基于强化瓮过程方法对中药上市后安全性结局与临床疗程相关性探讨

Discussion about relativity between post-marketed safety outcome and treatment course of traditional Chinese medicine drugs on basis of reinforced urn processes

该文借鉴国内、外的最新研究进展,结合作者的科研实践,基于理论探讨与模拟试验,初步讨论了应用强化瓮过程方法(RUPs)在中药安全性评价中探讨安全性结局与临床疗程相关性的可能,并扼要介绍了RUPs方法应用的步骤、要点等,拓展了RUPs方法的应用范围,使其不仅应用于I期临床人体耐受性试验,也为中药上市后在广泛应用条件下更为准确的估计针对某一种(类)特定安全性结局所允许的最长疗程(最大药物暴露程度)提供了可能,为中药安全性评价研究提供了一种新的方法。

Based on relevant research and development, the possibility of applying the reinforced urn processes （RUPs） statis- tical approach to traditional Chinese medicine（TCM） drugs safety research is discussed in this paper, primarily through theoretical dis- cussion and simulations. Also introduced are work flows and the key points for the application of the RUPs approach. This potentially new approach has recently been applied to the target estimation of phase I human tolerance clinical trials. A traditional RUPs approach has also been widely applied in the precise point-estimation of allowable longest treatment courses, according to the particular safety outcomes of post-marketed TCM.