米托蒽醌治疗多发性硬化有效性和安全性的Meta分析

Efficacy and safety of mitoxantrone in the treatment for multiple sclerosis: a Meta-analysis

目的:客观评价米托蒽醌(MX)治疗多发性硬化(MS)的有效性和安全性,为临床提供循证医学证据。方法:计算机检索万方数据库、中国学术期刊网全文数据库、维普数据库、PubMed、Cochrane Library自数据库建库至2012年12月已发表的MX治疗MS的随机对照试验,并对纳入文献采用Rev Man 5.0进行Meta分析。结果:3篇文献共281例患者纳入研究,MX治疗组171例,安慰剂组110例。Meta分析结果显示:MX治疗组复发率较安慰剂组偏低(MD=-1.02,95%CI为-1.69^-0.35,P=0.002 7),MX治疗组EDSS评分降低(MD=-0.36,95%CI为-0.70^-0.02,P=0.036),MRI确认的新发或扩大的损害数在两组间差异无统计学意义(MD=-0.79,95%CI为-1.68~0.09,P=0.079);MX治疗组闭经、恶心呕吐、脱发、继发性尿路感染的发生率较安慰剂组高,但因不良反应而中止治疗的例数在两组间差异无统计学意义(OR=2.72,95%CI为0.51~14.54,P=0.24)。结论:MX治疗MS的疗效优于安慰剂组,暂未发现严重的不良反应,但远期疗效及安全性仍需大样本、多中心随机对照试验进一步验证。

Objective： To provide reliable evidence for guiding clinical practice,we conducted a comprehensive and objective evaluation of the safety and efficacy of mitoxantrone in treatment of multiple sclerosis. Methods： Randomized controlled trials of mitoxantrone treatment for multiple sclerosis were searched in Wanfang database, China National Knowledge Internet（ CNKI）,VIP database,PubMed and the Cochrane Library since the build up of the database to December 2012. And then we used Rev Man 5. 0 to conduct a Meta-analysis. Results： Three randomized controlled trials were included in this study,281 patients including 171 cases in mitoxantrone treatment group and 110 cases in the placebo group. It showed that when compared with placebo group,the recurrence rate of mitoxantrone treatment group was obviously lower（ MD =- 1. 02,95% CI- 1. 69 to- 0. 35,P = 0. 002 7）,EDSS score was significantly lower（ MD =- 0. 36,95% CI- 0. 70 to- 0. 02,P = 0. 036）. And the number of new or expanded damage confirmed by the magnetic resonance imaging had no statistically significant difference between two groups（ MD =- 0. 79,95% CI- 1. 68 to 0. 09,P = 0. 079）. Amenorrhea,nausea,vomiting,hair loss and urinary tract infection of mitoxantrone treatment group were higher than placebo group. However,the number of patients quitting from treatment due to adverse reactions had no statistically difference between these two groups（ OR =2. 72,95%CI 0. 51 to 14. 54,P =0. 24）. Conclusion： Efficacy of mitoxantrone is superior to placebo in the treatment of multiple sclerosis,and serious adverse reactions have not been found so far. However,the long-term efficacy and safety still need large-sampled,and multicentered randomized controlled trials to be confirmed.