摘要
目的通过循证医学的方法对3个不同厂家利妥昔单抗进行超说明书用药病种药品遴选量化评估,为医疗机构合理用药及药品遴选提供依据。方法参考《中国医疗机构药品评价与遴选快速指南》,通过收集3个不同厂家的利妥昔单抗(商品名:美罗华®、汉利康®、达伯华®)药学特性、有效性、安全性、经济性、医保属性、基本药物、贮藏条件、药品有效期、全球使用情况和生产企业状况等数据,对利妥昔单抗在类风湿性关节炎(RA)、免疫性血小板减少症(ITP)、肉芽肿性/显微镜下多血管炎(GPA/MPA)中的应用进行遴选量化评估。结果3种利妥昔单抗治疗RA中,美罗华®得分64,达伯华®得分70,汉利康®得分为72,治疗RA时可优选汉利康®;3种利妥昔单抗治疗ITP及GPA/MPA中,达伯华®得分最高,分别为68及71,治疗ITP及GPA/MPA可优选达伯华。结论3种利妥昔单抗均可进入医院用药目录,治疗RA推荐汉利康®,治疗GPA/MPA推荐达伯华®,治疗ITP弱推荐达伯华®。
Objective Through the method of evidence-based medicine to quantitative evaluation of off-label disease selection of three rituximab biosimilar.Methods Referring to the"A Quick Guideline for Drug Evaluation and Selection in Chinese Medical Institutions",through the collection of rituximab pharmaceutical characteristics,efficacy,safety,economy,medical insurance attributes,base medicine attributes,storage conditions,drug expiration dates,global usage and production enterprise status and other data from three different manufacturers(trade names:Rituxan,Hanlikang,Dabohua),the application of rituximab in rheumatoid arthritis,immune thrombocytopenia(ITP),and granulomatous/microscopic polyangiitis was evaluated for quantitative evaluation.Results Among the three kinds of rituximab in the treatment of rheumatoid arthritis,the score of Rituximab was 64,the score of Dabohua was 70,and the score of Hanlikang was 72.For rheumatoid arthritis,Hanlikang was the best choice.In the treatment of thrombocytopenia and granulomatous/microscopic polyangiitis,Dabohua had the highest scores,68 and 71,respectively.Dabohua was the best choice for the treatment of thrombocytopenia and granulomatous/microscopic polyangiitis.Conclusion Three kinds of rituximab could enter the drug catalogue of medical institutions.Hanlikang is recommended for the treatment of rheumatoid arthritis.Dabohua is recommended for the treatment of granulomatous/microscopic polyangiitis and weakly recommended for the treatment of thrombocytopenia.
作者
雍素云
刘晓玲
朱亚宁
王鹏翀
张鹏
曹璐
YONG Suyun;LIU Xiaoling;ZHU Yaning;WANG Pengchong;ZHANG Peng;CAO Lu(Department of Pharmacy,Shaanxi Provincial People's Hospital,Xi'an 710000,China)
出处
《药物评价研究》
CAS
2023年第6期1299-1306,共8页
Drug Evaluation Research
