摘要
目的:总结近年来霉酚酸酯(MMF)在治疗增殖性狼疮性肾炎(PLN)中的随机对照试验(RCTs),采用Meta分析法评估MMF在治疗PLN中的作用及其不良反应,为PLN临床治疗提供指导。方法:制定原始文献的纳入标准、排除标准及检索策略,在美国医学索引、荷兰医学文摘及Cochrane图书馆内进行相关的随机对照试验检索、质量评价和资料提取。所有经肾活检证实Ⅲ、Ⅳ、Ⅴb型狼疮性肾炎的RCTs患者纳入研究,研究指标包括:临床总有效率(完全缓解和部分缓解)率、死亡率、终末期肾病(ESRD)发生率、复发率、感染率、胃肠道反应率、带状疱疹发生率、闭经发生率和白细胞减少发生率。应用RevMan4.2.8软件进行数据处理;计数资料的效应尺度以相对危险度(RR)及其95%可信区间(95%CI)表示。结果:符合纳入标准的307例PLN患者Meta分析结果显示,在诱导治疗期间,MMF组的临床缓解率、完全缓解率显著高于环磷酰胺(CTX)组(RR1.51/3.23,P<0.05),延长观察后MMF组患者比CTX组预后(ESRD和死亡)好(RR0.43,P<0.01),而且可降低感染(RR0.69,P<0.01)和白细胞减少症(RR0.66,P<0.05)的发生率;在维持性治疗期间,与硫唑嘌呤(Aza)相比,MMF未能改善PLN患者的预后(包括死亡率、复发、ESRD、肌酐翻倍),也未能降低不良反应绝经的发生率。结论:MMF诱导缓解PLN的疗效及不良反应(感染和白细胞减少症),均优于间断静脉CTX冲击治疗;在维持性疗效与Aza相仿。
Objective： In this systematic review of randomized controlled trials （RCTs） , we assess the benefits and side effects of mycophenolate mofetil （MMF） for proliferative lupus nephritis （PLN）. Methodology：The Cochrane Controlled TrialRegistry, MEDLINE, and EMBASE were searched for RCTs of treatment for PLN. All available RCTs of patients with biopsy-proven PLN were included, and data were extracted for remission （ including complete and partial remission）, overall mortality, end-stage renal disease, relapse, major infection, herpes zoster infection, amenorrhea, gastrointestinal symptoms and leukopenia. The software RevMan 4.2.8 was used to review management and data analysis. The results were expressed as RR and 95 % confidence intervals （CI） for categorical outcomes. Results：Four articles identified were eligible RCTs and were included. The majority compared MMF plus steroids versus cyclophosphamide （CTX） in induction therapy or azathioprine （Aza） plus steroids in maintenance therapy. Compared with pulse intravenous therapy with CTX plus steroids in induction therapy, MMF plus steroids increased the clinical remission （RR 1.51, P 〈 0.05 ） , complete remission significantly （ RR 3.23, P 〈 0.05 ）. It also significantly reduced the risk for the composite outcome of death or end-stage renal disease （ RR 0. 43, P 〈 0.01 ）, infection （ RR 0.69, P 〈 0. 01 ） and leukopenia （ RR 0.66, P 〈 0. 05）. Compared with Aza plus steroids in maintenance therapy, MMF plus steroids did not reduced the risk for all-cause mortality and amenorrhea and had no effect on renal outcomes（ ESRD, renal flare, death and serum creatinine doubling）. Conclusion：MMF was more effective than pulse intravenous CTX therapy in clinical remission of PLN and had fewer side effects during induction therapy. There was no significant difference between MMF and Aza in reducing the risk of ESRD, renal flare, death and serum creatinine doubling during maintenance therapy.
出处
《肾脏病与透析肾移植杂志》
CAS
CSCD
2007年第5期426-434,共9页
Chinese Journal of Nephrology,Dialysis & Transplantation
