构建质子泵抑制剂超说明书用药临床综合评价方法

Establishment of Comprehensive Clinical Evaluation Method for Off-Label Medication of Proton Pump Inhibitor

目的:建立质子泵抑制剂(PPI)超说明书用药临床综合评价方法,为PPI超说明书用药相关政策的制定提供参考。方法:基于多准则决策分析,利用文献调查法、德尔菲法、层次分析法和真实世界数据研究,建立PPI超说明书临床综合评价方法。结果:通过主题遴选和评价维度确立、证据评估、价值量化、评审与应用4个过程开展PPI超说明书用药临床综合评价,并以8种PPI用于预防急性黏膜病变为例进行实证研究,证实其可行性。结论:以多准则决策分析为基础的PPI超说明书用药临床综合评价方法能客观衡量多个药品间的优劣,为国家医保、国家基本药物、国家集中带量采购等相关政策的制定,以及优化医疗机构药品使用结构、提升资源配置效率提供参考。

OBJECTIVE:To establish a comprehensive clinical evaluation method for off-label medication of proton pump inhibitor(PPI),so as to provide reference for the formulation of policies related to the off-label medication of PPI.METHODS:Based on multi-criteria decision analysis,a comprehensive clinical evaluation method for off-label medication of PPI was established by using literature survey method,Delphi method,analytic hierarchical process and real-world data study.RESULTS:A comprehensive clinical evaluation for off-label medication of PPI was conducted through four processes:topic selection and evaluation dimension establishment,evidence assessment,value quantification,review and application.An empirical study with 8 kinds of PPI for the prevention of acute mucosal lesions was conducted to confirm its feasibility.CONCLUSIONS:The clinical comprehensive evaluation method for off-label medication of PPI based on multi-criteria decision analysis can objectively measure the advantages and disadvantages among various drugs,so as to provide reference for the formulation of relevant policies such as national health insurance,national essential drugs and national centralized volume-based procurement,as well as optimize the structure of drug application in medical institutions and improve the efficiency of resource allocation.