他克莫司与环孢霉素治疗单纯性V型狼疮性肾炎的疗效比较

Comparative Study on the Therapeutic Effect between Tacrolimus and Cyclosporine in the Treatment of Pure Class V Lupus Nephritis

目的比较他克莫司(Tacrolimus,TL)与环孢霉素(Cyclosporine,CsA)联合激素治疗单纯性V型狼疮性肾炎的疗效及安全性。方法选择本院确诊为V型狼疮性肾炎的35例患者,比较同期激素联合TL[0.07～0.08mg/(kg.d),n=17例]与激素联合CsA[3～5mg/(kg.d),n=18例]治疗6个月的疗效。主要观察治疗前后SLE-DAI、尿蛋白、血清白蛋白、血清补体C3、anti-dsDNA和ANA阳性率的变化,以及治疗前后的完全缓解率、部分缓解率。结果CsA或TL治疗后,治疗指标均出现明显的改善,其中,6个月治疗效果更为明显。治疗3个月TL组与CsA组有效率分别为77.7%和58.8%,经比较两组差异无统计学意义(P>0.05),但是,3个月TL治疗组在降低SLE-DAI、24h蛋白尿和增加血清白蛋白方面疗效比CsA组更明显(P<0.05)。治疗6个月TL组有效率及治疗指标的改善均较好于CsA组,但差异无统计学意义(P>0.05)。TL组无严重副作用出现。结论TL联合激素治疗单纯性V型狼疮性肾炎是有效和安全的。与CsA相比,TL可迅速缓解单纯性V型狼疮性肾炎患者蛋白尿和LN狼疮的活动。

Objective To compare the clinical effect and safety between Tacrolimus （TL） and Cyclosporine（CsA） in the treatment of pure class V lupus nephritis. Methods 35 patients with pure class V lupus nephritis, admitted to our hospital from October 2006 to October 2008, received therapy of TL or CsA, were selected. TL was initiated at a dose of 0.07—0.08mg/（kg·day） for the first 3 months, and later maintained at a dose of 0.05g/（kg·day）. CsA was initiated at a dose of 3-5mg/（kg·day） for the first 3 months, and later maintained at a dose of 2mg/（kg·day）. All patients received variable doses of prednisolone concomitant with TL or CsA therapy, at a dose of 0.5 mg/（kg·day） initially and maintained at 0.2-0.3mg/（kg·day）. The planned duration of study to assess treatment efficacy was at least 6 months. The effect of TL was evaluated by the changes of SLEDAI score, 24h urinary protein, serum albumin, serum immunologic parameters（serum C3 level,positive rate of anti-dsDNA and ANA） and adverse effects. Results Significant clinical improvement in lupus patients was observed after TL or CsA treatment and the most noticeable effect was found at 6 months of therapy. At 3th month, The remission occurred in 77.7% of patients in the TL group and in 58.8% of patients in CsA group. The complete and partial remission rates were 27.7% and 50% respectively for the TL group, and 17.6% and 41.1% respectively for the CsA group （P 〉0.05）. However, the improvement in SLEDAI scores, 24h proteinuria, serum albumin in the TL group is greater than that in the CsA group. At 6 months, although the effect of TL（ SLEDAI scores, 24h urinary protein, serum albumin, serum immunologic parameters） is better than that in the CsA group, however, this did not reach statistical significance. There was no serious adverse effect in the TL group. Conclusion Our study suggests that a 6-month course of TL is a safe and effective treatment of pure class V（membranous） lupus nephritis. As compared with CsA treatment, TL possibly results in a faster resolution of proteinuria and lupus activity.