目的 構(gòu)建綜合中藥特點的中成藥臨床綜合評價指標(biāo)體系,探索中成藥臨床綜合評價路徑,為中成藥治療或干預(yù)疾病的臨床綜合價值判斷提供科學(xué)、可操作、可量化的評價工具,提高中成藥臨床合理用藥水平和藥事服務(wù)質(zhì)量。方法 采用文獻(xiàn)研究法,梳理研究中開展藥品臨床綜合評價的流程、維度和方法。構(gòu)建體現(xiàn)中成藥特點的中成藥臨床綜合評價理論框架,初步形成指標(biāo)池。通過德爾菲法對形成的指標(biāo)池進(jìn)行遴選和優(yōu)化,形成中成藥臨床綜合評價指標(biāo)體系。采用多準(zhǔn)則決策法探索構(gòu)建中成藥臨床綜合評價路徑。結(jié)果 通過文獻(xiàn)研究法和德爾菲法對指標(biāo)體系進(jìn)行確認(rèn)、遴選和優(yōu)化,最終形成包含7個一級指標(biāo)和39個二級指標(biāo)的中成藥臨床綜合評價指標(biāo)體系。參考國際藥物經(jīng)濟(jì)學(xué)與結(jié)果研究學(xué)會(ISPOR)發(fā)布的多準(zhǔn)則決策分析(MCDA)實踐指南,探索構(gòu)建中成藥臨床綜合評價路徑。結(jié)論 構(gòu)建的中成藥臨床綜合評價指標(biāo)體系層次分明、系統(tǒng)性和可操作性強(qiáng),在一級指標(biāo)及二級指標(biāo)中分別融入了中成藥特色指標(biāo),可量化評價中成藥的臨床價值,多維度、多層次、全面綜合的反映中成藥的臨床綜合價值。構(gòu)建的中成藥臨床綜合價值評價路徑能夠為相關(guān)研究開展提供指導(dǎo),具有一定的合理性和可行性。

Objective To construct a clinical comprehensive evaluation indicator system of Chinese patent medicine based on the characteristics of Chinese patent medicine and explore the evaluation path. To provide a scientific, operable and quantifiable evaluation tool for the clinical comprehensive value evaluation of Chinese patent medicine in disease treatment or intervention, and to improve the clinical rational drug use level and pharmaceutical service quality of Chinese patent medicine.Methods The literature research method was used to sort out the process, dimensions and methods of clinical comprehensive evaluation of drugs in the study. To construct a theoretical framework for clinical comprehensive evaluation of Chinese patent medicines that reflects the characteristics of Chinese patent medicines, and initially form an indicator pool. The index pool was selected and optimized by Delphi method to form a clinical comprehensive evaluation indicator system of Chinese patent medicine. The multi-criteria decisionmaking method was used to explore the construction of clinical comprehensive evaluation path of Chinese patent medicine.Results Through literature research and Delphi method, the indicator system was confirmed, selected and optimized, and finally a comprehensive clinical evaluation system of Chinese patent medicine containing seven first-level indicators and 39 second-level indicators was formed. Referring to the MCDA practice guide published by ISPOR, the clinical comprehensive evaluation path of Chinese patent medicine was explored.Conclusion The clinical comprehensive evaluation index system of Chinese patent medicine is clear, systematic and operable. The characteristic indexes of Chinese patent medicine are integrated into the first-level indexes and the second-level indexes respectively, which can quantitatively evaluate the clinical value of Chinese patent medicine and reflect the clinical comprehensive value of Chinese patent medicine in a multi-dimensional, multi-level and comprehensive way. The constructed clinical comprehensive value evaluation path of Chinese patent medicine can provide guidance for related research,which has certain rationality and feasibility.

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