中医药大规模随机对照临床试验的病例募集

Case recruitment in large-scale clinical trials of traditional Chinese medicine

大型临床试验募集的病例在质和量上都有很严格的要求,募集工作的顺利与否关乎整个试验的成败。本文旨在以国家“十五”攻关课题“芪参益气滴丸对心肌梗死二级预防的临床试验研究”为主线,探讨在大样本、多中心临床试验病例募集工作中的主要困难及相应的解决办法。

Case recruitment of large-scale clinical trials should be strictly checked in quality and quantity for it is the key to clinical trial. This study discusses the main difficulties and countermeasures in the case recruitment of large sample, multi-center clinical trials according to the national research project ＂Myocardial Infarction Secondary Prevention Study in Traditional Chinese Medicine＂.