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比索洛尔与阿替洛尔治疗轻至中度高血压患者的疗效与安全性:一项双盲、平行组国际多中心研究。

Efficacy and safety of bisoprolol and atenolol in patients with mild to moderate hypertension: a double-blind, parallel group international multicentre study.

作者信息

Lithell H, Selinus I, Hosie J, Frithz G, Weiner L

机构信息

Department of Geriatrics, Uppsala University, Sweden.

出版信息

Eur Heart J. 1987 Dec;8 Suppl M:55-64. doi: 10.1093/eurheartj/8.suppl_m.55-a.

DOI:10.1093/eurheartj/8.suppl_m.55-a
PMID:2967186
Abstract

Three hundred and fifteen patients were randomly allocated to treatment for six months with bisoprolol 5 or 10 mg day-1 or atenolol, 50 mg day-1, in a double-blind, double-dummy parallel group, international multicentre study. Two hundred and ninety-two (175 men and 117 women) were eligible for statistical follow-up. Their mean age was 52.6 years (range 28-70). All patients had a supine diastolic blood pressure of 95-120 mmHg on two occasions during the four weeks of placebo treatment. Twenty-four patients ended the study prematurely and a further 19 had their regimes changed because of an insufficient effect. The reasons for drop-out were similar in the three treatment groups. Thus, 249 patients continued to receive the treatment they were allocated to, with 80, 83 and 86 patients in the three respective groups. The sex and age distributions and the number of previously treated hypertensives were similar in the three groups. At the end of placebo treatment the supine blood pressures in the three groups (bisoprolol 5 or 10 mg day-1 or atenolol 50 mg day-1, respectively) were 163.9/102.5, 157.4/101.8 and 160.0/102.2 mmHg, respectively. The systolic blood pressure was higher (P less than 0.05) in the group receiving bisoprolol 5 mg day-1 than in the 10 mg day-1 group. After 26 weeks of treatment the supine blood pressures in the three groups were 150.6/90.8, 142.0/89.1 and 148.6/91.7 mmHg, respectively. The largest estimated difference in blood pressure reduction was 4.6/2.3 mmHg between the group receiving bisoprolol 10 mg day-1 and the group receiving atenolol 50 mg day-1. A reduction in mean blood pressure of greater than or equal to 10 mmHg was noted in 66% of the patients in the bisoprolol group (10 mg day-1), in the other groups 66 and 59%, n.s. Bisoprolol is effective, well-tolerated and safe in the treatment of hypertension. A daily dose of 5 mg seems recommendable for the majority of hypertensive patients and seems equipotent with 50 mg day-1 of atenolol in the present study.

摘要

在一项双盲、双模拟平行组国际多中心研究中,315例患者被随机分配接受为期6个月的治疗,分别服用比索洛尔5或10毫克/天或阿替洛尔50毫克/天。292例(175例男性和117例女性)符合统计随访条件。他们的平均年龄为52.6岁(范围28 - 70岁)。所有患者在安慰剂治疗的4周内,有两次仰卧位舒张压为95 - 120毫米汞柱。24例患者提前结束研究,另有19例因效果不佳而改变治疗方案。三个治疗组的退出原因相似。因此,249例患者继续接受分配给他们的治疗,三个组分别有80、83和86例患者。三组的性别和年龄分布以及既往治疗过的高血压患者数量相似。在安慰剂治疗结束时,三组(分别为比索洛尔5或10毫克/天或阿替洛尔50毫克/天)的仰卧位血压分别为163.9/102.5、157.4/101.8和160.0/102.2毫米汞柱。接受比索洛尔5毫克/天的组收缩压高于接受10毫克/天的组(P小于0.05)。治疗26周后,三组的仰卧位血压分别为150.6/90.8、142.0/89.1和148.6/91.7毫米汞柱。接受比索洛尔10毫克/天的组与接受阿替洛尔50毫克/天的组之间,估计最大血压降低差异为4.6/2.3毫米汞柱。比索洛尔组(10毫克/天)66%的患者平均血压降低大于或等于10毫米汞柱,其他组分别为66%和59%,无显著差异。比索洛尔在治疗高血压方面有效、耐受性良好且安全。在本研究中,对于大多数高血压患者,每日5毫克的剂量似乎是可取的,且似乎与阿替洛尔每日50毫克等效。

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