Cairns J, Cohen L, Colton T, DeMets D L, Deykin D, Friedman L, Greenwald P, Hutchison G B, Rosner B
Harvard School of Public Health, Boston, MA.
Ann Epidemiol. 1991 Aug;1(5):395-405. doi: 10.1016/1047-2797(91)90009-2.
The Physicians' Health Study is a randomized, double-blind, placebo-controlled prevention trial of 22,071 US physicians, using a factorial design to evaluate the role of aspirin in the prevention of cardiovascular mortality and beta carotene in the reduction of cancer incidence. After approximately 5 years of follow-up, the aspirin component was terminated, 3 years ahead of schedule. Several factors were considered in the decision to terminate, including a cardiovascular mortality rate markedly lower than expected in both aspirin and placebo subjects, precluding the evaluation of the primary aspirin hypothesis, and a highly significant (P < .00001) and impressive (44%) reduction in the risk of first myocardial infarction in the aspirin group. Issues in the decision to terminate are described in this report.
医师健康研究是一项针对22071名美国医师的随机、双盲、安慰剂对照预防试验，采用析因设计来评估阿司匹林在预防心血管疾病死亡中的作用以及β-胡萝卜素在降低癌症发病率中的作用。经过约5年的随访，阿司匹林部分提前3年终止。终止该试验的决定考虑了几个因素，包括阿司匹林组和安慰剂组的心血管疾病死亡率均明显低于预期，这使得无法对阿司匹林的主要假设进行评估，以及阿司匹林组首次心肌梗死风险显著降低（P <.00001）且降幅可观（44%）。本报告描述了终止该试验决定过程中的相关问题。
