中药上市后安全性及有效性再评价临床试验设计要求

Design requirements for clinical trials on re-evaluation of safety and efficacy of post-marketed Chinese herbs

基于药物流行病学的中药上市后再评价是研究和收集在临床实际使用情况下的长期/广泛人群的安全性,由于中药的特殊性,有必要对某些中成药进行有效性再评价,确证上市后中药的有效性。在进行中药上市后再评价临床试验之前应首先明确研究目的,在病证结合的评价模式下选择适宜的设计类型。研究人群纳入比上市前临床试验更为宽泛,可以包含特殊人群等的药物监测,样本含量要符合统计学要求。常用的设计方法有队列研究、病例对照研究、巢式病例对照、实用性随机对照。

Re-evaluation of post-marketed based on pharmacoepidemiology is to study and collect clinical medicine safety in large population under practical applications for a long time. It is necessary to conduct re-evaluation of clinical effectiveness because of particularity of traditional Chinese medicine （TCM）. Right before carrying out clinical trials on re-evaluation of post-marketed TCM, we should determine the objective of the study and progress it in the assessment mode of combination of disease and syndrome. Specieal population, involving children and seniors who were excluded in pre-marketed clinical trial, were brought into drug monitoring. Sample size needs to comply with statistical requirement. We commonly use cohort study, case-control study, nested case-control, pragmatic randomized controlled trials.