Efficacy of mycophenolate mofetil in patients with diffuse proliferative lupus nephritis
Efficacy of mycophenolate mofetil in patients with diffuse proliferative lupus nephritis
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DOI：
10.1056/nejm200010193431604
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发表时间：
2000-10-19
影响因子：
158.5
通讯作者：
Lai, KN
中科院分区：
文献类型：
--
作者：
Chan, TM;Li, FK;Lai, KN
背景资料：环磷酰胺和泼尼松龙联合治疗重症狼疮性肾炎有效，但有严重的不良反应。霉酚酸酯是否可以取代环磷酰胺是未知的。方法：在42例弥漫性增生性狼疮性肾炎，我们比较了泼尼松龙和霉酚酸酯的治疗方案的疗效和副作用给予12个月的泼尼松龙和环磷酰胺的治疗方案，6个月，其次是泼尼松龙和硫唑嘌呤6个月。完全缓解定义为每24小时尿蛋白排泄量小于0.3 g，尿沉渣正常，血清白蛋白浓度正常，血清肌酐和肌酐清除率不超过基线值的15%。部分缓解定义为每24小时尿蛋白排泄量在0.3和2.9 g之间，血清白蛋白浓度至少为3.0 g/dl。21例接受吗替麦考酚酯和泼尼松龙治疗的患者（第1组）中有81%完全缓解，14%部分缓解，而在21名接受环磷酰胺和泼尼松龙治疗的患者中，分别有76%和14%的患者接受硫唑嘌呤和泼尼松龙治疗（第2组）。两组蛋白尿程度、血清白蛋白和肌酐浓度的改善相似。每组各有一名患者因副作用而停止治疗。第1组中19%的患者和第2组中33%的患者出现感染（P=0.29）。其他不良反应仅发生在第2组;它们包括闭经（23%的患者），脱发（19%），白细胞减少（10%）和死亡（10%）。复发率分别为15%和11%，respectively.Conclusions：对于弥漫性增生性狼疮肾炎的治疗，霉酚酸酯和泼尼松龙的联合应用是一种有效的环磷酰胺和泼尼松龙的治疗方案，然后是硫唑嘌呤和泼尼松龙。（N Engl J Med 2000;343：1156-62.）(C)2000年马萨诸塞州医学会。
Background: The combination of cyclophosphamide and prednisolone is effective for the treatment of severe lupus nephritis but has serious adverse effects. Whether mycophenolate mofetil can be substituted for cyclophosphamide is not known.Methods: In 42 patients with diffuse proliferative lupus nephritis we compared the efficacy and side effects of a regimen of prednisolone and mycophenolate mofetil given for 12 months with those of a regimen of prednisolone and cyclophosphamide given for 6 months, followed by prednisolone and azathioprine for 6 months. Complete remission was defined as a value for urinary protein excretion that was less than 0.3 g per 24 hours, with normal urinary sediment, a normal serum albumin concentration, and values for serum creatinine and creatinine clearance that were no more than 15 percent above the base-line values. Partial remission was defined as a value for urinary protein excretion that was between 0.3 and 2.9 g per 24 hours, with a serum albumin concentration of at least 3.0 g per deciliter.Results: Eighty-one percent of the 21 patients treated with mycophenolate mofetil and prednisolone (group 1) had a complete remission, and 14 percent had a partial remission, as compared with 76 percent and 14 percent, respectively, of the 21 patients treated with cyclophosphamide and prednisolone followed by azathioprine and prednisolone (group 2). The improvements in the degree of proteinuria and the serum albumin and creatinine concentrations were similar in the two groups. One patient in each group discontinued treatment because of side effects. Infections were noted in 19 percent of the patients in group 1 and in 33 percent of those in group 2 (P=0.29). Other adverse effects occurred only in group 2; they included amenorrhea (in 23 percent of the patients), hair loss (19 percent), leukopenia (10 percent), and death (10 percent). The rates of relapse were 15 percent and 11 percent, respectively.Conclusions: For the treatment of diffuse proliferative lupus nephritis, the combination of mycophenolate mofetil and prednisolone is as effective as a regimen of cyclophosphamide and prednisolone followed by azathioprine and prednisolone. (N Engl J Med 2000;343:1156-62.) (C) 2000 Massachusetts Medical Society.