Tacrolimus versus Cyclophosphamide in Steroid-Dependent or Steroid-Resistant Focal Segmental Glomerulosclerosis: A Randomized Controlled Trial
Tacrolimus versus Cyclophosphamide in Steroid-Dependent or Steroid-Resistant Focal Segmental Glomerulosclerosis: A Randomized Controlled Trial
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他克莫司与环磷酰胺治疗类固醇依赖性或类固醇抵抗性局灶节段性肾小球硬化症：一项随机对照试验
DOI：
10.1159/000346256
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发表时间：
2013-01-01
影响因子：
4.2
通讯作者：
Chen, Nan
中科院分区：
文献类型：
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作者：
Ren, Hong;Shen, Pingyan;Chen, Nan
背景资料：前瞻性研究了他克莫司（TAC）和环磷酰胺（CTX）治疗激素依赖型或激素耐药型原发性局灶节段性肾小球硬化症（FSGS）的疗效和安全性。方法：选择经活检证实的FSGS患者，随机分为CTX组和TAC组。CTX（0.5- 0.75g/m2·月，静脉注射）治疗的患者接受泼尼松0.8 mg/kg.day，而接受TAC（0.1 mg/kg.天）治疗的患者接受泼尼松0.5 mg/kg.天。监测TAC的血浆浓度并维持在5-10 ng/ml。治疗6个月后，对患者进行评估。完全缓解（CR）和部分缓解（PR）的患者继续治疗12个月，剂量逐渐减少，而没有反应的患者被排除在研究之外，并接受替代治疗。结果：共招募了33例患者，27例完成了12个月的随访。TAC治疗的患者（n = 15）表现出快速缓解。初始缓解时间平均为1.23 ± 0.21个月，CTX组为2.21 ± 0.77个月（n = 18），但无显著差异（p > 0.05）。在6个月时，两组显示出相似的结果。两组各10例缓解（CR 7例，PR 3例）。12个月时，CTX组有9例CR和3例PR，而TAC组有6例CR和5例PR。TAC的缓解率倾向于高于CTX，但无差异。CTX患者的感染患病率较高（50.0 vs. TAC中的13.3%，p < 0.05）。相比之下，TAC治疗的患者显示高血糖症的发生率高（26.7% vs. CTX组0.0%，p < 0.05）。结论：这些结果表明，CTX和TAC对激素依赖性和激素耐药的FSGS具有相似的疗效，表现为减少蛋白尿，改善血清白蛋白水平和肾功能。版权所有（C）2013 S. Karger AG，巴塞尔
Background: The efficacy and safety of tacrolimus (TAC) and cyclophosphamide (CTX) were prospectively examined in steroid-dependent or steroid-resistant primary focal segmental glomerulosclerosis (FSGS). Methods: Patients with biopsy-proven FSGS were enrolled and randomly divided into two groups: CTX and TAC. Patients treated with CTX (0.5-0.75 g/m(2).month, i.v.) received prednisone at 0.8 mg/kg.day, while patients treated with TAC (0.1 mg/kg.day) received prednisone at 0.5 mg/kg.day. The plasma concentration of TAC was monitored and maintained at 5-10 ng/ml. After a 6-month treatment the patients were evaluated. Patients with complete remission (CR) and partial remission (PR) continued the treatment for 12 months with the dose tapered, whereas the patients with no response were excluded from the study and underwent an alternative treatment. Results: A total of 33 patients were recruited and 27 completed the 12-month follow-up. The TAC-treated patients (n = 15) showed a quick remission. The initial remission time averaged 1.23 +/- 0.21 versus 2.21 +/- 0.77 months in the CTX group (n = 18), but no significant difference was achieved (p > 0.05). At 6 months, the two groups showed a similar outcome. Ten patients from each group showed remission (7 CR and 3 PR). At 12 months, the CTX group had 9 CR and 3 PR while the TAC group had 6 CR and 5 PR. Remission rates in TAC tended to be higher than that in CTX, but there was no difference. CTX patients had a high prevalence of infections (50.0 vs. 13.3% in TAC, p < 0.05). In contrast, TAC-treated patients showed a high incidence of hyperglycemia (26.7 vs. 0.0% in CTX, p < 0.05). Conclusion: These results suggest that CTX and TAC had a similar efficacy in steroid-dependent and steroid-resistant FSGS as manifested by reduced proteinuria, improved serum albumin level and renal function. Copyright (C) 2013 S. Karger AG, Basel