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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 objectively evaluate the efficacy and safety of mitoxantrone (MX) in the treatment of multiple sclerosis (MS) and provide evidence-based medical evidence. METHODS: The randomized controlled trials of MS treated with MX were published by database of Wanfang database, Chinese academic journal full-text database, VIP database, PubMed, Cochrane Library from database construction to December 2012. The data of RevMan 5.0 Meta-analysis. RESULTS: A total of 281 patients were enrolled in the three articles, including 171 MX patients and 110 placebo patients. Meta-analysis showed that the recurrence rate of MX group was lower than that of placebo group (MD = -1.02, 95% CI -1.69-0.35, P = 0.002 7), and the EDSS score of MX group was lower (MD = -0.36, 95% CI -0.70 to -0.02, P = 0.036). There was no significant difference between the two groups in the numbers of new or enlarged lesions confirmed by MRI (MD = -0.79, 95% CI -1.68-0.09, P = 0.079). The incidences of amenorrhea, nausea and vomiting, hair loss and secondary urinary tract infection in MX group were higher than those in placebo group. However, there was no significant difference between the two groups in the number of patients discontinuing treatment due to adverse reactions = 2.72, 95% CI 0.51-14.54, P = 0.24). Conclusion: The efficacy of MX in the treatment of MS is better than that of placebo group. No serious adverse reactions have yet been found. However, long-term efficacy and safety still require large sample size and multi-center randomized controlled trials.