G Ital Cardiol. 1982;12(8):541-54.
The Rome Project of Coronary Heart Disease Prevention (PPCC) is a primary prevention trial of coronary heart disease; it represents the Italian section of the WHO European Multifactor Preventive Trial of CHD. The study has been carried out in 4 working groups of male subjects aged 40-59 years at entry, two groups (a total of 3,131 men) being assigned to treatment and the other two (a total of 2,896 men) to control, with a 6-year follow-up. The preventive intervention aimed at reducing or modifying: mean levels of serum cholesterol (generally through dietary prescriptions and, in a smaller number of subjects, with drug treatment), smoking habits (subjects were advised to reduce or stop smoking); overweight (by means of diet); sedentary life-style (with increased physical activity). The intervention program has also involved other factors such as high levels of serum triglycerides, blood glucose and serum uric acid. The treatment was carried out through individual sessions on about one third of subjects belonging to the upper part of an estimated coronary risk score, while mass education was administered to the remaining two thirds. No intervention at all was offered to the control groups. Changes in the levels of risk factors were measured through periodical examinations of the whole population enrolled in the trial. Monitoring of both fatal and non fatal morbid events provided data on mortality and incidence trends. Over the 6 years of follow-up, the mean reduction in the mean levels of the main coronary risk factors in treated groups, as compared to controls, was as follows: serum cholesterol: 4.8%; systolic blood pressure: 4.6%; number of cigarettes per day: 8.7%; body weight: 2.4%; estimated coronary risk: 38.9%. At the end of the 6 years of observation, mortality for all causes was lower by 6.0% to 10.7% in treated groups than in controls; mortality for coronary heart disease was also lower (by 26.8% to 30.2%), as well as the incidence of fatal plus non-fatal coronary heart disease (by 25.4% to 30.9%). These differences were dependent on the different types of analysis. Those concerning coronary mortality and coronary incidence--hard criteria--are statistically significant.
罗马冠心病预防项目（PPCC）是一项冠心病一级预防试验；它代表了世界卫生组织欧洲冠心病多因素预防试验的意大利部分。该研究在4个初始年龄为40 - 59岁的男性工作组中进行，两组（共3131名男性）被分配接受治疗，另外两组（共2896名男性）作为对照，进行为期6年的随访。预防性干预旨在降低或改变：血清胆固醇平均水平（一般通过饮食处方，少数受试者采用药物治疗）、吸烟习惯（建议受试者减少或戒烟）；超重（通过饮食方式）；久坐的生活方式（增加体育活动）。干预项目还涉及其他因素，如血清甘油三酯、血糖和血清尿酸水平升高。对估计冠心病风险评分较高的约三分之一受试者通过个体辅导进行治疗，而对其余三分之二受试者进行群体教育。对照组不进行任何干预。通过对试验中纳入的全体人群进行定期检查来测量危险因素水平的变化。对致命和非致命发病事件的监测提供了死亡率和发病率趋势的数据。在6年的随访中，与对照组相比，治疗组主要冠心病危险因素平均水平的平均降低幅度如下：血清胆固醇：4.8%；收缩压：4.6%；每日吸烟量：8.7%；体重：2.4%；估计冠心病风险：38.9%。在6年观察期结束时，治疗组的全因死亡率比对照组低6.0%至10.7%；冠心病死亡率也较低（低26.8%至30.2%），致命加非致命冠心病的发病率也较低（低25.4%至30.9%）。这些差异取决于不同的分析类型。那些关于冠心病死亡率和冠心病发病率的——严格标准——在统计学上具有显著意义。
