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来氟米特联合激素延缓进展型IgA肾病肾功能减退的临床研究 被引量:23

Treatment of progressive IgA nephropathy with leflunomide and steroid delays exacerbation of renal function in patients:a prospective controlled clinical trial
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摘要 目的 观察来氟米特治疗进展型IgA肾病患者肾功能减退的疗效和安全性。方法 选择病理证实且伴有肾功能中度减退(内生肌酐清除率29—60ml/min)的IgA肾病患者60例,按开放、随机的原则分为来氟米特组和对照组,在应用激素的基础上加或不加来氟米特。试验中监测治疗前和治疗后3个月、6个月、9个月和12个月的24小时尿蛋白定量、肝肾功能、内生肌酐清除率、血常规和血白蛋白的变化以及药物治疗的副作用。结果 共有55例患者完成了试验,来氟米特组有3例(10%)、对照组有2例(6.7%)因不良反应等退出试验。自第6个月起两组患者尿蛋白量明显减少,但组间比较无显著性差异。血浆白蛋白水平同组治疗前后和两组间各时间节点比较均无显著性差异。治疗后6个月时两组血清肌酐无显著升高,内生肌酐清除率无显著下降;此后两组患者肾功能开始逐渐下降,两组间比较,来氟米特组血清肌酐值较对照组减小,差异显著;而内生肌酐清除率下降速率则慢于对照组。结论 来氟米特联合激素用于进展型IgA肾病的治疗疗效显著,与单用激素组比较可显著延缓肾功能的进展,且耐受性较好。来氟米特长期治疗进展型IgA肾病的可能性有待进一步观察。 Objective To evaluate the efficacy and safety of leflunomide in the treatment of progressive IgA nephropathy by a prospective controlled clinical trial. Methods Patients with biopsy-confirmed IgA nephropathy and moderate renal function insufficiency ( endogenous creatinine clearance rate, CCr29 -60min/ml) were recruited. Patients of recent onset who hadn't been treated with any immunosup- pressive drug were given either oral leflunomide (Group leflunomide) plus oral prednisone or oral prednisone alone (Group Control). 24-hour urinary protein excretion (URE), serum albumin and creatinine, CCr,hemoglobin,side effect of leflunomide were evaluated before the trial and every 3 months after treatment. Results Total 60 patients were enrolled,5 patients withdrew due to adverse events. The UAEs of patients in both groups decreased significantly after 6 months of treatment,but not statistically different between the two groups,while serum albumin remained unchanged throughout the trial in both groups. At 6 months,serum creatinine increased slightly and CCr decreased little in both groups. From the ninth months, Ccr exacerbated sharply in the two groups. And compared with control group, patients of leflunomide group had smaller serum creatinine than those of control group, which was statisticaUy different, and the decreasing speed of Ccr was delayed in leflunomide group. Conclusion Leflunomide combined with steroid treated patients of progressive IgA nephropathy effectively and could markedly delay further exacerbation of renal function compared with steroid alone. Leflunomide was tolerated generally well, and its efficacy in long-term therapy remained to be clarified.
出处 《临床内科杂志》 CAS 2006年第11期731-733,共3页 Journal of Clinical Internal Medicine
关键词 来氟米特 进展型IgA肾病 肾功能 治疗 Leflunomide Progressive IgA Nephropathy Renal Function Treatment
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参考文献12

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二级参考文献35

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