采用EVIDEM框架开展中成药临床综合评价

Clinical comprehensive evaluation of Chinese patent medicine based on EVIDEM

中成药临床综合评价是当前中医药评价领域内的一个重要方向,对中医药行业的发展有着积极推动作用。中成药临床综合评价体系的建立,有助于在证据和价值基础上对同类别不同中成药、不同剂型和规格中成药,以及不同生产厂家中成药的“临床综合价值”进行综合评估。建立科学合理的中成药综合评价指标体系是保证其发挥临床价值的重要前提。然而目前,尚未见到对中成药临床综合评价公认的系统论述以及可借鉴的方法学体系。由国际研究团队研发的证据与价值:对决策的影响(the evidence and value:impact on decision-making,EVIDEM)框架被用于评估医疗干预措施的综合价值。EVIDEM框架围绕证据与价值观,基于多准则决策分析(multi-criteria decision analysis,MCDA)模型和卫生技术评估(health technology assessment,HTA),为科学决策提供了方法学工具。该文在团队目前正在开展的EVIDEM实证研究基础上,提出基于EVIDEM框架的中成药临床综合评价主要包括4个环节、7个模块、10个步骤。通过该研究的应用探索,期望为未来中医药领域开展中成药临床综合评价提供方法借鉴和实践经验。

The clinical comprehensive evaluation of Chinese patent medicine is an important direction in the evaluation of traditional Chinese medicine(TCM),which positively promotes the development of TCM industry.The evaluation system of Chinese patent medicine is helpful to comprehensively evaluate the clinical value of different Chinese patent medicine in the same category,different dosage forms,and specifications,from different manufacturers on the basis of evidence and value.The establishment of a scientific and reasonable comprehensive evaluation index system for Chinese patent medicine is an important prerequisite to ensure clinical value.However,there has been neither a recognized systematic review on the clinical comprehensive evaluation of Chinese patent medicine nor a methodological system used for reference.The evidence and value:impact on decision-making(EVIDEM),developed by the international research team,is used to evaluate the comprehensive value of medical interventions.EVIDEM provides a methodological tool for scientific decision-making to evaluate evidence and value for health technologies on the basis of the multi-criteria decision analysis(MCDA)model and health technology assessment(HTA).Based on the ongoing EVIDEM research,the present study put forward that EVIDEM-based clinical comprehensive evaluation of Chinese patent medicine consisted of four aspects,seven modules,and ten steps,which is expected to references and practical experience for the follow-up comprehensive evaluation of Chinese patent medicine in the TCM field.