构建低分子肝素在防治复发性流产应用中的药品临床综合评价体系

Establishment of a Clinical Comprehensive Evaluation System for Low Molecular Weight Heparin in the Prevention and Treatment of Recurrent Spontaneous Abortion

关键词:  低分子肝素  复发性流产  药品临床综合评价  多准则决策分析  层次分析法

Key words:  low molecular weight heparin  recurrent spontaneous abortion  clinical comprehensive evaluation of drugs  multi-criteria decision analysis  analytic hierarchy process

摘要:

目的 从合理用药视角出发，构建低分子肝素（LMWH）在防治复发性流产（RSA）应用中的药品临床综合评价体系，为临床用药选择、药品管理决策提供方法学支撑。方法 以 LMWH 防治 RSA 为研究案例，采用多准则决策分析（MCDA），结合文献调研、27 名专家咨询评分结果及预设指标池，完成评价流程梳理、评估框架构建、指标权重确定与赋值标准制定，最终计算综合评分。结果 药品临床综合评价流程包含决策问题确定、评估框架制定、指标绩效获得、指标赋值标准确定、综合得分计算 5 个核心步骤；评估框架涵盖有效性、安全性、经济性、创新性、适宜性、可及性 5 个一级维度及 19 个二级指标，其中有效性（权重 33.87%）、安全性（权重 34.85%）为核心维度，且 27 名专家对二者 “非常重要” 认同率均达 100%；综合评价显示，低分子肝素钠综合评分最高（86.30 分），达肝素综合评分最低（69.98 分）。结论 本研究建立的评价体系方法学严谨，可推广至妊娠期专科用药或其他慢性病治疗药物的临床综合评价，为医院药师开展相关工作提供参考。

Abstract:

OBJECTIVE To establish a clinical comprehensive evaluation system for low molecular weight heparin (LMWH) in the prevention and treatment of recurrent spontaneous abortion (RSA) from the perspective of rational drug use, providing methodological support for clinical drug selection and pharmaceutical management decisions. METHODS Using the application of LMWH in RSA prevention and treatment as a case study, multi-criteria decision analysis (MCDA) was employed, combined with literature review, scoring results from 27 experts, and a preset indicator pool. The evaluation process was clarified, the evaluation framework was constructed, indicator weights were determined, assignment criteria were established, and comprehensive scores were calculated. RESULTS The clinical comprehensive evaluation process for drugs included five core steps: determination of the decision-making problem, formulation of the evaluation framework, acquisition of indicator performance, determination of indicator assignment criteria, and calculation of comprehensive scores. The evaluation framework covered five primary dimensions (effectiveness, safety, economy, suitability, and accessibility) and 19 secondary indicators. Among these, effectiveness (weight 33.87%) and safety (weight 34.85%) were identified as the core dimensions, with 100% of the 27 experts agreeing that both were "very important." The comprehensive evaluation showed that low molecular weight heparin sodium had the highest comprehensive score (86.30 points), while dalteparin had the lowest (69.98 points). CONCLUSION The evaluation system established in this study is methodologically rigorous and can be extended to the clinical comprehensive evaluation of specialized drugs during pregnancy or other drugs for chronic diseases, providing a reference for hospital pharmacists in related work.