Klausner M A, Sanghvi I S, Mullane J F, Irwin C
Ayerst Laboratories, New York, NY 10017.
J Clin Pharmacol. 1988 Apr;28(4):322-6. doi: 10.1002/j.1552-4604.1988.tb03151.x.
This double-blind, placebo-controlled, randomized multicenter study evaluated the antihypertensive efficacy and safety of cetamolol hydrochloride in 108 patients diagnosed as having mild to moderate hypertension. After a placebo lead-in period, patients received either cetamolol 5-10-15 mg/d (low dose), cetamolol 15-25-50 mg/d (high dose), or placebo, once daily for four weeks. Patients began at the lowest dose and were titrated to higher doses based on the first two assessments of diastolic blood pressure and heart rate, which were conducted each week after double-blind treatment was dispensed. After four weeks of treatment 82.4%, 81.3%, and 93.3% of the low-dose group, high-dose group, and placebo group, respectively, were titrated to the maximum dose level. After four weeks of treatment and 24 hours since the patient's last dose, both cetamolol groups showed a significantly greater (P less than or equal to .05) reduction in supine systolic/diastolic blood pressure (-18.1 +/- 2.3/-9.2 +/- 1.5 mm Hg [low dose] and -17.3 +/- 2.3/-8.3 +/- 1.6 mm Hg [high dose]) than the placebo group (-9.9 +/- 2.5/-3.5 +/- 1.7 mm Hg). In general, the changes in standing (stabilized) systolic and diastolic blood pressure were similar to those seen in supine measurements. Significantly more patients receiving cetamolol than those receiving placebo showed a "good response" (a decrease in diastolic blood pressure of 10 mm Hg or more or measuring less than 90 mm Hg with a decrease of at least 4 mm Hg).(ABSTRACT TRUNCATED AT 250 WORDS)
这项双盲、安慰剂对照、随机多中心研究评估了盐酸塞他洛尔对108例诊断为轻至中度高血压患者的降压疗效和安全性。在经过一个安慰剂导入期后,患者分别接受5 - 10 - 15毫克/天(低剂量)的塞他洛尔、15 - 25 - 50毫克/天(高剂量)的塞他洛尔或安慰剂治疗,每日一次,持续四周。患者从最低剂量开始,根据双盲治疗开始后每周进行的前两次舒张压和心率评估结果逐步增加至更高剂量。治疗四周后,低剂量组、高剂量组和安慰剂组分别有82.4%、81.3%和93.3%的患者被滴定至最大剂量水平。治疗四周且患者最后一次服药24小时后,两个塞他洛尔组的仰卧位收缩压/舒张压下降幅度(低剂量组为-18.1±2.3/-9.2±1.5毫米汞柱,高剂量组为-17.3±2.3/-8.3±1.6毫米汞柱)均显著大于安慰剂组(-9.9±2.5/-3.5±1.7毫米汞柱)(P≤0.05)。一般来说,站立位(稳定后)收缩压和舒张压的变化与仰卧位测量结果相似。接受塞他洛尔治疗的患者出现“良好反应”(舒张压下降10毫米汞柱或更多,或测量值低于90毫米汞柱且下降至少4毫米汞柱)的比例显著高于接受安慰剂治疗的患者。(摘要截选至250字)