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地尔硫䓬对劳力性心绞痛的疗效:一项多中心试验。

Efficacy of diltiazem in angina on effort: a multicenter trial.

作者信息

Hossack K F, Pool P E, Steele P, Crawford M H, DeMaria A N, Cohen L S, Ports T A

出版信息

Am J Cardiol. 1982 Feb 18;49(3):567-72. doi: 10.1016/s0002-9149(82)80013-1.

Abstract

During a multicenter study 57 patients with exercise-induced angina were evaluated with serial exercise testing to assess the efficacy of diltiazem, a calcium slow channel blocking agent, compared with a placebo. The study consisted of a 1 week single-blind placebo stabilization period followed by a double-blind triple crossover between diltiazem and placebo. Three dose levels were tested (120, 180 and 240 mg/day) in each patient. For the three time-related variables there was a significant dose-related response, with 240 mg/day being the most effective. The increases, over the washout placebo stabilization values, of the time-related variables for the 240 mg/day week compared with the corresponding placebo week were total duration of exercise 1.87 versus 1.05 minutes (p less than 0.002), time to onset of angina 1.81 versus 1.17 minutes (p less than 0.01) and time to appearance of 1 mm S-T segment depression 1.81 versus 1.01 minutes (p less than 0.002). Analysis of exercise variables indicated a significant reduction in heart rate, diastolic blood pressure, and pressure-rate product at submaximal exercise after administration of diltiazem. Diastolic blood pressure was significantly reduced at maximal exercise. Heart rate and pressure-rate product were unchanged at rest during submaximal or maximal exercise. Submaximal and maximal exercise S-T depression was not significantly altered by diltiazem. The reduction in pressure-rate product at submaximal exercise was a possible mechanism for the drug's beneficial effect in enhancing the three time-related variables.

摘要

在一项多中心研究中,对57例运动诱发型心绞痛患者进行了系列运动试验,以评估钙慢通道阻滞剂地尔硫䓬与安慰剂相比的疗效。该研究包括为期1周的单盲安慰剂稳定期,随后是地尔硫䓬与安慰剂之间的双盲三交叉试验。对每位患者测试了三个剂量水平(120、180和240毫克/天)。对于三个与时间相关的变量,存在显著的剂量相关反应,其中240毫克/天最为有效。与相应的安慰剂周相比,240毫克/天那一周的与时间相关变量相对于洗脱期安慰剂稳定值的增加情况为:运动总时长1.87分钟对1.05分钟(p<0.002),心绞痛发作时间1.81分钟对1.17分钟(p<0.01),以及出现1毫米S-T段压低的时间1.81分钟对1.01分钟(p<0.002)。运动变量分析表明,服用地尔硫䓬后次极量运动时心率、舒张压和压力-心率乘积显著降低。最大运动时舒张压显著降低。次极量或最大运动时静息心率和压力-心率乘积无变化。地尔硫䓬未显著改变次极量和最大运动时的S-T段压低。次极量运动时压力-心率乘积的降低可能是该药物在改善三个与时间相关变量方面产生有益作用的机制。

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