0期临床试验与中药注射剂上市后临床安全性再评价  

Phase 0 clinical trials and post-marketed re-evaluation of clinical safety in injection of traditional Chinese medicine

作　　者：谢雁鸣[1] 魏戌[1] 张占军[2] 王永炎[1] 

机构地区：[1]中国中医科学院中医临床基础医学研究所,北京100700 [2]北京师范大学认知神经科学与学习国家重点实验室,北京100875

出　　处：《中国中药杂志》2011年第20期2874-2876,共3页China Journal of Chinese Materia Medica

基　　金：国家"重大新药创制"科技重大专项(2009ZX09502-030);中国中医科学院自主选题研究项目(Z0133)

摘　　要：中药注射剂不良反应时有发生,临床安全性问题亟待解决,需要进行上市后临床安全性再评价,过敏反应是不良反应评价的主要内容之一。对含有毒药材的中成药、有安全问题的中药注射剂需要开展0期临床试验,0期临床试验使用"微剂量"研究周期内收集必要的药物安全性及药代动力学试验数据,微剂量可以反映中药注射剂的致敏情况。0期临床试验为上市后中药注射剂的安全性再评价提供了新的方法,是否进行0期临床试验,应依据品种是否有安全性问题而定,中药注射剂初始剂量以及样本含量的确定是研究设计的关键问题。Adverse drug reaction induced by injection of traditional Chinese medicine（TCM） often occurs. Post-marketed reevaluation of clinical safety in injection of TCM is indispensable, in order to solve the clinical safety problems. It is necessary to conduct Phase 0 clinical trials for containing toxic medicine and injection of TCM. Phase 0 clinical trials, involving very limited human exposure, and using microdose of drugs, are intended to collect the necessary safety and pharmacokinetic data in limited period. Micredose reflects allergies of injection of TCM. Phase 0 clinical trials provide a new method for pest-marketed re-evaluation of safety in injection of TCM. Its use depends on whether there is a safety problem for injection of TCM, and the determination of initial dose and sample size are key questions in study design.

关 键 词：0期临床试验 微剂量 中药注射剂 上市后临床安全性再评价 

分 类 号：R286[医药卫生—中药学]