Helgeland A
Am J Med. 1980 Nov;69(5):725-32. doi: 10.1016/0002-9343(80)90438-6.
In 1972--1973, 785 symptom-free men, aged 40 to 49 years, without target organ damage, with systolic blood pressures between 150 and 179 mm Hg and diastolic blood pressure below 110 mm Hg, were assigned at random to one of two groups: (406 to a drug treatment group and 379 to a control group) for a five-year controlled drug treatment trial to evaluate the effect of therapy on cardiovascular complications. Drug treatment started with hydrochlorothiazide. If systolic blood pressure remained above 140 mm Hg and/or diastolic blood pressure above 90 mm Hg, alphamethyldopa was added. If there were side effects, methyldopa was replaced with propranolol. The control group was not given a placebo. The mean observation time was 66 months (range 60 to 78 months). A difference in blood pressure between groups of about 17 mm Hg systolic and 10 mm Hg diastolic was maintained throughout the study. The study protocol had a rather low "ethical" blood pressure roof, 180 mm Hg systolic and/or 110 mm Hg diastolic. Seventeen percent of the control group had an increase in blood pressure above this level during the trial, and drug treatment was started. There was no effect on major cardiovascular morbidity comparing groups as established by randomization, with 18 events in the treatment group and 20 events in the control group. There was no difference between the groups in total mortality and mortality from cardiovascular events. However, in the subgroups with diastolic blood pressure greater than or equal to 100 mm Hg before randomization, there was a probable reduction in total morbidity from cardiovascular events in favor or the group receiving drug therapy, 7.6 and 16.4 percent events in the treated and control groups, respectively. Cerebrovascular events occurred only in the control group, 7 versus 0. Two cases of fatal aortic aneurysms also occurred in the control group. Other "pressure" complications, such as marked left ventricular hypertrophy in the electrocardiogram and left ventricular failure, occurred only in the control group. However, regarding coronary heart disease, including sudden death, the incidence tended to be higher in the treated group, although it was not statistically significant. Only 13 men (1.7 percent) failed to meet for regular examinations. At the end of the study these men were also followed up with regard to possible cardiovascular events.
1972年至1973年期间，785名40至49岁无症状男性，无靶器官损害，收缩压在150至179毫米汞柱之间且舒张压低于110毫米汞柱，被随机分为两组（406人进入药物治疗组，379人进入对照组），进行为期五年的对照药物治疗试验，以评估治疗对心血管并发症的影响。药物治疗从氢氯噻嗪开始。如果收缩压仍高于140毫米汞柱和/或舒张压高于90毫米汞柱，则加用α-甲基多巴。如果出现副作用，则用普萘洛尔替代甲基多巴。对照组未给予安慰剂。平均观察时间为66个月（范围60至78个月）。在整个研究过程中，两组之间收缩压相差约17毫米汞柱，舒张压相差约10毫米汞柱。研究方案设定的“伦理”血压上限相当低，收缩压180毫米汞柱和/或舒张压110毫米汞柱。在试验期间，17%的对照组患者血压升高超过此水平，并开始药物治疗。随机分组确定的两组之间，主要心血管疾病发病率无差异，治疗组有18例事件，对照组有20例事件。两组在总死亡率和心血管事件死亡率方面无差异。然而，在随机分组前舒张压大于或等于100毫米汞柱的亚组中，接受药物治疗组的心血管事件总发病率可能降低，治疗组和对照组的事件发生率分别为7.6%和16.4%。脑血管事件仅发生在对照组，7例对0例。对照组还发生了2例致命性主动脉瘤。其他“压力”并发症，如心电图显示明显左心室肥厚和左心室衰竭，仅发生在对照组。然而，关于冠心病，包括猝死，治疗组的发病率往往较高，尽管无统计学意义。只有13名男性（1.7%）未参加定期检查。在研究结束时，也对这些男性可能发生的心血管事件进行了随访。
