来氟米特治疗儿童肾病综合征型紫癜性肾炎的疗效及安全性

Efficacy and safety of leflunomide in treatment of Henoch-Schönlein purpura nephritis with nephrotic proteinuria in children

目的比较来氟米特(leflunomide,LEF)与吗替麦考酚酯(mycophenolate mofetil,MMF)及环磷酰胺(cyclophosphamide,CTX)治疗儿童肾病综合征型紫癜性肾炎(Henoch-Schönlein purpura nephritis,HSPN)的疗效,并对其安全性、实用性进行评价。方法选取于我院小儿肾脏风湿免疫科治疗的肾病综合征型HSPN共39例,随机分为3组,LEF组、MMF组及CTX组各13例患儿,均采用与糖皮质激素(激素)联合的方法治疗,观察3组治疗1、3、6、9个月时尿蛋白及血尿的变化,药物的不良反应及患儿治疗总费用情况。结果3组临床疗效比较,在降低尿蛋白及尿红细胞方面,治疗1、3、6、9个月时各组均有显著疗效,尿蛋白及尿红细胞下降明显,差异均有统计学意义(P<0.05)。在治疗第9个月时,LEF组及MMF组尿蛋白定量及尿红细胞均较CTX组下降明显,考虑与CTX组有1例尿蛋白在观察终点9个月时没有完全恢复正常,还有1例在治疗第6.5个月时复发有关;提示LEF与MMF的疗效稍优于CTX。患儿均表现耐受良好,未见严重不良反应发生,MMF组有1例在治疗1个月时出现丙氨酸转氨酶轻度升高,未使用药物治疗,3个月时随访结果显示丙氨酸转氨酶自行恢复正常。在治疗费用方面,LEF组为(8231±665)元,CTX组为(11523±469)元,两者费用接近,均低于MMF组的(19953±386)元。结论LEF与MMF及CTX治疗儿童肾病综合征型HSPN疗效相当,LEF的不良反应轻微,价格更为经济,实用性更强,值得在临床推广。

Objective To compare the efficacy and safety of leflunomide(LEF)to mycophenolate mofetil(MMF)and cyclophosphamide(CTX)in the treatment of Henoch-Schönlein purpura nephritis(HSPN)in children with nephrotic proteinuria.Methods Thirty-nine children who were diagnosed as HSPN with nephrotic proteinuria were randomly divided into three groups:LEF group,MMF group and CTX group.Each group had 13 children.Proteinuria,hematuria,adverse effect and cost were followed up at 1,3,6 and 9 months of medication.Results Proteinuria and hematuria were significantly decreased in each group at 1,3,6 and 9 months of medication.Compared to CTX group,proteinuria and hematuria in LEF group and MMF group were lower at 9 months.It was probably associated with one child whose proteinuria did not completely return to normal at 9 months and another child who suffered from a relapse of proteinuria and hematuria at 6.5 months in CTX group.The results suggested that the efficacy of LEF and MMF was slightly better than CTX.During the observation period,all children were well tolerated and no serious adverse reactions occurred.One case showed a slight increase of alanine aminotransferase at 1 month,and returned to normal range at 3 months without any medication in MMF group.The cost of LEF group was(8231±665)RMB and CTX group was(11523±469)RMB which was significantly lower than(19953±386)RMB in MMF group.Conclusion LEF is as effective as MMF and CTX in the treatment of HSPN with nephrotic proteinuria in children.The adverse reactions of LEF are mild,and the cost is cheaper.LEF is worth popularizing in clinical practice.