麦考酚酸酯治疗IgA肾病的随访对照观察  

A randomized control trial of mycophenolate mofeil treatment in severe IgA nephropathy

作　　者：陈香美[1] 陈仆[1] 蔡广研[1] 吴杰[1] 崔岩[1] 张燕平[1] 刘述文[1] 汤力[1] 

机构地区：[1]解放军总医院肾内科解放军肾病中心暨重点实验室,北京100853

出　　处：《中华医学杂志》2002年第12期796-801,共6页National Medical Journal of China

基　　金：国家自然科学基金创新研究群体科学基金资助项目 (3 0 12 10 0 5 );国家十五科技攻关基金资助项目 (2 0 0 1BA70 1A14a)

摘　　要：目的　对比研究麦考酚酸酯 (MMF)对IgA肾病的临床疗效、安全性和耐受性。方法　选择病理诊断IgA肾病IV～V级 (Lee分级 ) ,蛋白尿 >2 0g/d ,血肌酐 <35 5 μmol/L的患者共 6 2例 ,分为MMF组和对照组。MMF组初始剂量给MMF1 0g/d(体重 <5 0kg)或 1 5g/d(体重 >5 0kg) ,治疗 6个月后减量至 0 75～ 1 0g/d ,12个月后可减至 0 5～ 0 75g/d ;对照组给予醋酸泼尼松片 0 8mg·kg-1·d-1,规律减量。分别于治疗前及治疗后 3、6、12、18、2 4个月测定尿蛋白定量、尿N 乙酰氨基 β 葡萄糖苷酶酶 (NAG酶 )、内生肌酐清除率、血浆尿素氮、肌酐、白蛋白、甘油三酯、胆固醇及肝功能等多项临床指标。对MMF组 5例重复肾活检患者治疗前后的肾脏病理改变进行半定量分析。结果　 (1)治疗3个月时 ,MMF组尿蛋白定量 (1 9g/2 4h± 1 6g/2 4h)较治疗前 (3 2g/2 4h± 1 7g/2 4h)明显减少 (P<0 0 1) ,白蛋白 (41g/L± 6g/L)较治疗前 (37g/L± 7g/L)明显升高 (P <0 0 1) ;但对照组尿蛋白定量(2 3g/2 4h± 1 9g/2 4h)、白蛋白 (30g/L± 7g/L)与治疗前 (2 9g/2 4h± 1 4g/2 4h、37 1g/L± 5 8g/L)比较差异无显著意义 (P >0 0 5 )。治疗 6、12及 18个月时 ,两组尿蛋白定量均较治疗前明显降低 (P<0 0 1) ,白蛋白均明显升高 (Objective To investigate the effectiveness,safety and tolerance of mycophenolate mofeil(MMF) in severe IgA nephropathy and evaluate the dosage adjustment and course for clinical treatment Methods 62 patients with IgA nephropathy diagnosed by renal biopsy as Lee′s grade IV and V with urinary protein >2 0 g/d were enrolled randomly in the trial The initial dosage of MMF was 1 0 g/d(body weight <50 kg)or 1 5 g/d(body weight >50 kg) The dosage was reduced to 0 75～1 0 g/d after 6 months treatment, the maintaining dosage was 0 5～0 75 g/d after 12 months The total course of treatment lasted at least 12 months Another 31 patients matched with age,gender and severity of renal damage were given prednisone orally (0 8 mg·kg·d) (control group) Blood and urinary tests,hepatic and renal function,plasma albumin,serum triglyceride and cholesterol,24 h protein excretion,urinary NAG enzyme, creatinine clearance(Ccr) were performed before and 3,6,12,18 months after treatments in both groups.5 patients in MMF group received repeated renal biopsy Results (1) After 3 months treatment, decrease of urinary protein (1 9 g/24 h±1 6 g/24 h vs 3 2 g/24 h±1 7 g/24 h, P <0 01)and improvement of plasma albumin (41 g/L±6 g/L vs 37 g/L±6 g/L, P <0 01)were observed in MMF groups,while in control group, no significant changes were found in urinary protein(2 3 g/24 h±1 8 g/24 h vs 2 9 g/24 h±1 5 g/24 h, P <0 05)and plasma albumin(40 g/L±6 g/L vs 37 g/L±6 g/L, P <0 05). After treatment for 6, 12 and 18 months, both group showed obvious alleviation of proteinuria and albumin At the 12th and 18th month, the proteinuria in MMF group was significantly improved than that in control group(0 8 g/24 h±0 8 g/24 h vs 1 4 g/24 h±1 6 g/24 h and 0 6 g/24 h±0 7 g/24 h vs 1 4 g/24 h±1 3 g/24 h, P <0 05 respectively) The remission rate and total effective rate of MMF group were higher than those of the control group (44 4% vs 19 1% and 88 9% vs 61 9%, P <0 05 respe

关 键 词：麦考酚酸酯 治疗 IGA肾病 随访 对照观察 免疫抑制剂 

分 类 号：R692[医药卫生—泌尿科学]