甲氨蝶呤治疗系统性红斑狼疮疗效及安全性的Meta分析

Meta-analysis of efficacy and safety of methotrexate for systemic lupus erythematosus

目的采用循证医学的方法评价小剂量甲氨蝶呤治疗系统性红斑狼疮的疗效及安全性。方法计算机检索PubMed、EMbase、Cochrane、CNKI、维普、万方数据库,收集常规治疗联合甲氨蝶呤(试验组)对比常规治疗加或不加安慰剂(对照组)治疗系统性红斑狼疮的随机对照试验(RCT)。提取相关资料并按照Cochrane系统评价手册对纳入文献进行质量评价,采用RevMan 5.3软件对提取的数据进行Meta分析。结果共纳入8项RCT研究,共513例患者。Meta分析结果显示,与对照组相比,试验组在降低SLEDAI活动评分[MD=-0.84,95%CI(-1.31^-0.36),P<0.001]、降低激素使用剂量(P<0.05)、抗双链DNA滴度(P<0.05)、红细胞沉降率(ESR)[MD=-5.25,95%CI(-8.03^-2.48),P<0.001]、升高补体C3[MD=0.11,95%CI(0.07~0.15),P<0.001]及补体C4(P<0.05)方面均优于对照组,差异有统计学意义。试验组与对照组的不良反应发生率比较,差异无统计学意义[OR=0.72,95%CI(0.17~3.08),P=0.66]。结论在常规治疗的基础上加用甲氨蝶呤治疗系统性红斑狼疮疗效显著,能降低SLEDAI活动评分,减少激素用量,降低抗双链DNA滴度及红细胞沉降率,升高补体C3、C4,且不增加不良反应发生率。

Objective To systematically evaluate the efficacy and safety of low-dose methotrexate for systemic lupus erythematosus.Methods Retrieved from PubMed,EMbase,Cochrane Library,CNKI,Web of Science and Wanfang database,randomized controlled trials(RCTs)about methotrexate combined with routine treatment plan(the trial group)versus routine treatment plan with or without placebo(the control group)for systemic lupus erythematosus were collected.After data extraction and quality evaluation with Cochrane system evaluator manual,meta-analysis was conducted with Rev Man 5.3 statistical software.Results Eight RCT studies were included,involving 513 patients.Meta-analysis showed that the reduction of SLEDAI activity score[MD=-0.84,95%CI(-1.31 to-0.36),P<0.001],hormone dosage(P<0.05),anti-double stranded DNA titer(P<0.05)and erythrocyte sedimentation rate[MD=-5.25,95%CI(-8.03 to-2.48),P<0.001],increase of the complement C3[MD=0.11,95%CI(0.07-0.15),P<0.001]and complement C4(P<0.05)were significantly better than those of the control group.There was no statistical difference in the incidence of adverse reactions between the experimental group and the control group[OR=0.72,95%CI(0.17-3.08),P=0.66].Conclusion Methotrexate has good efficacy for systemic lupus erythematosus,which reduces SLEDAI activity score,hormone dosage,anti-double stranded DNA titer,erythrocyte sedimentation rate and increase in complement C3 and C4,without increasing the adverse reactions.