CHRONIC OBSTRUCTIVE PULMONARY-DISEASE EARLY INTERVENTION TRIAL (LUNG HEALTH STUDY) - BASE-LINE CHARACTERISTICS OF RANDOMIZED PARTICIPANTS
CHRONIC OBSTRUCTIVE PULMONARY-DISEASE EARLY INTERVENTION TRIAL (LUNG HEALTH STUDY) - BASE-LINE CHARACTERISTICS OF RANDOMIZED PARTICIPANTS
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DOI：
10.1378/chest.103.6.1863
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发表时间：
1993-06-01
期刊：
影响因子：
9.6
通讯作者：
VOELKER, HT
中科院分区：
文献类型：
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作者：
BUIST, AS;CONNETT, JE;VOELKER, HT
慢性阻塞性肺疾病早期干预试验，或肺健康研究，是由国家心肺血液研究所肺病部赞助的一项多中心随机临床试验。正在测试的假设是，在5年的时间里，综合干预方案可以降低轻度至中度气流阻塞的中年吸烟者的肺功能下降率和呼吸系统发病率和死亡率。试验的主要结局变量是支气管扩张剂后最大FEV1的年下降率。次要结局是呼吸系统和非呼吸系统发病率和死亡率的发展。在筛查了73,694名年龄在35岁至60岁之间的吸烟者后，5,887名参与者被随机分为三组：常规护理组，吸烟干预组每日使用异丙托溴铵计量吸入器，吸烟干预组吸入安慰剂。符合条件的参与者FEV1与强制肺活量（FVC）的比率为70%或更低，没有已知的生命限制条件，如果随机分配，表示愿意参加干预计划，并在进入试验前给予书面知情同意。肺活量测定、甲胆碱挑战和问卷调查在中心内和中心间严格标准化。本报告的目的是描述随机参与者在进入研究时的特征。对于男性和女性，肺功能的三个测量指标——平均横断面FEV1/FVC比率、FEV1和FEV1预测正常值的百分比——在连续5岁以上的队列中都显示出轻微的下降趋势。在服用异丙肾上腺素后，只有2.4%的男性和2.8%的女性的FEV1增加了15%或更多。对甲胆碱（定义为FEV下降，浓度达到25mg /ml时较基线下降20%）的阳性反应发生在63%的男性和87%的女性身上。咳嗽、痰多、大多数白天和晚上喘息和呼吸短促的横断面患病率分别为49%、43%、32%和43%。较年轻年龄组的参与者报告呼吸道症状的比例高于较年长年龄组。报告咳嗽、痰和/或喘息的参与者比没有报告的参与者平均预测较低的FEV1 %，并且对甲胆碱的阳性反应概率更高。呼吸短促似乎与男性肺功能低下和高反应性显著相关，但与女性无关。确定COPD发展高风险人群的最初目标似乎已经实现。
The Chronic Obstructive Pulmonary Disease Early Intervention Trial, or Lung Health Study, is a multicenter randomized clinical trial sponsored by the Division of Lung Diseases of the National Heart, Lung, and Blood Institute. The hypothesis being tested is that over a 5-year period, a comprehensive intervention program can reduce both the rate of decline in pulmonary function and the rates of respiratory morbidity and mortality in middle-aged smokers with mild to moderate airflow obstruction. The primary outcome variable of the trial is the annual rate of decline of maximum postbronchodilator FEV1. Secondary outcomes are the development of respiratory and nonrespiratory morbidity and mortality. After screening 73,694 cigarette smokers, aged 35 to 60 years, 5,887 participants were randomized into three equal groups: usual care, smoking intervention with daily use of a metered-dose inhaler with ipratropium bromide, and smoking intervention with inhalation of placebo. Eligible participants had a ratio of FEV1 to forced vital capacity (FVC) of 70 percent or less, were free of known life-limiting conditions, expressed willingness to enter the intervention program if so randomized, and gave written informed consent prior to entry into the trial. Spirometry, methacholine challenge, and questionnaires were strictly standardized within and across centers. The purpose of this report is to describe the characteristics of randomized participants at the time of entry into the study. For both sexes, three measures of lung function-average cross-sectional FEV1/FVC ratio, FEV1, and FEV1 percentage of predicted normal-showed slight downward trends for each successively older 5-year age cohort. The increase in FEV1 after isoproterenol was 15 percent or more in only 2.4 percent of men and 2.8 percent of women. A positive response to methacholine (defined as a fall in FEV, of >20 percent from baseline at concentrations up to 25 mg/ml) occurred in 63 percent of men and 87 percent of women. The cross-sectional prevalences of cough, phlegm, wheeze on most days or nights, and shortness of breath were 49 percent, 43 percent, 32 percent, and 43 percent, respectively. Respiratory symptoms were reported by a higher proportion of participants in the younger age groups than in the older age groups. Participants who reported cough, phlegm, and/or wheeze averaged lower FEV1 percent predicted and higher probability of positive response to methacholine than participants who did not. Shortness of breath appeared to be significantly associated with lower lung function and higher reactivity in men but not in women. The initial goal of identifying a population of men and women at elevated risk for development of COPD appears to have been attained.