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α-生育酚、β-胡萝卜素肺癌预防研究:设计、方法、参与者特征及依从性。ATBC癌症预防研究组

The alpha-tocopherol, beta-carotene lung cancer prevention study: design, methods, participant characteristics, and compliance. The ATBC Cancer Prevention Study Group.

出版信息

Ann Epidemiol. 1994 Jan;4(1):1-10. doi: 10.1016/1047-2797(94)90036-1.

DOI:10.1016/1047-2797(94)90036-1
PMID:8205268
Abstract

The Alpha-Tocopherol, Beta-Carotene (ATBC) Lung Cancer Prevention Study was a randomized, double-blind, placebo-controlled, 2 x 2 factorial design, primary prevention trial testing the hypothesis that alpha-tocopherol (50 mg/day) and beta-carotene (20 mg/day) supplements reduce the incidence of lung cancer and possibly other cancers. Total and disease-specific mortality and incidence of various diseases and symptoms were monitored for safety. Between 1985 and 1993, 29,133 eligible male smokers aged 50 to 69 years at entry were randomized to receive daily active supplements or placebo capsules for 5 to 8 years (median 6.1 years), accumulating 169,751 follow-up years. This report describes the study design, methods, and protocol as well as the baseline characteristics and capsule compliance of the participants. The ATBC Study is the largest lung cancer chemoprevention trial conducted to date.

摘要

α-生育酚、β-胡萝卜素(ATBC)肺癌预防研究是一项采用随机、双盲、安慰剂对照的2×2析因设计的一级预防试验,旨在验证α-生育酚(50毫克/天)和β-胡萝卜素(20毫克/天)补充剂可降低肺癌及可能的其他癌症发病率这一假设。为确保安全,对全因死亡率、特定疾病死亡率以及各种疾病和症状的发病率进行了监测。1985年至1993年期间,29133名符合条件的男性吸烟者(入组时年龄为50至69岁)被随机分配,接受为期5至8年(中位数为6.1年)的每日活性补充剂或安慰剂胶囊,累积随访时间达169751人年。本报告介绍了研究设计、方法和方案,以及参与者的基线特征和胶囊依从性。ATBC研究是迄今为止开展的规模最大的肺癌化学预防试验。

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