摘要
目的:探讨来氟米特(leflunomide,LEF)在狼疮性肾炎(LN)维持治疗中的疗效及安全性,并与雷公藤多甙(tripterygium,TW)进行比较。方法:2004年6月至2005年8月经诱导治疗获得临床完全缓解的122例LN患者(Ⅱ型24例、Ⅲ型9例、Ⅳ型65例、Ⅴ型24例),女性116例,男性6例,平均年龄(29.6±8.3)岁,按病理类型随机分为LEF组(n=61)和TW组(n=61),两组患者在性别、年龄、病理类型分布、诱导治疗方案等无差异。统计随访24月。本研究初步评价随访6月以上患者的复发率、副作用发生率统计所有病例。结果:①LEF组有14例(23.0%)退出,原因主要为为皮疹(9.8%)、腹泻(3.3%)、白细胞减少(3.3%)和肝功能异常(1.6%),TW组3例(4.9%)退出。随访时间超过6个月的患者67例,LEF组31例(随访时间6～14个月),TW组36例(随访时间为6～16个月)。②LEF组3例(9.7%)复发(1例在第5月出现肾外复发,2例分别在第7、14个月出现肾病复发),TW组5例(13.9%)复发(1例在第6个月出现肾外复发,4例分别在第3、6、8、14个月出现肾病复发)。③副作用:LEF组21例(34.4%)出现副作用,包括脱发(7例)、皮疹(9例)、白细胞下降(2例)、肝酶升高(4例),腹泻(3例)和停经(1例);TW组16例(26.2%)出现副作用,其中白细胞下降(1例)、肝酶升高(4例)和停经(11例)。结论:在维持治疗超过6个月的患者中,LEF维持治疗的疗效与TW相当,对月经的影响明显低于TW组。LEF组皮疹的发生率显著高于TW组,因而退出研究的比例高于TW组。LEF维持治疗的疗效还需长期随访评价。
Objective： To study the efficacy and side effects of low-dose prednisolone combined leflunomide （LEF） or Tripterygium （TW） for the maintenance therapy in patients with lupus nephritis （LN）. Methodology：One hundred and twenty two patients of LN （WHO type Ⅱ24, type Ⅲ 9, type Ⅳ 65, and type Ⅴ 24 cases）with complete remission by induced therapy were recruited from Jun. 2004 to Aug. 2005. They were 116 female and 6 male with a average age of （ 29.6 ± 8.3 ） years old, and randomized into the LEF group （ n = 61 ） or the TW group （ n = 61 ）. Both of them were no difference in sex, age, WHO classification, and induction therapy. All patients were follow-up 24 months. The primary evaluation was performed on efficacy and side effects. Results：①There were 67 cases follow-up ≥6 months, 31 from the LEF group （ follow-up 6 to 14 months） , and 36 from the TW group （ follow-up 6 to 16 months）. 14 cases（23.0% ） withdrew from the LEF grnup, maintv because of rash, diarrhea, leucopenia, and liver dysfunction, which was significantly higher than that of the TW group （4. 9% ）. ②The relapses were observed in patients follow-up ≥6 months in both groups, with 3 cases （9.7%） belong to the LEF group （ one was extra-renal relapsed on 5 months, and 2 were renal relapsed on 7, 14 months separately） , and 5 （ 13.9% ） in the TW group （one was extra-renal relapsed, and 4 were renal relapsed）. ③ The side effects were evaluated in all recruited patients. The total side effect rate in the LEF group was 34. 4%. However, the rate of the TW group was just 26.2%. Conclusion：LEF had the same efficacy as TW in the LN maintenance therapy in those follow-up ≥6 months patients, and it had weak effect on menses. The rate of rash increased significantly in the LEF group, as well as higher withdrawal numbers. The effect of LEF on LN maintenance therapy may require long-term follow-up study.
出处
《肾脏病与透析肾移植杂志》
CAS
CSCD
2005年第6期514-519,共6页
Chinese Journal of Nephrology,Dialysis & Transplantation
关键词
狼疮性肾炎
来氟米特
雷公藤多甙
治疗
副作用
lupus nephritis leflunomide tripterygium maintenance therapy side effect
