来氟米特在狼疮性肾炎维持治疗中的初步研究

Primary study of maintenance treatment for lupus nephritis with leflunomide

目的研究来氟米特在狼疮性肾炎维持治疗中的疗效及其不良反应。方法选择2005年10月至2009年6月间,肾活检病理类型为Ⅲ、Ⅳ或Ⅴ型的女性狼疮性肾炎患者23例,年龄(29±7)岁,分别经CTX、MMF、CsA诱导治疗后获得完全缓解,随机分为来氟米特组和硫唑嘌呤组(AZA组),分别随访6个月,观察两组患者24h尿蛋白、尿红细胞(RBC)计数、血浆白蛋白、血肌酐及补体C3、C4等指标及各自不良反应。结果随访至3个月及6个月时两组患者24尿蛋白定量、尿沉渣RBC计数,血浆蛋白、血Cr及补体C3、C4水平均无明显改变,组间比较差异无统计学意义(P>0.05)。随访6个月LFF组15例患者无一例复发,AZA组8例患者有1例复发,复发时间发生在入组后3个月,病理类型为Ⅴ型LN。LFF组有4例患者(26.7%)发生不良反应,包括皮疹1例(6.67%)、头痛、头晕1例(6.67%)、白细胞计数减少1例(6.67%)及肝酶升高1例(6.67%);AZA组有3例患者(37.5%)发生不良反应,包括肝酶升高2例(25.0%)、带状疱疹1例(12.5%)。LFF组不良反应较AZA组发生率低。结论初步观察发现来氟米特可以用于狼疮性肾炎维持性治疗,并且其不良反应相对较轻。

Objective To study the curative effect and side effect of Leflunomide（LEF） in the maintain treatment of lupus nephritis. Methods From Oct. 2005 to Jun. 2009,twenty three female patient with lupus nephritis,the types of renal pathology include Ⅲ、Ⅳ and Ⅴ ,which confirmation by renal biopsy in Our hospital, mean age was （29 ±7 ） years（ range from 16 to 45 ）. All the patient treated with CTX, MMF, CsA as induced treatment, when achieved complete remission, the 23 patients were assigned to LFF group and AZA group by the method of randomization. Two groups were followed six months. To investigation the Upro （g/24 h）, URBC （ × 10^4/ml） Serum Cr, ALB, C3, C4 and side effects. Results There no differences in Upro, URBC, Serum Cr, ALB, C3 and C4 in two groups when followed three months and six months. No patient was relapse in LFF group when fol- lowed in six months, but there was 1 patient remission in AZA group followed in six months. The patient renal pathology was type V. There were 4 patients （ 26.7% ） had side effect in LFF group, including tetter（6.67% ）, headache （6.67%） , WBC decreased （6.67%） and liver enzyme elevated （6. 67% ）. However, there were three patients had side effect include herpes zoster （ 12. 5 % ） and liver enzyme elevated （25.0%）. The side effects of LFF group was lightly than AZA group. Conclusion LFF may become a new drug in the maintain treatment of lupus nephritis,and the side effects are minor than AZA.