Chan Tak-Mao, Tse Kai-Chung, Tang Colin Siu-On, Mok Mo-Yin, Li Fu-Keung
Department of Medicine, University of Hong Kong, Queen Mary Hospital, New Clinical Building, Room 303, Pokfulam Road, Hong Kong.
J Am Soc Nephrol. 2005 Apr;16(4):1076-84. doi: 10.1681/ASN.2004080686. Epub 2005 Feb 23.
Mycophenolate mofetil (MMF) and the sequential use of cyclophosphamide followed by azathioprine (CTX-AZA) demonstrate similar short-term efficacy in the treatment of diffuse proliferative lupus nephritis (DPLN), but MMF is associated with less drug toxicity. Results from an extended long-term study, with median follow-up of 63 mo, that investigated the role of MMF as continuous induction-maintenance treatment for DPLN are presented. Thirty-three patients were randomized to receive MMF, and 31 were randomized to the CTX-AZA treatment arm, both in combination with prednisolone. More than 90% in each group responded favorably (complete or partial remission) to induction treatment. Serum creatinine in both groups remained stable and comparable over time. Creatinine clearance increased significantly in the MMF group, but the between-group difference was insignificant. Improvements in serology and proteinuria were comparable between the two groups. A total of 6.3% in the MMF group and 10.0% of CTX-AZA-treated patients showed doubling of baseline creatinine during follow-up (P = 0.667). Both the relapse-free survival and the hazard ratio for relapse were similar between MMF- and CTX-AZA-treated patients (11 and nine patients relapsed, respectively) and between those with MMF treatment for 12 or >/=24 mo. MMF treatment was associated with fewer infections and infections that required hospitalization (P = 0.013 and 0.014, respectively). Four patients in the CTX-AZA group but none in the MMF group reached the composite end point of end-stage renal failure or death (P = 0.062 by survival analysis). It is concluded that MMF and prednisolone constitute an effective continuous induction-maintenance treatment for DPLN in Chinese patients.
霉酚酸酯（MMF）以及环磷酰胺序贯硫唑嘌呤（CTX-AZA）在治疗弥漫性增殖性狼疮性肾炎（DPLN）方面显示出相似的短期疗效，但MMF的药物毒性较小。本文呈现了一项长期扩展研究的结果，该研究对MMF作为DPLN持续诱导 - 维持治疗的作用进行了调查，中位随访时间为63个月。33例患者被随机分配接受MMF治疗，31例被随机分配至CTX-AZA治疗组，两组均联合泼尼松龙治疗。每组超过90%的患者对诱导治疗反应良好（完全或部分缓解）。两组血清肌酐随时间保持稳定且相当。MMF组肌酐清除率显著增加，但组间差异不显著。两组在血清学和蛋白尿改善方面相当。MMF组6.3%的患者以及CTX-AZA治疗组10.0%的患者在随访期间基线肌酐翻倍（P = 0.667）。MMF治疗组和CTX-AZA治疗组患者的无复发生存率和复发风险比相似（分别有11例和9例复发），MMF治疗12个月或≥24个月的患者之间也是如此。MMF治疗相关的感染及需要住院治疗的感染较少（分别为P = 0.013和0.014）。CTX-AZA组有4例患者达到终末期肾衰竭或死亡的复合终点，而MMF组无患者达到（生存分析P = 0.062）。结论是，MMF和泼尼松龙对中国DPLN患者构成一种有效的持续诱导 - 维持治疗方案。
