目的 探讨来氟米特联合厄贝沙坦治疗狼疮性肾炎的临床疗效和安全性.方法 选取2012年1月—2013年9月在金湖县人民医院住院治疗的狼疮性肾炎患者80例,随机分为对照组(40例)和治疗组(40例).两组均采用标准激素治疗,给予醋酸泼尼松片1.0 mg/(kg·d),服用2个月后逐渐减量至10 mg/d;同时均口服厄贝沙坦片,2片/次,1次/d.在此基础上,对照组口服环磷酰胺片3 mg/(kg·d),连用10～14 d,休息1～2周重复.治疗组口服来氟米特片,开始治疗的最初3 d给予负荷剂量50 mg/d,之后给予维持剂量20 mg/d.两组均连续治疗6个月.对比两组治疗前后24 h尿蛋白定量、尿红细胞计数、尿β₂微球蛋白(β₂-MG)、血白蛋白、血β₂-MG、血肌酐(Cr)和补体C3等指标和不良反应.结果 治疗3个月,治疗组总有效率为95.0%,对照组为77.5%;治疗6个月,治疗组总有效率为95.0%,对照组为82.5%,两组总有效率比较差异均有统计学意义(P<0.05).治疗后,两组患者尿液指标包括24 h尿蛋白、β₂-MG、尿红细胞计数,血液指标包括血白蛋白、血β₂-MG、Cr、C3、血沉均较治疗前显著改善,同组治疗前后差异有统计学意义(P<0.05、0.01);且同组患者治疗6个月时这些项指标的改善程度优于治疗3个月,差异有统计学意义(P<0.05);治疗后,治疗组指标改善程度优于对照组治疗同期,两组比较差异有统计学意义(P<0.05、0.01).治疗组不良反应发生率为8.0%,对照组为25%,两组比较差异有统计学意义(P<0.05).结论 来氟米特联合厄贝沙坦治疗狼疮性肾炎有较好的临床疗效,起效迅速,不良反应生率低,具有临床运用价值.

Objective To explore the effect and safety of leflunomide combined with irbesartan in treatment of lupus nephritis. Methods Patients (80 cases) with lupus nephritis who came to the People's Hospital of Jinhu County from January 2012 to September 2013 were randomly divided into control (40 cases) and treatment (40 cases) groups. Patients in two groups accepted standard hormone therapy, and they were given Prednisone Acetate Tablets 1.0 mg/(kg·d), gradually reduced to 10 mg/d after taking for 2 months. The patients in the two groups were po administered with Irbesartan Tablets, 2 tablets/time, once daily. The patients in the control group were po administered with Cyclophosphamide Tablets 3 mg/(kg·d) for 10 — 14 d, and rested for 1 — 2 weeks, then the administration was repeated. The patients in the treatment group were po administered with Leflunomide Tablets, they were given loading dose of 50 mg/d at the first 3 d of treatment, and then given the maintenance dose of 20 mg/d. The patients in two groups were treated for 6 months. After treatment, the changes of 24 h urine protein, count of urine red blood cell, β₂-MG, albumin, blood β₂-MG, Cr, C3 and adverse reactions in two groups were compared. Results After treatment for 3 months, the efficacies in the treatment and control groups were 95.0% and 77.5%, and after 6 months treatment, the efficacies in the treatment and control groups were 95.0% and 82.5%, with difference between the two groups (P < 0.05). After treatment, urine indexes including 24 h urine protein, count of urine red blood cell, β₂-MG, and blood indexes including blood albumin, blood β₂-MG, Cr, C3, and blood sedimentation were improved significantly, and the differences were statistically significant before and after treatment in the same group (P < 0.05, 0.01). The indexes after 3 months treatment were improved more obviously than those after 6 months treatment, with significant difference (P < 0.05). After treatment, these indexes in the treatment group were improved better than those of control group during the same period, with significant difference between the two groups (P < 0.05, 0.01). The incidence rate of adverse reactions in the treatment and control groups were 8.0% and 25.0%, respectively, and there were differences between the two groups (P < 0.05). Conclusion Leflunomide combined with irbesartan has good clinical effect in treatment of lupus nephritis, and can play the role quickly with less adverse reaction, which has clinical application value.

国家自然科学基金资助项目(81070588)