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健康保险计划研究中的选择、随访与分析:一项乳腺癌筛查随机试验

Selection, follow-up, and analysis in the Health Insurance Plan Study: a randomized trial with breast cancer screening.

作者信息

Shapiro S, Venet W, Strax P, Venet L, Roeser R

出版信息

Natl Cancer Inst Monogr. 1985 May;67:65-74.

PMID:4047153
Abstract

Critical decisions made 20 years ago by those who planned the randomized trial at the Health Insurance Plan (HIP) of Greater New York to determine the efficacy of periodic screening for breast cancer are detailed. These decisions affected the age group to be screened, screening modalities, frequency of screening, sample size, primary measures for testing efficacy, and period of follow-up (long term). Results of follow-up, 16 years after entry, indicate that mortality due to breast cancer continues to be lower among study women than controls. Numerically, the differential has been stable; relatively, it has decreased. It is estimated that the study group would have experienced about a 30% reduction in breast cancer mortality if screening had been maintained. Relative case survival rates over a 14-year period after diagnosis show changes in contours of trend lines that result from screening. The study group's trend is slightly concave in contrast to the usual convex curve for the controls. The contour of the curve is more decidedly concave among subjects detected through mammography alone than for other subgroups detected through screening, although the relative survival rate remains highest in the mammography only group. Uncertainty persists about effects of screening in the HIP study on breast cancer mortality among women aged 40-49 years at entry.

摘要

详细介绍了20年前纽约大健康保险计划(HIP)中规划随机试验以确定乳腺癌定期筛查疗效的人员所做出的关键决策。这些决策影响了筛查的年龄组、筛查方式、筛查频率、样本量、测试疗效的主要指标以及随访期(长期)。入组16年后的随访结果表明,研究组女性因乳腺癌导致的死亡率仍低于对照组。从数字上看,差异一直稳定;相对而言,差异有所减小。据估计,如果持续进行筛查,研究组的乳腺癌死亡率将降低约30%。诊断后14年期间的相对病例生存率显示出筛查导致的趋势线轮廓变化。与对照组通常的凸曲线相比,研究组的趋势略显凹形。仅通过乳房X线摄影检测出的受试者曲线轮廓比通过筛查检测出的其他亚组更明显呈凹形,尽管仅乳房X线摄影组的相对生存率仍然最高。关于HIP研究中筛查对入组时年龄在40 - 49岁女性乳腺癌死亡率的影响仍存在不确定性。

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