Xie Qinfang, Li Xiaoling, Sun Jingjie, Yuan Boyao, Li Yijun, Wang Lijuan, Wang Manxia
Department of Neurology, Lanzhou University Second Hospital, Lanzhou, Gansu 730030, P.R. China.
Exp Ther Med. 2017 Jun;13(6):3061-3066. doi: 10.3892/etm.2017.4298. Epub 2017 Apr 4.
The present study performed a meta-analysis of randomized controlled trials in multiple sclerosis (MS) patients to evaluate the efficacy and safety of anti-B-cell monoclonal antibodies (mAbs). To the best of our knowledge, no previous meta-analysis has evaluated this. Relevant studies published until March 2015 were retrieved from the PubMed, EMBASE and Cochrane Library using the following keywords: 'Clinical trial', 'randomized', 'multiple sclerosis' or 'MS' and 'monoclonal antibodies' or 'mAbs'. Two authors independently selected the articles and extracted the data. The meta-analysis was performed using Review Manager version 5.3 software. Four randomized clinical trials comprising a total of 745 patients were selected. Anti-B-cell mAb treatment reduced the formation of gadolinium-enhancing lesions [mean difference (MD)=-5.62; 95% confidence interval (CI)=-8.00 to -3.24; P<0.001) and was associated with smaller volume changes of lesions on T2-weighted magnetic resonance imaging (MD=-604.40; 95% CI=-941.23 to -267.57; P<0.001). It also significantly reduced the proportion of MS patients having at least one relapse [odds ratio (OR)=0.25; 95% CI=0.14-0.44; P<0.001). Compared to placebo, anti-B-cell mAb treatment did not increase the frequency of adverse events (OR=0.90; 95% CI=0.54-1.49; P=0.68) and serious adverse events (OR=1.13; 95% CI=0.70-1.80; P=0.62). In conclusion, the present meta-analysis suggested that anti-B-cell mAbs are a relatively effective and safe treatment for MS.
本研究对多发性硬化症（MS）患者的随机对照试验进行了荟萃分析，以评估抗B细胞单克隆抗体（mAbs）的疗效和安全性。据我们所知，此前尚无荟萃分析对此进行评估。使用以下关键词从PubMed、EMBASE和Cochrane图书馆检索截至2015年3月发表的相关研究：“临床试验”、“随机”、“多发性硬化症”或“MS”以及“单克隆抗体”或“mAbs”。两位作者独立筛选文章并提取数据。使用Review Manager 5.3版软件进行荟萃分析。共选择了四项随机临床试验，涉及745名患者。抗B细胞mAb治疗减少了钆增强病灶的形成[平均差（MD）=-5.62；95%置信区间（CI）=-8.00至-3.24；P<0.001]，并且与T2加权磁共振成像上病灶的较小体积变化相关（MD=-604.40；95%CI=-941.23至-267.57；P<0.001）。它还显著降低了至少有一次复发的MS患者比例[比值比（OR）=0.25；95%CI=0.14 - 0.44；P<0.001]。与安慰剂相比，抗B细胞mAb治疗未增加不良事件（OR=0.90；95%CI=0.54 - 1.49；P=0.68）和严重不良事件（OR=1.13；95%CI=0.70 - 1.80；P=0.62）的发生频率。总之，本荟萃分析表明，抗B细胞mAbs是一种相对有效且安全的MS治疗方法。
