[关键词]
[摘要]
目的 对我国已上市的3种用于慢性阻塞性肺疾病(COPD)维持治疗的三联吸入制剂进行临床综合评价,为医疗机构遴选药品、优化用药目录以及合理使用提供参考。方法 收集并整理布地格福吸入气雾剂、倍氯福格吸入气雾剂、氟替美维吸入粉雾剂相关的临床应用指南、专家共识、药品说明书、药品注册资料以及文献资料,依据《中国医疗机构药品评价与遴选快速指南(第三版)》中有效性、安全性、药学特性、经济性、其他属性5个维度进行量化综合评价。结果 3种三联吸入制剂的5个维度评分从高到低依次为布地格福吸入气雾剂(80.1分)、氟替美维吸入粉雾剂(78.3分)、倍氯福格吸入气雾剂(76.7分)。在经济性、安全性2个维度中,布地格福吸入气雾剂得分均最高,氟替美维在药学特性和有效性2个维度得分最高。结论 3种三联吸入制剂均为强推荐,用于COPD维持治疗时表现出良好的临床效用,布地格福吸入气雾剂在综合评价中更具优势。
[Key word]
[Abstract]
Objective A comprehensive clinical evaluation was conducted on the three triple-inhalation formulations currently marketed in China for the maintenance treatment of chronic obstructive pulmonary disease (COPD), aiming to provide a reference for healthcare institutions in drug selection, formulary optimization, and rational clinical use. Methods Collect and organize clinical practice guidelines, expert consensus documents, package inserts, drug registration materials, and literature related to Budesonide/Glycopyrronium/Formoterol Inhalation Aerosol, Beclomethasone/Formoterol/Glycopyrronium Inhalation Aerosol, and Fluticasone Furoate/Umeclidinium/Vilanterol Inhalation Powder. Conduct a comprehensive quantitative evaluation based on the five dimensions outlined in the Chinese Medical Institution Drug Evaluation and Selection Quick Guide (Third Edition): pharmaceutical properties, efficacy, safety, economic attributes, and other characteristics. Results The five-dimensional scores of the three tripleinhalation formulations, ranked from highest to lowest, are Budesonide/Glycopyrronium/Formoterol Inhalation Aerosol (80.1 points), Fluticasone Furoate/Umeclidinium/Vilanterol Inhalation Powder (78.3 points), and Beclomethasone/Formoterol/Glycopyrronium Inhalation Aerosol (76.7 points). In the two dimensions of economic efficiency and safety, Budesonide/Glycopyrronium/Formoterol Inhalation Aerosol scored the highest, while Fluticasone Furoate/Umeclidinium/Vilanterol performed best in the dimensions of pharmaceutical properties and efficacy. Conclusion All three triple-inhalation formulations are strongly recommended, as they demonstrate favorable clinical utility in the maintenance treatment of COPD. Among them, Budesonide/Glycopyrronium/Formoterol Inhalation Aerosol shows the greatest overall advantage in the comprehensive evaluation.
[中图分类号]
R974
[基金项目]
老年慢病患者合理用药重点实验室(201509010012)