Mycophenolate Mofetil versus Cyclophosphamide for Induction Treatment of Lupus Nephritis
Mycophenolate Mofetil versus Cyclophosphamide for Induction Treatment of Lupus Nephritis
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DOI：
10.1681/asn.2008101028
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发表时间：
2009-05-01
影响因子：
13.6
通讯作者：
Wofsy, David
中科院分区：
文献类型：
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作者：
Appel, Gerald B.;Contreras, Gabriel;Wofsy, David
最近的研究表明，霉酚酸酯（MMF）可能提供优于静脉环磷酰胺（IVC）治疗狼疮肾炎，但这些疗法还没有在国际随机对照试验进行比较。在这里，我们报告了一项多国、两阶段（诱导和维持）研究中比较MMF和IVC作为活动性狼疮肾炎诱导治疗的结果。在一项为期24周的诱导研究中，我们将370例III至V型狼疮性肾炎患者随机分配至开放标签的MMF（目标剂量3 g/d）或IVC（每月0.5至1.0 g/m2）。两组均接受泼尼松治疗，从最大起始剂量60 mg/d开始逐渐减量。主要终点是预先设定的尿蛋白/肌酐比值降低和血清肌酐稳定或改善。次要终点包括肾完全缓解、全身疾病活动和损害以及安全性。总体而言，我们没有发现两组之间的反应率有显著差异：185例患者中有104例（56.2%）对MMF有反应，而185例患者中有98例（53.0%）对IVC有反应。治疗组间的次要终点也相似。MMF组有9例死亡，IVC组有5例死亡。在不良事件、严重不良事件或感染的发生率方面，我们没有发现MMF组和IVC组之间存在显著差异。尽管两个治疗组中的大多数患者都出现了临床改善，但该研究并未达到其主要目标，即表明作为狼疮性肾炎的诱导治疗，MMF优于IVC，这是上级的。
Recent studies have suggested that mycophenolate mofetil (MMF) may offer advantages over intravenous cyclophosphamide (IVC) for the treatment of lupus nephritis, but these therapies have not been compared in an international randomized, controlled trial. Here, we report the comparison of MMF and IVC as induction treatment for active lupus nephritis in a multinational, two-phase (induction and maintenance) study. We randomly assigned 370 patients with classes III through V lupus nephritis to open-label MMF (target dosage 3 g/d) or IVC (0.5 to 1.0 g/m(2) in monthly pulses) in a 24-wk induction study. Both groups received prednisone, tapered from a maximum starting dosage of 60 mg/d. The primary end point was a prespecified decrease in urine protein/creatinine ratio and stabilization or improvement in serum creatinine. Secondary end points included complete renal remission, systemic disease activity and damage, and safety. Overall, we did not detect a significantly different response rate between the two groups: 104 (56.2%) of 185 patients responded to MMF compared with 98 (53.0%) of 185 to IVC. Secondary end points were also similar between treatment groups. There were nine deaths in the MMF group and five in the IVC group. We did not detect significant differences between the MMF and IVC groups with regard to rates of adverse events, serious adverse events, or infections. Although most patients in both treatment groups experienced clinical improvement, the study did not meet its primary objective of showing that MMF was superior to IVC as induction treatment for lupus nephritis.