霉酚酸酯治疗增生性狼疮肾炎的系统评价

Mycophenolate Mofetil for Proliferative Lupus Nephritis: A Systematic Review

目的评价在糖皮质激素基础上使用霉酚酸酯治疗增生性狼疮肾炎的有效性和安全性。方法计算机检索中国生物医学文献光盘数据库(1979．11～2006．2)、中国循证医学／Cochrane中心数据库(2005年)、Cochrane图书馆临床对照试验资料库(2005年第4期)、MEDLINE(1966．11～2006．2)、EMbase (1975～2006．2)和SCI(1985～2006．2)等数据库,收集霉酚酸酯治疗增生性狼疮肾炎的随机对照试验,对纳入研究的方法学质量进行评价。选择临床总有效率及完全缓解率作为近期疗效指标,肾脏存活率、患者生存率及狼疮肾炎复发率作为远期疗效指标,治疗期及随访期发生感染、闭经、白细胞减少、腹泻等副作用的患者比例作为安全性评价指标,提取数据并采用Cochrane协作网推荐的RevMan 4．2．7软件进行统计分析。结果共检索到符合纳入标准的随机对照试验9篇(512例)。对近期疗效指标的Meta分析结果显示,霉酚酸酯与环磷酰胺／硫唑嘌呤比较治疗临床疗效差异无统计学意义。肾脏存活率、肾病复发率的Meta分析结果显示,霉酚酸酯与环磷酰胺／硫唑嘌呤比较,其临床疗效差异无统计学意义。远期疗效指标和安全性评价各项指标的Meta分析提示,霉酚酸酯优于环磷酰胺／硫唑嘌呤。结论霉酚酸酯在改善增生性狼疮肾炎患者的近期疗效、肾脏存活率及防止肾病复发方面并不优于目前常规的环磷酰胺／硫唑嘌呤治疗,但在提高患者生存率及药物安全性方面可能优于后者。由于本系统评价纳入文献的方法学质量不够高,加之例数有限,尚需开展多中心、大样本随机双盲试验进一步证实霉酚酸酯的疗效和安全性。

Objective To assess the effectiveness and safety of mycophenolate mofetil （MMF） in the treatment of proliferative lupus nephritis. Methods We searched CBM （November 1979 to February 2006）, Chinese Cochrane Centre Database （2005）, The Cochrane Library （Issue 4, 2005）, MEDL1NE （November 1966 to February 2006） and EMBASE （1975 to February 2006） for randomize controlled trials. Data were extracted and analyzed using The Cochrane Collaboration＇s RevMan 4.2.7. Results Nine randomize controlled trials involving 512 patients met the inclusion criteria. The meta-analysis showed that the total clinical effective rate and complete remission rate were not significantly higher for MMF than for cyclophosphamide, azathioprine, or both. Renal survival rate and relapse rate of MMF were not significantly different from those for cyclophosphamide, azathioprine, or both. Patient survival rate and safety of MMF were significantly improved compared with cyclophosphamide, azathioprine, or both. Conclusion More large-scale multi-center randomized trials are needed to investigate the role of MMF in the treatment of proliferative lupus nephritis.