Randomized trial of breast self-examination in Shanghai: Final results
Randomized trial of breast self-examination in Shanghai: Final results
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DOI：
10.1093/jnci/94.19.1445
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发表时间：
2002-10-02
影响因子：
10.3
通讯作者：
Self, SG
中科院分区：
文献类型：
--
作者：
Thomas, DB;Gao, DL;Self, SG
背景资料：在进行乳房自我检查（BSE）的妇女中，乳腺癌可能在早期被发现，并且比不进行BSE的妇女小。然而，乳房自我检查对降低乳腺癌死亡率的有效性尚未得到证实。这项研究的目的是确定一个强化的疯牛病教学计划是否会减少死于乳腺癌的妇女人数。研究方法：从1989年10月至1991年10月，上海市519个工厂的266064名妇女被随机分配到BSE指导组（132979名妇女）和对照组（133085名妇女）。在BSE的最初指导之后，在1年和3年后进行强化会议，在医疗监督下至少每6个月进行一次BSE实践，持续5年，并每月进行一次BSE实践的持续提醒。研究人员对这些妇女的乳腺癌死亡率进行了跟踪调查，直到2000年12月。使用考克斯比例风险模型估计死于乳腺癌的累积风险比。所有统计学检验均为双侧检验。结果：指导组有135例（0.10%）乳腺癌死亡，对照组有131例（0.10%）。随访10 - 11年的累积乳腺癌死亡率相似（指导组女性相对于对照组女性的累积风险比= 1.04，95%置信区间= 0.82 - 1.33; P = 0.72）。然而，更多的良性乳腺病变诊断在指导组比对照组。结论：强化BSE指导并不能降低乳腺癌的死亡率。在没有乳房X光检查的情况下鼓励BSE的计划不太可能降低乳腺癌的死亡率。选择实践BSE的女性应该被告知其疗效未经证实，并且它可能会增加良性乳腺活检的机会。
Background: Among women who practice breast self-examination (BSE), breast cancers may be detected when they are at an earlier stage and are smaller than in women who do not practice BSE. However, the efficacy of breast self-examination for decreasing breast cancer mortality is unproven. This study was conducted to determine whether an intensive program of BSE instruction will reduce the number of women dying of breast cancer. Methods: From October 1989 through October 1991, 266064 women associated with 519 factories in Shanghai were randomly assigned to a BSE instruction group (132979 women) or a control group (133085 women). Initial instruction in BSE was followed by reinforcement sessions 1 and 3 years later, by BSE practice under medical supervision at least every 6 months for 5 years, and by ongoing reminders to practice BSE monthly. The women were followed through December 2000 for mortality from breast cancer. Cumulative risk ratios of dying from breast cancer were estimated using Cox proportional hazards models. All statistical tests were two-sided. Results: There were 135 (0.10%) breast cancer deaths in the instruction group and 131 (0.10%) in the control group. The cumulative breast cancer mortality rates through 10 to 11 years of follow-up were similar (cumulative risk ratio for women in the instruction group relative to that in the control group = 1.04, 95% confidence interval = 0.82 to 1.33; P =.72). However, more benign breast lesions were diagnosed in the instruction group than in the control group. Conclusions: Intensive instruction in BSE did not reduce mortality from breast cancer. Programs to encourage BSE in the absence of mammography would be unlikely to reduce mortality from breast cancer. Women who choose to practice BSE should be informed that its efficacy is unproven and that it may increase their chances of having a benign breast biopsy.