国产苯磺酸氨氯地平降压效果及安全性的多中心随机临床对照研究

Clinical Efficacy and Safety of Domestic Produced Amlodipine Besylate in Patients with Mild to Moderate Hypertension: a Multi-center Randomized Controlled Clinical Trial

目的 比较国产苯磺酸氨氯地平 (安内真 ) 5mg与进口苯磺酸氨氯地平 (络活喜 ) 5mg每天一次口服治疗原发性轻、中度高血压的有效性和安全性。方法 多中心、随机平行对照研究 ,98例轻、中度高血压患者被随机分入安内真组和络活喜组 ,分别每天一次口服安内真 5mg或络活喜 5mg ,2周后如坐位舒张压 >90mmHg或坐位收缩压 >14 0mmHg ,则改为安内真 10mg或络活喜 10mg、每天一次口服。结果 服药 2 ,4周时 ,安内真与络活喜两组平均舒张压和收缩压均明显下降 ,两组比较无明显差异 ;治疗 4周时两组控制血压的总有效率分别为 75 56% ,77 0 8% ,两组间无明显差异 ;不良反应事件发生率低 ,两组相似。结论 国产苯磺酸氨氯地平 (安内真 ) 5mg或 10mg每日一次治疗原发性轻、中度高血压安全有效 ,其疗效与进口苯磺酸氨氯地平 (络活喜 )

Objective To compare clinical efficacy and safety of domestic produced Amlodipine besylate tablets (Anneizhen) and imported amlodipine (Novasc) in patients with mild to moderate hypertension. Methods This is a multi-center, randomized controlled trial. 98 patients with mild to moderate hypertension were divided into two groups, Anneizhen group and Novasc group by randomization. The dosage is 5 mg per day. If sitting DBP was higher than 90 mmHg or SBP was higher than 140 mmHg after two weeks, the dose of Anneizhen or Novasc was titrated to 10 mg per day. Results The average DBP or SBP of Anneizhen group and Novasc group both decreased markedly after two or four weeks. No significant difference in BP between them was found. The response rates of two groups were 75 56%,77 08% respectively after four weeks treatment. The incidence of adverse event of Anneizhen group was as low as that of Novasc. Conclusion Domestic produced Amlodipine besylate tablets (Anneizhen) (5 mg or 10 mg per day) was proved to be as effective and safe as Novasc in patients with mild to moderate hypertension.