-α,IL-6,and IL-1βthan oral and patch control groups.Additionally,it exhibited lower MDA activity and higher SOD content and GSH-Px activity compared with the two control groups.(P<0.05).(iii)Overall efficacy.The total effective rate was 93.33%in the experimental group,86.66%in the oral control group,and 83.33%in the patch control group.(iv)Pharmacological substance analysis.A total of 152 compounds were identified in the blood-absorbed components of Manggari.Among them,the core compounds—4-hydroxycoumarin,N-methylanthranilic acid,genistein,and ginsenoside-Rk1—showed binding energies to the key target proteins TNF-αand IL-1βrange from−4.7 to−7.1 kcal/mol,with the majority of the binding energies being below−5.0 kcal/mol,suggesting that it generally has a good binding affinity.Conclusion Mongolian medicine hot compress therapy effectively modulates inflammatory and oxidative stress responses through the combined action of its thermal effects and active pharmaceutical ingredients Manggari.It inhibits cervical nerve root inflammation and alleviates radicular pain,improving clinical symptoms,reducing pain severity,and alleviating neck functional disability.展开更多
Randomized controlled trials(RCTs)are the important methods for evaluating medical treatments(1,2).Currently,traditional RCTs are not fully applicable to medical artificial intelligence(AI).AI systems produce results ...Randomized controlled trials(RCTs)are the important methods for evaluating medical treatments(1,2).Currently,traditional RCTs are not fully applicable to medical artificial intelligence(AI).AI systems produce results that are inherently probabilistic,and their performance can vary across different settings.They are highly sensitive to changes in deployment environments,patient population characteristics,clinical workflows,and continuous software updates(1).To bridge this gap,we propose the CARE framework:Clinical endpoint redefinition,Adversarial safety testing,and Real-world Environment adaptability.This provides a new way to design RCTs tailored to the unique characteristics of medical AI.展开更多
BACKGROUND Depression in children and adolescents has become a serious public health problem that threatens their physical and mental health,and effective short-term interventions are particularly crucial.Most existin...BACKGROUND Depression in children and adolescents has become a serious public health problem that threatens their physical and mental health,and effective short-term interventions are particularly crucial.Most existing treatments are either pharmacological or psychotherapy,but limited studies have evaluated whether a combination of intervention models leads to superior outcomes.AIM To compare the short-term efficacy of cognitive behavioral therapy(CBT)plus sertraline vs pharmacological treatment alone(sertraline)in adolescents with depression.METHODS A single-center randomized controlled study was conducted,and a total of 100 adolescent patients with depression were included who met the diagnostic criteria based on the inclusion and exclusion criteria.The patients were randomly divided into two groups:50 patients in the study group,who received a comprehensive intervention model(CBT treatment+sertraline treatment+ecological intervention),and 50 patients in the control group,who received only systematic sertraline monotherapy.The Children’s Depression Inventory(CDI)was used to evaluate short-term efficacy in both groups.The Adverse Reaction Symptom Scale(TESS)was used to evaluate treatment safety.RESULTS The results showed that there was no significant difference in CDI scores between the two groups before treatment(15.9±6.5 vs 13.6±7.3,P>0.05).After 3 months of treatment,the median CDI score in the study group was 5 points(interquartile range,3 points)and in the control group it was 7.5 points(interquartile range,8 points),with a significant difference between the two groups(Z=-3.052,P0.05);the incidence of various types of side effects(such as extrapyramidal reactions and cholinergic symptoms)was similar between the two groups(all P>0.05).The main adverse events were mild muscle stiffness(6%)and dry mouth(6%-8%).No serious adverse reactions occurred.CONCLUSION The comprehensive treatment model of CBT combined with sertraline and ecological intervention was significantly better than drug therapy alone in improving depression in children and adolescents in the short term,and demonstrated a good safety profile.This model should be promoted in clinical practice to improve the overall effectiveness of treatments for adolescent depression.展开更多
摘要The important work of Yu,et al.[1]who presented one of the first randomized controlled trials(RCTs)to directly compare robot-assisted and manual percutaneous coronary intervention(PCI),is commendable;offering important insights into the feasibility and outcomes of this emerging technology.While the analysis is timely,several issues warrant further consideration.
基金supported by the Chinese Academy of Medical Science Innovation Fund for Medical Science(2022-I2M-1-003)the National Natural Science Foundation of China(82173606,82273726)the Beijing Nova Program of Science and Technology(20230484397).
摘要Background:Risk-adapted colorectal cancer(CRC)screening has the potential to balance effectiveness with resource demands,yet evidence comparing it with established methods remains limited.This study aims to compare outcomes of risk-adapted CRC screening with colonoscopy and fecal immunochemical test(FIT)strategies.Methods:We adopted a hybrid methodology combining real-world data from a population-based CRC screening randomized controlled trial(TARGET-C)with projections from a validated Markov-based microsimulation model(MIMIC-CRC).The TARGET-C trial enrolled 19,582 participants aged 50-74 years from 6 centers in China,randomized in a 1:2:2 ratio into three groups.After applying the exclusion criteria,the final analysis included 3883 participants in the one-time colonoscopy group,7793 in the annual FIT group,and 7697 in the risk-adapted screening group.In the latter group,screening allocation was determined by a composite risk score incorporating age,sex,family history of CRC,smoking status,and body mass index,with high-risk participants referred for colonoscopy and low-risk participants for FIT.The primary outcome was detection rates of advanced neoplasm(CRC and advanced adenoma)over 4 rounds.Secondary outcomes included screening participation,colonoscopy demand,and costs from a societal perspective.Long-term effectiveness and cost-effectiveness were modeled over 15 years using MIMIC-CRC.Results:Across 4 rounds,overall participation rates(attending at least one screening round)were 42.3%(colonoscopy),99.8%(FIT),and 92.5%(risk-adapted).Detection rates of advanced neoplasms were 2.8%,2.3%,and 2.6%,respectively,with no significant differences(P>0.05).Colonoscopies needed to detect 1 advanced neoplasm were 15.4,7.9,and 9.3,respectively.From a societal perspective,the cost for detecting 1 advanced neoplasm was 15,341,21,754,and 24,300 Chinese Yuan,respectively.Over 15 years,risk-adapted screening reduced incidence by 16.7%and mortality by 21.5%compared with no screening,slightly less effective than colonoscopy(24.6%and 24.8%,respectively).Under observed real-world adherence,colonoscopy was the most cost-effective;under perfect full adherence,risk-adapted screening was the most cost-effective.Conclusions:In this population-based CRC screening trial,risk-adapted screening,colonoscopy,and FIT demonstrated comparable effectiveness,but differed in participation rates,resource utilization,and cost-effectiveness.Risk-adapted screening could serve as a complementary approach to established strategies,particularly when health resources are limited.Trial registration:Chinese Clinical Trial Registry(ChiCTR1800015506).
基金the Science and Technology Innovation Project of the China Academy of Chinese Medical Sciences:Registration and Enrollment Study on the Evaluation of the Efficacy of Traditional Chinese Medicine in the Real World(No.CI2021A05408)Standard Project of Chinese Acupuncture Society:Expert Consensus on Acupuncture and Moxibustion Treatment for High Altitude Sickness(No.Z0674,surplus funds)+1 种基金Project of China Academy of Chinese Medical Sciences:Research on the Key Technology of the Real-World Case Registry(No.2022031)Project of the National Key Research and Development Program:Development of International Clinical Research Service Standard for Acupuncture and Moxibustion(No.2019YFC1712205)。
摘要OBJECTIVE:To investigate the efficacy and safety of electro-thumbtack needles(ETN)compared with sham acupuncture(SA)on symptoms during high-altitude exposure.METHODS:In this pilot,single-blind,randomized,controlled study,we assessed the impact of ETN acupuncture on symptoms associated with high-altitude exposure.Participants were randomized into two groups:an ETN group and a SA group.The intervention involved routine skin disinfection and stimulation of seven acupuncture points:bilateral Neiguan(PC6),bilateral Hegu(LI4),bilateral Taiyang(EX-HN5),and Zhongwan(CV12),with pressure for approximately 1 min on each point.The primary outcome was the Lake Louise Score after intervention.Secondary outcome measures were heart rate,blood pressure,blood oxygen saturation,headache visual analogue scale score,clinical function score,and sleep scale scores after the intervention.RESULTS:We enrolled 125 patients with high-altitude exposure;59 in the ETN group and 66 in the SA group.AMS was present in 37.90%of the 125 patients.The Lake Louise Score in the ETN group was significantly lower than that in the SA group 6 h postintervention[P=0.05;adjusted mean difference:0.56;95%confidence interval(CI)(0.01,1.11)].The changes in blood pressure,blood oxygen saturation,and Groningen Sleep Quality Survey,Stanford Sleepiness Scale,visual analog scale,and clinical functioning scores 48 h postintervention showed no significant differences between the groups.Decreases in cerebral oxygen saturation postintervention differed significantly between the ETN and SA groups[P<0.05;t=-1.39;95%CI(3.50,0.59)].CONCLUSIONS:This study assessed the feasibility of ETN to address AMS and was a preliminary evaluation of its efficacy.This study provides a basis for the development of intervention programs and scale implementation.ETN is a possible intervention in AMS for special populations,such as those with drug contraindications or pregnant women.This study may guide future research by presenting novel insights,strategic directions,and foundational evidence.
基金funded by grant(No.2022YFC3500601)from the National Key R&D Program of China。
摘要Background:Auriculotherapy is a simple,convenient,nonpharmacological option that has shown positive effects for insomnia patients,but its efficacy and safety remain unknown.Objective:The aim of this study is to evaluate the efficacy and safety of auricular therapy for insomnia.Design,setting,participants and intervention:An 18-week(2-week screening,4-week treatment,and 12-week follow-up),recruiter-and assessor-blinded,randomized,sham-controlled trial was performed.Patients were recruited from outpatient settings at three clinical centers in China from 2 February 2023 to 26 January 2024.Participants had insomnia for more than 3 months and met the criteria classified in the Diagnostic and Statistical Manual of Mental Disorders(Fifth Edition).Patients were randomly assigned in a 1:1 ratio to receive auricular therapy(AT)or sham AT(SAT)for 4 consecutive weeks,twice a week,and once every 3 days.Main outcome measures:Primary outcome was the response rate at week 4 after treatment,defined as the percentage of patients with at least a 50%reduction in Pittsburgh Sleep Quality Index(PSQI)from baseline.Secondary outcomes consisted of response rates at other time points,PSQI and 4 related scales,actigraphy-recorded sleep efficiency,sleep arousal frequency,and total sleep time.Results:A total of 234 participants were screened,and 156 patients(122 female[78.2%];mean[standard deviation]age,37.2[13.5]years)were included in the intention-to-treat analysis,with 78 participants randomized to each group.A total of 117 participants(75%)were followed up for 3 months.The AT group had a higher response rate at week 4 than the SAT group(39.73%[29/73]vs 23.29%[17/73],P=0.03),and the response rates for the AT and SAT groups at week 2 were 28.38%(21/74)and 13.33%(10/75),respectively(P=0.02).The differences between the two groups in the PSQI at each time point(P<0.05)and the Insomnia Severity Index at weeks 4 and 12(both P=0.03)were also statistically significant.The other partial outcomes also showed statistically significant differences.Adverse events occurred in 2 cases in the AT group(2.60%).Conclusion:Four-week AT treatment was an effective and safe alternative therapy for insomnia,although the difference with the SAT treatment did not reach the minimal clinically important difference.Adverse events were mild or transient.
基金the Capital Health Development Research Project:Research on the Treatment of Non-infectious Uveitis Based on Disease-Syndrome Combination”(No.2022-2-4174)Beijing Natural Science Foundation(No.7244501)+1 种基金Study on the Mechanism of Liangxue Sanjie Decoction in Treating Subretinal Fibrosis Secondary to Neovascular Age-related Macular Degeneration Based on mi R155-mediated Autophagy”(No.82405489)Hospital Capability Enhancement Project of Xiyuan Hospital,China Academy of Chinese Medical Sciences:a Randomized Controlled Trial of Acupuncture with Huoxue Tongluo Therapy for Neovascular Age-related Macular Degeneration(No.XYZX0202-10)。
摘要OBJECTIVE:To observe the clinical efficacy and safety of Chinese herbal medicine Jiawei Simiao Yongan granules(加味四妙勇安颗粒,JWSMYAG)in the treatment of non-infectious anterior uveitis(NIAU).METHODS:We conducted a single-center,randomized,open-labeled clinical trial in adults with NIAU.Patients received standard treatment or a combination of JWSMYAG(twice daily)for three months,with a 3-month withdrawal period for observation.The primary endpoint was the recurrence rate within six months.RESULTS:A total of 98 patients were included in the intention-to-treat analysis,including 49 patients in the Traditional Chinese Medicine(TCM)group and 49 patients in the control group.Compared with the control group,the number of relapses was significantly lower in the TCM group[24.5%vs 6.1%,P=0.0224;Hazard Ratio=0.208,95%Confidence Interval(0.059,0.737)];in addition,patients in the TCM group had lower symptom scores of eye pain,insomnia,and bitter taste within two weeks(all P10 mm Hg,the scoring of anterior chamber cells,the number of patients with keratic precipitates(+)after 1/2 weeks of treatment,and the scores of conjunctival hyperemia,headache,photophobia,and lacrimation.The difference in the number of adverse events between the two groups over six months was not statistically significant.CONCLUSION:JWSMYAG can reduce the recurrence rate of NIAU,alleviate ocular pain,insomnia,and bitter taste symptoms in patients with NIAU,and have a favorable safety profile.
摘要Objectives This study aimed to design and evaluate a detection system for the accidental dislodgement of head-and-neck medical supplies through hand position recognition and tracking in Intensive Care Unit(ICU)patients.Methods We conducted a single-center,prospective,parallel-group feasibility randomized controlled trial.We recruited 80 participants using convenience sampling from the ICU of a hospital in Ningbo City,Zhejiang Province,between March 2025 and June 2025,and they were randomly assigned to either the control group(routine care)or the intervention group(routine care plus image recognition-based detection system).The system continuously tracked patients’hand positions via bedside cameras and generated real-time alarms when hands entered predefined risk zones,notifying on-duty nurses to enable early intervention.System stability was assessed by continuous system uptime;system performance and clinical feasibility were evaluated by the frequencies of risk actions and accidental dislodgement of medical supplies(ADMS).Results All 80 participants completed the intervention,with 40 patients in each group.The baseline characteristics and median observation time of the two groups were balanced(intervention group:48 h/patient vs.control group:49 h/patient).Compared with the control group,the intervention group showed fewer ADMS(2/40 vs.9/40)and detected more risk actions per 100 h(36 vs.25);all system-detected events had corroborating images with complete concordance on manual review,and all nurse-recorded hand-contact events were accurately captured.Conclusions The study demonstrated that the image recognition-based detection system can function stably in clinical settings,providing accurate and continuous surveillance while supporting the early detection of risk actions.By reducing the observation burden and offering real-time cognitive support,the system complements routine nursing care and serves as an additional safety measure in ICU practice.With further optimization and larger multicenter validation,this approach could have the potential to make a significant contribution to the development of smart ICUs and the broader digital transformation of nursing care.
基金Sanming Project of Medicine in Shenzhen(No.SZZYSM202105010)the National Key Research and Development Program Project Fund:Clinical Evaluation of Interventions for Subthreshold Depression,Insomnia,and Mild Cognitive Impairment(No.2019YFC1710103)。
摘要OBJECTIVE:To evaluate the efficacy of Traditional Chinese Medicine(TCM)psychosomatic integration therapy in treating subthreshold depression(SD).METHODS:A multicenter randomized controlled trial was conducted.Eligible participants were evaluated by physicians and randomly assigned to either the intervention or control group.The intervention group received group psychotherapy,Jue tune music therapy,and Yuleyin oral formula(郁乐饮).The control group received only group psychotherapy.The intervention period lasted 12 weeks,followed by a 12-week follow-up.The primary outcome was the Center for Epidemiologic Studies Depression Scale(CES-D)score at week 12.Secondary outcomes included dropout rate,scores of the Hamilton Anxiety Scale(HAMA)and the Hamilton Depression Rating Scale(HAMD-17)at week 12,and CES-D scores at weeks 4,8,16,20,and 24.RESULTS:A total of 505 patients were randomly allocated to the two groups,and 496 participants[77%female;(38±16)years]were included in the final analysis.The primary outcome showed no statistically significant difference in CES-D scores between the intervention and control groups at week 12(P>0.05).However,the intervention group exhibited significant reductions in CES-D scores at weeks 4,8,12,16,20,and 24 compared to baseline,and at week 24 compared to week 12(P<0.0001).The control group also showed significant reductions in CES-D scores at weeks 4 and 8 during the intervention period(P<0.0001).Although no significant differences were observed between groups at each specific time point,the intervention group showed a more consistent downward trend.Additionally,both HAMD and HAMA scores significantly decreased from baseline to week 12 in both groups(P<0.0001).CONCLUSIONS:TCM psychosomatic integration therapy,which includes group psychotherapy,Jue tune music therapy,and Yuleyin oral formula,may be effective in improving symptoms of SD,with good safety and feasibility.The complete TCM intervention demonstrated better long-term effectiveness than group psychotherapy alone.Further high-quality studies are needed to validate these findings.
摘要Background:The optimal sequencing of surgery and chemotherapy in advanced epithelial ovarian cancer remains debated.While primary debulking surgery(PDS)has been considered the standard approach,recent randomized trials have questioned its survival advantage over neoadjuvant chemotherapy(NACT)followed by interval debulking surgery(IDS).The study aimed to systematically evaluate phase Ⅲ randomized controlled trials comparing PDS and NACT.Methods:Following PRISMA guidelines(PROSPERO ID 1169057),PubMed and Scopus were systematically searched in October 2025 for phase Ⅲ randomized clinical trials evaluating cytoreductive strategies in ovarian carcinoma.Only full-text English studies reporting overall survival(OS)or disease-free survival(DFS)were included.Risk ratios(RR)with 95%confidence intervals(CI)were calculated.Results:Five phase Ⅲ trials(EORTC 55971,CHORUS,JCOG0602,SCORPION,TRUST)comprising 2296 patients met the inclusion criteria.PDS(n=1139)and NACT(n=1157)showed comparable OS(RR 0.99,95%CI 0.94-1.03,p=0.55,I2=0%)and DFS(PDS RR 0.98,95%CI 0.95-1.02,p=0.27,I2=0%).Subgroup analyses confirmed the absence of significant differences for patients with CC0(RR 0.96,95%CI 0.87-1.05,p=0.35,I2=0%),FIGO stage Ⅲ disease(RR 0.97,95%CI 0.92-1.03,p=0.34,I2=0%),or age under 70 years(RR 1.03,95%CI 0.97-1.09,p=0.38,I2=0%).Conclusions:PDS and NACT provide no significant survival outcomes in advanced ovarian cancer.No clear survival benefit for PDS was observed.Refinement of patient selection,integration of predictive biomarkers,and re-evaluation of PDS in the context of HIPEC and Poly-ADP-Ribose Polymerase(PARP)inhibitor use are warranted to guide individualized treatment strategies.
基金sponsored by the China Academy of Chinese Medical Sciences Youth Science and Technology Training Program(Project No.ZZ15-YQ-009).
摘要Objective:This study aimed to compare the efficacy of Traditional Chinese Medicine(TCM)Five-Element Music Therapy(FEMT)versus Western Art Music Therapy(WAMT)in reducing negative emotions and improving sleep quality among clinical nurses and to inform future psychological support strategies.Methods:This randomized controlled trial was conducted at the Department of Nursing,Xiyuan Hospital Jining Branch.Sixty nurses were randomized to receive either personalized FEMT based on TCM pattern differentiation or standardized WAMT.The intervention lasted 4 weeks.The outcomes were measured using the Hospital Anxiety and Depression Scale(HADS)and the Pittsburgh Sleep Quality Index(PSQI)at baseline,postintervention,and at 1-week follow-up.Results:Fifty-seven participants completed the study,29 in the FEMT group and 28 in the WAMT group.At the 4th week,both groups showed significant within-group improvements in HADS scores(FEMT:P=0.002;WAMT:P0.05).The WAMT group reported significantly higher scores on music acceptability and familiarity than the FEMT group(mean acceptability:9.39 vs.8.28,P=0.013;mean familiarity:9.29 vs.8.10,P<0.001).Conclusion:Both FEMT and WAMT were effective.FEMT was more effective than WAMT in reducing anxiety and depression symptoms,while WAMT was more familiar and acceptable.Music therapy is a viable intervention for improving nurses’well-being.
摘要Objective:Conventional total hip arthroplasty(cTHA)may be technically challenging in some scenarios.Robotic-assisted THA(rTHA)was introduced in the 1980s with an active ROBODOC system.Considering the miscellaneous drawbacks of this early system,more recent semi-active systems were subsequently introduced.The present meta-analysis aimed to compare the operative and clinical outcomes of rTHA assisted by semi-active systems with those of cTHA in randomized controlled trials(RCTs).Methods:The present study was conducted in line with the recommendations of the Preferred Reporting Items for Systematic Review and Meta-Analyses 2020 expanded statement.Three databases were searched for relevant studies(July 2025)in English,including PubMed,Web of Science Core Collection and Scopus.The outcome data included the operative time,amount of intraoperative and total blood loss,duration of hospital stay,number of patients in the Lewinnek or Callanan safe zones,postoperative Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC)score,postoperative Harris hip score and leg length discrepancy(LLD).The risk of bias in the included studies was assessed via the risk of bias assessment tool.Results:Eleven RCTs with 834 patients were included in this study.No significantdifferences were found between rTHA and cTHA regarding blood loss,hospital stay,WOMAC score or Harris hip score.While cTHA had a significantlyshorter operative duration(MD:22.12;95%CI:9.75,34.48),rTHA was associated with a significantlygreater frequency of patients in the Lewinnek(OR:4.11;95%CI:2.04,8.31)and Callanan(OR:3.93;95%CI:1.15,13.57)safe zones and a significantly lower LLD(SMD:-0.45;95%CI:-0.60,-0.30).Conclusion:Compared with cTHA,rTHA is a more accurate surgical technique with comparable blood loss,hospital stay and clinical scores.
基金supported by a grant from the Korea Health Technology R&D Project through the Korea Health Industry Development Institute(KHIDI)funded by the Ministry of Health&Welfare,Republic of Korea(grant number:RS-2023-KH139336)。
摘要Background:Research on the benefits of mobilization-focused manual therapy for whiplash syndrome is needed.Objective:This study evaluated the effectiveness of manual therapy as an adjunct to integrative Korean medicine treatment(IKMT)for acute neck pain following traffic accidents.Design,setting,participants and interventions:A single-center,two-arm,assessor-blinded,randomized clinical trial was conducted between 20 November 2020 and 26 July 2022.This study included 120patients with acute neck pain after a traffic accident.IKMT was performed in the intervention and control groups during hospitalization.The intervention group also underwent four mobilization-focused manual therapy sessions.Main outcome measures:The primary outcome was a change from the baseline in the numeric rating scale of neck pain on day 5 of hospitalization.Results:A total of 120 participants were allocated to two groups(60 patients each),and the modified intention-to-treat analysis set included 60 and 59 patients in the intervention and control groups,respectively.On day 5,the intervention group showed more improvement in numeric rating(by 0.97[0.38,1.57])and visual analogue(by 9.84[4.15,15.54])scale scores,compared to the control group.The area under the curve of cumulative values up to day 5 was smaller in the intervention group than in the control group,with numeric rating and visual analogue scale scores of 2.81(1.33,4.29)and 31.02(15.81,46.22),respectively.Conclusion:Administration of manual therapy as an adjunct to IKMT among patients with traffic accident-induced acute neck pain resulted in faster and better improvement in neck pain up to day 5compared to IKMT alone.However,the outcomes showed no significant differences at the 12-week follow-up.Trial registration:Clinical Trials.gov(NCT04660175).
基金supported by the National Natural Science Foundation of China(Grant Nos.92365206,and 12441504)the Innovation Program for Quantum Science and Technology(Grant No.2021ZD0301802)。
摘要Superconducting qubits are compelling platforms for charge-parity detection and,due to their theoretical sensitivity on the meV energy scale,hold promise for rare event searches.In this work,we realize high-fidelity mapping of charge-parity states onto qubit states using an offset-charge-tunable transmon qubit and efficiently characterize the fidelity of the charge-parity detection via randomized benchmarking.Specifically,a gate control line is applied to control offset charge,allowing us to achieve the single-qubit gate fidelity up to 99.96%.We combine a net-zero-based pulse on the gate line with a spin-echo-based sequence to realize charge-parity mapping,achieving a fidelity of 99.37%.Then,we demonstrate continuous monitoring of the charge-parity state with over 93.4%fidelity at a 4-μs sampling interval.Finally,an error analysis of charge-parity detection is performed,and it is found that qubit readout is currently the largest source of error.We believe this work lays the foundation for future exploration of ultra-low energy particles.
基金supported by the Aeronautical Science Foundation of China(202400080M9001)the Natural Science Basic Research Program of Shaanxi(2024JC-YBQN-0518)。
摘要This work presents a cracked template and vacuum metal evaporation strategy for fabricating structurally randomized copper(Cu)mesh films.Regulating the internal stress distribution within the coating during template cracking enables the controlled fabrication of Cu mesh films with varying discrete degrees of mesh aperture area and distinct probability distributions of metal line inclination.The influence of structural parameter randomization within the Cu mesh films on properties has been systematically investigated,encompassing higher-order diffraction energy homogenization,optoelectronic performance,and electromagnetic interference shielding effectiveness(EMI SE).Results demonstrate that increasing structural randomization effectively suppresses higher-order diffraction energy,achieving a reduction to-3.93 dB in normalized higher-order diffraction energy.Furthermore,the Cu mesh film exhibited minimal degradation on imaging system performance,with resolution decreasing only marginally from 80.6 to 71.8 lp/mm.Simultaneously,the most randomized Cu mesh film demonstrates an ultra-low sheet resistance(3.31Ω/sq),high visible light transmittance(88.7%at 550 nm),an exceptional figure of merit(FoM=913.69),and robust EMI SE within the X-band(average SE of 33.18 dB).These findings underscore that metal mesh films incorporating structural randomization offer an effective strategy for enhancing EMI shielding in high-performance optoelectronic imaging systems.
基金Supported by“12th Five-year” National Science and Technology Pillar Program by the Ministry of Science and Technology of the People’s Republic of China:Clinical Evaluation and Technical Operation Specification Research on Preventing Bronchial Asthma Attacks by Acupoint Application in Winter Disease Summer Treatment(No. 2015BAI04B11)。
摘要OBJECTIVE:To assess the efficacy of point application therapy(PAT)in alleviating the exacerbation of chronic respiratory diseases represented by bronchial asthma.METHODS:In this multicenter randomized placebocontrolled trial,eligible bronchial asthma patients received placebo PAT on the dog days of the first summer to establish a baseline,and then patients who continued to participate in the trial and repassed the eligibility review were randomized to receive regular or placebo PAT in the next two consecutive summers.The primary outcome was the change from baseline in the number of asthma exacerbations at 24 months.Secondary outcomes included severity of asthma exacerbation,asthma control test(ACT)score,percentage of forced expiratory volume in 1 s(FEV1)to the predicated value(FEV1%pred),peak expiratory flow(PEF),ratio of FEV1 to forced vital capacity(FEV1/FVC),and use of palliative drugs during bronchial asthma exacerbations at 12 and 24 months.The adverse events(AEs)were also assessed.RESULTS:A total of 835 patients with bronchial asthma were randomized in this trial.Compared with the placebo control,the PAT significantly decreased the mean number of asthma exacerbations(1.42;95%confidence interval,0.69 to 2.14;P<0.001),and increased the FEV1%pred at 24 months(P=0.039)and FEV1/FVC at 12 months(P=0.01)and 24 months(P=0.01).There were no significant differences between the groups in PEF or ACT score at 12 and 24 months,or in FEV1%pred at 12 months.Treatment-related AEs were mild and more common in the PAT group than in the placebo PAT group.No serious AEs were reported.CONCLUSION:PAT conducted on dog days could reduce asthma exacerbations in patients with bronchial asthma.
基金the Program of Discipline Backbone of high-level Public Health Talents of Beijing Municipal Health Commission:Epidemiological Survey of Acute Myocardial Infarction Inpatients in Hospital of Traditional Chinese Medicine in Beijing Area(Discipline backbone-02-25)Beijing Municipal Hospital Administration Green Seedling Talent Project:Study on Characteristics of Clinical Syndromes,Status of Traditional Chinese Medicine Treatment and Prognosis of Patients with Chronic Heart Failure in Traditional Chinese Medicine Regional Health Service Center(QML20231006)。
摘要OBJECTIVE:To evaluate the efficacy and safety of Yi'anning pills(益安宁丸)for the treatment of stable angina pectoris in coronary heart disease with Qi-blood deficiency syndrome and liver-kidney deficiency syndrome.METHODS:This study was a multicenter,randomized,double-blind,double-dummy,positive-controlled clinical trial.Participants were randomly divided into the experimental group and the control group(3∶1)using the randomized block method.All participants received guideline-standardized treatment for stable angina pectoris associated with coronary heart disease,among whom the first 64 participants underwent the treadmill exercise test.The experimental group was also treated with Yi'anning pills and Xinyuan capsules(心元胶囊)simulant,while the control group received Yi'anning pills simulant and Xinyuan capsules,both for 8 weeks.The primary clinical outcome was the total Seattle Angina Questionnaire(SAQ)score,and the secondary clinical outcomes were the individual SAQ scores,treadmill exercise test results,rate of nitroglycerin cessation or reduction,classification of angina pectoris severity,and therapeutic effect against Traditional Chinese Medicine syndrome.RESULTS:Overall,158 participants were included from nine sub-centers,including 119 in the experimental group and 39 in the control group.After 8 weeks of treatment,the experimental intervention was superior to the control intervention in terms of the increase in total SAQ score(P0.05)and improving the angina-free rate after treatment(P>0.05),but the differences were not statistically significant.The rate of nitroglycerin cessation or reduction was higher in the experimental group than in the control group(P0.05).CONCLUSION:Based on the standardized treatment of stable angina pectoris in coronary heart disease,Yi'anning pills outperformed Xinyuan capsules in terms of the total SAQ score,demonstrating a good clinical effect and safe application.
基金funded by Innovative Research on Evidence-Based Evaluation Methods for Clinical Efficacy of Traditional Chinese Medicine(90020172120103).
摘要Objective:To evaluate the efficacy and safety of Ruyi Zhenbao tablet(RYZBT),a traditional Tibetan medicinal formula,for the treatment of lumbar disc herniation(LDH),that is frequently associated with lower back pain(LBP),through rigorous randomized controlled trials(RCTs).Methods:This multicenter,randomized,positive-controlled trial study will include 400 participants diagnosed with LDH,and include an enrollment period,a 4-week treatment period,and a 4-week follow-up period.Participants will be randomly assigned at a 1:1 ratio for treatment with either RYZBT or diclofenac sodium sustained-release tablet(DSSRT)for 4 weeks.The time points of visits are set at baseline,during treatment(weeks 1,2,and 4),and during follow-up(weeks 2 and 4 post-treatment).The relevant outcome will be recorded at each timepoint.The primary outcomes include the Visual Analog Scale(VAS)scores for LBP and leg pain,as well as the Japanese Orthopaedic Association scores for functional assessment.Secondary outcomes comprise the VAS scores for numbness,Oswestry Disability Index,rescue treatments,patient health education,and safety assessments.Discussion:This study has been designed to provide robust and reliable evidence of the efficacy and safety of RYZBT in alleviating LDH symptoms,with the goal of supporting evidence-based clinical applications.By using DSSRT as a positive control,the placebo effect will be effectively minimized,enabling a more accurate assessment of RYZBT efficacy.
基金funded by the National Natural Science Foundation of China(81573915 and 81973640)the Scientific and Technological Innovation Project of the China Academy of Chinese Medical Sciences(CI2021B009).
摘要Objective:To assess the efficacy and safety of Qixuekang oral liquid in the treatment of leukopenia during chemotherapy and radiotherapy.Methods:This randomized,double-blind,placebo-controlled,multicenter clinical trial was conducted between July 2018 and May 2021.A total of 234 patients with malignant tumors were enrolled from 12 medical centers.They were randomly assigned to receive either Qixuekang oral liquid or placebo in addition to standard chemotherapy and radiotherapy,with a treatment duration≤42 days.The primary outcome was defined as the change in peripheral white blood cell(WBC)count,determined by routine laboratory hematology tests,from baseline(D-7 to D0)to Day 42(±2 days)of dosing(D42).Results:In the full analysis set comprising 227 patients(113 and 114 in the experimental and control groups,respectively),a significant reduction in WBC count was observed after treatment(P.05).Conclusion:Qixuekang oral liquid may exert a therapeutic effect in mitigating leukopenia induced by chemotherapy and radiotherapy,while exhibiting favorable safety profiles.
基金Traditional Chinese Medicine(Mongolian Medicine)Science and Technology Program of the Health Commission of the Inner Mongolia Autonomous Region(ZMY-2024137)Natural Science Foundation of Inner Mongolia Autonomous Region(2024QN08066 and 2025MS08085).
摘要Objective To systematically evaluate the clinical efficacy of topical preparations of Mongolian medicine Manggari hot compress therapy(hereafter referred to as Manggari hot compress therapy)in treating cervical spondylotic radiculopathy(CSR)and explore the possible pharmacological material basis in the formula,providing evidence for the clinical application of Mongolian medicine in the treatment of CSR.Methods The clinical trial employed a randomized,controlled,open-label,and outcome-assessor-blinded design.The CSR patients who were treated at the Department of Traditional Therapeutics Outpatient Clinic,Xilinguole Meng Mongolian General Hospital between July 1,2024 and August 31,2025,were enrolled.They were randomly assigned to three groups:an oral control group(administration of oral administration of mecobalamin tablets combined with cervical electric traction),an experimental group(Manggari external hot compress),and a patch control group(flurbiprofen gel plaster).The intervention lasted two weeks.Before and after treatment,the following subjective indicators were recorded:Mongolian Medicine Syndrome(MMS)score,Visual Analog Scale(VAS)score,Northwick Park Neck Pain Questionnaire(NPQ)score,and tongue morphology.Serum levels of inflammatory markers[tumor necrosis factor(TNF)-α,interleukin(IL)-6,and IL-1β)]and oxidative stress markers[malondialdehyde(MDA)content,superoxide dismutase(SOD)activity,and glutathione peroxidase(GSH-Px)activity]were measured using enzyme-linked immunosorbent assay(ELISA).Overall therapeutic efficacy was evaluated.One month after treatment completion,a follow-up assessment was conducted,and the MMS,VAS,and NPQ scores were recorded again for all patients.For the pharmacological substance exploration,ultra-high-performance liquid chromatography-Q-exactive orbitrap-mass(UHPLC-QE-MS)was employed to analyze blood-absorbed prototype components of Manggari,under both positive and negative ion modes.The targeting relationship between the core active compounds and the target protein was validated using molecular docking.Results This study ultimately included 90 patients with CSR for analysis.Baseline characteristics showed no statistically significant differences among the three groups(P>0.05).(i)Symptom scores.After treatment,the MMS,VAS,and NPQ scores decreased significantly from baseline in all three groups(P0.05).After treatment,the experimental group showed significantly greater reductions in MMS,VAS,and NPQ scores than oral control and patch control groups(P<0.001).At follow-up,these differences remained significant(P<0.001).(ii)Inflammatory and oxidative stress markers.After treatment,serum levels of TNF-α,IL-6,and IL-1β,and MDA activity decreased significantly from baseline in all three groups(P<0.001),and SOD content and GSH-Px activity increased significantly from baseline(P<0.05).After treatment,the experimental group had significantly lower serum levels of TNF-α,IL-6,and IL-1βthan oral and patch control groups.Additionally,it exhibited lower MDA activity and higher SOD content and GSH-Px activity compared with the two control groups.(P<0.05).(iii)Overall efficacy.The total effective rate was 93.33%in the experimental group,86.66%in the oral control group,and 83.33%in the patch control group.(iv)Pharmacological substance analysis.A total of 152 compounds were identified in the blood-absorbed components of Manggari.Among them,the core compounds—4-hydroxycoumarin,N-methylanthranilic acid,genistein,and ginsenoside-Rk1—showed binding energies to the key target proteins TNF-αand IL-1βrange from−4.7 to−7.1 kcal/mol,with the majority of the binding energies being below−5.0 kcal/mol,suggesting that it generally has a good binding affinity.Conclusion Mongolian medicine hot compress therapy effectively modulates inflammatory and oxidative stress responses through the combined action of its thermal effects and active pharmaceutical ingredients Manggari.It inhibits cervical nerve root inflammation and alleviates radicular pain,improving clinical symptoms,reducing pain severity,and alleviating neck functional disability.
摘要Randomized controlled trials(RCTs)are the important methods for evaluating medical treatments(1,2).Currently,traditional RCTs are not fully applicable to medical artificial intelligence(AI).AI systems produce results that are inherently probabilistic,and their performance can vary across different settings.They are highly sensitive to changes in deployment environments,patient population characteristics,clinical workflows,and continuous software updates(1).To bridge this gap,we propose the CARE framework:Clinical endpoint redefinition,Adversarial safety testing,and Real-world Environment adaptability.This provides a new way to design RCTs tailored to the unique characteristics of medical AI.
摘要BACKGROUND Depression in children and adolescents has become a serious public health problem that threatens their physical and mental health,and effective short-term interventions are particularly crucial.Most existing treatments are either pharmacological or psychotherapy,but limited studies have evaluated whether a combination of intervention models leads to superior outcomes.AIM To compare the short-term efficacy of cognitive behavioral therapy(CBT)plus sertraline vs pharmacological treatment alone(sertraline)in adolescents with depression.METHODS A single-center randomized controlled study was conducted,and a total of 100 adolescent patients with depression were included who met the diagnostic criteria based on the inclusion and exclusion criteria.The patients were randomly divided into two groups:50 patients in the study group,who received a comprehensive intervention model(CBT treatment+sertraline treatment+ecological intervention),and 50 patients in the control group,who received only systematic sertraline monotherapy.The Children’s Depression Inventory(CDI)was used to evaluate short-term efficacy in both groups.The Adverse Reaction Symptom Scale(TESS)was used to evaluate treatment safety.RESULTS The results showed that there was no significant difference in CDI scores between the two groups before treatment(15.9±6.5 vs 13.6±7.3,P>0.05).After 3 months of treatment,the median CDI score in the study group was 5 points(interquartile range,3 points)and in the control group it was 7.5 points(interquartile range,8 points),with a significant difference between the two groups(Z=-3.052,P0.05);the incidence of various types of side effects(such as extrapyramidal reactions and cholinergic symptoms)was similar between the two groups(all P>0.05).The main adverse events were mild muscle stiffness(6%)and dry mouth(6%-8%).No serious adverse reactions occurred.CONCLUSION The comprehensive treatment model of CBT combined with sertraline and ecological intervention was significantly better than drug therapy alone in improving depression in children and adolescents in the short term,and demonstrated a good safety profile.This model should be promoted in clinical practice to improve the overall effectiveness of treatments for adolescent depression.