西尼地平胶囊治疗轻中度原发性高血压的疗效和安全性评价

目的:评价西尼地平胶囊治疗轻中度原发性高血压的疗效和安全性。方法:采用多中心、随机双盲法将221例轻中度原发性高血压患者分为西尼地平胶囊组和西尼地平片组,分别接受西尼地平胶囊5 mg/d或西尼地平片5 mg/d治疗。各中心按病例入选顺序依次使用所分配的药物编号。2、4和6周时若舒张压≥90 mmHg,则剂量加倍,共8周。治疗前后测量坐位血压,记录所有不良反应。另有49例病人行24 h动态血压监测,观察西尼地平胶囊或西尼地平片对血压波动的影响。结果:西尼地平胶囊与西尼地平片均能有效降低血压,治疗总有效率分别为90.7%和81.5%(P>0.05),两组降压程度无统计学意义(P>0.05)。24 h动态血压监测显示西尼地平胶囊组舒张压和收缩压的降压T/P比值分别为58%和61%。西尼地平胶囊和西尼地平片具有良好的耐受性。结论:西尼地平胶囊5~10 mg,每日1次是治疗轻中度原发性高血压的安全有效药物。

Efficacy and safety evaluation of cilnidipine capsule in treatment of essential hypertension

Objective:To evaluate the efficacy and tolerability of cilnidipine capsule in treatment of mild to moderate essential hypertension.Methods: 221 patients with mild to moderate essential hypertension were randomly allocated to receiving either cilnidipine capsule 5 mg/d or cilnidipine tablet 5 mg/d in 6 hospitals,which could be increased to 10 mg/d if blood pressure control was not satisfactory.Sitting position blood pressure was taken and all the side effects were recorded throughout therapy.24 h-ambulatory blood pressure was monitored in other hypertensive patients(n=49).Results: Both cilnidipine capsule and cilnidipine tablet were effective for lowering blood pressure.90.7% and 81.5% of the patients in each group were considered to improve in 8 weeks with no significant statistical difference between the two groups.Ambulatory blood pressure monitoring of cilnidipine capsule showed that T/P of diastolic blood pressure and systolic blood pressure was 58% and 61% respectively.Both drugs were well tolerated.Conclusion: Cilnidipine capsule is very effective in treatment of mild to moderate essential hypertension in a daily dose of 5～10 mg with good tolerability.