含钆对比剂的临床综合评价

Clinical application evaluation of gadolinium-based contrast agent

目的比较含钆对比剂(钆喷酸葡胺、钆特酸葡胺、钆特醇、钆双胺、钆贝葡胺和钆布醇)的临床综合价值,以期为医院临床诊断合理用药和目录准入决策提供参考。方法首先,根据《药品临床综合评价管理指南2021年版试行》,通过文献复习、专家调研和专家论证会构建核磁共振增强扫描诊断用药临床综合评价指标体系,采用层次分析法确定各指标权重。其次,采用系统文献综述、Meta分析及其他相关数据资料分析的方法,根据指标体系对6种含钆对比剂的各维度、各指标进行定性、定量整合分析。最后,开发定量临床综合评价工具,根据评价药品各维度临床综合评价证据进行评分,结合指标体系权重计算得到各含钆对比剂的综合评分。结果钆喷酸葡胺得分最高(81.98分),其后依次为钆布醇(76.06分)、钆特醇(60.39分)、钆特酸葡胺(59.51分)、钆贝葡胺(56.60分)和钆双胺(46.34分)。结论钆喷酸葡胺的临床综合价值高于钆布醇、钆特醇、钆特酸葡胺、钆贝葡胺和钆双胺。

Objective To compare the comprehensive clinical value of gadolinium-based contrast agents(GBCAs),such as Gadopentetate Dimeglumine,Gadoterate Meglumine,Gadoteridol,Gadodiamide,Gadobenate Dimeglumine and Gadobutrol,in order to provide reference for rational drug use in clinical diagnosis and catalogue access decision-making.Methods Firstly,a comprehensive clinical evaluation index system for GBCAs was constructed through literature review,ex⁃pert surveys and expert demonstrations,and the analytic hierarchy process was used to determine the weight of each index.Secondly,using systematic literature review,Meta analysis and other related data analysis methods,GBCAs were analyzed ac⁃cording to the indicator system.Finally,a quantitative evaluation tool was developed for scoring,combined with the weight of the index system to calculate the comprehensive score of gadolinium-based contrast agent.Results Gadopentetate Dimeglu⁃mine had the highest score(81.98),followed by Gadobutrol(76.06),Gadoteridol(60.39),Gadoterate Meglumine(59.51),Gadobenate Dimeglumine(56.60)and Gadodiamide(46.34).Conclusion The comprehensive clinical value of Gadopen⁃tetate Dimeglumine is higher than that of other five GBCAs.