Kuller L H
Department of Epidemiology, University of Pittsburgh Graduate School of Public Health, Pennsylvania 15261.
Prev Med. 1991 Jan;20(1):119-24. doi: 10.1016/0091-7435(91)90012-s.
Participants in a primary prevention trial using tamoxifen to prevent breast cancer should comprise a sample of (a) age-eligible women from the "general population," (b) higher risk sisters of breast cancer patients, (c) women participating in mammography screening programs, or (d) patients of (or other users of) primary care physicians' offices. The recruitment should consider the risk of breast cancer among eligible women, likelihood of adherence to protocol, and unbiased and accurate measurement of endpoints. The Risks for coronary heart disease, hypertension, diabetes, osteoporosis, and other cancers, especially uterine cancer, must also be evaluated. Recruitment is feasible and should not be the limiting factor in the decision to undertake a primary prevention trial.
在一项使用他莫昔芬预防乳腺癌的一级预防试验中,参与者应包括以下样本:(a)来自“普通人群”的符合年龄要求的女性;(b)乳腺癌患者的高危姐妹;(c)参加乳房X线筛查项目的女性;或(d)初级保健医生办公室的患者(或其他使用者)。招募应考虑符合条件女性患乳腺癌的风险、遵守方案的可能性以及终点指标的无偏且准确的测量。还必须评估冠心病、高血压、糖尿病、骨质疏松症和其他癌症,尤其是子宫癌的风险。招募是可行的,不应成为决定进行一级预防试验的限制因素。