来氟米特联合泼尼松治疗难治性原发性肾病综合征的随机对照试验

目的:观察长程应用来氟米特联合泼尼松治疗难治性原发性肾病综合征的疗效。方法:60例激素治疗难治性肾病综合征病人随机分为2组,每组30例。试验组予来氟米特联合泼尼松治疗,对照组予麦考酚酸酯联合泼尼松治疗,疗程均为12 mo。观察治疗后2组疗效与不良反应,并于治疗后3,6,9和12 mo检查血清蛋白、尿蛋白定量、肾小球滤过率等指标。结果:2组治疗12 mo后,24 h尿蛋白均下降,其中试验组在治疗后3 mo尿蛋白定量与对照组有显著差异(P<0．05),其余时间点2组尿蛋白无显著差异(P>0．05);而血清蛋白与肾小球滤过率均有不同程度升高,各时间点2组无显著差异(P>0．05)。试验组有效率87％(16／30),对照组为93％(28／30),2组疗效差异无显著意义(P>0．05)。治疗3 mo时,试验组有效率高于对照组(P<0．05)。试验组不良反应发生率33％,对照组10％,差异显著(P< 0．05)。结论:来氟米特联合泼尼松能够有效缓解难治性肾病综合征。

Leflunomide combined with prednisone in treatment of refractory primary nephrotic syndrome: a randomized controlled trial

AIM: To investigate the efficacy of leflunomide combined with prednisone in the long term treatment of refractory primary nephrotic syndrome. METHODS: Sixty refractory primary nephrotic patients were devided into two groups randomly with 30 for each. The patients in trial group accepted leflunomide and prednisone, while those in control group accepted mycophenolate mofetil and prednisone, with a same course of 12 mo duration. The adverse reactions and the concerned efficacies including serum albumin, proteinuria and glomercular filtration rate etc. were observed in the period of 1, 3, 6, 9, 12 mo after the treatment. RESULTS: After 12 mo therapy, proteinuria of 24 h in both groups both decreased, especially in trial group at mo 3 was much lower than that in control group (P < 0.05), but no significant difference in other time periods (P > 0.05). Serum albumin and glomercular filtration rate improved more or less, however with no significant difference in different time periods between the two groups (P > 0.05). The efficacy rates of trial and control groups were 87 % (16/30) and 93 % (28/30), showing no remarkable difference clinically between them (P > 0.05), but the former was higher than that of the latter at mo 3 after the treatment (P < 0.05). The adverse reaction rate in trial and control groups were 33 % and 10 %, with significant different (P < 0.05) . CONCLUSION: Leflunomide combined with prednisone possesse effective relief in treating refractory nephrotic syndrome.