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目的 :对存在微量白蛋白尿、高血压的 2型糖尿病患者 ,评估和比较candesartan、lisinopril或两者合用后 ,对血压、尿白蛋白排泄的影响。设计 :前瞻性、随机、平行组、双盲研究。先使用 4周的安慰剂 ,再以candesartan或lisinopril单独治疗 12周 ,随后再单独或两者合用治疗 12周。参与单位 :有 4个国家的三级医院和基本医疗中心参与了此项研究 (共 37个中心 )。研究对象 :共 199例患者 ,年龄 30~ 75岁。干预方法 :candesartan每日 1次 ,16mg ;lisinopril每日 1次 ,2 0mg。主要结局的测量指标 :血压和尿白蛋白肌酐比。结果 :第 12周时 ,candesartan组和lisinopril组舒张压降低的平均值 (95 %可信区间 )分别为 9 5mmHg(7 7mmHg~ 11 2mmHg ,P <0 0 0 1)及 9 7mmHg(7 9mmHg~ 11 5mmHg ,P <0 0 0 1) ,尿白蛋白肌酐比的降低值分别为 30 % (15 %~ 4 2 % ,P<0 0 0 1)及 4 6 % (35 %~ 5 6 % ,P <0 0 0 1)。第 2 4周时 ,联合用药组舒张压降低的平均值 (16 3mmHg,13 6mmHg~ 18 9mmHg,P <0 0 0 1)明显高于candesartan组 (10 4mmHg,7 7mmHg~ 13 1mmHg,P <0 0 0 1)或lisinopril组 (10 7mmHg,8 0mmHg~ 13 5mmHg ,P <0 0 0 1)。尿白蛋白肌酐比降低的平均值 (5 0 % ,36 %~ 6 1% ,P <0 0 0 1)也高于cand
OBJECTIVE: To assess and compare the effects of candesartan, lisinopril, or both on blood pressure and urinary albumin excretion in type 2 diabetic patients with microalbuminuria and hypertension. Design: Prospective, randomized, parallel-group, double-blind study. Four weeks of placebo were used before treatment with candesartan or lisinopril alone for 12 weeks followed by 12 or 12 weeks alone or in combination. Participating units: Tier-3 hospitals and basic medical centers in 4 countries participated in this study (37 centers). Participants: A total of 199 patients, aged 30 to 75 years. Intervention method: candesartan once daily, 16mg; lisinopril once daily, 20mg. The main outcome measures: blood pressure and urinary albumin creatinine ratio. RESULTS: At week 12, the mean (95% confidence interval) decrease in diastolic blood pressure in the candesartan and lisinopril groups was 9 5 mmHg (7 7 mmHg to 11 2 mmHg, P 0 01 0) and 9 7 mmHg (P <0.01) and urinary albumin creatinine ratio decreased by 30% (15% -42%, P <0 0 01) and 46% (35% ~ 56% P <0 0 0 1). At week 2-4, the mean decrease in diastolic blood pressure (16 3 mmHg, 13 6 mmHg to 18 9 mmHg, P 0 01) in the combination group was significantly higher than those in the candesartan group (104 mmHg, 77 mmHg to 131 mmHg, P 0 0 0 1) or lisinopril group (10 7 mmHg, 80 mmHg ~ 13 5 mmHg, P <0 0 0 1). Urine albumin creatinine ratio decreased the average (50%, 36% ~ 61%, P <0 0 0 1) is also higher than the cand