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上海乳房自我检查随机试验:方法与初步结果

Randomized trial of breast self-examination in Shanghai: methodology and preliminary results.

作者信息

Thomas D B, Gao D L, Self S G, Allison C J, Tao Y, Mahloch J, Ray R, Qin Q, Presley R, Porter P

机构信息

Fred Hutchinson Cancer Research Center, Seattle, WA 98104, USA.

出版信息

J Natl Cancer Inst. 1997 Mar 5;89(5):355-65. doi: 10.1093/jnci/89.5.355.

DOI:10.1093/jnci/89.5.355
PMID:9060957
Abstract

BACKGROUND

The efficacy of breast self-examination in helping to reduce mortality from breast cancer has not been rigorously demonstrated.

PURPOSE

To assess efficacy, a large, randomized trial was initiated in Shanghai, China.

METHODS

From October 1989 to October 1991, 267040 current and retired female employees associated with 520 factories in the Shanghai Textile Industry Bureau were randomly assigned on the basis of factory to either a self-examination instruction group (133375 women) or a control group (133665 women). The women were born within the period from 1925 through 1958. Women in the instruction group were given intensive training in breast self-examination, including the use of silicone breast models and personalized instruction, plus two subsequent reinforcement sessions and multiple reminders to practice the technique. Women in the control group were asked to attend training sessions on the prevention of low back pain. All women have been followed for the development of breast diseases and for death from breast cancer.

RESULTS

A high level of participation during the first 4-5 years of the trial was documented among women in the instruction group. Randomly sampled women in this group demonstrated greater proficiency in detecting lumps in breast models than did randomly sampled women in the control group. Approximately equal numbers of breast cancers were detected in the two groups (331 in the instruction group and 322 in the control group) through 1994, which is the last year for which case-finding efforts have been completed. The breast cancers detected in the instruction group were not diagnosed at an appreciably earlier stage or smaller size than those in the control group. More benign breast lesions were detected in the instruction group than in the control group (1457 versus 623, respectively), suggesting a higher index of suspicion for women who received training. Cumulative breast cancer mortality rates through 5 years from entry into the study were nearly equivalent for the two groups.

CONCLUSIONS

Breast self-examination has not led to a reduction in mortality from breast cancer in this study cohort in the first several years since the trial began. A shift toward the diagnosis of disease at a less advanced stage in women given instruction has also not been demonstrated. Longer follow-up of participants in this trial is required before final assessment can be made of the efficacy of breast self-examination.

IMPLICATIONS

At this time, there is insufficient evidence to recommend for or against the teaching of breast self-examination.

摘要

背景

乳房自我检查在降低乳腺癌死亡率方面的功效尚未得到严格证实。

目的

为评估其功效,在中国上海开展了一项大型随机试验。

方法

1989年10月至1991年10月,上海纺织工业局下属520家工厂的267040名在职及退休女职工按工厂被随机分为自我检查指导组(133375名女性)和对照组(133665名女性)。这些女性出生于1925年至1958年期间。指导组的女性接受了乳房自我检查的强化培训,包括使用硅胶乳房模型和个性化指导,另外还有两次强化课程以及多次提醒她们练习该技术。对照组的女性被要求参加预防腰痛的培训课程。所有女性都被随访观察乳房疾病的发生情况以及乳腺癌死亡情况。

结果

试验开始后的前4至5年,指导组女性的参与度很高。该组随机抽样的女性在检测乳房模型中的肿块方面比对照组随机抽样的女性表现出更高的熟练度。到1994年(病例发现工作完成的最后一年),两组检测出的乳腺癌数量大致相等(指导组331例,对照组322例)。指导组检测出的乳腺癌在诊断时阶段并未明显更早,大小也未明显更小。指导组检测出的良性乳房病变比对照组更多(分别为1457例和623例),这表明接受培训的女性怀疑指数更高。从进入研究开始的5年里,两组的累积乳腺癌死亡率几乎相当。

结论

在本研究队列中,自试验开始的最初几年,乳房自我检查并未降低乳腺癌死亡率。也未证明接受指导的女性在疾病诊断阶段有向较早期转变的情况。在对乳房自我检查的功效进行最终评估之前,需要对该试验的参与者进行更长时间的随访。

启示

目前,没有足够的证据支持或反对进行乳房自我检查的教学。

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