稳心颗粒治疗心房颤动的随机对照试验质量评价  

Quality assessment of randomized controlled trials on Wenxin granule for treatment of atrial fibrillation

作　　者：刘为民[1] 姜锐[2] 丁沙沙[2] 傅威[3] 王淑勤[3] 李雪[3] 康婧[1] 吴东宁[1] 刘波[1] 毛文超[1] 何丽云[1] 刘保延[4] 

机构地区：[1]中国中医科学院中医临床基础医学研究所,北京100700 [2]天津中医药大学,天津300193 [3]山东步长制药有限公司驻京办事处,北京100022 [4]中国中医科学院,北京100700

出　　处：《中国中药杂志》2012年第1期109-114,共6页China Journal of Chinese Materia Medica

基　　金：国家重点基础研究发展计划(973)项目(2006CB504601);国家科技支撑计划项目(2006BAI04A21-2)

摘　　要：目的:调查稳心颗粒治疗房颤随机对照试验(RCT)文献质量。方法:采用Jadad评分量表、CONSORT标准进行评价。结果:共检索到符合纳入标准的RCT文献66篇。采用Jadad量表评分,其中4分2篇,3分1篇,2分54篇,1分7篇,0分2篇。仅2篇文章描述采用随机数字表分组,无1例报道如何执行随机隐藏,1篇文章中提及盲法,文章中提及失访情况的有59篇(89.4%),按照CONSORT标准,仅6篇(9.1%)描述了如何产生随机序列,其中4篇(6.1%)为半随机,19篇(28.8%)有纳入标准,有6篇(9.1%)文章提及随访记录,51篇(77.3%)描写了不良事件,均未进行样本含量计算、意向性分析和分层分析,均未报道伦理审查和知情同意情况。结论:目前稳心颗粒治疗房颤的临床研究较多,在研究设计方法、文章报告全面性、质量等方面有待提高。Objective: To investigate the statement on randomized controlled trials on Wenxin granule for treatment of atrial fibrillation and to judge whether those trials could offer high quality evidence or not,thus improve design level and quality.Method: RCTs were searched from home and abroad about atrial fibrillation treated with Wenxin granule,which reported before October,2010.Jadad scale and CONSORT statement were used.Result: There were 66 RCTs retrieved that met inclusion criteria.Using Jadad rating scale,only 2 literatures gain score 4 and 1 literature gains score 3,54 literatures gain score 2,7 literatures gain score 1,2 literatures gain score 0.Only 2 literatures described random number table as the method of grouping.None of the RCTs was reported the allocation concealment.Only 1 literature was used blinding.Fifty-nine literatures were mentioned the lost to follow-up conditions.According to the CONSORT standards,only six literatures(9.1%) mentioned the method of generating the random sequence.Four literatures(6.1%) were quasi-random.Nineteen literatures(28.8%) had inclusion criteria.Six literatures(9.1%) had the follow-up record.Fifty one literatures(77.3%) described the adverse events.None had the estimation of the sample size,intention-to-treat analysis and stratified analysis.None had the ethical approval or informed consent.Conclusion: The quality of clinical trials of Wenxin granule in treating atrial fibrillation needs to be improved.

关 键 词：稳心颗粒 心房颤动 随机对照试验 质量评价 

分 类 号：R259[医药卫生—中西医结合]