《中国中西医结合杂志》刊载中医药随机对照试验报告质量的研究  

Quality evaluation of randomized controlled clinical trials in Chinese Journal of Integrated Traditional and Western Medicine

作　　者：张明妍[1] 杨丰文[1] 李越[1] 刘玉[1] 赵梦瑜[1] 郑文科[1] 张俊华[1] 

机构地区：[1]天津中医药大学循证医学中心,天津300193

出　　处：《中国循证医学杂志》2017年第3期357-363,共7页Chinese Journal of Evidence-based Medicine

基　　金：国家自然科学基金(编号:81473544;81473544);教育部新世纪优秀人才专项资金(编号:NCET-13-0936)

摘　　要：目的评价《中国中西医结合杂志》刊登的中医药临床随机对照试验(RCT)的质量,并分析其变化。方法计算机检索CNKI数据库,查找《中国中西医结合杂志》2014年刊载的RCT。以CONSORT 2010清单评价纳入RCT的报告质量,同时分析其方法学质量及伦理学要求执行情况,并与2004年同类研究对比。结果共纳入80个RCT。干预措施排前3位的依次为中成药、汤剂、针灸。纳入RCT的条目报告符合率>80%的条目有摘要、受试者、随机序列、知情同意;条目报告符合率50%~80%的有引言、干预措施、危害、资助;其余条目报告符合率<50%。其中,文题、试验设计、结局指标、样本量、随机方法类型、分配隐藏、盲法、纳入分析的例数、结局与估计值、推广性、解释、试验注册与试验方案13个条目的报告符合率<10%。与2004年对比,报告质量、方法学质量、伦理学报告均有提高。在摘要结构化、背景和目的阐释、受试者纳入、不良反应、中医药干预措施质量控制标准、中医药诊断评估标准、随访、资助、伦理审批和知情同意方面进步显著;在随机设计类型、分配隐藏、随机化实施、样本量计算、盲法、意向性分析方面进步较小。但是,流程图的使用一直缺如。结论《中国中西医结合杂志》临床随机对照试验报告质量、方法学质量及伦理学要求执行较以往有进步,但试验设计、结局指标、样本量、随机化、盲法、试验注册及流程图的使用仍需进一步提高。Objective To evaluate the quality of randomized controlled trials （RCTs） of traditional Chinese medicine published in Chinese Journal of Integrated Traditional and Western Medicine, and to analyze changes. Methods We searched CNKI to collect RCTs published in Chinese Journal of Integrated Traditional and Western Medicine （CJITWM） in 2014. Reporting quality of RCTs was evaluated by using CONSORT 2010 checklist, the methodological quality and ethics requirements were also analyzed. The changes of quality was also analyzed by comparing with those of 2004. Results A total of 80 RCTs were included. The top three interventions were Chinese patent medicine, decoction, acupuncture. Items with high reporting rate （〉80%） included abstract, participants, randomization sequences and informed consent. Items with reporting rate of 50% to 80% including introduction, interventions, harms and funding, and others were all less than 50%. Among them, the reporting quality of title, trial design, outcomes, sample size, type of randomization, allocation concealment, blinding, numbers analyzed, outcomes and estimation, generalizability, interpretation, registration and protocol was less than 10%. Compared with those of 2004, the quality of reporting, methodology, and ethics has all increased. Significant progress was made in items of structured summary, background and objectives, collecting participants, adverse reactions, quality control standards of TCM interventions, diagnostic evaluation criteria of TCM, follow-up, funding, ethical approval and informed consent. But small progress was made in randomization, allocation concealment and implementation, sample size, blinding and ITT. Therehas been no participant flow. Conclusion The quality of reporting, methodology, and ethics of RCTs published in Chinese Journal of Integrated Traditional and Western Medicine have made some progress, however, trial design, outcomes selection, estimation of sample size, randomization, blinding, registration and participant flow are still

关 键 词：中医药 随机对照试验 报告质量评价 CONSORT 

分 类 号：R28[医药卫生—中药学] G353.1[医药卫生—中医学]