西尼地平治疗轻中度原发性高血压的有效性和安全性

Efficacy and safety of cilnidipine for the treatment of patients with mild to moderate essential hypertension

目的:评价西尼地平治疗轻中度原发性高血压的有效性和安全性。方法:采用随机对照、双盲双模拟研究设计。48例患者分为试验组和对照组各24例。试验组患者口服西尼地平片和苯磺酸氨氯地平模拟片,西尼地平起始剂量为5 mg,qd,4周后若舒张压≥90 mmHg,则增加至10 mg,qd,直至试验结束。对照组口服苯磺酸氨氯地平片和西尼地平模拟片,给药方法及剂量调整与试验组相同。结果:8周后试验组和对照组的收缩压降低幅度分别为(11.13±7.31)和(16.10±7.68)mmHg,最大舒张压降低幅度分别为(11.01±4.17)和(13.27±4.57)mmHg,治疗前后组内比较均有统计学意义。8周末两组间收缩压降低幅度有显著差异(P<0.05)。两组均无严重不良反应发生,每组各有5例发生药物不良反应,无统计学差异(P>0.05)。结论:西尼地平每日服用1次降压安全有效。

Objective： To investigate the efficacy and safety of cilnidipine in the treatment of mild to moderate essential hypertension. Methods： The study design was randomized, controlled, double blind and double simulated. One half of 48 patients （n = 24） were orally given cilnidipine and amlodipine besylate mimesis tablet. The initial dose of cilnidipine was 5 mg per day; after 4 weeks, the dose was increased to 10 mg per day until the end of the study if the diastolic blood pressure was equal or above 90 mmHg. Other patients （n = 24） were orally given amlodipine besylate and cilnidipine mimesis tablet in the same administration and doses. Results ： At 8 weeks after treatment, systolic blood pressure was decreased by （ 11. 13± 7.31 ） mmHg and （ 16. 10 ± 7.68 ） mmHg in cilnidipine and amlodipine groups （P 〈 0. 05 ）, respectively. The diastolic blood pressure was decreased by （ 11.01 ± 4.17 ） mmHg and （ 13.27± 4.57 ） mmHg in cilnidipine and amlodipine group, respectively. There were significant differences in systolic and diastolic blood pressure before and after both treatments. No serious adverse reaction occurred after 2 treatments; however, the adverse reaction occurred in 5 patients in either cilnidipine or amlodipine group （P 〉 0.05） , respectively. Conclusion： Oral cilnidipine once daily is effective and safe in the treatment of mild to moderate essential hypertension.