来氟米特治疗膜性肾病临床对照研究

Clinical trial on the effect of leflunomide in treating primary membranous nephropathy

目的观察来氟米特(LEF)联合激素治疗膜性肾病的临床疗效及安全性。方法将30例临床表现为肾病综合征,肾活检明确为原发性膜性肾病(PMN)的患者随机分为两组。LEF治疗组采用LEF联合泼尼松龙治疗,环磷酰胺(CTX),对照组采用间断静脉CTX冲击联合泼尼松龙治疗;动态观察疗效及不良反应发生情况。结果经过6个月和12个月的治疗,LEF治疗组完全缓解率分别为13.33%和20.00%,总有效率分别为60.00%和73.33%;CTX对照组完全缓解率均为6.67%,总有效率分别为33.33%和46.67%,两组间总有效率比较,差异有统计学意义(P<0.05)。LEF治疗组经过6个月和12个月的治疗,与治疗前相比尿蛋白呈非常显著下降,血浆清蛋白有非常显著回升(P<0.01),而CTX对照组尿蛋白量及血浆清蛋白水平虽然也有显著改善(P<0.05),但是改善程度不如LEF治疗组(P<0.05)。LEF治疗组出现反复1例,CTX对照组出现复发和反复各有1例。LEF治疗组发生轻度转氨酶升高及腹泻各1例,而CTX对照组发生带状疱疹及肺部感染各1例,白细胞减少、胃肠道症状及转氨酶升高各2例,LEF治疗组不良反应发生轻微,且不良反应发生率明显低于CTX对照组(P<0.05)。结论LEF联合激素治疗膜性肾病具有比环磷酰胺联合激素治疗更好的疗效,而且复发率低、不良反应小、耐受性好。。

Objective To investigate the efficacy and safety of leflunomide（LEF）combined prednisone in the treatment of primary membranous nephropathy（PMN）. Methods Thirty patients with PMN were divied into two groups randomly. Patients in the test group received LEF and prednisone. Patients in the control group received CTX and prednisone. Chnical data were observed in the 6^th and 12^th month. Results After receiving LEF therapy in the lest group,the proteinuria was decreased significantly（P〈0. 01 ） ;the serum albumin was increased significantly（P〈0. 01 ） ;the complete relieving rate was 20% ,and the total effective rate was 73.33%. Contrasted with the control group, the efficacy of the test group was more statisfactory （P〈0. 05 ）, and the side effect was milder（P〈0. 05 ）. Conclusion The efficacy of LEF combined prednisone in the treatment of PMN is better than that of CTX combined prednisone, and the side effect is milder.