糖皮质激素联合环磷酰胺和来氟米特治疗狼疮性肾炎的临床研究

A Clinical Trial of Treatment for Lupus Nephritis by Glucocorticoid Combined with Cyclophosphamide and Leflunomide

目的观察糖皮质激素(GC)联合环磷酰胺(CTX)及来氟米特(LEF)治疗Ⅲ型、Ⅳ型、Ⅴ型、Ⅲ+Ⅴ型和Ⅳ+Ⅴ型狼疮性肾炎(LN),比较其与传统二联治疗方案的临床疗效及安全性。方法 42例患者被随机分为3组:A组(GC+CTX组)、B组(GC+LEF组)、C组(GC+CTX+LEF组)。随访1年,观察尿蛋白定量等临床疗效指标及安全性。结果 42例患者均完成1年观察,完全缓解率分别为A组35.7%,B组42.8%,C组78.6%。观察结束时C组尿蛋白与A组比较明显下降,补体C3水平较A组明显升高,差异均有统计学意义(均P<0.05)。对Ⅳ+Ⅴ型LN,C组治疗3个月后即明显减少尿蛋白,与A组比较差异有统计学意义(P<0.05)。C组与B组、A组与B组疗效指标比较差异均无统计学意义(P均>0.05)。治疗过程中3组间不良反应差异无统计学意义(P均>0.05)。结论 GC+CTX+LEF联合多靶点治疗总体疗效优于LN的传统治疗方案GC+CTX,尤其对Ⅳ+Ⅴ型LN疗效较好,且不良反应无明显增加,耐受性良好。

Objective To study the efficacy and safety of treating lupus nephritis （ LN ） with glucocorticoid （ GC ） and eyclophos- phamide （CTX） and leflunomide （LEF） （multi -target therapy） , compared to traditional intravenous cyclophosphamide （IVCY） therapy and leflunomide （LEF） therapy. Methods Forty two patients were randomly divided into three groups ： group A （ GC ＋ CTX, n = 14） , group B （GC ＋ LEF, n = 14） , group C （GC ＋ CTX ＋ LEF, n = 14）. We observed the urine protein quantitative and other clinical inde- xes and safety during the follow - up. Results It revealed a higher complete remission rate in multi - target therapy group than that in IV- CY group （78.6% vs 35.7% ） and LEF group （78.6% vs 42.8% ） after 1 year, respectively. For class 1V ＋ V LN, the urine protein quantitative in multi- target therapy group significantly reduced after 3 months＇ treatment, with a significant statistic difference compared to IVCY group （ P 〈 0.05 ）. There was no statistic difference between multi - target therapy group and LEF group, and no difference be- tween IVCY group and LEF group, either. The adverse reaction among three groups had no obvious difference. Conclusion The multi - target therapy （ GC ＋ CTX ＋ LEF） was superior to IVCY for severe lupus nephritis and well tolerated.