目的分析中成药治疗脑小血管病相关认知功能障碍(vascular cognitive impairment caused by cerebral small vessel disease,CSVD-VCI)的随机对照试验(RCT)的结局指标应用情况,并针对存在的问题提供建议。方法全面检索3个英文数据库、4...目的分析中成药治疗脑小血管病相关认知功能障碍(vascular cognitive impairment caused by cerebral small vessel disease,CSVD-VCI)的随机对照试验(RCT)的结局指标应用情况,并针对存在的问题提供建议。方法全面检索3个英文数据库、4个中文数据库和2个临床研究线上注册网站,筛选近10年符合本研究纳入标准的RCT,提取信息,评估偏倚风险,分析其结局指标。结果检索获文献10455篇,剔重后余8681篇,筛选后纳入30篇RCT报告,偏倚风险总体较高。其结局指标分为8大类,即临床症状指标、神经影像学指标、神经电生理指标、血液生化学指标、血液流变学指标、中医证候积分、临床有效率、安全性指标。其中,纳入RCT的报告频次和报告率最高的是临床症状指标;有2个RCT以中医证候积分为结局指标,并报告相应评价标准。结论中成药治疗CSVD-VCI的RCT结局指标应用目前存在临床上的合理性和局限性,且在研究设计层面结局指标主次不明、设盲不足、报告不详,影响了中成药治疗CSVD-VCI的RCT质量。建议本领域研究者在未来完善顶层设计,同时积极开展本领域核心指标集的筹建工作,进而提升临床研究质量。展开更多
In recent years,the real-world studies(RWS)have attracted extensive attention,and the realworld evidence(RwE)has been acceptedto support the drug development in Chinaand abroad.However,there is stll a lack of standard...In recent years,the real-world studies(RWS)have attracted extensive attention,and the realworld evidence(RwE)has been acceptedto support the drug development in Chinaand abroad.However,there is stll a lack of standards for the evaluation of the quality of RWE.It is necessary to formulate a quality evaluation and reporting specification for RWE especially in traditional Chinese medicine(TCM).To this end,under the guidance of China Association of Chinese Medicine,the Quality Evaluation and Reporting Specification for Real-World Evidence of Traditional Chinese Medicine(QUERST)Group,including 24 experts(clinical epidemiologists,clinicians,pharmacologists,ethical reviewerand statisticians),was established to develop the specification.This specification contains the listing of classification of RWS design and RWE,the general principles and methods of RWE quality evaluation(26 tools or scales),25 types of bias in RWS,the special considerations in evaluating the quality of RWE of TCM,and the 19 reporting standards of RWE.This specification aims to propose the quality evaluation principles and key points of RWE,and provide guidance for the proper use of RWE in the development of TCM new drugs.展开更多
文摘目的分析中成药治疗脑小血管病相关认知功能障碍(vascular cognitive impairment caused by cerebral small vessel disease,CSVD-VCI)的随机对照试验(RCT)的结局指标应用情况,并针对存在的问题提供建议。方法全面检索3个英文数据库、4个中文数据库和2个临床研究线上注册网站,筛选近10年符合本研究纳入标准的RCT,提取信息,评估偏倚风险,分析其结局指标。结果检索获文献10455篇,剔重后余8681篇,筛选后纳入30篇RCT报告,偏倚风险总体较高。其结局指标分为8大类,即临床症状指标、神经影像学指标、神经电生理指标、血液生化学指标、血液流变学指标、中医证候积分、临床有效率、安全性指标。其中,纳入RCT的报告频次和报告率最高的是临床症状指标;有2个RCT以中医证候积分为结局指标,并报告相应评价标准。结论中成药治疗CSVD-VCI的RCT结局指标应用目前存在临床上的合理性和局限性,且在研究设计层面结局指标主次不明、设盲不足、报告不详,影响了中成药治疗CSVD-VCI的RCT质量。建议本领域研究者在未来完善顶层设计,同时积极开展本领域核心指标集的筹建工作,进而提升临床研究质量。
基金the National Natural Science Foundation of China(No.82074282)NMPA Key Laboratory for Clinical Research and Evaluation of Traditional Chinese Medicine。
文摘In recent years,the real-world studies(RWS)have attracted extensive attention,and the realworld evidence(RwE)has been acceptedto support the drug development in Chinaand abroad.However,there is stll a lack of standards for the evaluation of the quality of RWE.It is necessary to formulate a quality evaluation and reporting specification for RWE especially in traditional Chinese medicine(TCM).To this end,under the guidance of China Association of Chinese Medicine,the Quality Evaluation and Reporting Specification for Real-World Evidence of Traditional Chinese Medicine(QUERST)Group,including 24 experts(clinical epidemiologists,clinicians,pharmacologists,ethical reviewerand statisticians),was established to develop the specification.This specification contains the listing of classification of RWS design and RWE,the general principles and methods of RWE quality evaluation(26 tools or scales),25 types of bias in RWS,the special considerations in evaluating the quality of RWE of TCM,and the 19 reporting standards of RWE.This specification aims to propose the quality evaluation principles and key points of RWE,and provide guidance for the proper use of RWE in the development of TCM new drugs.
