国产西尼地平治疗原发性高血压的多中心随机双盲双模拟临床研究

Double-blind double-dummy randomized controlled multicenter clinical trial of domestic cilnidipine on treatment of essential hypertension

目的 对西尼地平治疗原发性高血压患者的疗效与安全性进行临床评价。方法 用多中心双盲双摸拟随机平行对照的试验方法,研究国产西尼地平与对照药苯磺酸氨氯地平对233例轻中度原发性高血压患者的降压疗效及药物不良反应。结果 治疗8周后,西尼地平组平均坐位收缩压(SBP)及舒张压(DBP)下降幅度分别为16.2,1 2.7 mmHg,苯磺酸氨氯地平组分别下降23.1,15.1 mmHg;两药总有效率分别为76.6％和87.7％,与治疗前比较有显著性差异(P<0.01);两药对心率无明显影响;两组药物不良反应的发生率分别为16.7％和12.9％。长期服用西尼地平疗效能持续,并有良好的耐受性。结论 西尼地平治疗轻中度原发性高血压具有明确的降压疗效与良好的安全性。

Objective Evaluate the antihypertensive effects and safety of domestic cilnidipine. Methods The antihypertensive effects and safety of cilnidipine were compared with amlodipine in double-blind double-dummy randomized controlled multicenter clinical trial in 233 patients with mild to moderate essential hypertension. Results After 8 weeks of therapy, mean sitting systolic blood pressure and diastolic blood pressure were reduced by 16.2 and 12.7 mmHg, in cilnidipine 23.1 and 15.1 mmHg in amlodipine, respectively. The results showed that there was significant difference in the efficiency between cilnidipine and amlodipine (76.6% vs 87.7% ).The change of heart rates was not significant both of them. The rate of adverse effects were 16.7% in cilnidipine and 12.9% in amlodipine. The antihypertensive effects of cilnidipine could persist for long time. Conclusion Cilnidipine was effective and relatively safe for mild to moderate essential hypertension.