中医药治疗乳腺增生症随机对照临床试验设计质量评价  

Design Quality Evaluation in Randomized Controlled Clinical Trials of Chinese Medicine Treatment of Cyclomastopathy

作　　者：艾艳珂[1] 王鑫[1] 白文静[1] 吴东宁[1] 何丽云[1] 

机构地区：[1]中国中医科学院中医临床基础医学研究所、北京市东城区东直门内南小街16号,100700

出　　处：《中医杂志》2015年第10期847-850,共4页Journal of Traditional Chinese Medicine

基　　金：国家中医药管理局中医药行业科研专项(201307001)

摘　　要：目的评价中医药治疗乳腺增生症随机对照临床试验的设计质量。方法收集2009年1月至2013年12月中国期刊全文数据库、万方数据库、维普数据库中中医药治疗乳腺增生症随机对照临床试验文献,从伦理设计、方法学设计、医学设计和管理设计4个方面对临床试验设计进行评价。结果共纳入文献248篇。25篇(10.1%)在研究设计时考虑受试者签署知情同意书,全部文献均未说明研究方案是否经过伦理委员会批准后执行。16篇(6.5%)文献介绍了具体的随机方法,1篇(0.4%)说明使用不透光信封法进行随机分配隐匿;6篇(2.4%)报告采用单盲法,6篇(2.4%)报告采用双盲法;全部研究均无明确的研究假设,亦未说明样本量计算的依据。130篇(52.4%)有较明确的诊断标准,40篇(16.1%)有纳入标准和排除标准;7篇(2.8%)文献有合并用药规定,全部研究均未考虑治疗依从性的计算方法及对依从性低的病例的统计分析处理方法;246篇(99.2%)采用复合疗效指标,51篇(20.6%)报告安全性评价结果,1篇(0.4%)说明结局指标测量时间;29篇(11.7%)文献报告了随访。所有研究均未考虑管理设计。结论中医药治疗乳腺增生症的随机对照临床试验设计质量有待提高,需加强多学科合作。Objective To evaluate the design quality of randomized controlled clinical trial of Chinese Medicine treatment of cyclomastopathy. Methods All published research articles about randomized controlled clinical trial of Chinese Medicine treatment of cyclomastopathy from Chinese Journal Full-Text Database, Wan Fang Data, and Vip Database from January of 2009 to December of 2013 were reviewed. The clinical trial design was evaluated from the aspects of ethics design, methodology design, medicine design and management design. Results There were 248 published research articles in total. In 25 papers （10. 1% ）, informed consent was considered to be signed by subjects when a study was designed. All 248 papers did not show whether the research scheme was approved by an ethics committee before it was carried out. Sixteen papers （6. 5% ） described the random methods, among them only 1 paper （0.4%） mentioned that random allocation concealment by opaque envelopes was used. Six papers （2. 4% ） reported to adopt single blind method, while 6 papers described to use double blind method. Neither specific research hypothesis nor basis of calculating sample size was found in the 248 papers. 130 papers （52. 4% ） presented definite diagnostic criteria, and 40 papers （ 16. 1% ） provided inclusive and exclusive criteria. Only 7 papers （ 2. 8% ） contained contents of combined medication. All papers did not show calculating method of treatment compliance and statistical method of poor compliance cases. 246 papers （99.2%） adopted composite effect index. 51 papers （20. 6% ） reported safety evaluation results. One paper （0. 4% ） illustrated the time for outcome measurements. 29 papers （ 11.7% ） reported follow-ups. Management design was not considered in all the papers. Conclusion The design quality of randomized controlled clinical trials of Chinese Medicine of treatment of cyclomastopathy should be improved. Multidisciplinary cooperation should be strengthened.

关 键 词：乳腺增生症 中医药治疗 随机对照试验 临床试验设计 质量评价 

分 类 号：R269[医药卫生—中西医结合]