Randomized controlled trial of pulse intravenous cyclophosphamide versus mycophenolate mofetil in the induction therapy of proliferative lupus nephritis
Randomized controlled trial of pulse intravenous cyclophosphamide versus mycophenolate mofetil in the induction therapy of proliferative lupus nephritis
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DOI：
10.1111/j.1440-1797.2005.00444.x
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发表时间：
2005-10-01
期刊：
影响因子：
2.5
通讯作者：
Morad, Z
中科院分区：
文献类型：
--
作者：
Ong, LM;Hooi, LS;Morad, Z
背景：本研究的目的是评价霉酚酸酯诱导治疗增殖性狼疮性肾炎的疗效。方法：来自8个中心的44名新诊断为世界卫生组织III类或IV类狼疮性肾炎的患者随机分配到霉酚酸酯（MMF） 2 g/天，持续6个月或静脉注射环磷酰胺（IVC） 0.75-1 g/m(2)，每月6个月。结果：IVC组25例患者中有13例（52%）缓解，MMF组19例患者中有11例（58%）缓解（P = 0.70）。IVC组和MMF组分别有12%和26%的患者达到完全缓解（P = 0.22）。血红蛋白、红细胞沉降率、血清白蛋白、血清补体、蛋白尿、尿活动、肾功能和系统性红斑狼疮疾病活动指数评分的改善在两组中相似。治疗结束时24例随访肾活检显示两组患者活动评分显著降低。两组慢性指数均升高，但仅IVC组明显升高。不良事件相似。两组各有3例患者发生重大感染。在胃肠道副作用方面没有差异。结论：MMF联合皮质类固醇是治疗中重度增殖性狼疮性肾炎的有效诱导疗法。
Background: The aim of the present study was to evaluate the efficacy of mycophenolate mofetil in the induction therapy of proliferative lupus nephritis.Methods: Forty-four patients from eight centres with newly diagnosed lupus nephritis World Health Organization class III or IV were randomly assigned to either mycophenolate mofetil (MMF) 2 g/day for 6 months or intravenous cyclophosphamide (IVC) 0.75-1 g/m(2) monthly for 6 months in addition to corticosteroids.Results: Remission occurred in 13 out of 25 patients (52%) in the IVC group and 11 out of 19 patients (58%) in the MMF group (P = 0.70). There were 12% in the IVC group and 26% in the MMF group that achieved complete remission (P = 0.22). Improvements in haemoglobin, the erythrocyte sedimentation rate, serum albumin, serum complement, proteinuria, urinary activity, renal function and the Systemic Lupus Erythematosus Disease Activity Index score were similar in both groups. Twenty-four follow-up renal biopsies at the end of therapy showed a significant reduction in the activity score in both groups. The chronicity index increased in both groups but was only significant in the IVC group. Adverse events were similar. Major infections occurred in three patients in each group. There was no difference in gastrointestinal side-effects.Conclusions: MMF in combination with corticosteroids is an effective induction therapy for moderately severe proliferative lupus nephritis.