Li Xiayu, Li Heng, Chen Jianghua, He Qiang, Lv Rong, Lin Weiqin, Li Qun, He Xuelin, Qu Lihui, Suya Wang
Kidney Disease Center, The First Affiliated Hospital, College of Medicine, Zhejiang University, #79 Qingchun Road, Hangzhou, Zhejiang Province 310003, People's Republic of China.
Nephrol Dial Transplant. 2008 Jun;23(6):1919-25. doi: 10.1093/ndt/gfm637. Epub 2007 Oct 1.
Treatment of adults with steroid-dependent minimal change nephrotic syndrome (SD-MCNS) can be a significant challenge. Cyclophosphamide (CYC) and cyclosporin (CYA) are often effective steroid-sparing agents. Tacrolimus (TAC) may be another treatment option.
This open, prospective cohort study enrolled Chinese adults with SD-MCNS. At the start of the study, we administered TAC or intravenous CYC together with prednisone (0.5 mg/kg/day), the dose of which was tapered off throughout the study. The TAC cohort received oral TAC (target trough blood level of 4-8 ng/ml) for 24 weeks and the CYC cohort received intravenous CYC (750 mg/m(2) body surface) once every 4 weeks for 24 weeks.
Twenty-six patients met the criteria for enrollment (14 patients in the CYC group and 12 patients in the TAC group). One patient from each group discontinued treatment because of a drug-related side effect. Complete remission (CR) after the 24-week therapeutic period was 76.9% (10/13) in the CYC group and 90.9% (10/11) in the TAC group. The mean time required for CR in the TAC group was significantly less than in the CYC group (P = 0.031). Eight of 13 (61.5%) patients in the CYC group and 8 of 11 (72.7%) patients in the TAC group successfully stopped steroids and changed their status from steroid dependence. Sixty percent (6/10) of the CYC patients and 50% (5/10) of the TAC patients who achieved CR maintained remission during the follow-up period of 23.0 +/- 10.1 months. Four (40%) CYC patients and five (50%) TAC patients experienced relapses, and two CYC patients experienced frequent relapses.
A 24-week course of TAC is a favorable steroid-sparing agent for treatment of Chinese adults with SD-MCNS. Therapy with TAC accompanied by a tapering dose of prednisolone appears to yield quicker remission than treatment with CYC together with prednisone.
治疗成年激素依赖型微小病变肾病综合征（SD-MCNS）可能是一项重大挑战。环磷酰胺（CYC）和环孢素（CYA）通常是有效的激素替代药物。他克莫司（TAC）可能是另一种治疗选择。
这项开放性前瞻性队列研究纳入了患有SD-MCNS的中国成年人。在研究开始时，我们给予TAC或静脉注射CYC以及泼尼松（0.5mg/kg/天），在整个研究过程中逐渐减少泼尼松的剂量。TAC组接受口服TAC（目标谷血浓度为4-8ng/ml）24周，CYC组每4周接受一次静脉注射CYC（750mg/m²体表面积），共24周。
26例患者符合入组标准（CYC组14例，TAC组12例）。每组各有1例患者因药物相关副作用而停止治疗。24周治疗期后的完全缓解（CR）率在CYC组为76.9%（10/13），在TAC组为90.9%（10/11）。TAC组达到CR所需的平均时间显著短于CYC组（P = 0.031）。CYC组13例患者中有8例（61.5%），TAC组11例患者中有8例（72.7%）成功停用激素并从激素依赖状态转变。达到CR的CYC组患者中有60%（6/10），TAC组患者中有50%（5/10）在23.0±10.1个月的随访期内维持缓解。4例（40%）CYC组患者和5例（50%）TAC组患者复发，2例CYC组患者频繁复发。
24周疗程的TAC是治疗中国成年SD-MCNS患者的一种良好的激素替代药物。与泼尼松联合CYC治疗相比，TAC联合逐渐减量的泼尼松龙治疗似乎能更快地诱导缓解。
