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奥斯陆研究饮食与戒烟试验。102个月后的结果。

Oslo Study Diet and Antismoking Trial. Results after 102 months.

作者信息

Hjermann I, Holme I, Leren P

出版信息

Am J Med. 1986 Feb 14;80(2A):7-11. doi: 10.1016/0002-9343(86)90154-3.

DOI:10.1016/0002-9343(86)90154-3
PMID:3511692
Abstract

The five year (60-month) results from the Oslo Study Diet and Antismoking Trial were published in the Lancet in December 1981. The trial involved 1,232 healthy men, aged 40 to 49 years, at high risk for coronary heart disease, with serum cholesterol values in the range of 7.5 to 9.8 mmol/liter (enzymatic method: 6.9 to 9.0, mean value 7.8 mmol/liter). Eighty percent of the men were daily cigarette smokers at the start of the study, and all participants were normotensive, i.e., systolic blood pressure was less than 150 mm Hg. Subjects were randomly assigned to either a control or intervention group. Follow-up visits were scheduled every six months for the intervention group and yearly for the control group. Once the trial was completed, the regular six-month follow-up visits were discontinued, but eight to nine years (96 to 108 months) after the start of the trial, participants were called for a new follow-up. Risk factors were recorded, and clinical events were diagnosed according to the same procedure as during the trial. The mean serum cholesterol levels in the intervention group remained unchanged three years after the end of the trial, but the cholesterol levels in the control group declined. Daily cigarette smoking increased in the intervention group but remained stable in the control group. At the new follow-up, the difference in incidence of fatal and nonfatal myocardial infarction and sudden coronary death was the same as at the end of the trial three years earlier, yielding significant differences between the two groups for sudden death, total coronary death, and total coronary events. Although the study was not designed to show differences in total mortality, this difference became marginally significant, with 19 deaths in the intervention group and 31 in the control group. It is concluded that although net differences in risk factors between the two groups had been reduced during the three years after the regular intervention period, the significant difference in coronary events and sudden death was maintained.

摘要

奥斯陆饮食与戒烟试验的五年(60个月)结果于1981年12月发表在《柳叶刀》杂志上。该试验涉及1232名40至49岁的健康男性,他们患冠心病的风险较高,血清胆固醇值在7.5至9.8毫摩尔/升之间(酶法:6.9至9.0,平均值7.8毫摩尔/升)。研究开始时,80%的男性每天吸烟,所有参与者血压正常,即收缩压低于150毫米汞柱。受试者被随机分为对照组或干预组。干预组每六个月安排一次随访,对照组每年安排一次随访。试验完成后,定期的六个月随访停止,但在试验开始八至九年(96至108个月)后,参与者被要求进行新的随访。记录危险因素,并按照与试验期间相同的程序诊断临床事件。试验结束三年后,干预组的平均血清胆固醇水平保持不变,但对照组的胆固醇水平下降。干预组的每日吸烟量增加,但对照组保持稳定。在新的随访中,致命和非致命心肌梗死及心源性猝死的发生率差异与三年前试验结束时相同,两组在猝死、总心源性死亡和总冠心病事件方面存在显著差异。尽管该研究并非旨在显示总死亡率的差异,但这种差异变得略微显著,干预组有19人死亡,对照组有31人死亡。得出的结论是,尽管在常规干预期后的三年中,两组之间危险因素的净差异有所减少,但冠心病事件和猝死的显著差异仍然存在。

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