De Divitiis O, Liguori V, Di Somma S, Brignoli M, Ferraro S, Petitto M, Fazio S, Marsullo G, Salvatore M, Gradnik R
Section of Cardioangiology, 2nd Medical School, University of Naples, Italy.
Eur Heart J. 1987 Dec;8 Suppl M:43-54. doi: 10.1093/eurheartj/8.suppl_m.43.
In order to verify the anti-ischaemic effect of a new beta-blocking agent, bisoprolol, a double blind parallel groups trial was carried out in comparison with verapamil. 26 patients with a history of spontaneous and/or effort angina were studied. After a two-week treatment with placebo, they were randomized in two groups. One group was treated for 4 weeks with bisoprolol 10 mg o.d. and for the following 4 weeks with bisoprolol 20 mg o.d. The other group received verapamil 80 mg t.i.d. for the first 4 weeks and 120 mg t.i.d. for the remaining 4 weeks. Throughout the study isosorbide dinitrate 20 mg b.i.d. was administered and sublingual nitroglycerin was allowed when necessary. 21 patients completed the study. Both bisoprolol and verapamil significantly reduced the number of angina episodes and nitroglycerin tablets consumption, as well as ischaemic episodes recorded on Holter ECG. The total number and severity of ectopic ventricular beats were reduced too. On multistage treadmill exercise test, both drugs increased effort time and time to ST depression = 1 mm, and reduced ST depression and double-product. The effect of bisoprolol on double product was greater than that of verapamil because of the better control of heart rate. The relationship ST/double product suggested that beta-blockers act essentially through the reduction of myocardial oxygen consumption and verapamil possibly with an additive effect on coronary circulation. Radionuclide ventriculography showed no deterioration of rest ventricular function with both drugs. In conclusion, bisoprolol and verapamil showed a satisfactory anti-ischaemic effect, with good tolerability.
为验证新型β受体阻滞剂比索洛尔的抗缺血作用，开展了一项与维拉帕米对比的双盲平行组试验。研究了26例有自发性和/或劳力性心绞痛病史的患者。在接受两周安慰剂治疗后，他们被随机分为两组。一组先接受4周每日一次10mg比索洛尔治疗，随后4周接受每日一次20mg比索洛尔治疗。另一组在最初4周接受每日三次80mg维拉帕米治疗，在剩余4周接受每日三次120mg维拉帕米治疗。在整个研究过程中，每日两次给予20mg二硝酸异山梨酯，必要时允许使用舌下硝酸甘油。21例患者完成了研究。比索洛尔和维拉帕米均显著减少了心绞痛发作次数、硝酸甘油片消耗量以及动态心电图记录的缺血发作次数。室性早搏的总数和严重程度也有所降低。在多级平板运动试验中，两种药物均增加了运动时间和出现ST段压低=1mm的时间，并减少了ST段压低和双乘积。由于比索洛尔对心率控制更佳，其对双乘积的作用大于维拉帕米。ST/双乘积关系表明，β受体阻滞剂主要通过降低心肌耗氧量起作用，而维拉帕米可能对冠脉循环有相加作用。放射性核素心室造影显示，两种药物均未使静息心室功能恶化。总之，比索洛尔和维拉帕米显示出令人满意的抗缺血作用，且耐受性良好。
