国产西尼地平片治疗轻中度原发性高血压

Cilnidipine Treatment for Mild-to-moderate Essential Hypertension

目的观察国产西尼地平治疗轻中度原发性高血压的疗效与安全性。方法采用多中心、随机、双盲双模拟、平行对照的方法,选择门诊轻、中度原发性高血压患者234例,分别给予西尼地平片或氨氯地平片治疗8周,观察其对血压、心率、心电图及实验室检查的影响。结果两组治疗后血压明显下降,与治疗前比较有显著性差异(P<0.01)。西尼地平组平均坐位收缩压及舒张压分别下降(17.9±10.0)和(14.9±5.3)mmHg,氨氯地平组分别下降(19.6±9.6)和(14.9±6.3)mmHg。显效和总有效率试验组分别为85.1%和92.5%,对照组分别为78.0%和87.2%。两药对心率均无明显影响,试验组治疗前后心率分别为74.7和75.2次/min,对照组治疗前后心率分别为75.1和74.7次/min。试验组和对照组不良反应发生率分别为9.7%和8.6%,两组之间无统计学差异。较为常见的是头痛、头胀,面红、潮热和下肢水肿,均较轻微。动态血压监测显示西尼地平收缩压和舒张压的T/P比值分别为0.69和0.65。结论国产西尼地平片治疗轻、中度原发性高血压安全、有效,可作为长效制剂使用。

Objective To evaluate the efficacy and safety of domestic produced cilnidipine in patients with mild-to-moderate essential hypertension. Methods Patients （n=234） were randomly assigned to receive cilnidipine （5 mg/d）or amlodipine（5 mg/d） for 8 weeks. The dosage was double when DBP was sustained ≥90 mm Hg or the magnitude of reduction of DBP was less than 10 mm Hg. Results SBP/DBP was decreased significantly for（17. 9±10.0）/（14. 9±5.3） mm Hg and（19.6±9.6）/（14.9±6.3）ram Hg in cilnidipine group and am- lodipine group respectively. Response rate was 92.5% in cilnidipine group, and 87.2% in amlodipine group with no changes in heart rate. Adverse reactions were slight, such as headache, flushing, hectic fever, edema of lower extremities. The T/P ratio of cilnidipine were 0.69 for SBP and 0.65 for DBP. Conclusion cilnidipine was proved to be a stable, safe and effective antihypertensive medication analogus to amlodipine with little adverse reactions.