Forche G, Kopera H, Marsoner H J
Int J Clin Pharmacol Ther Toxicol. 1983 May;21(5):234-40.
Bepridil is a novel substance with antianginal and specific antiarrhythmic activities. To investigate its effect on bronchomotor and cardiovascular function a placebo-controlled, randomized, double-blind study was performed in 12 healthy volunteers of both sexes. The test preparations were administered by intravenous infusion. Bepridil was given in a dose of 2 mg/kg, which is sufficient to produce a therapeutic plasma level. With body plethysmography the airway resistance was determined before and 110 min after test drug administration. Oscillatory resistance (Oscillation method, Siregnost FD5, Siemens), blood pressure, and electrocardiogram were recorded before administration of the test preparation and thereafter in short intervals for 20 min and in longer intervals for 2 h. Analysis of the data does not indicate that Bepridil affects respiratory function in other ways than a placebo. Hence Bepridil in therapeutic doses is unlikely to produce untoward effects on the respiratory system. Likewise no unwanted effects on the cardiovascular system were recorded; the observed antitachydardia effect is of therapeutic value. The usefulness of the oscillation method to investigate influences on bronchomotor function has been confirmed.
苄普地尔是一种具有抗心绞痛和特异性抗心律失常活性的新型物质。为研究其对支气管运动和心血管功能的影响,对12名男女健康志愿者进行了一项安慰剂对照、随机、双盲研究。试验制剂通过静脉输注给药。苄普地尔的给药剂量为2mg/kg,该剂量足以产生治疗性血浆水平。使用体容积描记法在给药前和给药后110分钟测定气道阻力。在给药前记录振荡阻力(振荡法,Siregnost FD5,西门子)、血压和心电图,此后每隔短时间记录20分钟,每隔长时间记录2小时。数据分析表明,苄普地尔对呼吸功能的影响与安慰剂无异。因此,治疗剂量的苄普地尔不太可能对呼吸系统产生不良影响。同样,未记录到对心血管系统的不良影响;观察到的抗心动过速作用具有治疗价值。振荡法用于研究对支气管运动功能影响的有效性已得到证实。