小剂量氨氯地平联合用药治疗老年高血压的疗效和安全性评价

Efficacy and safety of combination regimens based on amlodipine in elderly hypertensive patients

目的评价小剂量氨氯地平联合复方阿米洛利或者替米沙坦治疗老年高血压的临床疗效和安全性。方法采用随机开放对照盲终点评估的方法,入选老年原发性高血压患者106例,随机分为氨氯地平+复方阿米洛利(阿米洛利组)和氨氯地平+替米沙坦组(替米沙坦组),均服药12w,每2周随访一次,观察收缩压、舒张压、心率、降压达标率、有效率和不良反应。结果治疗第2周末,阿米洛利组和替米沙坦组的达标率分别为58.5%和47.2%,组间比较有统计学差异(P<0.05)。而治疗12w后,两组降压达标率分别为67.9%和71.7%,有效率分别为81.1%和83.0%,组间比较差异均无统计学意义(P>0.05)。阿米洛利组收缩压下降值为(24.3±15.8)mmHg,舒张压下降值为(15.2±9.2)mmHg,替米沙坦组收缩压下降值为(26.8±13.4)mmHg,舒张压下降值为(15.7±9.4)mmHg,较治疗前均有显著差异(P<0.01);两组不良反应发生率分别为9.4%和7.6%(P>0.05),实验室检查均无明显改变,未见低血钾及体位性低血压的发生。结论小剂量氨氯地平联合复方阿米洛利或替米沙坦能显著降低老年高血压患者血压,耐受性好,不良反应少;氨氯地平联合复方阿米洛利方案在尽早达标方面更具优势。

Objective To evaluate the efficacy and safety of two combination regimens based on amlodipine in elderly patients with essential hypertension （EH）.Methods A randomized,controlled,opened,blind-endpoint assessment clinical trial was carried out in elderly hypertensive patients in Hunan community,106 patients with blood pressure≥140/90 mmHg were assigned to amlodipine plus amiloride compound group（amiloride group,n=53）,amlodipine plus telmisartan group （ telmisartan group,n=53）.Antihypertensive efficacy,safety,adverse reactions were evaluated every 2 weeks in the period of 12 weeks.Results After 2 weeks′ combination treatment,the rate of reaching standard was 58.5% of amiloride group,47.2% of telmisartan group （P0.05）.But after 12 weeks,the rate of reaching standard was 67.9% of amiloride group and 71.7% of telmisartan group,respectively with effective rate of 81.1% and 83.0%,there were not significant differences between two groups（P0.05）.The blood pressure was reduced by （24.3±15.8/15.2±9.2）,（26.8±13.4/15.7±9.4） mmHg in amiloride and telmisartan group respectively,there was not significant difference between the two groups （P0.05）;The total side effect was similar and mild in two groups.Conclusions Amlodipine associated combination with amiloride or telmisartan can reduce significantly the blood pressure of elderly hypertensive patients,with safety,good tolerance.In combination with amiloride,the blood pressure could reach the target more rapidly.