经典名方类中成药上市后精确临床定位的探索与实践:以复方阿胶浆为例

Exploration and practice of post-marketing clinical positioning of classic Chinese patent medicine: a case study of Fufang E’jiao Jiang

经典名方类中成药上市后临床定位的研究是药品上市后再评价的重要环节,精准的临床定位有利于最大限度发挥其临床疗效和临床价值。由于经典名方类中成药上市前临床定位宽泛,疗效机制研究缺乏系统性,因此难以提出有别于化学药的临床定位,从而限制了经典名方类中成药进一步做大做强。本文仅以复方阿胶浆为例探讨经典名方类中成药上市后临床定位的研究,首先通过文献研究筛选其优势病种,结合临床需求,选取特定人群作为研究对象。然后围绕临床问题根据PICOS原则进行临床设计以细化临床定位。投入临床应用后,一方面要注意临床证据评价以优化证据,另一方面也应重视临床价值评估,寻找经典名方类中成药二次开发切入点,促进中药新药研发。笔者结合课题组前期开展的系列研究,探索性提出经典名方类中成药上市后临床定位研究流程,并根据临床实践中发现的问题,提出深入研究的切入点以及完善临床研究评价体系的设想,希望为将来上市后经典名方类中成药临床定位研究模式的建立提供参考。

The research on the post-marketing clinical positioning of classic Chinese patent medicines(CPM) is an important part of the post-marketing re-evaluation of drugs. Accurate clinical positioning is conducive to maximize its clinical efficacy and clinical value. Due to the wide pre-marketing clinical orientation of CPM and the lack of systematic research on the mechanism of curative effect, it is difficult to put forward a clinical orientation different from chemical drugs, which limits the further expansion and strength of CPM. In this paper, we took Fufang E’jiao Jiang as an example to discuss the research of clinical positioning of CPM after marketing. Firstly, we screened out the dominant diseases through literature research and selected the specific population as the research object according to the clinical needs. Then clinical design was conducted to refine the clinical positioning based on the clinical problems according to the principles of PICOS. After the CPM being put into clinical application, on the one hand, we should pay attention to the evaluation of clinical evidence to optimize the evidence;on the other hand, we should also pay attention to the evaluation of clinical value, looking for the entry point for the secondary development of CPM, so as to promote the research and development of new Chinese medicines. Combined with the series of studies carried out by the research group in the early stage, the author tentatively proposed the research process of clinical positioning of CPM after marketing. According to the problems found in clinical research practice, the author proposed the entry point of accurate clinical positioning in-depth research of CPM after marketing and the idea of improving the clinical research evaluation system. It is hoped this paper could provide reference for the establishment of clinical positioning research mode of CPM.