贝利尤单抗治疗系统性红斑狼疮狼疮性肾炎的快速卫生技术评估  

Rapid health technology assessment of belimumab in the treatment of systemic lupus erythematosus/lupus nephritis

作　　者：雍素云 刘晓玲[1] 朱亚宁[1] 王鹏翀 张鹏[1] 曹璐 YONG Su-yun;LIU Xiao-ling;ZHU Ya-ning;WANG Peng-chong;ZHANG Peng;CAO Lu(Department of Pharmacy,Shaanxi Provincial People's Hospital,Xi'an 710000,China)

机构地区：[1]陕西省人民医院药学部,西安710000

出　　处：《临床药物治疗杂志》2023年第5期56-62,共7页Clinical Medication Journal

摘　　要：目的快速评价贝利尤单抗治疗系统性红斑狼疮(SLE)/狼疮性肾炎(LN)的安全性、有效性和经济性,为临床合理用药提供参考。方法计算机检索Pubmed、Embase、the Cochrane Library、中国期刊全文数据库、万方数据知识服务平台、维普数据库、中国生物医学文献服务系统及卫生技术评估(HTA)相关网站,根据纳入和排除标准由2名研究者独立筛选文献,提取数据,并对纳入文献进行质量评价与定性合成分析。结果共纳入文献37篇,其中系统评价/meta分析22篇,HTA报告2篇,药物经济学研究13篇;文献总体质量较好。结果显示,贝利尤单抗可以改善SLE患者的耀斑复燃发生率,提高SLE应答指数,降低SLE活动度评分,减少糖皮质激素使用剂量,提高LN患者的完全缓解率;贝利尤单抗不增加不良事件、严重不良事件及特殊不良事件发生率;在儿童、≥65岁老年人、SLE伴皮肤型红斑狼疮患者中贝利尤单抗可能安全有效;经济学研究结果显示,在多个国家及我国香港地区贝利尤单抗治疗具有成本优势。结论贝利尤单抗在SLE/LN患者中有良好的安全性和有效性,但药物经济学无中国本土研究,需开展相关研究。Objective To quickly evaluate the safety,efficacy and economy of belimumab in the treatment of systemic lu⁃pus erythematosus(SLE)/lupus nephritis(LN),so as to provide reference for clinical rational drug use.Methods The follow⁃ing databases were searched including Pubmed,Embase,the Cochrane Library,CNKI,Wanfang Database,VIP Database,China Biomedical Literature Service System and the official website of health technology assessment(HTA)institutions.Ac⁃cording to the inclusion and exclusion criteria,two researchers independently screened the literature,extracted data,and con⁃ducted quality evaluation and qualitative synthesis analysis on the included literature.Results A total of 37 studies were includ⁃ed,including 22 systematic reviews/meta analysis,2 HTA reports and 13 pharmacoeconomic studies.The overall quality of lit⁃erature is good.The results showed that belimumab improved the incidence of flare recurrence rate,reduced the SLE activity score,lowered the dosage of glucocorticoids,and enhanced the complete remission rate of LN patients.Belimumab did not in⁃crease the incidence of adverse events,serious adverse events and special adverse events;Belimumab may be safe and effec⁃tive in children,the elderly people≥65 years old,and SLE with cutaneous lupus erythematosus.The economic research re⁃sults showed that belimumab had cost advantages in several countries and Hong Kong Special Administrative Region of the Peo⁃ple's Republic of China.Conclusion Belimumab is effective and safe in the treatment of SLE/LN patients.However,there is no pharmacoeconomic study on belimumab in mainland of China,so relevant research needs to be carried out.

关 键 词：贝利尤单抗 系统性红斑狼疮 狼疮性肾炎 快速卫生技术评估 

分 类 号：R969[医药卫生—药理学] R593.24[医药卫生—药学]