Juhani Knuuti M, Wahl M, Wiklund I, Smith P, Alhainen L, Härkönen R, Puska P, Tzivoni D
Department of Clinical Physiology, Turku University Central Hospital, Finland.
Am J Cardiol. 1992 Jun 15;69(19):1525-32. doi: 10.1016/0002-9149(92)90697-w.
The aim of this study was to compare the efficacy and safety of continuous and intermittent transdermal nitrate therapy using ambulatory electrocardiographic (Holter) monitoring. Eighty-five patients with stable angina pectoris and positive exercise test results participated during their concomitant antiischemic medication in a randomized open trial lasting 12 weeks. After a 3-week run-in period with continuous therapy (10 mg/24 hours), patients were randomized to either continuous- or intermittent-therapy groups. In the intermittent-therapy group the patients removed their patch at night (the mean patch-off period was 10 hours). Forty-eight-hour Holter monitoring was performed in each patient after randomization, and again after 2 and 12 weeks. Eighteen patients withdrew, 9 in each group. A total of 11,194 hours of electrocardiography were recorded and 607 ischemic episodes were detected, of which 79% were asymptomatic and 95% appeared during daytime. The number of ischemic episodes per 48 hours with intermittent therapy was 3.1 +/- 0.7 (mean +/- SEM) after randomization, 1.8 +/- 0.4 at 2 weeks and 2.0 +/- 0.6 at 12 weeks. With continuous therapy the respective numbers were 3.8 +/- 1.1, 3.5 +/- 0.9 and 4.2 +/- 1.2. The differences were not statistically significant because a large number of patients (30%) had no ischemic episodes on Holter recording. However, when examining 47 patients with episodes during the study, the number of episodes was significantly reduced in the intermittent-therapy group (p less than 0.05 at 12 weeks). The changes in asymptomatic and symptomatic episodes were concordant. No changes and differences between the treatment groups were seen in nighttime episodes.(ABSTRACT TRUNCATED AT 250 WORDS)
本研究旨在通过动态心电图(Holter)监测比较持续和间歇经皮硝酸盐治疗的疗效和安全性。85例稳定型心绞痛且运动试验结果阳性的患者在接受抗缺血药物治疗期间参与了一项为期12周的随机开放试验。在持续治疗(10毫克/24小时)的3周导入期后,患者被随机分为持续治疗组或间歇治疗组。在间歇治疗组中,患者夜间取下贴片(平均贴片去除期为10小时)。随机分组后,对每位患者进行48小时的Holter监测,2周和12周后再次进行监测。18例患者退出,每组9例。共记录了11194小时的心电图,检测到607次缺血发作,其中79%无症状,95%发生在白天。随机分组后,间歇治疗组每48小时的缺血发作次数为3.1±0.7(平均值±标准误),2周时为1.8±0.4,12周时为2.0±0.6。持续治疗组的相应次数分别为3.8±1.1、3.5±0.9和4.2±1.2。差异无统计学意义,因为大量患者(30%)在Holter记录中无缺血发作。然而,在研究期间检查47例有发作的患者时,间歇治疗组的发作次数显著减少(12周时p<0.05)。无症状和有症状发作的变化是一致的。治疗组之间在夜间发作方面未见变化和差异。(摘要截断于250字)