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目的对比研究来氟米特(LEF)与环磷酰胺(CTX)治疗伴肾功能减退IgA肾病的临床疗效和安全性。方法选择经肾活检证实为原发性IgA肾病,伴肾功能减退但血肌酐<265μmol/L的肾病患者70例,随机分为LEF组和CTX组。LEF组初始口服LEF50mg/d,3d后改为20mg/d;CTX组每月静滴一次,每次静滴0.75g/m2体表面积,6个月后改为3个月一次。所有患者均给予强的松0.6～0.8mg·kg-.1d-1口服并规律减量。比较两组治疗12个月内的疗效和安全性。结果(1)两组患者24h尿蛋白定量、血浆白蛋白水平均较治疗前明显改善(P<0.05),但两组间比较,差异无统计学意义(P>0.05);血肌酐和肾小球滤过率与治疗前比较,差异无统计学意义(P>0.05)。(2)两组完全缓解率和总有效率相比,差异均无统计学意义(35.3%﹠31.3%,P>0.05;82.4%﹠75.0%,P>0.05)。(3)LEF组各项不良反应发生率均低于CTX组,差异有统计学意义(P<0.05)。结论与传统CTX相比,LEF联合强的松治疗伴肾功能减退IgA肾病疗效相似,但不良反应少,耐受性好。
Objective To compare the clinical efficacy and safety of leflunomide (LEF) and cyclophosphamide (CTX) in the treatment of IgA nephropathy with renal dysfunction. Methods Seventy patients with primary IgA nephropathy confirmed by renal biopsy and with renal dysfunction and serum creatinine <265μmol / L were randomly divided into LEF group and CTX group. LEF group, the initial oral LEF50mg / d, 3d to 20mg / d; CTX group intravenously once a month, intravenous infusion of 0.75g / m2 body surface area, 6 months later changed to 3 months. All patients were given prednisone 0.6 ~ 0.8mg · kg-1d-1 oral and regular reduction. The curative effect and safety of the two groups were compared within 12 months. Results (1) 24h urinary protein and plasma albumin levels were significantly improved in both groups (P <0.05), but there was no significant difference between the two groups (P> 0.05); serum creatinine and renal There was no significant difference in the filtration rate of the ball before treatment (P> 0.05). (2) There was no significant difference between the two groups in complete remission rate and total effective rate (35.3% & 31.3%, P> 0.05; 82.4% & 75.0%, P> 0.05). (3) The incidence of adverse reactions in LEF group was lower than that in CTX group, the difference was statistically significant (P <0.05). Conclusion Compared with the traditional CTX, LEF combined prednisone treatment with IgA nephropathy with similar efficacy, but less adverse reactions, well tolerated.