Introduction.Well-designed,strictly implemented,and fully standardized randomized controlled trials(RCTs)are a prerequisite for developing reliable scientific evidence,which can improve clinical practice,health outcom...Introduction.Well-designed,strictly implemented,and fully standardized randomized controlled trials(RCTs)are a prerequisite for developing reliable scientific evidence,which can improve clinical practice,health outcomes,and ultimately benefit patients.Suboptimal reporting is pervasive in medical research,resulting in biased research records and persistent uncertainty about the quality of available evidence.1,2,3,4 The standardization of research reports has attracted considerable attention.In 1996,the Consolidated Standards of Reporting Trials(CONSORT)was first published to improve the quality of RCTs and enhance the reproducibility of trial methods,results,and inferences.展开更多
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
Both large-scale prospective randomized controlled trials(RCTs)and smaller investigator-initiated trials are essential for evaluating the efficacy and safety of medical interventions.Robust protocols and statistical d...Both large-scale prospective randomized controlled trials(RCTs)and smaller investigator-initiated trials are essential for evaluating the efficacy and safety of medical interventions.Robust protocols and statistical designs ensure the reliability of trial outcomes and improve the credibility of research findings.By reviewing the statistical approaches used in the TORCHLIGHT,NCC2167,and NeoTENNIS trials,this article illustrates the principles underlying large-sample confirmatory RCTs,small-sample exploratory adaptive designs,and single-arm two-stage designs.This discussion is aimed at helping researchers apply these design methods more effectively,to increase the likelihood of success in clinical studies.展开更多
目的系统评价中药联合灸法(灸药结合)对肿瘤化疗患者骨髓抑制的防治作用。方法计算机检索从建库至2025年7月,在PubMed、Cochrane Library、Web of Science、CNKI、万方、维普等数据库,收集以中药联合灸法为干预措施防治肿瘤化疗骨髓抑...目的系统评价中药联合灸法(灸药结合)对肿瘤化疗患者骨髓抑制的防治作用。方法计算机检索从建库至2025年7月,在PubMed、Cochrane Library、Web of Science、CNKI、万方、维普等数据库,收集以中药联合灸法为干预措施防治肿瘤化疗骨髓抑制的随机对照实验(randomized controlled trial,RCT),采用Cochrane5.1.0偏倚风险评估工具进行文献质量评价,Revman 5.4软件进行Meta分析。结果纳入文献19篇,共计1545例研究对象,其中实验组771例,对照组774例。Meta分析结果显示,与单纯化疗相比,灸药结合可以降低白细胞减少率[RR=0.27,95%CI(0.18,0.40),P<0.00001]、降低血小板减少率[RR=0.28,95%CI(0.18,0.44),P<0.00001]、升高血细胞计数[白细胞计数MD=0.99,95%CI(0.72,1.26),P<0.00001;血小板计数MD=21.14,95%CI(16.59,25.68),P<0.00001;血红蛋白计数MD=9.12,95%CI(5.54,12.70),P<0.00001]、提高KPS评分[MD=6.09,95%CI(2.02,10.17),P=0.003]、提高临床疗效[RR=2.50,95%CI(1.67,3.76),P<0.00001]、缓解恶心呕吐症状[RR=0.25,95%CI(0.18,0.35),P<0.00001]、缓解肝肾功能损害[RR=0.36,95%CI(0.23,0.55),P<0.00001]。结论相较于单纯化疗,灸药结合对肿瘤化疗患者骨髓抑制具有较好的有效性及安全性,但因为纳入的研究较少,质量有限,还有待更多大样本、高质量、多中心的研究以验证。展开更多
Irreversible fibrotic scarring after rotator cuff tear(RCT)compromises the mechanical properties of the healing tendon,yet the underlying mechanisms remain poorly understood.Here,we analyzed the histological features ...Irreversible fibrotic scarring after rotator cuff tear(RCT)compromises the mechanical properties of the healing tendon,yet the underlying mechanisms remain poorly understood.Here,we analyzed the histological features of human RCT scars,characterized by disruption of tendon architecture,disorganized collagen fibrils,and imbalance in type Ⅰ/Ⅲ collagen ratios and fibril diameters.Using single-cell RNA sequencing of tendon stumps from patients with RCT,we deconvolved the cellular and molecular landscape of the fibrotic scarring microenvironment.Heterogenous pro-fibrotic subclusters were identified and validated to participate into scar formation,including tendon stem cell,senescent tenocyte,SOX9-driven pro-fibrotic macrophage,and pro-fibrotic endothelial cells undergoing endothelial-mesenchymal transition(EndoMT).Furthermore,we found that osteopontin and TGF-βsignaling were key drivers of extracellular matrix deposition,and their blockade ameliorated fibrotic scarring after RCT.Collectively,our study dissected the dynamic scarring microenvironment in human RCT and highlights potential therapeutic targets for preventing pathological scar formation.展开更多
Objective Randomized controlled trials(RCTs)of Chinese patent medicines and classic tra-ditional Chinese medicine prescriptions were systematically reviewed from both Chinese and English journals published in 2023.A p...Objective Randomized controlled trials(RCTs)of Chinese patent medicines and classic tra-ditional Chinese medicine prescriptions were systematically reviewed from both Chinese and English journals published in 2023.A preliminary summary and evaluation were conducted on the generation and translation of clinical evidence for these treatments.This analysis aims to inform future research on clinical efficacy evaluation and guide the rational application of evidence.Methods RCTs of Chinese patent medicines and classic traditional Chinese prescriptions published in 2023 were comprehensively retrieved from the Artificial Intelligence Clinical Evi-dence Database for Chinese Patent Medicine(AICED-CPM),with supplementary searches conducted in China National Knowledge Infrastructure(CNKI),Wanfang Data,Chinese Sci-ence and Technology Journal Database(VIP),Chinese Biomedical Literature Database(SinoMed),Cochrane Library,PubMed,Embase,and Web of Science.The study characteris-tics and methodological quality of these RCTs were systematically analyzed and evaluated.Results A total of 1443 RCTs of Chinese patent medicines were included,comprising 1399 Chinese articles and 44 English articles.Additionally,334 RCTs of classic traditional Chinese medicine prescriptions were found,with 331 published in Chinese and 3 in English.196567 participants were included,covering 585 types of Chinese patent medicines(487 oral,61 in-jectable,and 37 topical)and 179 classic traditional Chinese medicine prescriptions.The in-volved studies encompassed 22 types of diseases,with research primarily focusing on dis-eases of the circulatory system,the respiratory system,and the genitourinary system.The sample sizes ranged from 18 to 3777 participants,and most studies were conducted at a sin-gle center.Methodologically,the implementation of allocation concealment and blinding re-mained insufficiently emphasized.Conclusion Overall,compared with 2022,both the number of RCT publications and their methodological quality have improved in 2023,with heightened attention to research on diseases of the genitourinary system.However,quality control and standardized management in the design and implementation processes still require enhancement to produce more high-quality clinical evidence and accelerate the translation and application of this evidence.展开更多
Osteoporosis is a known risk factor for rotator cuff tears(RCTs),but the causal correlation and underlying mechanisms remain unclear.This study aims to evaluate the impact of osteoporosis on RCT risk and investigate t...Osteoporosis is a known risk factor for rotator cuff tears(RCTs),but the causal correlation and underlying mechanisms remain unclear.This study aims to evaluate the impact of osteoporosis on RCT risk and investigate their genetic associations.Using data from the UK Biobank(n=457871),cross-sectional analyses demonstrated that osteoporosis was significantly associated with an increased risk of RCTs(adjusted OR[95%CI]=1.38[1.25–1.52]).A longitudinal analysis of a subset of patients(n=268117)over 11 years revealed that osteoporosis increased the risk of RCTs(adjusted HR[95%CI]=1.56[1.29–1.87]),which is notably varied between sexes in sex-stratified analysis.Causal inference methods,including propensity score matching,inverse probability weighting,causal random forest and survival random forest models further confirmed the causal effect,both from cross-sectional and longitudinal perspectives.展开更多
[目的]通过系统评价和Meta分析,评估针刺及针药合用在改善干燥综合征患者口干和眼干症状方面的疗效。[方法]检索中国知网(CNKI)、万方数据库、维普网(VIP)、中国生物医学文献数据库(CBM)、PubMed、Cochrane Library、EMbase和Web of Sci...[目的]通过系统评价和Meta分析,评估针刺及针药合用在改善干燥综合征患者口干和眼干症状方面的疗效。[方法]检索中国知网(CNKI)、万方数据库、维普网(VIP)、中国生物医学文献数据库(CBM)、PubMed、Cochrane Library、EMbase和Web of Science等数据库,收集截至2024年10月1日的针刺或针药合用治疗干燥综合征口干眼干症状的随机对照试验(RCT)文献。由两名研究者独立筛选文献、提取数据并评估偏倚风险,使用RevMan 5.4软件进行Meta分析,效应量采用标准化均数差(SMD)和优势比(OR),并评估研究间的异质性。[结果]本研究共纳入16项随机对照试验(RCT),涉及1319例干燥综合征患者。Meta分析显示,单纯针刺治疗与对照组相比差异无统计学意义[OR=3.73,95%CI(0.42,33.08),P=0.24],而针药合用治疗显示出明显的临床疗效优势[OR=3.60,95%CI(2.53,5.11),P<0.05]。在客观生物学指标方面,针刺治疗能显著提高患者唾液流率[MD=1.98,95%CI(0.20,3.75),P<0.05],针药合用治疗同样能显著提高患者唾液流率[MD=0.25,95%CI(0.03,0.47),P<0.05]。Schirmer测试结果表明,针药合用治疗能有效改善干燥综合征患者的泪液分泌[MD=1.47,95%CI(0.54,2.40),P<0.05]。但存在异质性,经治疗时长(>4周/≤4周)和干预方案(纯针刺/针药合用)的亚组分析后,异质性仍高于50%,提示潜在异质性来源可能涉及操作者技术差异、穴位配伍特异性及受试人群基线特征等因素。在症状评估维度,治疗组显著降低中医证候积分[SMD=-1.29,95%CI(-1.97,-0.61),Z=-3.74,P<0.05]和ESSPRI评分[SMD=-1.73,95%CI(-2.51,-0.95),Z=-4.34,P<0.05],尽管两者异质性分别达84.90%和90%,但敏感性分析证实结果稳健。所有异质性大的结局指标采用随机效应模型,异质性来源的系统分析表明,操作者资质、干预方案细节(如穴位选择、针刺频数)及疗效评估时点差异可能是影响研究间异质性的关键因素。[结论]针刺及针药合用治疗显著改善了干燥综合征患者的临床疗效、唾液流率、Schirmer测试、中医证候积分及患者汇报指数(ESSPRI)评分,且安全性良好。未来需要更多大规模、高质量的随机对照试验,以进一步验证针刺的长期疗效并探讨不同针刺方案的具体作用机制。展开更多
基于严格设计随机对照试验（RCTs）的直接比较（direct comparison）或称为头对头比较（head to head comparison）的系统评价,已被公认为是评价干预措施疗效的最高级别证据,称之为传统系统评价.但是,如果想进行一个系统评价,目的是比...基于严格设计随机对照试验（RCTs）的直接比较（direct comparison）或称为头对头比较（head to head comparison）的系统评价,已被公认为是评价干预措施疗效的最高级别证据,称之为传统系统评价.但是,如果想进行一个系统评价,目的是比较两种干预措施A vs B的效果,但目前的RCTs没有两者的直接比较研究,却都有同干预措施C的比较（即A vs C和B vs C）,此时,可以将C作为公共比较组,借助间接比较方法得出A vs B的效果,或者虽然有直接比较研究证据,但这些研究数量较少或质量较低,此时也可以用间接比较证据进行补充.展开更多
基金supported by the Talent Development Plan for High-level Public Health Technical Personnel Project in Beijing,Beijing Municipal Health Commission[No.XKGG-02-03].
文摘Introduction.Well-designed,strictly implemented,and fully standardized randomized controlled trials(RCTs)are a prerequisite for developing reliable scientific evidence,which can improve clinical practice,health outcomes,and ultimately benefit patients.Suboptimal reporting is pervasive in medical research,resulting in biased research records and persistent uncertainty about the quality of available evidence.1,2,3,4 The standardization of research reports has attracted considerable attention.In 1996,the Consolidated Standards of Reporting Trials(CONSORT)was first published to improve the quality of RCTs and enhance the reproducibility of trial methods,results,and inferences.
文摘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 a grant from the National Science and Technology Major Project(Grant No.2024ZD0519800).
文摘Both large-scale prospective randomized controlled trials(RCTs)and smaller investigator-initiated trials are essential for evaluating the efficacy and safety of medical interventions.Robust protocols and statistical designs ensure the reliability of trial outcomes and improve the credibility of research findings.By reviewing the statistical approaches used in the TORCHLIGHT,NCC2167,and NeoTENNIS trials,this article illustrates the principles underlying large-sample confirmatory RCTs,small-sample exploratory adaptive designs,and single-arm two-stage designs.This discussion is aimed at helping researchers apply these design methods more effectively,to increase the likelihood of success in clinical studies.
基金supported by the National Natural Science Foundation of China(NO.82230085,82272572,82030071)National Key Research and Development Program of China(NO.2022YFC2010204)Natural Science Foundation of Hunan Province(NO.2024JJ6637)。
文摘Irreversible fibrotic scarring after rotator cuff tear(RCT)compromises the mechanical properties of the healing tendon,yet the underlying mechanisms remain poorly understood.Here,we analyzed the histological features of human RCT scars,characterized by disruption of tendon architecture,disorganized collagen fibrils,and imbalance in type Ⅰ/Ⅲ collagen ratios and fibril diameters.Using single-cell RNA sequencing of tendon stumps from patients with RCT,we deconvolved the cellular and molecular landscape of the fibrotic scarring microenvironment.Heterogenous pro-fibrotic subclusters were identified and validated to participate into scar formation,including tendon stem cell,senescent tenocyte,SOX9-driven pro-fibrotic macrophage,and pro-fibrotic endothelial cells undergoing endothelial-mesenchymal transition(EndoMT).Furthermore,we found that osteopontin and TGF-βsignaling were key drivers of extracellular matrix deposition,and their blockade ameliorated fibrotic scarring after RCT.Collectively,our study dissected the dynamic scarring microenvironment in human RCT and highlights potential therapeutic targets for preventing pathological scar formation.
基金National Multidisciplinary Innovation Team of Traditional Chinese Medicine (ZYYCXTD-D-202204)Science and Technology Project of Haihe Laboratory of Modern Chinese Medicine (22HHZYSS00013)。
文摘Objective Randomized controlled trials(RCTs)of Chinese patent medicines and classic tra-ditional Chinese medicine prescriptions were systematically reviewed from both Chinese and English journals published in 2023.A preliminary summary and evaluation were conducted on the generation and translation of clinical evidence for these treatments.This analysis aims to inform future research on clinical efficacy evaluation and guide the rational application of evidence.Methods RCTs of Chinese patent medicines and classic traditional Chinese prescriptions published in 2023 were comprehensively retrieved from the Artificial Intelligence Clinical Evi-dence Database for Chinese Patent Medicine(AICED-CPM),with supplementary searches conducted in China National Knowledge Infrastructure(CNKI),Wanfang Data,Chinese Sci-ence and Technology Journal Database(VIP),Chinese Biomedical Literature Database(SinoMed),Cochrane Library,PubMed,Embase,and Web of Science.The study characteris-tics and methodological quality of these RCTs were systematically analyzed and evaluated.Results A total of 1443 RCTs of Chinese patent medicines were included,comprising 1399 Chinese articles and 44 English articles.Additionally,334 RCTs of classic traditional Chinese medicine prescriptions were found,with 331 published in Chinese and 3 in English.196567 participants were included,covering 585 types of Chinese patent medicines(487 oral,61 in-jectable,and 37 topical)and 179 classic traditional Chinese medicine prescriptions.The in-volved studies encompassed 22 types of diseases,with research primarily focusing on dis-eases of the circulatory system,the respiratory system,and the genitourinary system.The sample sizes ranged from 18 to 3777 participants,and most studies were conducted at a sin-gle center.Methodologically,the implementation of allocation concealment and blinding re-mained insufficiently emphasized.Conclusion Overall,compared with 2022,both the number of RCT publications and their methodological quality have improved in 2023,with heightened attention to research on diseases of the genitourinary system.However,quality control and standardized management in the design and implementation processes still require enhancement to produce more high-quality clinical evidence and accelerate the translation and application of this evidence.
基金the Scientific Research Innovation Capability Support Project for Young Faculty(ZYGXQNJSKYCXNLZCXM-H8)Fundamental Research Funds for the Central Universities(2024ZYGXZR077)+3 种基金Guangdong Basic and Applied Basic Research Foundation(2023B1515120006)Guangzhou Basic and Applied Basic Research Foundation(2024A04J5776)the Research Fund(2023QN10Y421)Guangzhou Talent Recruitment Team Program(2024D03J0004),all related to this study.
文摘Osteoporosis is a known risk factor for rotator cuff tears(RCTs),but the causal correlation and underlying mechanisms remain unclear.This study aims to evaluate the impact of osteoporosis on RCT risk and investigate their genetic associations.Using data from the UK Biobank(n=457871),cross-sectional analyses demonstrated that osteoporosis was significantly associated with an increased risk of RCTs(adjusted OR[95%CI]=1.38[1.25–1.52]).A longitudinal analysis of a subset of patients(n=268117)over 11 years revealed that osteoporosis increased the risk of RCTs(adjusted HR[95%CI]=1.56[1.29–1.87]),which is notably varied between sexes in sex-stratified analysis.Causal inference methods,including propensity score matching,inverse probability weighting,causal random forest and survival random forest models further confirmed the causal effect,both from cross-sectional and longitudinal perspectives.
文摘[目的]通过系统评价和Meta分析,评估针刺及针药合用在改善干燥综合征患者口干和眼干症状方面的疗效。[方法]检索中国知网(CNKI)、万方数据库、维普网(VIP)、中国生物医学文献数据库(CBM)、PubMed、Cochrane Library、EMbase和Web of Science等数据库,收集截至2024年10月1日的针刺或针药合用治疗干燥综合征口干眼干症状的随机对照试验(RCT)文献。由两名研究者独立筛选文献、提取数据并评估偏倚风险,使用RevMan 5.4软件进行Meta分析,效应量采用标准化均数差(SMD)和优势比(OR),并评估研究间的异质性。[结果]本研究共纳入16项随机对照试验(RCT),涉及1319例干燥综合征患者。Meta分析显示,单纯针刺治疗与对照组相比差异无统计学意义[OR=3.73,95%CI(0.42,33.08),P=0.24],而针药合用治疗显示出明显的临床疗效优势[OR=3.60,95%CI(2.53,5.11),P<0.05]。在客观生物学指标方面,针刺治疗能显著提高患者唾液流率[MD=1.98,95%CI(0.20,3.75),P<0.05],针药合用治疗同样能显著提高患者唾液流率[MD=0.25,95%CI(0.03,0.47),P<0.05]。Schirmer测试结果表明,针药合用治疗能有效改善干燥综合征患者的泪液分泌[MD=1.47,95%CI(0.54,2.40),P<0.05]。但存在异质性,经治疗时长(>4周/≤4周)和干预方案(纯针刺/针药合用)的亚组分析后,异质性仍高于50%,提示潜在异质性来源可能涉及操作者技术差异、穴位配伍特异性及受试人群基线特征等因素。在症状评估维度,治疗组显著降低中医证候积分[SMD=-1.29,95%CI(-1.97,-0.61),Z=-3.74,P<0.05]和ESSPRI评分[SMD=-1.73,95%CI(-2.51,-0.95),Z=-4.34,P<0.05],尽管两者异质性分别达84.90%和90%,但敏感性分析证实结果稳健。所有异质性大的结局指标采用随机效应模型,异质性来源的系统分析表明,操作者资质、干预方案细节(如穴位选择、针刺频数)及疗效评估时点差异可能是影响研究间异质性的关键因素。[结论]针刺及针药合用治疗显著改善了干燥综合征患者的临床疗效、唾液流率、Schirmer测试、中医证候积分及患者汇报指数(ESSPRI)评分,且安全性良好。未来需要更多大规模、高质量的随机对照试验,以进一步验证针刺的长期疗效并探讨不同针刺方案的具体作用机制。
文摘基于严格设计随机对照试验（RCTs）的直接比较（direct comparison）或称为头对头比较（head to head comparison）的系统评价,已被公认为是评价干预措施疗效的最高级别证据,称之为传统系统评价.但是,如果想进行一个系统评价,目的是比较两种干预措施A vs B的效果,但目前的RCTs没有两者的直接比较研究,却都有同干预措施C的比较（即A vs C和B vs C）,此时,可以将C作为公共比较组,借助间接比较方法得出A vs B的效果,或者虽然有直接比较研究证据,但这些研究数量较少或质量较低,此时也可以用间接比较证据进行补充.
