Marquand A, Prost P L, Grippat J C
Service de Cardiologie, CHG Fréjus.
Ann Cardiol Angeiol (Paris). 1994 May;43(5):301-6.
A randomised, parallel, double-blind trial was undertaken in 80 patients to compare the efficacy of bisoprolol with that of celiprolol, using causal (BPc) as well as ambulatory (AMBP) blood pressure measurement. After a two week wash-out and two week placebo run-in, patients in whom diastolic blood pressure (DBP) was between 95 and 114 mmHg were given either bisoprolol (10 mg/day) or celiprolol (200 mg/day) for 12 weeks. When efficacy was insufficient (DBP > 95 mmHg), the dose could be doubled after 4 weeks and a diuretic added after 8 weeks. BPc was measured at each visit and an AMBP obtained the day before the start of active treatment and at its end. Six patients dropped out of the trial because of adverse events. Clinical safety/acceptability of both drugs was good. Demographic data, and blood pressure and heart rate figures in both groups were comparable at the end of the placebo period. Mean fall in BPc in the bisoprolol group was 32.5/20.3 mmHg and 23/17.4 mmHg in the celiprolol group, with a significant difference between the two groups concerning systolic pressure (SBP). Ambulatory measurement showed evidence during the periods 24 hours (H), day and night, of a greater fall with bisoprolol (10.7/8.9 mmHg; 13.9/10.8 mmHg; 7.3/7.2 mmHg) than in the celiprolol group (4.9/21.6; 7.3/3.8; 2.9/2 mmHg), the difference being significant for diastolic blood pressure (DBP: p < 0.01; p < 0.05; p < 0.05. Thus bisoprolol was more effective than celiprolol in mild to moderate hypertension, but the difference was significant for SBP by casual measurement and for DBP by ambulatory measurement.
一项随机、平行、双盲试验纳入了80例患者,采用偶测血压(BPc)和动态血压监测(AMBP)比较比索洛尔与塞利洛尔的疗效。经过两周的洗脱期和两周的安慰剂导入期后,舒张压(DBP)在95至114 mmHg之间的患者被给予比索洛尔(10 mg/天)或塞利洛尔(200 mg/天)治疗12周。当疗效不足(DBP>95 mmHg)时,4周后剂量可加倍,8周后加用利尿剂。每次就诊时测量BPc,并在积极治疗开始前一天和结束时进行AMBP监测。6例患者因不良事件退出试验。两种药物的临床安全性/可接受性良好。安慰剂期结束时,两组的人口统计学数据、血压和心率数值具有可比性。比索洛尔组BPc的平均下降幅度为32.5/20.3 mmHg,塞利洛尔组为23/17.4 mmHg,两组收缩压(SBP)存在显著差异。动态血压监测显示,在24小时、白天和夜间期间,比索洛尔组的下降幅度(10.7/8.9 mmHg;13.9/10.8 mmHg;7.3/7.2 mmHg)大于塞利洛尔组(4.9/21.6;7.3/3.8;2.9/2 mmHg),舒张压(DBP)差异有统计学意义(p<0.01;p<0.05;p<0.05)。因此,在轻度至中度高血压中,比索洛尔比塞利洛尔更有效,但偶测SBP和动态监测DBP时差异有统计学意义。