缬沙坦与氨氯地平联合用药和缬沙坦单药治疗高血压合并2型糖尿病的对照试验

Controlled trial of Valsartan and Amlodipine in combination with Valsartan monotherapy in the treatment of hypertensive patients with type 2 diabetes

目的 评价缬沙坦与氨氯地平联合用药和缬沙坦单药治疗高血压合并2型糖尿病患者的有效性和安全性.方法 本研究为随机、双盲、平行对照研究.125例高血压合并2型糖尿病患者经2周洗脱期后,给予4周缬沙坦（80 mg/d）单药治疗,89例平均坐位舒张压（SeDBP）仍≥90 mm Hg的患者随机分为缬沙坦（80 mg/d）和氨氯地平（5 mg/d）联合用药治疗组及缬沙坦（80 mg/d）单药治疗组,共随机双盲治疗8周,以SeDBP下降差值和尿白蛋白排泄率（UAER）下降值作为主要疗效指标.54例患者（联合用药组28例,单药组26例）完成了24h动态血压监测,并作为降压疗效的评价指标.结果 随机、双盲治疗8周末,联合用药组SeDBP下降值为（13.7±5.8）mm Hg,达目的血压占65.9％;单药治疗组SeDBP下降值为（7.7±6.9）mm Hg,达目的血压占37.8％,两组组间比较差异有统计学意义（P＜0.01）.联合用药组尿白蛋白排泄率（UAER）为（7.15±2.13）μg/min,单药治疗组尿白蛋白排泄率（UAER）为（8.76±3.01）μg/min（P＜0.05）.24h动态血压监测结果,联合用药组和单药治疗组舒张压/收缩压（DBP/SBP）的谷/峰比率（T/P）分别为83.1％/76.0％和85.8％/79.5％（P＜0.05）.联合用药组与单药治疗组的不良反应发生率分别为5.2％和 10.7％（P＜0.01）.结论 缬沙坦与氨氯地平联合用药治疗高血压合并2型糖尿病的降压疗效明显优于缬沙坦单药治疗,且具有明显的肾脏保护作用.

Objective Evaluation of effect of Valsartan and Amlodipine in combination with Valsartan monotherapy in the treatment of hypertension and its efficacy and safety in patients with type 2 diabetes.Methods The study was randomized,double blind,parallel controlled study.125 cases of hypertensive patients with type 2 diabetes mellitus and after a 2 week washout period after 4 weeks,given Valsartan （80 mg/d） monotherapy,89 cases of mean sitting diastolic blood pressure（SeDBP） was ≥ 90 mm Hg patients were randomly divided into Valsartan （80 mg/d） and Amlodipine （5 mg/d） combined treatment group and Valsartan （80 mg/d） monotherapy group,were randomized double-blind treatment for 8 weeks,the difference and urinary albumin excretion rate （UAER） decreased with SeDBP decrease as the main therapeutic effect index.54 patients （treatment group of 28 cases,26 cases of single drug group） completed 24 h ambulatory blood pressure monitoring,and as the evaluation index of the antihypertensive efficacy of.Results A rendomized,double blind treatment at the end of the 8 week,the combination group decreased SeDBP value was （13.7±5.8）mm Hg,reach the goal blood pressure accounted for 65.9％; single drug treatment group decreased SeDBP value was （7.7±6.9）mm Hg,reach the goal blood pressure accounted for 37.8％,two groups had significant difference （P＜0.01）.The combined group of urinary albumin excretion rate （UAER） was （7.15±2.13）μg/min,single drug treatment group of urinary albumin excretion rate （UAER） was （8.76±3.01）μg/min（P＜0.05）.24 h ambulatory blood pressure monitoring results,the combination group and monotherapy group diastolic/systolic blood pressure （DBP/SBP） of the trough to peak ratio （T/P） were 83.1％/76.0％ and 85.8％/79.5％ （P＜0.05）.The combination group and monotherapy group,the adverse reaction rate were 5.2％ and 10.7％（P＜0.01）.Conclusion Antihypertensive efficacy of Valsartan and Amlodipine combination therapy is better than Valsartan in the treatment of hypertension and type 2 diabetes treatment,and has obvious protective effect on kidney.