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目的:本文前瞻性地观察了雷公藤多苷联合小剂量泼尼松治疗特发性膜性肾病的临床疗效和安全性,并与他克莫司联合小剂量泼尼松进行比较。方法:2010年7月至2012年3月经肾活检诊断为特发性膜性肾病的患者(<65岁,性别不限)(尿蛋白>3.5 g/24h),随机进入雷公藤多苷联合小剂量泼尼松组(TW组)和他克莫司联合小剂量泼尼松组(FK506组)。主要疗效指标为治疗12月内的累计有效率(即完全缓解率+部分缓解率)。次要指标包括治疗6月的累计有效率,治疗6月、12月的完全缓解率,停药后的复发率及安全性。结果:共100例患者入组,每组各50例。治疗12月,TW组和FK506组累计有效率分别为76.9%和79.9%(率差3%,95%CI:-18.7%~21.3%)。TW组和FK506组治疗6月和12月的完全缓解率分别为8.8%vs 10.6%和31.7%vs 33.7%。平均复发时间TW组vs FK506组:14.08月vs 13.01月,P=0.049。FK506组血清肌酐倍增(6%vs2%)及新发高血压(24%vs 8%)较TW组高,TW组育龄期女性月经紊乱发生率显著高于FK506组(7/7 vs 0/10)。结论:雷公藤多苷联合小剂量泼尼松能有效降低膜性肾病患者蛋白尿,与他克莫司联合小剂量泼尼松相比缓解率及平均缓解时间相当,停药后复发率更低,治疗过程中血清肌酐倍增患者更少。
AIM: To prospectively observe the clinical efficacy and safety of tripterygium glycosides combined with low-dose prednisone in the treatment of idiopathic membranous nephropathy and to compare with low-dose prednisone combined with tacrolimus. Methods: Patients with idiopathic membranous nephropathy who were diagnosed with idiopathic membranous nephropathy by renal biopsy from July 2010 to March 2012 were randomized to receive either tripterygium glycosides combined with small intestine Dose prednisone group (TW group) and tacrolimus combined with low dose prednisone group (FK506 group). The main efficacy indicators for the treatment of the cumulative efficiency within 12 months (complete remission rate + partial response rate). The secondary indicators include the cumulative effective rate of treatment in June, the complete remission rate in June and December of treatment, the relapse rate and safety after discontinuation. Results: A total of 100 patients were enrolled in each group of 50 patients. In December, the cumulative effective rates in the TW and FK506 groups were 76.9% and 79.9%, respectively (rate difference 3%, 95% CI: -18.7% to 21.3%). The complete remission rates for both groups in June and December in the TW and FK506 groups were 8.8% vs 10.6% and 31.7% vs 33.7%, respectively. The average time to relapse between TW group and FK506 group: 14.08 months vs 13.1 months, P = 0.049. The serum creatinine doubling (6% vs 2%) and new-onset hypertension (24% vs 8%) in FK506 group were higher than those in TW group. The incidence of menstrual disorders in women of childbearing age in TW group was significantly higher than that in FK506 group (7/7 vs 0/10 ). CONCLUSION: Tripterygium glycosides combined with low-dose prednisone can effectively reduce the proteinuria in patients with membranous nephropathy. Compared with low-dose prednisone combined with tacrolimus, the response rate and the average response time are similar, and the recurrence rate after stopping is lower , Serum creatinine doubling less in the course of treatment.