PHYSICIANS HEALTH STUDY--CONTINUED FOLLOW UP

医生健康研究——持续跟进

• 批准号: 2467942
• 负责人: CHARLES H HENNEKENS
• 金额: $ 23.87万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 1991
• 资助国家: 美国
• 起止时间: 1991-02-01 至 2003-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2467942
• 关键词: cancer prevention; cardiovascular disorder prevention; carotene; chemoprevention; clinical research; clinical trials; human subject; human therapy evaluation; longitudinal human study; meta analysis; nutrition related tag; physicians; smoking; tobacco abuse

DESCRIPTION (Applicant's Description) In the May 2, 1996 issue of The New England Journal of Medicine, the results of two large-scale randomized trials which included beta carotene were published: the Physicians' Health Study (PHS) and the Beta Carotene and Retinol Efficacy Trial (CARET). In the PHS, conducted among 22,071 US male physicians, after an average of 12 years of supplementation with beta carotene or placebo, there were no differences between the groups in the rates of malignant neoplasms, cancer mortality, cardiovascular mortality, or mortality from all causes. In the CARET study, 18,314 men and women at high risk of lung cancer, due to smoking or asbestos exposure, were assigned to a combination of beta carotene and retinol. This trial was terminated early by its Data Monitoring Board primarily because of an inability to demonstrate a benefit, but also because of observed possible increased risks of lung cancer, cardiovascular mortality, and total mortality consistent with the results of the Alpha-Tocopherol/Beta Carotene Cancer Prevention Study (ATBC). In a press conference convened by the National Cancer Institute (NCI) on January 17, 1996, NCI Director Dr. Richard Klausner emphasized the critical importance of continued follow-up of the trial cohorts. Given the unexpected results of ATBC and CARET, and the finding of no effect of beta carotene in the PHS, continued surveillance of all these trial cohorts is crucial to ensure complete documentation of the long-term health effects of beta carotene supplementation. To help achieve this goal, we have established the Antioxidant Trialists' Collaborative Group which will conduct a systematic meta-analysis of the post-publication results of continued follow-up in all completed trials, to fully assess the effects of beta carotene supplementation among smokers and non-smokers. Post-trial follow-up has already been funded by NCI for CARET, ATBC, the Chinese Cancer Prevention Study, and the two Dartmouth trials of skin cancer and colon polyps. This application proposes to continue by mail the post-trial follow-up of the PHS cohort for 5 years. Continued follow-up of the PHS cohort is particularly important given the unique aspects of the trial, including its large populations of never and ex-smokers which are more representative of the general population of health-conscious individuals who take vitamin supplements, its highly compliant population and record of extremely complete follow-up, its long duration of randomized beta carotene supplementation, and its extremely cost-efficient design for follow-up of a chemoprevention trial cohort.

申请人的描述（applicant's description） 在1996年5月2日的《新英格兰医学杂志》上， 两个大规模的随机试验，其中包括β-胡萝卜素， 发表：医生健康研究（PHS）和β胡萝卜素， 视黄醇疗效试验（CARET）。 在PHS中，在22，071名美国男性中进行 在平均12年的β补充剂之后， 胡萝卜素或安慰剂组之间， 恶性肿瘤率、癌症死亡率、心血管死亡率，或 各种原因造成的死亡。 在CARET研究中，18，314名男性和女性在高中 肺癌的风险，由于吸烟或石棉暴露，被分配到一个 β-胡萝卜素和视黄醇的组合。 这项试验提前结束了 其数据监测委员会主要是因为无法 证明获益，但也因为观察到可能增加的风险 肺癌、心血管疾病死亡率和总死亡率 α-生育酚/β-胡萝卜素癌症预防的结果 研究（ATBC）。 在国家癌症中心召开的新闻发布会上， 1996年1月17日，NCI主任Richard Klausner博士 强调继续对审判进行跟踪至关重要 同伙 鉴于ATBC和CARET的意外结果，以及 没有影响β胡萝卜素在PHS，继续监测所有这些 试验队列对于确保完整记录长期 补充β-胡萝卜素对健康的影响 为了帮助实现这一目标， 我们成立了抗氧化剂试验员协作小组， 将对发表后的结果进行系统的荟萃分析， 在所有已完成的试验中继续随访，以充分评估 吸烟者和非吸烟者之间的β-胡萝卜素补充。 审判后 NCI已经为CARET、ATBC、中国癌症研究中心（CNCA） 预防研究，以及皮肤癌和结肠癌的两项达特茅斯试验 息肉 本申请建议通过邮寄方式继续审理后 PHS队列随访5年。 继续跟踪小灵通 鉴于试验的独特方面，队列特别重要， 包括大量的从不吸烟和戒烟的人， 具有健康意识的个人的一般人群的代表， 服用维生素补充剂，其高度依从的人口和记录， 非常完整的后续行动，其长期的随机β胡萝卜素 补充，其极其具有成本效益的设计，为后续行动的一个 化学预防试验队列。