富马酸二甲酯治疗多发性硬化疗效与安全性的Meta分析  

Efficacy and safety of dimethyl fumarate in the treatment of multiple sclerosis:a meta-analysis

作　　者：李凤云 兰瑞[1] 赵铎[1] 刘福贵[1] 陈良辰 LI Fengyun;LAN Rui;ZHAO Duo;LIU Fugui;CHEN Liangchen(Dept.of Encephalopathy,the First Affiliated Hospital of Henan University of CM,Zhengzhou 450000,China;First Clinical Medical College,Henan University of Chinese Medicine,Zhengzhou 450000,China)

机构地区：[1]河南中医药大学第一附属医院脑病科,郑州450000 [2]河南中医药大学第一临床医学院,郑州450000

出　　处：《中国药房》2024年第14期1776-1780,共5页China Pharmacy

基　　金：国家自然科学基金项目(No.81973618);河南省中医药科学研究专项课题(No.2019ZYBJ09)。

摘　　要：目的 评价富马酸二甲酯(DMF)治疗多发性硬化(MS)的疗效和安全性。方法 检索中国生物医学文献服务系统、Web of Science、PubMed、the Cochrane Library、Embase、中国知网、万方数据、维普网,收集DMF(试验组)对比其他药物或安慰剂(对照组)的随机对照试验。筛选、提取数据,评价文献质量后,采用RevMan 5.3软件进行Meta分析。结果 共纳入6篇文献,共计638例患者。Meta分析结果显示,试验组治疗后病灶发生变化的患者比例显著低于对照组[MD=-0.65,95%CI(-1.27,-0.02),P=0.04];两组患者的复发率[RR=1.06,95%CI(0.52,2.17),P=0.88]、治疗后出现新发病灶患者比例[RR=1.05,95%CI(0.62,1.80),P=0.85]、治疗后临床扩展致残量表评分[MD=0.02,95%CI(-0.18,0.23),P=0.82]、不良事件发生率[RR=1.33,95%CI(0.97,1.84),P=0.08]、严重不良事件发生率[RR=0.95,95%CI(0.48,1.90),P=0.89]比较,差异均无统计学意义。敏感性分析结果显示,本研究所得复发率和不良事件发生率结果不稳健,其他结果稳健。结论 DMF可在一定程度上控制MS患者的病灶进展,未增加不良事件及严重不良事件的发生风险,但在降低复发率、控制残疾进展方面未有显著优势。OBJECTIVE To evaluate the efficacy and safety of dimethyl fumarate(DMF) in the treatment of multiple sclerosis(MS).METHODS Retrieved from CBM,Web of Science,PubMed,the Cochrane Library,Embase,CNKI,Wanfang Data,and VIP,randomized controlled trials(RCTs) about DMF(trial group) versus other drugs or placebo(control group) were collected.After data screening and extraction,quality evaluation,meta-analysis was conducted by using RevMan 5.3 software.RESULTS A total of 6 literature were included,involving 638 patients.Results of meta-analysis showed that the proportion of patients with lesion changes after treatment in the trial group was lower than control group [MD=-0.65,95%CI(-1.27,-0.02),P=0.04];there was no statistical significance in recurrence rate [RR=1.06,95%CI(0.52,2.17),P=0.88],the proportion of patients with new lesions after treatment [RR=1.05,95%CI(0.62,1.80),P=0.85],expanded disability status scale after treatment [MD=0.02,95%CI(-0.18,0.23),P=0.82],the incidence of adverse events [RR=1.33,95%CI(0.97,1.84),P=0.08] or severe adverse events [RR=0.95,95%CI(0.48,1.90),P=0.89] between 2 groups.Results of sensitivity analysis showed the study obtained unstable recurrence rate and the incidence of adverse events,while other results were robust.CONCLUSIONS DMF can control the lesion progression in MS patients to some extent and doesn't increase the incidence of adverse events and serious adverse events,but there is no significant advantage in reducing the recurrence rate and controlling the disability progression.

关 键 词：富马酸二甲酯 多发性硬化 疾病修饰治疗 复发率 不良事件 

分 类 号：R969[医药卫生—药理学]