Staessen J, Fagard R, Lijnen P, Rorive G, Amery A
Department of Pathophysiology, University of Leuven, Belgium.
J Cardiovasc Pharmacol. 1988 Dec;12(6):718-25. doi: 10.1097/00005344-198812000-00014.
In this double-blind study in general practice, 444 patients were randomized to ketanserin (K, 40 mg b.i.d.) and 229 patients were randomized to propranolol (P, 80 mg b.i.d.). After 3 months, more patients on K (15%) than on P (9%) had been withdrawn (p less than 0.02). Although at 3 months the falls in systolic blood pressure (SBP) and diastolic blood pressure (DBP) were similar in both groups, the reduction in SBP was slower on K, and up to 2 months SBP was higher on K than on P (p less than 0.04 or less). At randomization and after 3 months, average weights were similar in both groups. However, during the first month of the study, patients on K gained weight, and this change in weight differed (p less than 0.02) from the unchanged weight on P. On K, BP lowering was greater when weight gain was less. Multiple regression analysis showed that after adjusting for BP at randomization and subsequent weight changes, DBP at 1 month on K was lower with advancing age, whereas SBP and DBP at 1 and 3 months on P were higher with age. Severe adverse effects were absent. However, dry mouth, edema, fatigue, and dizziness occurred more frequently with K (p less than 0.04 or less).
在这项全科医疗双盲研究中，444例患者被随机分配至酮色林组（K组，40毫克，每日两次），229例患者被随机分配至普萘洛尔组（P组，80毫克，每日两次）。3个月后，K组的撤组患者比例（15%）高于P组（9%）（p<0.02）。虽然3个月时两组收缩压（SBP）和舒张压（DBP）的下降幅度相似，但K组SBP下降较慢，且在2个月内K组SBP高于P组（p<0.04或更低）。随机分组时及3个月后，两组平均体重相似。然而，在研究的第一个月，K组患者体重增加，且这种体重变化与P组体重未变存在差异（p<0.02）。在K组，体重增加较少时血压降低幅度更大。多元回归分析显示，在对随机分组时的血压及随后的体重变化进行校正后，K组1个月时DBP随年龄增长而降低，而P组1个月和3个月时SBP和DBP随年龄增长而升高。未出现严重不良反应。然而，K组口干、水肿、疲劳和头晕的发生率更高（p<0.04或更低）。
