霉酚酸酯与环磷酰胺比较治疗狼疮性肾炎的系统评价

Mycophenolate Mofetil versus Cyclophosphamide in Induction Therapy for Lupus Nephritis:A Systematic Review

目的系统评价霉酚酸酯和环磷酰胺诱导缓解治疗狼疮性肾炎的疗效和安全性。方法计算机检索MEDLINE、EMbase、SCIE、Cochrane Library、Cochrane临床对照试验注册资料库、CBM和CNKI等数据库,查找霉酚酸酯与环磷酰胺比较治疗狼疮性肾炎的随机对照试验(检索时间均从建库至2010年8月),按纳入排除标准选择文献、评价质量和提取有效数据后,采用RevMan 5.0软件进行Meta分析。结果共纳入8个随机对照试验,共773例患者。Meta分析结果显示,霉酚酸酯组总缓解率、完全缓解率高于环磷酰胺组[OR=1.49,95%CI(1.10,2.02);OR=1.67,95%CI(1.08,2.57)],但两组在部分缓解率、完成诱导治疗比例方面差异无统计学意义。两组在药物不耐受比例、感染和白细胞减少发生率方面差异无统计学意义,但霉酚酸酯组腹泻的发生率高于环磷酰胺组,差异有统计学意义[OR=2.99,95%CI(1.87,4.78)]。Ⅳ型狼疮性肾炎患者的Meta分析结果也显示了相似的结果。结论霉酚酸酯治疗狼疮性肾炎患者(Ⅲ型、Ⅳ型、Ⅴ型)的总诱导缓解疗效优于环磷酰胺,但腹泻发生率高于环磷酰胺。

Objective To assess the efficacy and safety of mycophenolate mofetil（MMF） versus cyclophosphamide（CTX） in the induction treatment for lupus nephritis（LN）.Methods Such databases as MEDLINE,EMBASE,SCIE,The Cochrane Library,the Cochrane Controlled Trials Register,CBM,and CNKI were searched from their establishment date to August of 2010 to retrieve the randomized controlled trials（RCTs） about MMF versus CTX for LN.The methodology quality of included studies was evaluated.The efficacy indexes i.e.the clinical total remission（TR）,complete remission（CR）,partial remission（PR）,pathological activity index,the chronicity index and complete induction therapy rate（CIR）,and the safety indexes i.e.the rate of patient intolerance-to-drug,the incidence of infection,leukopenia and diarrhea,were abstracted.Finally the Meta-analyses were conducted by using Cochrane Collaboration＇s RevMan 4.2.Results Eight RCTs involving 773 patients met the inclusive criteria.The results of meta-analyses showed that the total remission rate（OR=1.49,95%CI 1.10 to 2.02） and complete remission rate（OR=1.67,95%CI 1.08 to 2.57） were significantly higher in the MMF group than the CTX group.There was no significant difference in the rate of partial remission,the complete induction rate,the rate of patient intolerance-to-drug,the incidence of infection and leukopenia.However,the incidence of diarrhea was higher in the MMF group（OR=2.99,95%CI 1.87 to 4.78）.The results of meta-analyses for type IV LN were the same.Conclusion MMF is superior to CTX in the induction therapy to Lupus Nephritis（type III,IV,V）,but the incidence of diarrhea is higher.