Maharaj B, van der Byl K
Department of Experimental and Clinical Pharmacology, University of Natal Medical School, Durban, South Africa.
J Hum Hypertens. 1993 Oct;7(5):447-50.
This randomised, double-blind study compared the efficacy and safety of a fixed combination of hydroflumethiazide 50 mg and reserpine 0.125 mg (H-R) and chlortalidone 12.5 mg and atenolol 50 mg (C-A) in adult black patients with mild to moderate hypertension (a resting supine diastolic blood pressure (DBP) between 95 and 115 mmHg after a two week placebo washout period). If the DBP did not reach 90 mmHg after four weeks, the dosage was doubled. There were 27 patients in the H-R group and 22 in the C-A group who completed the study. In the H-R group, supine systolic and diastolic BP were reduced from 156.5 (95% confidence intervals 150.1-162.9) and 102.0 (97.5-106.5) mmHg to 137.0 (130.6-143.4) and 87.4 (83.0-91.9) mmHg, respectively. The corresponding values in the C-A group were 154.1 (147.0-161.2) and 103.4 (98.5-108.4) mmHg to 136.4 (129.3-143.5) and 91.2 (86.2-96.1) mmHg, respectively. Normalisation, response and control of DBP was achieved in 88.9, 92.6 and 100% of patients, respectively, in the H-R group, and in 81.8, 95.5 and 95.5% of patients in the C-A group, respectively. The dose was doubled in 14.8% of patients on H-R and 40.1% on C-A. No clinically significant abnormalities in laboratory variables and no serious adverse effects were encountered. Both drugs have been shown to be efficacious and safe in the treatment of mild to moderate hypertension in black patients.(ABSTRACT TRUNCATED AT 250 WORDS)
这项随机双盲研究比较了氢氟噻嗪50毫克与利血平0.125毫克的固定组合(H-R)和氯噻酮12.5毫克与阿替洛尔50毫克的固定组合(C-A)在成年黑人轻度至中度高血压患者(经过两周安慰剂洗脱期后静息仰卧位舒张压(DBP)在95至115毫米汞柱之间)中的疗效和安全性。如果四周后DBP未达到90毫米汞柱,则剂量加倍。H-R组有27名患者,C-A组有22名患者完成了研究。在H-R组中,仰卧位收缩压和舒张压分别从156.5(95%置信区间150.1 - 162.9)和102.0(97.5 - 106.5)毫米汞柱降至137.0(130.6 - 143.4)和87.4(83.0 - 91.9)毫米汞柱。C-A组的相应值分别为154.1(147.0 - 161.2)和103.4(98.5 - 108.4)毫米汞柱降至136.4(129.3 - 143.5)和91.2(86.2 - 96.1)毫米汞柱。H-R组分别有88.9%、92.6%和100%的患者实现了DBP正常化、达标和控制,C-A组分别有81.8%、95.5%和95.5%的患者实现了上述目标。H-R组14.8%的患者和C-A组40.1%的患者剂量加倍。未发现实验室变量有临床显著异常,也未出现严重不良反应。两种药物在治疗黑人患者轻度至中度高血压方面均显示出有效且安全。(摘要截选至250字)