Tacrolimus monotherapy in membranous nephropathy:: A randomized controlled trial
Tacrolimus monotherapy in membranous nephropathy:: A randomized controlled trial
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DOI：
10.1038/sj.ki.5002215
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发表时间：
2007-05-01
影响因子：
19.6
通讯作者：
Luno, J.
中科院分区：
文献类型：
--
作者：
Praga, M.;Barrio, V.;Luno, J.
膜性肾病是成人肾病综合征的常见原因。尽管一些膜性肾病患者达到自发缓解，但其他患者的肾功能继续恶化。我们进行了一项前瞻性随机试验，评估他克莫司单药治疗对活检证实的膜性肾病患者实现完全或部分缓解的效果。 25 名患者接受他克莫司（0.05mg/kg/天）治疗超过 12 个月，并在 6 个月内逐渐减量，而对照组有 23 名患者。 6、12 和 18 个月后，治疗组的缓解概率分别为 58%、82% 和 94%，而对照组仅为 10%、24% 和 35%。治疗组蛋白尿的下降明显更大。值得注意的是，对照组有 6 名患者，治疗组只有 1 名患者达到了血清肌酐增加 50% 的次要终点。他克莫司组中没有患者在减量期间出现复发。在他克莫司停药后第 18 个月缓解的患者中，近一半的患者再次出现肾病综合征。我们的结论是，他克莫司对于膜性肾病和保留肾功能的患者来说是一种非常有用的治疗选择。大多数患者的病情得到缓解，肾功能恶化的风险显着降低。
Membranous nephropathy is a common cause of nephrotic syndrome in adults. Although some patients with membranous nephropathy achieve a spontaneous remission, renal function continues to deteriorate in others. We conducted a prospective randomized trial evaluating monotherapy with tacrolimus to achieve complete or partial remission in patients with biopsy- proven membranous nephropathy. Twenty-five patients received tacrolimus (0.05mg/kg/day) over 12 months with a 6-month taper, whereas 23 patients were in the control group. The probability of remission in the treatment group was 58, 82, and 94% after 6, 12, and 18 months but only 10, 24, and 35%, respectively in the control group. The decrease in proteinuria was significantly greater in the treatment group. Notably, six patients in the control group and only one in the treatment group reached the secondary end point of a 50% increase in their serum creatinine. No patient in the tacrolimus group showed a relapse during the taper period. Nephrotic syndrome reappeared in almost half of the patients who were in remission by the 18th month after tacrolimus withdrawal. We conclude that tacrolimus is a very useful therapeutic option for patients with membranous nephropathy and preserved renal function. The majority of patients experienced remission with a significant reduction in the risk for deteriorating renal function.