Miao Lining, Sun Jing, Yuan Hang, Jia Ye, Xu Zhonggao
Department of Nephrology, Second Hospital, Jilin University School of Medicine, Changchun, China.
Nephrology (Carlton). 2006 Oct;11(5):449-54. doi: 10.1111/j.1440-1797.2006.00667.x.
Tacrolimus is a calcineurin inhibitor that has been increasingly used in transplant medicine. However, the efficacy and safety of combined therapy of low-dose tacrolimus and prednisone in the treatment of nephrotic syndrome (NS) with slight mesangial proliferation has not been reported.
Sixty patients with NS with slight mesangial proliferation were randomly divided into a prednisone therapy group (control), a combined low-dose tacrolimus (2 mg/day) and a prednisone therapy group (tacrolimus group). The efficacy and safety of tacrolimus was analysed. The initial dose of prednisone was 1 mg/kg per day and 30 mg/day in the control group and tacrolimus group, respectively. The duration of treatment was 6 months.
After a 6-month trial of combined low-dose tacrolimus and prednisone, complete remission was achieved in 29 patients (96.66%) and partial remission in one patient (3.33%). In the control group, complete remission was achieved in 27 patients (90%) and partial remission in three patients (10%). A significant improvement in proteinuria levels was observed in the tacrolimus group compared with the control group, starting at the second week and remaining throughout the study period. Furthermore, a significant improvement in serum albumin levels was observed in the tacrolimus group compared with the control group, starting at the first month and remaining until the third month. The main side-effect was obesity (100%) and acne (46.66%) in the control group. However, these adverse events were not observed in the tacrolimus group.
The results demonstrated that combined therapy of low-dose tacrolimus and prednisone is an effective and safe therapeutic method for NS with slight mesangial proliferation.
他克莫司是一种钙调神经磷酸酶抑制剂，已越来越多地应用于移植医学。然而，低剂量他克莫司与泼尼松联合治疗轻度系膜增生性肾病综合征（NS）的疗效和安全性尚未见报道。
60例轻度系膜增生性NS患者被随机分为泼尼松治疗组（对照组）、低剂量他克莫司（2mg/天）与泼尼松联合治疗组（他克莫司组）。分析他克莫司的疗效和安全性。对照组和他克莫司组泼尼松的初始剂量分别为1mg/（kg·天）和30mg/天。治疗持续时间为6个月。
低剂量他克莫司与泼尼松联合治疗6个月后，29例患者（96.66%）达到完全缓解，1例患者（3.33%）达到部分缓解。对照组中，27例患者（90%）达到完全缓解，3例患者（10%）达到部分缓解。与对照组相比，他克莫司组蛋白尿水平从第2周开始有显著改善，并在整个研究期间持续存在。此外，与对照组相比，他克莫司组血清白蛋白水平从第1个月开始有显著改善，并持续到第3个月。对照组的主要副作用是肥胖（100%）和痤疮（46.66%）。然而，他克莫司组未观察到这些不良事件。
结果表明，低剂量他克莫司与泼尼松联合治疗是轻度系膜增生性NS的一种有效且安全的治疗方法。
