干扰素β对临床孤立综合征的疗效及安全性Meta分析

Efficacy and safety of interferon β in clinically isolated syndrome:a meta-analysis

目的评价干扰素β与安慰剂对照治疗临床孤立综合征(CIS)的有效性及安全性。方法采用Cochrane系统评价的方法,检索Cochrane图书馆、Medline、EMbase、中国生物医学文献数据库及中文全文期刊数据库(CNKI)关于干扰素β与安慰剂对照治疗CIS随机对照试验,对满足质量评价标准的文献,使用Cochrane协作网提供的RevMan4.2.10统计软件进行Meta分析。结果纳入干扰素β与安慰剂对照治疗CIS的随机对照试验4项,共计患者1362例,根据随机分配、分配方案隐藏及盲法描述三项指标进行文献质量评分,A级1项,B级3项,Meta分析结果显示,干扰素β治疗使CIS转化为临床确诊的多发性硬化(CDMS)发生率的RR值为0.64,P<0.01。流感样症状发生的RR值为1.88,P<0.05;注射部位异常反应发生的RR值为5.28,P<0.01。发热发生的RR值为2.55,P<0.05;肌痛发生的RR值为1.87,P<0.05;白细胞减少发生的RR值为3.19,P<0.01;转氨酶升高发生的RR值为4.69,P<0.01;而抑郁发生的RR值为1.22,P=0.26;寒战发生的RR值为1.51,P=0.35,尚不能认为两组间差异有统计学意义。结论干扰素β治疗使CIS转化为CDMS的发生率降低;不良事件以干扰素β治疗组更为常见。

Objective To evaluate the efficacy and safety of interferon β in patients with clinically isolated syndrome （CIS）, compared with placebo. Methods According to evaluation guidelines of Cochrane Collaboration, randomized controlled trials （RCTs） comparing Interferon β and placebo in CIS were searched using the Cochrane Library （Central）, MEDLINE and EMBase. A number of Chinese neurological journals were also retrieved manually. In addition, the quality of methodology in those trials was critically assessed. We used the RevMan 4.2.10 software provided by Cochrane Collaboration for data analysis. Results Four RCTs with interferon-beta and placebo control on CIS were included, involving 1362 patients. All included studies were graded in terms of randomization, allocation and blinding. One study was graded level A and the other three graded level B. Meta-analysis showed less progression from CIS to CDMS among patients on interferon-beta than those on placebo （RR 0.64, P〈0.01）. Compared with placebo, more adverse effects were also found with the interferon-beta group. These included flu-like syndromes （RR 1.88, P〈 0.05）, injection site reaction （RR 5.28, P〈0.01）, fever （RR 2.55, P〈0.01）, myalgia （RR 1.87, P〈0.05）, leukopenia （RR 3.19, P〈0.01） and increased aminotransferase （RR 4.69, P〈0.01）. There were no significant differences in the risk of depression （RR 1.22, P=0.26） and chills （RR 1.51, P=0.35） between the two groups. Conclusion （1）Treatment with interferon beta led to less progression from CIS to CDMS. （2）Adverse effects were more frequent among patients on interferon beta than those on placebo.