阿伦单抗治疗多发性硬化的有效性及安全性的Meta分析

A meta-analysis to determine efficacy and safety of alemtuzumab in multiple sclerosis

目的:评价阿伦单抗治疗多发性硬化的有效性及安全性。方法:通过检索Pubmed、EMBASE、Cochrane图书馆以及其他电子数据库获取文献,时间为2015年2月截止。使用检索关键词"多发性硬化"、"multiple sclerosi"、"MS"以及药名"阿伦单抗"、"alemtuzumab"。两名作者独立检索以及提取数据。使用Rev Man5.3软件对提取资料进行统计分析。结果:共3个试验1 695名患者纳入研究。阿伦单抗在钆增强病变的数量(Or=0.33,95%CI=[0.23,0.48],P<0.000 01)、持续残疾累积概率(Or=0.51,95%CI=[0.38,0.69],P<0.000 1)以及疾病复发率(Or=0.42,95%CI=[0.34,0.52],P<0.000 1)方面均优于干扰素。但在T2信号新病灶数量(Or=0.10,95%CI=[0.01,1.75],P=0.11)上阿伦单抗与干扰素的疗效无明显差异。在安全性方面,阿伦单抗与干扰素在治疗过程中发生严重不良反应的概率无明显差异(Or=1.00,95%CI=[0.80,1.26],P=0.99),但阿伦单抗更易出现一般不良反应(Or=2.29,95%CI=[1.40,3.75],P=0.001)。结论:这篇Meta分析结论显示,临床疾病参数以及其他疾病活动指标表明阿伦单抗治疗多发性硬化比干扰素更为有效。同时,阿伦单抗的安全性也在可接受范围。

Objective ：To perform a meta-analysis of randomized controlled trims （RCTs） in multiple sclerosis （MS） patients to evaluate the efficacy and safety of alemtuzumab. Methods： We searched PubMed, EMBASE, the Cochrane Library and so on up to February 2015 using the keywords： ＇multiple sclerosis＇ or ＇MS＇ and the drug names： alemtuzumab. Two authors independently selected the articles and extracted the data. We performed meta-analysis using Review Manager （RevMan） version 5.3 software. Results： Three RCTs with a total of 1 695 patients were selected. Compared to the interferon beta, the number of gadolinium-enhancing lesions （ odds ratio （OR） = 0. 33,95 % Confidence interval （CI） = [ 0. 23,0. 48 ], P〈 0. 000 01 ）, the cumulative probability of sustained disability （ Or = 0. 51,95 % CI = [ 0. 38,0. 69 ], P〈0. 000 1 ） and the proportion of patients who had at least one relapse of MS （ Or = 0. 42,95 % CI= [0. 34,0. 52 ], P〈0. 000 1 ） were significantly less in the alemtuzumab group, meanwhile the number of new T2-hyperintense lesions （ Or = 0. 10,95 % CI = [ 0. 01,1.75 ], P = 0. 11 ） showed no significant difference. Comparing adverse e-Jents between two groups, alemtuzumab treatment did not increase the frequency of serious adverse events （ Or = 1.00,95% CI = [ 0. 80,1.26 ], P = 0. 99 ） but increase the frequency of any adverse events （ Or = 2. 29,95% CI = [ 1.40,3. 75 ], P = 0. 001 ）. Conclusion： Alemtuzumab is a relatively effective and safe treatment for MS.