奥法妥木单抗治疗复发型多发性硬化有效性及安全性的Meta分析  

Meta-analysis of the efficacy and safety of ofatumumab in the treatment of relapsing multiple sclerosis

作　　者：王雅洁 何春 李万英 WANG Yajie;HE Chun;LI Wanying(不详;Department of Neurology,The Linfen Central Hospital of Changzhi Medical College,Linfen 041000,China)

机构地区：[1]长治医学院附属临汾市中心医院神经内科,041000

出　　处：《中国神经免疫学和神经病学杂志》2025年第2期131-137,共7页Chinese Journal of Neuroimmunology and Neurology

摘　　要：目的评价奥法妥木单抗治疗复发型多发性硬化(relapsing multiple sclerosis,RMS)的有效性及安全性。方法检索Pubmed、Cochrane Library Databases、EMbase、Web of Science、CNKI、CQVIP、CBM、CMCI数据库已发表的关于奥法妥木单抗治疗RMS的随机对照研究,检索时间为建库至2023-4-31。根据入组和排除标准筛选文献,收集患者的临床资料,采用Review Manager5.4软件进行Meta分析,评价奥法妥木单抗治疗RMS的有效性及安全性。结果共纳入4篇文献,共2215例患者。与对照组相比,奥法妥木单抗可降低RMS患者的复发率(OR=0.39,95%CI:0.32~0.47;P<0.01),减少总钆增强T1病灶(MD=-0.47,95%CI:-0.55~-0.39;P<0.01)和新发或扩大的高T2信号病灶(MD=-3.42,95%CI:-3.82~-3.02;P<0.01)。奥法妥木单抗与对照组间任何不良事件发生率(OR=1.09,95%CI:0.89~1.34;P=0.42)、严重不良事件发生率(OR=1.24,95%CI:0.90~1.69;P=0.19)、感染率(OR=0.98,95%CI:0.83~1.15;P=0.77)及药物注射相关不良事件发生率(OR=1.97,95%CI:0.86~4.5;P=0.11)比较差异均无统计学意义。结论奥法妥木单抗治疗RMS有效且安全。Objective To determine whether ofatumumab is efficacious and safe in the treatment of relapsing multiple sclerosis(RMS).Methods Double-blind randomized controlled trials on ofatumumab in the treatment of RMS were collected from PubMed,Cochrane Library databases,EMbase,Web of Science,CNKI,CQVIP,CBM,CMCI databases from published up to April 2023.Screen the literature based on the inclusion and exclusion criteria and collect the clinical data of patients.Review manager 5.4 software was used to conduct meta-analysis to evaluate the effectiveness and safety of ofatumumab in the treatment of RMS.Results Totally 4 articles and 2215 patients were included.Meta-analysis showed that ofatumumab was statistically more effective than control for reduced the rates of relapse(OR=0.39,95%CI:0.32-0.47,P<0.01),reduced cumulative gadolinium-enhancing lesions on T1-weighted MRI(MD=-0.47,95%CI:-0.55--0.39,P<0.01)and new or newly enlarged hyper intense lesions on T2-weighted MRI(MD=-3.42,95%CI:-3.82--3.02,P<0.01).Compared with the control group,there was no statistically significant difference in the occurrence rates of any adverse events(OR=1.09,95%CI:0.89-1.34,P=0.42),serious adverse events(OR=1.24,95%CI:0.90-1.69,P=0.19),infection(OR=0.98,95%CI:0.83-1.15,P=0.77)and injection-related reactions(OR=1.97,95%CI:0.86-4.5,P=0.11)in the ofatumumab group.Conclusions Ofatumumab is effective and safe in the treatnent in RMS.

关 键 词：奥法妥木单抗 复发型 多发性硬化 META分析 

分 类 号：R744.51[医药卫生—神经病学与精神病学]