Guermonprez J L, Blin P, Peterlongo F
Department de Cardiologie Hopital Broussais, Paris, France.
Eur Heart J. 1993 Jul;14 Suppl B:30-4. doi: 10.1093/eurheartj/14.suppl_b.30.
The efficacies and safety of nicorandil, 20 mg b.d., and diltiazem, 60 mg t.d., in the treatment of stable angina pectoris were compared in a double-blind randomized parallel group study involving 123 patients. The duration of the study was 3 months. Exercise tolerance tests were performed by the patients when on placebo (day 0) and at the end of the study period (day 90). Both groups were comparable at day 0 in terms of demography and cardiovascular status. Nicorandil and diltiazem were both found to decrease the frequency of anginal attacks and the consumption of nitroglycerin tablets (P < 0.01). Maximum exercise capacity, the amount of work that could be performed before reaching ischaemic threshold, and the amount of work required to reach onset of angina were significantly increased for both groups of patients on day 90 compared with day 0 (increase in maximum exercise capacity: nicorandil--6.9 +/- 18.9 kj, diltiazem--9.6 +/- 16.2 kj, P = 0.44 ns; increase in work to ischaemic threshold: nicorandil--9.4 +/- 18.1 kJ, diltiazem--14.7 +/- 15.4 kJ, P = 0.10 ns; increase in work to onset of angina: nicorandil--10.0 +/- 20.1 kJ, diltiazem--11.4 +/- 14.9 kJ, P = 0.68 ns). Differences between the two groups were not significant. The double product of systolic blood pressure x heart rate and peak exercise for both drugs was either unchanged or slightly decreased at ischaemic threshold.(ABSTRACT TRUNCATED AT 250 WORDS)
在一项涉及123例患者的双盲随机平行组研究中,比较了每日两次服用20毫克尼可地尔和每日三次服用60毫克地尔硫䓬治疗稳定型心绞痛的疗效和安全性。研究持续时间为3个月。患者在服用安慰剂时(第0天)和研究期末(第90天)进行运动耐量测试。两组在第0天的人口统计学和心血管状况方面具有可比性。尼可地尔和地尔硫䓬均能降低心绞痛发作频率和硝酸甘油片的消耗量(P<0.01)。与第0天相比,两组患者在第90天时的最大运动能力、达到缺血阈值前可完成的工作量以及达到心绞痛发作所需的工作量均显著增加(最大运动能力增加:尼可地尔——6.9±18.9千焦,地尔硫䓬——9.6±16.2千焦,P=0.44,无显著差异;达到缺血阈值的工作量增加:尼可地尔——9.4±18.1千焦,地尔硫䓬——14.7±15.4千焦,P=0.10,无显著差异;达到心绞痛发作的工作量增加:尼可地尔——10.0±20.1千焦,地尔硫䓬——11.4±14.9千焦,P=0.68,无显著差异)。两组之间的差异不显著。两种药物在缺血阈值时收缩压×心率的双乘积和峰值运动要么未改变,要么略有下降。(摘要截断于250字)