基于《中国医疗机构药品评价与遴选快速指南（第二版）》的前蛋白转化酶枯草溶菌素9单克隆抗体临床综合评价

Clinical comprehensive evaluation of proprotein convertase subtilisin kexin 9 monoclonal antibodies based on the Quick Guideline for Drug Evaluation and Selection in Chinese Medical Institutions（the 2nd edition）

摘要

目的: 基于多维度评估方法,对前蛋白转化酶枯草溶菌素9（proprotein convertase subtilisin kex-in 9,PCSK9）单克隆抗体进行全面分析,为临床用药选择及医疗机构药物遴选提供参考依据。方法: 参考《中国医疗机构药品评价与遴选快速指南（第二版）》评价体系,对部分评分细则进行适当调整,从药学特性、有效性、安全性、经济性及其他属性5个方面,对国内已上市的6种PCSK9单克隆抗体进行量化评估,并根据得分结果确定推荐等级。结果: 量化评分结果从高到低排序分别为依洛尤单抗（79.31 分）、阿利西尤单抗(74.85 分）、托莱西单抗(73.86 分）、瑞卡西单抗(71.95 分）、昂戈瑞西单抗(70.9 分）、伊努西单抗(70.88分）。结论: 6 种 PCSK9 单克隆抗体均表现出良好的降脂疗效,均为强推荐。

Abstract

Objective: To conduct a comprehensive analysis of proprotein convertase subtilisin kexin 9 （PCSK9）monoclonal antibodies based on a multi-dimensional evaluation method,providing a reference for clinical medication selection and drug selection in medical institutions. Methods: Referring to the evaluation system in the Quick Guide for Drug Evaluation and Selection in Chinese Medical Institutions（the 2nd edition）,with appropriate adjustments to some scoring criteria,a quantitative assessment was conducted on six PCSK9 monoclonal antibodies available in the domestic market from five aspects：pharmaceutical characteristics,efficacy,safety,economy,and other attributes.The recommendation grades were determined based on the scoring results. Results: The quantitative scoring results,ranked from high to low,were as follows：evolocumab(79.31 points）,alirocumab(74.85 points）,tolersimab(73.86 points）,recaticimab(71.95 points）,ongericimab(70.9 points）,and ebronucimab （70. 88 points）. Conclusion: All six PCSK9 monoclonal antibodies demonstrated good lipid-lowering efficacy. Among them,evolocumab,alirocumab,and tolersimab are strongly recommended,while the others are weakly recommended.

关键词

前蛋白转化酶枯草溶菌素9单克隆抗体 / 药品遴选 / 依洛尤单抗 / 阿利西尤单抗 / 托莱西单抗 / 伊努西单抗 / 昂戈瑞西单抗 / 瑞卡西单抗

Key words

PCSK9 monoclonal antibody / drug selection / evolocumab / alirocumab / tafolecimab / ebro-nucimab / ongericimab / recaticimab

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基金资助

河北省中医药管理局科研计划资助项目（2020005;2025248）