摘要
目的系统评价西尼莫德治疗复发型多发性硬化(RMS)的有效性、安全性和经济性。方法检索PubMed、Embase、theCochrane Library、中国知网、万方、中国生物医学文献服务系统(SinoMed)数据库及卫生技术评估(HTA)机构官方网站,检索时限为各数据库自建库起至2024年1月23日。纳入西尼莫德治疗RMS的HTA报告、系统评价(SR)/Meta分析和药物经济学研究并进行描述性汇总分析。结果初检获得1384篇文献,最终纳入3篇HTA报告,4篇SR/Meta分析,3篇经济学研究,其中除1篇文献质量相对较低外,其余文献质量均较高。干预措施均为使用西尼莫德(2 mg),对照措施包括使用安慰剂、奥法妥木单抗、奥扎莫德、芬戈莫德、干扰素β、醋酸格拉替雷、特立氟胺、富马酸二甲酯等。有效性方面,西尼莫德相比安慰剂可显著降低患者的年复发率、活动病灶数(基于磁共振成像)及残疾进展(6个月时确认)、脑容量丢失和认知功能障碍风险(P<0.05);相比奥扎莫德(0.5 mg)、醋酸格拉替雷、干扰素β-1a、干扰素β-1b和特立氟胺可显著降低年复发率(P<0.05);相比奥法妥木单抗、奥扎莫德(1 mg)和芬戈莫德的年复发率无显著差异(P>0.05)。安全性方面,西尼莫德与安慰剂或其他治疗药物相似,极少患者因不良事件停药,但西尼莫德首次给药引起的心动过缓和黄斑水肿较安慰剂更常见。经济性方面,相比干扰素β-1a、富马酸二甲酯、芬戈莫德和安慰剂,西尼莫德在英国、瑞士和意大利具有成本-效果优势,但尚缺乏基于中国人群的经济学研究。结论西尼莫德治疗RMS具有良好的有效性和安全性,在部分欧洲国家具有成本-效果优势,但其在中国的经济性有待进一步验证。
Objective To systematically evaluate the efficacy,safety,and economy of siponimod in the treatment of relapsing multiple sclerosis(RMS).Methods The databases of PubMed,Embase,the Cochrane Library,CNKI,WanFang,SinoMed and official websites of Health Technology Assessment(HTA)were searched from the establishment of each database or website to January 23,2024.HTA reports,systematic review(SR)/Meta-analysis,and pharmacoeconomic studies on siponimod in the treatment of RMS were included and descriptive summary analysis was performed.Results A total of 1384 articles were initially retrieved,and three HTA reports,four SR/Meta analyses and three pharmacoeconomic studies were finally included.Among them,all except one article with relatively low quality,the quality of other articles was high.The intervention measures were the use of siponimod(2 mg),and the control measures included the use of placebo,ofatumumab,ozanimod,fingolimod,interferon β,glatiramer acetate,teriflunomide,dimethyl fumarate,etc.In terms of efficacy,compared with placebo,siponimod could significantly reduce the annual recurrence rate,the number of active lesions(based on magnetic resonance imaging)and disability progression(confirmed at six months),brain volume loss and cognitive dysfunction risk(P<0.05);compared with ozanimod(0.5 mg),glatiramer acetate,interferon β-1a,interferon β-1b and teriflunomide,siponimod could significantly reduce the annual recurrence rate(P<0.05).There was no significant difference in the annual recurrence rate between siponimod and ofatumumab,ozanimod(1 mg),fingolimod,respectively(P>0.05).In terms of safety,simimod was similar to placebo or other therapeutic drugs,and very few patients were withdrawn from treatment due to adverse events.However,bradycardia and macular edema after the first dosing of siponimod were more common than placebo.In terms of economy,compared with interferon β-1a,dimethyl fumarate,fingolimod and placebo,siponimod had a cost-effectiveness advantage in the UK,Switzerland and Italy,but there was still a lack of economic research based on the Chinese population.Conclusion Siponimod has shown good efficacy and safety in the treatment of RMS,and has cost-effectiveness advantages in some European countries,but its economic efficiency in China remains to be further verified.
作者
贺兰芝
周鹏翔
赵应学
罗海坤
周甘平
HE Lanzhi;ZHOU Pengxiang;ZHAO Yingxue;LUO Haikun;ZHOU Ganping(Jiangbin Hospital of Guangxi Zhuang Autonomous Region,Nanning,Guangxi,China 530021;Peking University Third Hospital,Beijing,China 100191;Peking University Health Science Center,Beijing,China 100191)
出处
《中国药业》
2025年第16期108-112,共5页
China Pharmaceuticals
基金
广西壮族自治区卫生健康委员会自筹经费科研课题[Z-A20220246,Z-A20240229]。
关键词
西尼莫德
复发型多发性硬化
快速卫生技术评估
系统评价
siponimod
relapsing multiple sclerosis
rapid health technology assessment
systematic review
