卫生技术评估为4种生物制剂在炎症性肠病快速遴选中提供循证医学证据的应用与实践

Health technology assessment of evidence-based medical evidence for the rapid selection of four biologics for inflammatory bowel disease

目的为医疗机构合理采购及炎症性肠病(IBD)患者合理选择生物制剂提供循证医学证据。方法依据《中国医疗机构药品评价与遴选快速指南》制订评估体系,查阅相关药品说明书、临床指南、国家基本药物目录、国家医保目录及Drugbank等相关网站信息,并检索中国知网、PubMed、万方、维普等数据库中相关文献,收集英夫利西单抗、阿达木单抗、维得利珠单抗和乌司奴单抗4种生物制剂在IBD治疗方面的相关信息,从药学特性、有效性、安全性、经济性、其他属性五个方面进行量化评分,并依据评分结果划分推荐级别。结果4种生物制剂的评分分别为:英夫利西单抗71.5分,阿达木单抗77.75分,维得利珠单抗76.5分,乌司奴单抗85分,4种生物制剂评分均在70分以上,较强推荐进入医疗机构目录。英夫利西单抗和阿达木单抗在药学特征方面较有优势,评分均为19分;英夫利西单抗、阿达木单抗、维得利珠单抗和乌司奴单抗在有效性方面均有较强优势,评分均为18分;乌司奴单抗在安全性方面和经济性方面均较有优势,评分分别为16.5分和20分;阿达木单抗在其他属性方面较有优势,评分为12.75分。结论本次卫生技术评估可为医疗机构开展药品评价与遴选提供实践经验,同时为临床在IBD患者选择生物制剂时提供循证依据。

Objective To provide evidence-based medical evidence for rational procurement in medical institutions and rational selection of biological agents for patients with inflammatory bowel disease(IBD).Methods The evaluation system was established according to the“Quick Guide for Drug Evaluation and Selection in Chinese Medical Institutions”.By referring to drug specifications,clinical guidelines,National Essential Medicine Directory,National Medical Insurance Directory,Drugbank and other related websites.We searched related literatures in CNKI,PubMed,Wanfang and VIP databases,and collected information about infliximab,adalimumab,vedolizumab and ustekinumab for IBD.Quantitative scoring was used for five aspects of pharmaceutical characteristics,efficacy,safety,economy and other attributes,and recommendation levels were divided according to the scoring.Results The scores of the four biological agents were:71.5 for infliximab,77.75 for adalimumab,76.5 for vedolizumab,and 85 for ustekinumab.The scores of the four agents were all above 70,suggesting inclusion in the list of medical institutions.Infliximab and adalimumab had advantages in pharmaceutical characteristics with score of 19.Infliximab,adalimumab,vedolizumab and ustekinumab all had strong advantages in effectiveness with the scores of 18.Ustekinumab had advantages in both safety and economic burden with scores of 16.5 and 20 respectively.Adalimumab was superior to other attributes with score of 12.75.Conclusion Health technology assessment can provide practical experience for medical institutions to evaluate and select drug,and provide evidence-based medical evidence for selection of biological agents for IBD patients.