LUNG HEALTH STUDY--LONG TERM FOLLOW-UP

1986年至1994年进行的肺健康研究(LHS)表明， 中年长期吸烟者的吸烟干预方案 吸烟者可能会对死亡率产生非常显著的有益影响 在五年内FEV1下降的可能性。然而，FEV1只是一个替代品 呼吸系统发病率和死亡率的临床结果的标志。 本研究建议对前LHS患者进行长期的试验后随访 参与者评估以下疾病的发病率和死亡率 记录在案的呼吸系统和心血管疾病及其他原因 通过医院、诊所和死亡记录。A肺功能测试11 到12年后进入LHS也建议确定长 LHS吸烟干预计划对肺功能的长期影响。 研究的主要目标如下：1)确定、使用 一项意向治疗分析，LHS吸烟干预是否 显著降低临床重要呼吸系统疾病的发生率 和心血管疾病在研究后的12到15年内 2)确定吸烟的有益影响 肺功能测量干预计划将持续到11日 到12年的随访；3)估计影响的程度 FEV1和FVC对心血管和呼吸系统疾病风险的影响 和死亡率，控制吸烟史后；4)研究 其他因素的作用[性别、呼吸道、反应性、体重增加和合作 发病率]在确定肺功能下降率方面 以及心血管和呼吸系统发病率和死亡率的风险。 最初的10个LHS临床中心都计划参加。的 将偏见降至最低，所有幸存的LHS参与者将被邀请 参与，给出潜在的样本量为5600。

The Lung Health Study (LHS), conducted from 1986-1994, demonstrated that a smoking intervention program in middle-aged long-term cigarette smokers can result in a highly significant beneficial effect on the rate of FEV1 decline over five years. However, FEV1 is only a surrogate marker for clinical outcomes of respiratory morbidity and mortality. The present study proposes long-term post-trial follow-up of former LHS participants to assess the incidence of morbidity and mortality from respiratory and cardiovascular diseases and other causes, as documented by hospital, clinic, and death records. A pulmonary function test 11 to 12 years after entry into the LHS is also proposed to determine long term effects of the LHS smoking intervention program on lung function. The main objectives of the study are as follows: 1) to determine, using an intent-to-treat analysis, whether the LHS smoking intervention significantly reduces the incidence of clinically important respiratory and cardiovascular disease over a 12- to 15-year period following study enrollment; 2) to determine whether the beneficial effect of the smoking intervention program on measures of lung function persists through 11 to 12 years of follow-up; 3) to estimate the magnitude of the effects of FEV1 and FVC on the risks of cardiovascular and respiratory morbidity and mortality, after controlling for smoking history; 4) to study the role of other factors [gender, airways, reactivity, weight gain, and co- morbidities] in determining the rate of decline in pulmonary function and the risks of cardiovascular and respiratory morbidity and mortality. All ten of the original LHS clinical centers plan to participate. Of minimize bias, all surviving participants of the LHS will be invited to participate, giving a potential sample size of 5600.