Santoro G, Savonitto S, Di Bello V, Alberti D, Giusti C
Institute of Internal Medicine II, University of Pisa, Italy.
Am J Cardiol. 1991 Aug 15;68(5):457-62. doi: 10.1016/0002-9149(91)90778-j.
To investigate the antiischemic efficacy and duration of action of the dihydropyridine calcium antagonist felodipine, 15 patients with stable exertional angina were enrolled in a double-blind, crossover study comparing 2 doses (5 and 10 mg) of felodipine extended release (ER) and placebo given once daily for 1 week. Bicycle exercise tests were repeated at the end of each treatment period 4 and 24 hours after dosing. Four hours after dosing with both felodipine doses, only 5 patients discontinued the exercise test because of greater than 2 mm of ST-segment depression, whereas 10 continued until exhaustion (p less than 0.01 vs placebo). Compared with placebo, total exercise time was increased by 19% (p less than 0.001), with no difference between doses. After 24 hours, exercise duration was prolonged up to physical exhaustion in 6 patients taking felodipine 10 mg (p less than 0.05 vs both placebo and felodipine 5 mg); moreover, 11 patients taking 10 mg and 5 taking 5 mg increased time to 1 mm of ST depression greater than or equal to 15% compared with exercise time during the placebo test. Mean time to 1 mm of ST depression at 24 hours was increased by 8% with 5 mg and by 18% with 10 mg (p less than 0.001 vs placebo; p less than 0.01 between doses). Total exercise time at 24 hours was increased with both doses (p less than 0.001), with greater efficacy with the 10-mg dose (p less than 0.05 vs 5 mg).(ABSTRACT TRUNCATED AT 250 WORDS)
为研究二氢吡啶类钙拮抗剂非洛地平的抗缺血疗效及作用持续时间,15例稳定型劳力性心绞痛患者参与了一项双盲交叉研究,比较每日一次给予两种剂量(5毫克和10毫克)的非洛地平缓释片(ER)及安慰剂,疗程为1周。在每个治疗期结束时、给药后4小时和24小时重复进行自行车运动试验。给予两种非洛地平剂量后4小时,只有5例患者因ST段压低超过2毫米而中止运动试验,而10例患者持续运动至力竭(与安慰剂相比,P<0.01)。与安慰剂相比,总运动时间增加了19%(P<0.001),两种剂量之间无差异。24小时后,6例服用10毫克非洛地平的患者运动持续时间延长至体力耗竭(与安慰剂和5毫克非洛地平相比,P<0.05);此外,11例服用10毫克和5例服用5毫克的患者与安慰剂试验期间的运动时间相比,ST段压低1毫米的时间增加了≥15%。24小时时ST段压低1毫米的平均时间,5毫克剂量增加了8%,10毫克剂量增加了18%(与安慰剂相比,P<0.001;两种剂量之间,P<0.01)。两种剂量在24小时时的总运动时间均增加(P<0.001),10毫克剂量的疗效更佳(与5毫克相比,P<0.05)。(摘要截选至250字)