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普萘洛尔 - 氢氯噻嗪联合用药治疗原发性高血压

Propranolol-hydrochlorothiazide combination in essential hypertension.

作者信息

Stevens J D, Mullane J F

出版信息

Clin Ther. 1982;4(6):497-509.

PMID:7046937
Abstract

The effect of a propranolol-hydrochlorothiazide combination tablet was compared with the effects of its two components alone in the twice-daily treatment of mild to moderate essential hypertension (100 to 125 mmHg diastolic blood pressure). Propranolol alone or in combination was given at 80, 160, 240, or 320 mg/day; hydrochlorothiazide, at 50 mg/day. After a 3-week placebo period, a 12-week single-blind dose-finding test with the combination was held: 149/158 (94%) patients had decreases greater than or equal to 10 mmHg in diastolic blood pressure. Mean systolic and diastolic pressures were reduced by 26.6 mmHg 917%) and 19.2 mmHg (18.6%), respectively (P less than 0.001). A 10-week double-blind parallel treatment test followed, in which patients were assigned by random code to combination tablet, propranolol, or hydrochlorothiazide. There were significantly larger increases (P less than 0.05) in mean systolic or diastolic pressure with each component than with the combination from the end of dose-finding to each of the last four biweekly visits, to the mean of those four visits, and to the endpoint (last visit). The mean increases in pressure at the endpoint evaluation were (systolic/diastolic): combination (n = 47), 3.0/1.5 mmHg; propranolol (n = 51), 10.2/6.3 mmHg; hydrochlorothiazide (n = 52), 13.1/9.3 mmHg. During the double-blind period, no significant differences were demonstrated between the proportions of patients in each treatment group reporting new complaints. This study showed the combination to be as safe as, and more effective than, either component given at the same dose strength.

摘要

将普萘洛尔 - 氢氯噻嗪复方片剂与单独使用其两种成分的效果进行了比较,用于轻度至中度原发性高血压(舒张压为100至125 mmHg)的每日两次治疗。单独使用或联合使用的普萘洛尔剂量为80、160、240或320 mg/天;氢氯噻嗪为50 mg/天。经过3周的安慰剂期后,进行了为期12周的复方片剂单盲剂量探索试验:149/158(94%)的患者舒张压下降大于或等于10 mmHg。平均收缩压和舒张压分别降低了26.6 mmHg(17%)和19.2 mmHg(18.6%)(P<0.001)。随后进行了为期10周的双盲平行治疗试验,患者通过随机编码被分配到复方片剂、普萘洛尔或氢氯噻嗪组。从剂量探索结束到最后四次每两周一次的访视、这四次访视的平均值以及终点(最后一次访视),各成分组的平均收缩压或舒张压的升高均显著大于(P<0.05)复方片剂组。终点评估时压力的平均升高值为(收缩压/舒张压):复方片剂组(n = 47),3.0/1.5 mmHg;普萘洛尔组(n = 51),10.2/6.3 mmHg;氢氯噻嗪组(n = 52),13.1/9.3 mmHg。在双盲期,各治疗组报告新不适症状的患者比例之间未显示出显著差异。本研究表明,该复方片剂与相同剂量强度的任何一种成分相比,安全性相同且更有效。

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