Pucci P, Fantoccoli D, Dovellini E V, Leoncini M, Sarro F, Fazzini P F
Divisione di Cardiologia, Ospedale di Careggi, Firenze.
G Ital Cardiol. 1990 Jun;20(6):526-32.
In 15 subjects (13 male, 2 female) with reproducible threshold ischaemic effort angina, the efficacy and the duration of the effect of two different formulations of gallopamil in equal doses were evaluated. One of these was gallopamil slow release administered twice daily (at 7.00 a.m. and 6.00 p.m.) in doses of 100 mg. The other was action gallopamil immediate release administered four times daily (at 7.00 a.m., 1.00 p.m., 6.00 p.m., 11.00 p.m.) in doses of 50 mg. The double-blind study followed the cross-over model. After one week of run-in with placebo and two-weeks of treatment with active preparations, the patients underwent a clinical examination, an ambulatory electrocardiogram monitoring for 24 hours and two cycloergometric effort tests. The ergometric tests were carried out at 10.00 a.m. and at 5.00 p.m. on the same day so that there was a three-hour interval between the administration of both preparations (slow release and immediate release) and the morning test. The ergometric test which was carried out at 5.00 p.m. was at a ten-hour interval from the administration of slow release and at a four-hour interval from the administration of immediate release. For each period of treatment the gallopamil plasma concentrations were dosed during the ergometric test. In both these tests, the two preparations significantly increased the duration of the exercise compared to the basal values with placebo (7.9 +/- 2.3 minutes with placebo, 9.2 +/- 2.0 minutes with slow release.(ABSTRACT TRUNCATED AT 250 WORDS)
在15名(13名男性,2名女性)患有可重复性阈值缺血性劳力性心绞痛的受试者中,评估了两种等剂量不同剂型维拉帕米的疗效和作用持续时间。其中一种是维拉帕米缓释片,每日两次(上午7点和下午6点)给药,剂量为100毫克。另一种是维拉帕米速释片,每日四次(上午7点、下午1点、下午6点、晚上11点)给药,剂量为50毫克。双盲研究采用交叉模型。在服用安慰剂一周和服用活性制剂两周后,患者接受了临床检查、24小时动态心电图监测以及两次运动耐力测试。运动耐力测试在同一天上午10点和下午5点进行,以便在两种制剂(缓释片和速释片)给药与上午测试之间有3小时间隔。下午5点进行的运动耐力测试与缓释片给药间隔10小时,与速释片给药间隔4小时。在每个治疗阶段,在运动耐力测试期间测定维拉帕米血浆浓度。在这两项测试中,与安慰剂的基础值相比,两种制剂均显著延长了运动持续时间(安慰剂组为7.9±2.3分钟,缓释片组为9.2±2.0分钟。(摘要截短于250字)