Meany T B, Richardson P, Camm A J, Coltart J, Griffith M, Maltz M B, Signy M
Department of Cardiology, Kings College Hospital, United Kingdom.
Am J Cardiol. 1989 Jun 20;63(21):66J-70J. doi: 10.1016/0002-9149(89)90208-7.
In a double-blind parallel group study, 46 patients with chronic stable angina were randomized, after a 2-week placebo washout period, to 1 of 3 treatment groups for an additional 2 weeks. Groups 1 and 2 received nicorandil (5 mg, n = 5; 10 mg, n = 10) twice daily, respectively, increasing to 10 and 20 mg (n = 20) twice daily after 1 week of treatment; group 3 continued to receive placebo. A symptom-limited Bruce protocol exercise test was performed before and 2 hours after the initial dose and, after 2 weeks of treatment, 2 and 12 hours after administration. The following parameters were measured: resting, peak exercise and recovery blood pressure and heart rate, exercise duration, time to onset of angina and time to 1 mm of ST-segment depression. After initial dosing, there were significant increases in exercise duration (16%--n = 5, n = 10 vs -2% [placebo]) and time to onset of angina (20%, n = 5; 26%, n = 10 vs 5% [placebo]) (p less than 0.05). Time to onset of 1 mm of ST-segment depression increased in the nicorandil-treated groups compared with that in the placebo group (27%, n = 5; 25%, n = 10 vs 8% [placebo]). Calculated total exercise work increased in both nicorandil groups compared with exercise work in the placebo group (30%, n = 5; 19%, n = 10 vs 3% [placebo]). A decrease in resting systolic blood pressure (12%) in the 10-mg group was the only significant alteration in the hemodynamic parameters.(ABSTRACT TRUNCATED AT 250 WORDS)
在一项双盲平行组研究中,46例慢性稳定型心绞痛患者在经过2周的安慰剂洗脱期后,被随机分为3个治疗组之一,再接受2周治疗。第1组和第2组分别每日两次服用尼可地尔(5毫克,n = 5;10毫克,n = 10),治疗1周后增加至每日两次10毫克和20毫克(n = 20);第3组继续接受安慰剂治疗。在初始剂量前、初始剂量后2小时以及治疗2周后给药后2小时和12小时进行症状限制型布鲁斯方案运动试验。测量以下参数:静息、运动峰值和恢复时的血压及心率、运动持续时间、心绞痛发作时间和ST段压低1毫米的时间。初始给药后,运动持续时间(16%——n = 5,n = 10 vs -2%[安慰剂])和心绞痛发作时间(20%,n = 5;26%,n = 10 vs 5%[安慰剂])显著增加(p小于0.05)。与安慰剂组相比,尼可地尔治疗组ST段压低1毫米的发作时间增加(27%,n = 5;25%,n = 10 vs 8%[安慰剂])。与安慰剂组的运动功相比,两个尼可地尔组的计算总运动功均增加(30%,n = 5;19%,n = 10 vs 3%[安慰剂])。10毫克组静息收缩压下降(12%)是血流动力学参数中唯一的显著变化。(摘要截短于250字)