Xu Jing, Zhang Wen, Xu Yaowen, Shen Pingyan, Ren Hong, Wang Weiming, Li Xiao, Pan Xiaoxia, Chen Nan
Department of Nephrology, Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, PR China.
Contrib Nephrol. 2013;181:152-62. doi: 10.1159/000348475. Epub 2013 May 8.
Although idiopathic membranous nephropathy (IMN) is the most common cause of adult-onset nephrotic syndrome, the management of IMN remains controversial. The aim of this prospective study was to compare the efficacy and drug safety of tacrolimus with that of cyclophosphamide (CTX; control group) in IMN patients receiving corticosteroid therapy. A total of 100 IMN patients with nephrotic syndrome were randomly assigned to receive a combination of corticosteroid therapy and either CTX or tacrolimus. During a follow-up period of at least 18 months, the remission rate after 2 months in the tacrolimus group was 65.1%, which was higher than that of the CTX group (44.2%) (p = 0.02). The mean time to partial or complete remission was 2.20 months in the tacrolimus group and 3.92 months in the CTX group (p < 0.001). We also found significantly greater improvements in the serum albumin levels in the tacrolimus group compared with the CTX group at the 2-month (p = 0.003) and 3-month time points (p = 0.01). The serum creatinine levels remained stable in both groups. Although remission was quicker and more common in the tacrolimus group (compared with the CTX group) before 3 months, there was no superiority of tacrolimus after 6 months. Glucose intolerance, urinary tract infections, and pneumonia were the major side effects observed in this study. All of the side effects were mild and controlled, and there were fewer side effects in the tacrolimus group compared with the CTX group, indicating a better treatment tolerance in the tacrolimus group.
尽管特发性膜性肾病（IMN）是成人肾病综合征最常见的病因，但IMN的治疗仍存在争议。这项前瞻性研究的目的是比较他克莫司与环磷酰胺（CTX；对照组）在接受糖皮质激素治疗的IMN患者中的疗效和药物安全性。总共100例患有肾病综合征的IMN患者被随机分配接受糖皮质激素治疗联合CTX或他克莫司。在至少18个月的随访期内，他克莫司组2个月后的缓解率为65.1%，高于CTX组（44.2%）（p = 0.02）。他克莫司组部分或完全缓解的平均时间为2.20个月，CTX组为3.92个月（p < 0.001）。我们还发现，在2个月（p = 0.003）和3个月时间点（p = 0.01）时，他克莫司组的血清白蛋白水平与CTX组相比有显著更大的改善。两组的血清肌酐水平均保持稳定。虽然在3个月前他克莫司组的缓解更快且更常见（与CTX组相比），但6个月后他克莫司组并无优势。葡萄糖不耐受、尿路感染和肺炎是本研究中观察到的主要副作用。所有副作用均较轻且可控，与CTX组相比，他克莫司组的副作用更少，表明他克莫司组的治疗耐受性更好。
