国产与进口苯磺酸左旋氨氯地平门诊治疗60例原发性高血压的临床疗效对照研究

目的比较了国产苯磺酸左旋氨氯地平(压氏达)与进口国产苯磺酸左旋氨氯地平(络活喜)门诊治疗原发性高血压的临床疗效、安全性及不良反应。方法采用随机、对照、双盲法观察国产苯磺酸左旋氨氯地平治疗轻、中度原发性高血压8周的疗效。60例原发性原发性高血压的门诊患者经2周的安慰剂洗脱期后随机分为两组,每组各30例,分别服用国产苯磺酸左旋氨氯地平5mg,2次/日或进口苯磺酸左旋氨氯地平(络活喜)5mg,1次/日,治疗8周。治疗开始前及治疗8周末进行相关实验室检查,每2周随访1次,记录受试者的血压、心率、不良反应。结果两组治疗前后收缩压与舒张压的下降均有显著性差异,国产苯磺酸左旋氨氯地平组(压氏达)有效率为83.6%,进口苯磺酸左旋氨氯地平组(络活喜)有效率为85.2%,组间比较无显著性差异(P>0.05)。两组患者不良反应轻微。结论国产苯磺酸左旋氨氯地平是治疗原发性高血压安全有效的药物,不良反应轻微,患者能很好耐受,且具有价格优势,是理想的一线降压药物。

The Clinical Compare Efficacy and Safety of 60 Essential Hypertension Essential Hypertension Section for Outpatients Treated with Homemade and Import Amlodipine Besylate Tablets

Objective To evaluate the efficacy and safety of essential bypertension treated with homemade amlodipine besylate tablets （yashida）. Methods A randomized, double blind study was carried out in 60 patients with stage 1 and 2 essential hypertension. Patients were randomly divided into two groups and given homemade amlodipine besylate tablets （amlodipine besylate tablets group） 5rag, 2 times/per day and import amlodipine besylate tablets （norvase group） 5rag, once/per day, for 8 weeks, respectively. At the beginning and end of the treatment, patients＇liver and renal functions were examined, and their blood pressure, heart rate and side-effects were recorded every two weeks. Results The average reduction in blood pressure readings for the two treatment groups were 83.6% and 85.2%, respectively. No significant differences were found between two groups （P〉0.05）. SBP and DBP decreased significantly on the second week following treatment, and reached their peaks on the fourth week following treatment, and this good effect lasted until the end of the study. No significant changes were found in HR, routine blood examination, liver and renal functions, as well as electrocardiography after treatment. Adverse reactions were slight. Conclusion Homemade amlodipine besylate tablets are safe and effective for the treatment of mild and moderate essential hypertension. There are slight adverse reactions and the price is lower. So it can be well tolerated by the patients and has now become the first line drug for hypertension.