泼尼松联合环磷酰胺治疗系统性红斑狼疮的有效性和安全性系统评价与meta分析

目的 系统评价泼尼松联合环磷酰胺治疗系统性红斑狼疮的有效性与安全性。方法 计算机检索中国知网、万方、维普、PubMed及Cochrane Library，收集泼尼松联合环磷酰胺治疗系统性红斑狼疮的随机对照试验，检索期限为自建库起至2019年9月。由2位研究者独立进行文献筛选、资料提取，根据Cochrane协作网系统评价员手册的风险偏倚评价工具对纳入研究进行评价，采用RevMan 5.3软件进行meta分析。结果 共纳入7个随机对照试验，meta分析结果显示：在治疗系统性红斑狼疮时，相对于单用泼尼松，泼尼松联合环磷酰胺可提高总体有效率[RR=1.21，95%CI（1.13，1.30），P<0.000 01]，降低免疫球蛋白水平[IgA：MD=-0.68，95%CI（-0.91，-0.44），P<0.000 01；IgG：MD=-2.96，95%CI（-3.73，-2.19），P<0.000 01；IgM：MD=-0.48，95%CI（-0.53，-0.42），P<0.000 01]，提高补体水平[C3：MD=0.23，95%CI（0.17，0.29），P<0.000 01；C4：MD=0.11，95%CI（0.06，0.16），P<0.000 1]，降低血清炎性细胞因子水平[IL-6：MD=-9.17，95%CI（-11.24，-7.10），P<0.000 01；IL-10：MD=-16.53，95%CI（-17.06，-16.00），P<0.000 01；INF-α：MD=-1.98，95%CI（-3.90，-0.06），P=0.04]，且不会增加不良反应发生[RR=0.92，95%CI（0.55，1.52），P=0.73]。结论 泼尼松联合环磷酰胺可提高总体有效率，改善免疫功能，无严重不良反应。但本研究纳入文献数量和质量不高，仍需高质量、多中心的随机对照试验进一步验证。

Systematic Evaluation and Meta-analysis of Efficacy and Safety of Prednisone Combined with Cyclophosphamide in the Treatment of Systemic Lupus Erythematosus

OBJECTIVE To systematically evaluate the efficacy and safety of prednisone combined with cyclophosphamide in the treatment of systemic lupus erythematosus. METHODS CNKI, Wanfang, VIP, PubMed and Cochrane Library were searched by computer to collect randomized controlled trials of prednisone combined with cyclophospamide in the treatment of systemic lupus erythematosus from inception to September 2019. Literature screening and data extraction were independently conducted by two researchers. The included studies were evaluated according to the risk bias assessment tool in the Cochrane collaborative reviewers' manual, and meta analysis was performed in RevMan 5.3. RESULTS A total of 7 randomized controlled trials were included, and meta-analysis showed that in the treatment of systemic lupus erythematosus, prednisone combined with cyclophospamide could improve the overall effective rate[RR=1.21, 95%CI(1.13, 1.30), P<0.000 01], reduce the level of immunoglobulin[IgA:MD=-0.68, 95%CI(-0.91, -0.44), P<0.000 01; IgG:MD=-2.96, 95%CI(-3.73, -2.19), P<0.000 01; IgM:MD=-0.48, 95%CI(-0.53, -0.42), P<0.000 01], improve the level of complement[C3:MD=0.23, 95%CI(0.17, 0.29), P<0.000 01; C4:MD=0.11, 95%CI(0.06, 0.16), P<0.00 01], reduce the level of serum inflammatory cytokines[IL-6:MD=-9.17, 95%CI(-11.24, -7.10), P<0.000 01; IL-10:MD=-16.53, 95%CI(-17.06, -16.00), P<0.000 01; INF-α:MD=-1.98, 95%CI(-3.90, -0.06), P=0.04], no significant difference in the incidence of adverse reactions[RR=0.92, 95%CI(0.55, 1.52), P=0.73]. CONCLUSION Prednisone combined with cyclophosphamide can improve the overall efficiency and immune function without serious adverse reactions. However, the number and quality of the included studies are not high, which still need to be further verified by high-quality, multi-center randomized controlled trials.