Trafford J A, Latta D, Little P S, Parsley J, Ankier S I, Quail D
Renal Unit, Royal Sussex County Hospital, Brighton, England.
Curr Med Res Opin. 1989;11(9):550-6. doi: 10.1185/03007998909112671.
A two-centre, double-blind, placebo controlled, randomized 3-way crossover study was undertaken to assess the efficacy, tolerability and safety of celiprolol in mild to moderate essential hypertension. A 4-week single-blind placebo run-in/screening period, during which no antihypertensive medication was given, was followed by 3 consecutive 4-week treatment periods with placebo or celiprolol (200 mg or 400 mg daily). At the end of the 4-week placebo run-in/screening period, 26 hospital out-patients with a seated mean blood pressure (systolic/diastolic) of 161.4/101.7 mmHg and a mean pulse rate of 75 beats/min entered the double-blind crossover phase of the study. Results showed that there was no significant difference in seated mean systolic or diastolic blood pressure between 200 mg celiprolol daily (149.2/92.3 mmHg) and 400 mg celiprolol daily (149.1/92.5 mmHg). However, mean seated systolic and diastolic blood pressures were significantly (p less than 0.05) lower on celiprolol than on placebo (157.1/98.2 mmHg). Neither dose of celiprolol had a significant effect on seated pulse rate. No patient was withdrawn due to an adverse event and no laboratory assessment outside the normal range was reported to be of any clinical significance. It is concluded that oral celiprolol, 200 mg or 400 mg daily, is effective and well tolerated for controlling mild to moderate essential hypertension. Since both doses had very similar effects on blood pressure there is no advantage in this group of patients for the 400 mg daily dose of celiprolol.
一项双中心、双盲、安慰剂对照、随机三向交叉研究旨在评估塞利洛尔治疗轻至中度原发性高血压的疗效、耐受性和安全性。在为期4周的单盲安慰剂导入/筛查期内，未给予抗高血压药物，随后是连续3个为期4周的治疗期，分别使用安慰剂或塞利洛尔（每日200毫克或400毫克）。在4周安慰剂导入/筛查期结束时，26名门诊患者进入了该研究的双盲交叉阶段，这些患者坐位平均血压（收缩压/舒张压）为161.4/101.7毫米汞柱，平均脉搏率为每分钟75次。结果显示，每日服用200毫克塞利洛尔（149.2/92.3毫米汞柱）和每日服用400毫克塞利洛尔（149.1/92.5毫米汞柱）时，坐位平均收缩压或舒张压无显著差异。然而，服用塞利洛尔时的坐位平均收缩压和舒张压显著低于安慰剂组（157.1/98.2毫米汞柱）（p<0.05）。两种剂量的塞利洛尔对坐位脉搏率均无显著影响。没有患者因不良事件退出研究，也没有报告超出正常范围的实验室评估具有任何临床意义。结论是，每日口服200毫克或400毫克塞利洛尔对控制轻至中度原发性高血压有效且耐受性良好。由于两种剂量对血压的影响非常相似，对于该组患者，每日400毫克塞利洛尔并无优势。
