马来酸氨氯地平治疗原发性高血压疗效观察

The efficacy and safety of amlodipine maleate on patients with mild to moderate essential hypertension

目的 :观察马来酸氨氯地平的降压疗效和不良反应。 方法 :130例原发性高血压患者采用随机、单盲和组间平行对照法分为治疗组、对照组各 6 5例 ,分别口服马来酸氨氯地平和苯磺酸氨氯地平 6周。 结果 :6周末 ,两组患者坐位平均收缩压和舒张压均较治疗前有显著下降 ,治疗组收缩压 /舒张压下降幅度为 2 3.0 2 / 14 .82mmHg ,对照组为 2 3.89/ 16 .79mmHg(P >0 .0 5 )。治疗组与对照组显效率、总有效率、达标率分别为 70 .77%vs 78.6 9%、81.5 4 %vs86 .89%、6 3.0 8%vs78.6 9% (P >0 .0 5 )。不良反应发生率分别为 12 .31%和 13.11% (P >0 .0 5 ) ,主要表现为程度较轻的头痛、头晕、面部潮红等。对 2 0例马来酸氨氯地平组患者做动态血压资料分析发现 ,白天和夜间平均收缩压 /舒张压均比治疗前显著下降 ,收缩压和舒张压的谷峰比值为 73%和 6 8%。 结论 :马来酸氨氯地平片与苯磺酸氨氯地平比较 ,价格便宜 ,也是一种有效、安全的降压药 ,能平稳控制 2

Objective: To assess the efficacy and safety of amlodipine maleate on patients with mild to moderate hypertension compared with amlodipine benzene sulfonate. Methods: This study was a randomized, single-blind, actively-controlled clinical trial. All 130 patients were randomized to amlodipine maleate and amlodipine benzene sulfonate group, and treated for 6 weeks. Results: At the end of study, the sitting SBP and DBP were significantly and similarly reduced by amlodipine maleate and amlodipine benzene sulfonate. The change of SBP/ DBP after therapy were 23.02/14.82 mmHg for amlodipine maleate and 23.89/16.79 mmHg for amlodipine benzene sulfonate (P>0.05). The total response rate was 81.54% for amlodipine maleate and 86.89% for amlodipine benzene sulfonate . The adverse event rate was 12.31% in amlodipine maleate and 13.11% in amlodipine benzene sulfonate (P>0.05), manifested as headache, dizziness, and palpitation, Most of them were mild. ABPM showed that amlodipine maleate reduced all average blood pressure (day, night) and the mean of trough-to- peak ratio was 73% for SBP and 68% for DBP in 20 patients. Conclusion: Amlodipine maleate could effectively lower the blood pressure in mild to moderate hypertensive patients with the same efficacy as Amlodipine beneate sulfonate, it was well tolerated and could control the blood pressure smoothly throughout the 24 hours.