Bory M, Gillet T, Bonnet J L, Sebag C L, Djiane P, Habib G
Service de cardiologie A, CHU Timone, Marseille.
Arch Mal Coeur Vaiss. 1991 Feb;84(2):235-42.
Diltiazem and Nifedipine could be synergic. The aim of this study was to investigate the benefits of their association. Eighteen patients, 15 men and 3 women, average age 61 +/- 6 years, with stable angina on effort, were studied. Eight patients had single vessel disease and 10 patients had multivessel disease. The patients underwent a randomised double-blind trial with 4 successive treatment periods each lasting one week: placebo; 360 mg/day of Diltiazem; 60 mg/day of Nifedipine; 180 mg/day of Diltiazem with 30 mg/day of Nifedipine. The benefits were evaluated clinically, by exercise stress testing and with drug plasma concentrations at the end of each sequence. The results at the end of the 3 treatment periods were significantly better than with placebo. Diltiazem was significantly better than Nifedipine with respect to the development of angina during exercise testing (1 patient compared with 7 patients) and to maximum load (118.3 +/- 33.3 watts compared with 105.9 +/- 35.4 watts) (p less than 0.05). The association of the two drugs did not give better results than Diltiazem alone. Compared with placebo, the total duration of exercise testing and the duration of 1 mm ST depression were significantly longer during the 3 treatment sequences but there were no significant differences between each of them. Secondary effects were significantly more common with Nifedipine (7 patients) and with the drug association (9 patients) than with Diltiazem alone (3 patients) or placebo (1 patient). Plasma concentrations of Diltiazem were 328 +/- 35 ng/l with the 360 mg/day dosage and 137 +/- 52 ng/l with the 180 mg/day dosage.(ABSTRACT TRUNCATED AT 250 WORDS)
地尔硫䓬和硝苯地平可能具有协同作用。本研究旨在探讨两者联合使用的益处。研究对象为18例患者,其中15例男性,3例女性,平均年龄61±6岁,患有劳力性稳定型心绞痛。8例患者为单支血管病变,10例患者为多支血管病变。患者接受了一项随机双盲试验,包括4个连续的治疗期,每个治疗期持续1周:安慰剂;地尔硫䓬360毫克/天;硝苯地平60毫克/天;地尔硫䓬180毫克/天与硝苯地平30毫克/天联合使用。通过临床评估、运动负荷试验以及每个疗程结束时的药物血浆浓度来评估疗效。3个治疗期结束时的结果明显优于安慰剂。在运动试验中,地尔硫䓬在心绞痛发作方面(1例患者与7例患者相比)和最大负荷方面(118.3±33.3瓦与105.9±35.4瓦相比)明显优于硝苯地平(p<0.05)。两种药物联合使用并未比单独使用地尔硫䓬产生更好的效果。与安慰剂相比,在3个治疗疗程中,运动试验的总时长和ST段压低1毫米的时长明显更长,但各治疗组之间无显著差异。硝苯地平(7例患者)和联合用药组(9例患者)的副作用明显比单独使用地尔硫䓬组(3例患者)和安慰剂组(1例患者)更常见。地尔硫䓬360毫克/天剂量时血浆浓度为328±35纳克/升,180毫克/天剂量时为137±52纳克/升。(摘要截取自250字)