钾离子竞争性酸阻滞剂的临床综合评价

Clinical comprehensive evaluation of potassium-competitive acid blockers

目的对我国已上市的3种钾离子竞争性酸阻滞剂(P-CAB)进行临床综合评价,为医疗机构遴选新药、优化用药目录以及合理使用该类药物提供参考。方法收集并整理富马酸伏诺拉生片、替戈拉生片、盐酸凯普拉生片相关的临床应用指南、专家共识、药品说明书、药品注册资料(包括Ⅲ期临床试验)以及PubMed、中国知网等数据库的Meta分析/系统综述等相关文献资料,依据《中国医疗机构药品评价与遴选快速指南(第二版)》中药学特性、有效性、安全性、经济性、其他属性5个维度对三者进行量化综合评价。结果3种P-CAB的5个维度评分从高到低依次为富马酸伏诺拉生片(81.8分)、替戈拉生片(75.7分)、盐酸凯普拉生片(75.6分)。在药学特性、有效性、经济性及其他属性4个维度中,富马酸伏诺拉生片得分均最高;而安全性得分稍低。结论3种P-CAB均为强推荐,表现出良好的临床效用;其中,富马酸伏诺拉生片在药学特性、有效性、经济性方面更有优势。

OBJECTIVE To conduct a clinical comprehensive evaluation of potassium-competitive acid blockers(P-CAB)and provide reference for medical institutions to select new drugs,optimize drug catalogs,and use such drugs reasonably.METHODS clinical application guidelines,expert consensus,drug instructions,drug registration data(including phaseⅢclinical trials),metaanalysis/systematic review of databases such as PubMed and CNKI related to Vonoprazan fumarate tablets,Tegorasen tablets,and Keverprazan hydrochloride tablets already on the market in China were collected and organized.Based on the Quick Guidelines for Drug Evaluation and Selection in Chinese Medical Institutions(Second Edition),a comprehensive evaluation of the three P-CAB drugs was conducted from five dimensions:pharmaceutical characteristics,efficacy,safety,economy,and the other property.RESULTS The five dimensions of the three P-CAB were ranked from high to low as follows:Vonoprazan fumarate tablets(81.8 points),Tegorasen tablets(75.7 points),and Keverprazan hydrochloride tablets(75.6 points).Among them,Vonoprazan fumarate tablets scored the highest in 4 dimensions of pharmaceutical properties,efficacy,economy,and the other property;but the safety score was slightly low.CONCLUSIONS The three types of P-CAB are comprehensively strongly recommended and demonstrated good clinical efficacy.Vonoprazan fumarate tablets have more advantages in terms of pharmaceutical properties,efficacy,and economy.