Villanova C, Maddalena F, Rocco C G
Unità di Cura Intensiva Coronarica, Ospedale Civile, Padova.
Minerva Cardioangiol. 1994 Dec;42(12):583-9.
This controlled, double-blind, completely randomized study assessed the efficacy and safety of nicardipine and nifedipine, both in slow-release formulations, in patients with unstable angina. Thirty patients (28 M, 2F) were included in the final analysis, mean age 56.5 +/- 9.1 years (SD), mean weight 73.5 +/- 9.2 kg, mean height 171.5 +/- 6.5 cm, all with unstable angina. Nicardipine was given at a daily dosage of 80-120 mg, and nifedipine 40-60 mg, for up to one month. At the end of treatment with nicardipine supine systolic and diastolic blood pressure (SBP and DBP) dropped respectively 7.7% and 5.5% at 8 am and 8.6% and 7.1% at 8 pm. Nifedipine reduced SBP and DBP by respectively 6.5% and 13.1% at 8 am and 5.3% and 9.4% at 8 pm. There was no clinical or statistical difference between the treatments. Heart rate did not change appreciably during either treatment. On completion of nicardipine treatment, 87.5% of patients had suffered no angina attacks, compared with 66.7% for nifedipine. The remaining 12.5% of patients treated with nicardipine presented only one mild angina attack per day, while the other 33.3% of the nifedipine patients had one moderate angina attack per day. No untoward effects were reported with nicardipine; one patient receiving nifedipine presented cardiopalmus and another complained of headache. These results indicate that nicardipine is at least as safe and effective as nifedipine in the treatment of unstable angina.
这项对照、双盲、完全随机的研究评估了缓释制剂尼卡地平和硝苯地平在不稳定型心绞痛患者中的疗效和安全性。最终分析纳入了30例患者(28例男性,2例女性),平均年龄56.5±9.1岁(标准差),平均体重73.5±9.2千克,平均身高171.5±6.5厘米,均患有不稳定型心绞痛。尼卡地平的每日剂量为80 - 120毫克,硝苯地平为40 - 60毫克,用药长达1个月。在尼卡地平治疗结束时,上午8点仰卧位收缩压和舒张压(SBP和DBP)分别下降了7.7%和5.5%,晚上8点分别下降了8.6%和7.1%。硝苯地平上午8点时SBP和DBP分别降低了6.5%和13.1%,晚上8点时分别降低了5.3%和9.4%。两种治疗方法在临床和统计学上均无差异。在任何一种治疗期间心率均无明显变化。尼卡地平治疗结束时,87.5%的患者未发生心绞痛发作,而硝苯地平组为66.7%。接受尼卡地平治疗的其余12.5%的患者每天仅出现1次轻度心绞痛发作,而接受硝苯地平治疗的患者中有33.3%每天出现1次中度心绞痛发作。未报告尼卡地平有不良影响;1例接受硝苯地平治疗的患者出现心悸,另1例抱怨头痛。这些结果表明,在治疗不稳定型心绞痛方面,尼卡地平至少与硝苯地平一样安全有效。