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口服缓释硝酸甘油治疗慢性稳定性心绞痛:一项多中心、双盲、随机交叉试验

Oral sustained-release nitroglycerin in chronic stable angina: a multicenter, double-blind, randomized crossover trial.

作者信息

Berkenboom G M, Sobolski J C, Degre S G

出版信息

Am J Cardiol. 1984 Jan 1;53(1):15-7. doi: 10.1016/0002-9149(84)90676-3.

Abstract

Forty-six patients with stable angina pectoris were randomized to receive either oral sustained-release nitroglycerin (SRNG, 6.5 mg) or placebo (P) 3 times a day for a 2-week double-blind trial. They were investigated for the frequency of anginal episodes, for sublingual nitroglycerin consumption and for exercise tolerance. There was a slight but significant decrease in the number of anginal episodes (6.4 +/- 1.5 episodes/week with P, 4.9 +/- 1.7 with SRNG, p less than 0.005) and sublingual nitroglycerin consumption (3.9 +/- 1 tablets/week with P, 2.7 +/- 1 with SRNG, p less than 0.005). The patients performed 3 upright multistage (increments of 30 W every 3 minutes) exercise tests on a bicycle ergometer before the start of the study and 1 hour after the intake of SRNG or P, at the end of each double-blind phase. Exercise capacity, expressed as exercise duration, increased from 8.9 +/- 3.8 minutes with P to 10.2 +/- 3.8 minutes with SRNG (14.6%; p less than 0.001). At symptom-limited exercise, ST depression was significantly reduced (p less than 0.05) during the SRNG phase. Thirty-four patients (74%) reached a higher peak heart rate (139 beats/min with P, 145 beats/min with SRNG; p less than 0.001) and 35 patients (76%) a higher rate-pressure product (+6%; p less than 0.001). These changes in exercise tolerance are relatively modest and at least 11 patients would have benefited from larger doses of nitrates.(ABSTRACT TRUNCATED AT 250 WORDS)

摘要

46例稳定型心绞痛患者被随机分为两组,在为期2周的双盲试验中,一组每日3次口服缓释硝酸甘油(SRNG,6.5毫克),另一组服用安慰剂(P)。对他们进行了心绞痛发作频率、舌下含服硝酸甘油的用量及运动耐量的调查。心绞痛发作次数有轻微但显著的减少(安慰剂组为6.4±1.5次/周,SRNG组为4.9±1.7次/周,p<0.005),舌下含服硝酸甘油的用量也有减少(安慰剂组为3.9±1片/周,SRNG组为2.7±1片/周,p<0.005)。在研究开始前以及在每次双盲阶段结束时,服用SRNG或P 1小时后,患者在自行车测力计上进行3次直立多级(每3分钟增加30瓦)运动试验。以运动持续时间表示的运动能力从安慰剂组的8.9±3.8分钟增加到SRNG组的10.2±3.8分钟(增加了14.6%;p<0.001)。在症状限制运动时,SRNG阶段ST段压低显著降低(p<0.05)。34例患者(74%)达到了更高的峰值心率(安慰剂组为139次/分钟,SRNG组为145次/分钟;p<0.001),35例患者(76%)达到了更高的心率-血压乘积(增加6%;p<0.001)。这些运动耐量的变化相对较小,至少有11例患者本可从更大剂量的硝酸盐中获益。(摘要截短于250字)

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