环磷酰胺与霉酚酸酯治疗狼疮性肾炎疗效比较的系统评价

Comparision of cyclophosphamide versus mycophenolate mofetil in lupus nephritis:a systematic re-view

目的比较环磷酰胺的标准治疗与霉酚酸酯治疗狼疮性肾炎的有效性和安全性。方法检索Cochrane图书馆、MEDLINE、EMBASE、中国生物医学文献光盘数据库、中国循证医学/Cochrane中心数据库相关的随机对照试验,并进行meta分析。结果共纳入11个随机对照试验,meta分析显示霉酚酸酯治疗组的总有效率和完全缓解率高于环磷酰胺治疗组,两组复发率比较差异无统计学意义,环磷酰胺组的死亡率、感染率、闭经率均高于霉酚酸酯组,霉酚酸酯组的腹泻发生率高于环磷酰胺组。结论在应用糖皮质激素的基础上,霉酚酸酯治疗狼疮性肾炎的疗效至少与环磷酰胺相当,药物的总体不良反应轻于环磷酰胺。

Objectives To assess the effectiveness and safety of cyclophosphamide versus mycophenolate mofetil （MMF） in treatment of lupus nephritis. Methods The studies were identified by searching of the Coehrane Library, MEDLINE, EMBASE, CBM, and Chinese Cochrane Center Database. The studies were randomized trials with patients of World Health Organization （WHO） class III, IV, and V lupus nephritis, and in these studies the effectiveness of mycophenolate mofetil and cyclophosphamide in combination with corticosteroid was compared. The data were analyzed using the Cochrane Collaboration＇s RevMan 4.2. Results Eleven randomized controlled trials with total of 636 patients met the criteria were included. The meta analysis showed that the total clinical effective rate （RR = 0.86, 95%CI 0.78 to 0.95） and complete remission rate （RR = 0.77, 95%CI 0.65 to 0.92） were significantly higher for MMF than for cyclophosphamide when they were used in combination of corticosteroid. There was no significant difference in the relapse rate （RR = 1.23, 95%CI 0.71 to 2.14） between cyclophosphamide and MMF. Patient survival rate （RR = 3.21, 95%CI 1.05 to 9.75） for MMF was significantly higher than that for cyclophosphamide. The infection rate （RR = 2.09, 95%CI 1.48 to 2.94） and amenorrhea rate （RR = 7.37, 95%CI 2.99 to 18.18） for cyclophosamide were significantly higher those for MMF. The diarrhea rate （RR = 0.26, 95%CI 0.10 to 0.67） for MMF was signifi- cantly higher than that for cyclophosphamide. Conclusions MMF has the same efficacy and less side effects than cyclophosphamide in treatment of lupus nephritis when in combination with corticosteroid. If the patients with lupus nephritis can afford, MMF should be recommended. For the adolescent patients with lupus nephritis, MMF should be the first choice. However, results in most of the studies used in this paper were from adults patients not from children. More randomized, controlled clinical trials of large samples size are needed to evaluate the efficacy of MMF in children with lupus nephritis. Long-term follow-up are needed to determine its dosage in treatment and the maintenance treatment.