基于循证医学的我国基本药物目录遴选方法体系研究

Evidence-based research on the selection method system for China＇s essential medicine list

目的提出适合我国的基本药物目录遴选方法体系。方法收集并分析WHO、各国的基本药物目录遴选、调整技术文件以及循证医学、药物经济学评估、医保预算分析等相关研究文献，提出我国基本药物目录遴选的方法体系，并对该方法的可行性进行分析和实证。结果采用WHO所推荐的GRADE循证评价方法，对药物安全性、有效性进行评价，补充药物经济学评价，对药物经济效率全面评估，补充医保预算分析以确保基本药物的可支付性。该方法体系的理论已发展成熟，配套软件已开发成熟并应用。以浙江省糖尿病基本药物遴选为例进行实证，本方法具有较好的可行性。但医保等数据资料的共享尚存在壁垒，对科学遴选造成一定阻碍。结论目前基本药物遴选已具备较为完善的理论基础和方法工具，本研究提出的遴选方法体系具有一定的可操作性。建议决策者采用科学的方法遴选药物，促进数据资料的共享，从而提升基本药物目录的科学性和适用性。

Objective To find a selection method system appropriate for China＇s essential drug list. Methods Collection and analysis of technical paper literature on essential drug list developement, adjustment technical papers, and literature on evidence-based medicine, pharmacoeconomies evaluation, and medical insurance budget analysis from WHO and other countries. On such basis, a method system for selecting China＇s essential medicine list can be proposed, with its feasibility analyzed and demonstrated. Results The GRADE assessment proposed by WHO was used to evaluate the efficacy and safety of the drug ; the pharmacy economics evaluation is added to assess the economic efficiency ; these were aided by the pharmacoeconomics evaluation for a comprehensive evaluation of the pharmacoeeonomics of the drug in question, supplementing analysis of the medical insurance, and ensuring its affordahility of essential medicine so selected. The theory of this system is well developed, and supporting software ready for application. Examples in Zhejiang Province regarding essential medicine for diabetes have proved this method feasible. Data acquisition constitutes a major roadblock for scientific selection due to barriers against medical insurance data sharing. Conclusions Theoretic basis and method tools are fully available for essential medicine selection, and the selection method system as proposed in this study prove feasible to some extent. Decision makers are recommended to scientifically select the essential drugs, and to encourage data sharing, in order to make the list more scientific and pragmatic.