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

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

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5mg／d或西尼地平片5mg／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≥90mmHg，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24h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）。24h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5～10mg，每日1次是治疗轻中度原发性高血压的安全有效药物。

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 through. out 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,