摘要
目的:基于《中国医疗机构药品评价与遴选快速指南(第二版)》对全球首个葡萄糖激酶激活剂多格列艾汀进行快速遴选评价,为医疗机构合理引进药物提供参考。方法:应用《中国医疗机构药品评价与遴选快速指南(第二版)》的评价方法,对多格列艾汀的药学特性、有效性、安全性、经济性以及其他属性(包括医保情况、基本药物情况、贮藏条件、药品有效期、全球使用情况和企业信誉度)开展临床综合评价。结果:多格列艾汀的药学特性得分为25分,有效性得分为15分,安全性得分为18.5分,经济性得分为8.2分,其他属性得分为3.5分,总分为70.2分。该药作用机制独特,安全性和经济性良好。但仍需更多的临床研究证据提高其指南推荐地位。该药的遴选评价推荐级别为“强推荐”。结论:本次卫生技术评估可为医疗机构开展新药遴选评价提供技术经验,同时为医疗机构遴选葡萄糖激酶激活剂多格列艾汀提供决策支持。
OBJECTIVE:To perform rapid selection and evaluation of doglietine,the first glucokinase activator in the world,based on the Quick Guideline for Drug Evaluation and Selection in Chinese Medical Institutions(the Second Edition),so as to provide reference for rational drug introduction in medical institutions.METHODS:The evaluation method of the Quick Guideline for Drug Evaluation and Selection in Chinese Medical Institutions(the Second Edition)was applied to perform the comprehensive clinical evaluation of pharmaceutical properties,efficacy,safety,economy and other attributes of doglietine(including medical insurance status,essential drugs status,storage conditions,drug validity,global use and corporate reputation).RESULTS:Doglietine scored 25 points for pharmaceutical properties,15 points for efficacy,18.5 points for safety,8.2 points for economy and 3.5 points for other attributes,with a total score of 70.2 points.Doglietine had a unique mechanism of action,high safety and economy.However,more clinical research evidence was needed to improve its guideline recommendation status.The recommendation level of the drug was“strong recommendation”.CONCLUSIONS:This health technology evaluation provides technical experience for medical institutions to perform new drug selection evaluation,and also provides decision support for medical institutions to select glucokinase activator doglietine.
作者
朱晓冉
田冬冬
张玥
冯运佳
蔡玥
董占军
ZHU Xiaoran;TIAN Dongdong;ZHANG Yue;FENG Yunjia;CAI Yue;DONG Zhanjun(Dept.of Pharmacy,Hebei General Hospital,Hebei Key Laboratory of Clinical Pharmacy,Shijiazhuang 050051,China)
出处
《中国医院用药评价与分析》
2025年第2期211-214,共4页
Evaluation and Analysis of Drug-use in Hospitals of China
基金
河北省2023年度医学科学研究课题计划(No.20230423)。
