波生坦、安立生坦及马昔腾坦的药品遴选实践

Practice of drug selection of bosentan,ambrisentan and macitentan

目的药物遴选波生坦、安立生坦、马昔腾坦,为医院决策者遴选和临床合理使用提供循证依据。方法以《中国医疗机构药品评价与遴选快速指南》为依据制定百分制评估体系,对评分细则进一步优化,并参考药品说明书、临床指南及万方、维普、中国知网、PubMed、Embase、Cochrane Library等数据库相关文献,从有效性、药学特性、安全性、经济性、国家医保、基本药物情况、贮藏条件、有效期、全球使用情况及药品生产企业状况10个方面对波生坦、安立生坦和马昔腾坦进行量化评分,并根据评分结果划分推荐级别。结果最终得分波生坦84.2分,安立生坦80.0分,马昔腾坦80.3分。三药均是WHO功能分级Ⅱ~Ⅲ级肺动脉高压患者靶向治疗的一线用药,波生坦在特殊人群(儿童患者)用药方面略优,但由于波生坦肝毒性较大,中度肝损伤患者用药不做优选,安立生坦和马昔腾坦在患者依从性方面略优,安立生坦经济性最为优秀。三药总分均高于80分,较强推荐进入医疗机构药品使用目录。结论波生坦、安立生坦、马昔腾坦在不同属性方面各有优势,医疗机构可根据本机构患者人群特点及是否有可替代药品,决定是否引进三药。

AIM Drug selection of bosentan,ambrisentan and macitentan to provide evidence-based basis for hospital decision-makers’selection and clinical rational use.METHODS According to the 100-point evaluation system established by the“Quick Guide for Drug Evaluation and Selection in Chinese Medical Institutions”,and further optimize of the scoring rules,by consulting the drug instructions,clinical treatment guidelines,and searching relevant literature in databases such as Wanfang,VIP,CNKI,PubMed,Embase,Cochrane Library,etc.,to collect and sort out the relevant information of bosentan,ambrisentan and macitentan.Quantitatively score the three drugs from 10 aspects of effectiveness,pharmaceutical properties,safety,economy,medical insurance attributes,basic drug attributes,storage conditions,drug expiration date,drug use,and production enterprise status,and divide the recommendation level according to the score results.RESULTS Bosentan and ambrisentan and macitentan’s final score were 84.2,80.0,80.3,respectively.The three drugs are the first-line drugs for targeted therapy of pulmonary arterial hypertension patients with WHO functional classification-,bosentan is slightly better in the use of special populations(children),but due to the greater hepatotoxicity of bosentan,it is not preferred for patients with moderate liver injury.Ambrisentan and macitentan are slightly better in terms of patient compliance,and ambrisentan is the most economical.The total score of the three drugs is higher than 80 points,and it is strongly recommended to enter the drug use catalog of medical institutions.CONCLUSION Bosentan,ambrisentan and macitentan have their own advantages in different attributes.Medical institutions can decide whether to introduce the three drugs according to the characteristics of the patient population in their institutions and whether there are alternative drugs.