目的 基于中醫(yī)藥特點和團(tuán)隊前期發(fā)表的《中成藥全生命周期價值評估核心指標(biāo)專家共識》的工作基礎(chǔ),定量化開展中成藥上市后價值評估。方法 使用德爾菲專家咨詢法結(jié)合層次分析法,通過26位專家,2輪咨詢,確定上市后中成藥價值評估指標(biāo)的權(quán)重。結(jié)果 2輪專家積極系數(shù)為88.46%、100%,權(quán)威程度為0.86、0.84,Kendall協(xié)調(diào)系數(shù)為0.231、0.234、各指標(biāo)間變異系數(shù)為0.071~0.262;最終形成定量化的包括7個評估維度51個評估指的中成藥上市后價值評估指標(biāo)體系,權(quán)重分別為“安全性及風(fēng)險管理32.42%”“有效性25.65%”“藥品質(zhì)量15.62%”“可及性9.21%”“適宜性7.71%”“創(chuàng)新性5.53%”和“成本3.85%”。結(jié)論 不僅進(jìn)一步明確了上市后中成藥價值評估的核心要素,也為精準(zhǔn)評價不同中成藥的價值內(nèi)涵及優(yōu)勢提供有效支持。

Objective Based on the characteristics of traditional Chinese medicine(TCM) and the expert consensus on the core indicators of the evaluation of the whole life Cycle Value of proprietary Chinese medicine(PCM) published by the team, the postmarket value evaluation of proprietary Chinese medicine was quantitatively carried out.Methods The weight of the value evaluation index of PCM after listing was determined by using Delphi expert consultation method combined with analytic hierarchy process(AHP) through 26 experts and two rounds of consultation.Results Expert positive coefficient, authority degree and Kendall coordination coefficient were 88.46% and 100%, 0.86 and 0.84, 0.231 and 0.234, respectively, and the coefficient of variation among each index ranged from 0.071 to 0.262. Finally, a quantitative value evaluation index system including seven evaluation dimensions and 51 evaluation indexes was formed after the listing of proprietary Chinese medicines. Weights respectively as "32.42% security and risk management", "effectiveness 25.65%", "15.62% drug quality", "9.21% accessibility" and "7.71% suitability", " 5.53%innovative" and "3.85% cost".Conclusion This study not only further clarified the core elements of value evaluation of proprietary Chinese medicines after listing, but also provided effective support for accurate evaluation of the value connotation and advantages of different proprietary Chinese medicines.

R951

首都醫(yī)科大學(xué)醫(yī)療保障研究院開放性課題(YB2022B10); 中央級公益性科研院所基本科研業(yè)務(wù)費專項資金(ZZ13-YQ-076)