环孢素和他克莫司治疗特发性膜性肾病伴肾病综合征患者的效果及安全性

Efficacy and safety of cyclosporine A versus tacrolimus treatment for nephrotic idiopathic membranous nephropathy

目的探讨环孢素联合泼尼松(CsA/GC)对他克莫司联合泼尼松(TAC/GC)治疗特发性膜性肾病(idiopathic membranous nephropathy,IMN)伴肾病综合征患者的效果及安全性。方法选取139例(CsA/GC组78例,TAC/GC组61例)肾活检证实的IMN伴肾病综合征患者。评估两组患者治疗效果及不良反应。结果随访中位时间CsA/GC组和TAC/GC组分别(13.5 vs 16.0)个月。CsA/GC组2例(2.6%)失访。随访结束时两组总缓解率相似(89.7%vs 85.4%,P>0.05)。TAC/GC组达部分缓解所需时间短于CsA/GC组、需要较大剂量维持缓解的患者比例低于CsA/GC组(6.0 vs 8.5)个月和(21.3%vs 38.5%)(均P<0.05);无牙龈增生(0.0%vs 7.7%,P<0.05)。两组复发率相似(19.2%vs 26.2%,P>0.05)。两组肾损害发生率为25.6%和24.6%,需住院治疗的感染、肝酶升高差异无统计学意义(均P>0.05)。TAC/GC组2例药物性糖尿病;CsA/GC组2例深静脉血栓。结论低剂量环孢素和他克莫司均能有效地治疗IMN。他克莫司达部分缓解更快、需要应用较大剂量维持缓解的患者比例低、没有牙龈增生;但其对糖代谢的影响应该引起临床关注。

Objective A retrospective cohort study was conducted to evaluate the efficacy and safety of cyclosporine combined with prednisone(CsA/GC)in tacrolimus combined with prednisone(TAC/GC)in the treatment of idiopathic membranous nephropathy(IMN)with nephrotic syndrome.Methods A total of 139 patients with IMN patients with nephrotic syndrome confirmed by renal biopsy were enrolled in this study.Seventy eight patients were in the CsA/GC group and sixty one belong TAC/GC group.The therapeutic effect and adverse events in the two groups were assessed.Results The median follow-up time was(13.5 vs 16.0)months in the CsA/GC group and TAC/GC group.Two cases(2.6%)in CsA/GC group were lost to follow-up.At the end of follow-up,the overall remission rates were similar between two groups(89.7%vs 85.4%,P>0.05).Compared with the CsA/GC group,the TAC/GC group needed less time to achieve partial remission and larger doses to maintain remission was significantly lower[(6.0 vs 8.5)months and(21.3%vs 38.5%),both P<0.05],respectively.No gingival hyperplasia(0.0%vs 7.7%,P<0.05).The relapse rates were similar between two groups(19.2%vs 26.2%,P>0.05).The incidence of renal damage in two groups was 25.6%and 24.6%,and there were no statistically significant differences between two groups in infection of requiring hospitalization,and liver enzyme elevation(all P>0.05).Two cases of drug diabetes mellitus in TAC/GC group.There were 2 cases of deep vein thrombosis in CsA/GC group.Conclusion Both low dose cyclosporine and tacrolimus can effectively treat IMN.Tacrolimus had a faster partial remission,a lower proportion of patients who needed a larger dose to maintain remission,and no gingival hyperplasia.But its effect on glucose metabolism should cause clinical concern.