Wei Xu, Zhang Zhanjun, Xie Yanming, Wang Yongyan
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China.
Zhongguo Zhong Yao Za Zhi. 2011 Oct;36(20):2874-6.
Adverse drug reaction induced by injection of traditional Chinese medicine(TCM) often occurs. Post-marketed re-evaluation 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. Microdose reflects allergies of injection of TCM. Phase 0 clinical trials provide a new method for post-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.
中药注射剂引起的药品不良反应屡有发生。为解决临床安全问题，对中药注射剂进行上市后临床安全性再评价不可或缺。对于含毒性药材的中药注射剂开展0期临床试验很有必要。0期临床试验涉及的人体暴露非常有限，使用微剂量药物，旨在在有限时间内收集必要的安全性和药代动力学数据。微剂量可反映中药注射剂的过敏情况。0期临床试验为中药注射剂上市后安全性再评价提供了一种新方法。其应用取决于中药注射剂是否存在安全问题，而初始剂量的确定和样本量的确定是研究设计中的关键问题。
