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 observe the efficacy and safety of domestic cilnidipine in the treatment of mild to moderate essential hypertension. Methods A total of 234 patients with mild to moderate essential hypertension were enrolled in the study. The patients were given cilnidipine or amlodipine for 8 weeks respectively. Blood pressure, heart rate, ECG and laboratory tests. Results After treatment, the blood pressure decreased obviously in both groups, which was significantly different from that before treatment (P <0.01). Mean sit-systolic and diastolic blood pressure decreased (17.9 ± 10.0) and (14.9 ± 5.3) mmHg for the sitatipn group, and (19.6 ± 9.6) and (14.9 ± 6.3) mmHg for the amlodipine group, respectively. The markedly effective and total effective rate test group was 85.1% and 92.5% respectively, while the control group was 78.0% and 87.2% respectively. The two drugs had no significant effect on the heart rate, heart rate before and after treatment in the experimental group was 74.7 and 75.2 times / min, before and after treatment in the control group heart rate was 75.1 and 74.7 beats / min. The incidence of adverse reactions in the experimental and control groups were 9.7% and 8.6%, respectively, with no significant difference between the two groups. More common are headaches, head swell, redness, hot flashes and lower extremity edema, are minor. Ambulatory blood pressure monitoring showed that the T / P ratio of systolic and diastolic blood pressure of cilnidipine was 0.69 and 0.65, respectively. Conclusion Domestic cilnidipine tablets are safe and effective in the treatment of mild to moderate essential hypertension and can be used as long-acting preparations.