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超越随机对照试验:有组织的乳腺钼靶筛查可大幅降低乳腺癌死亡率。

Beyond randomized controlled trials: organized mammographic screening substantially reduces breast carcinoma mortality.

作者信息

Tabár L, Vitak B, Chen H H, Yen M F, Duffy S W, Smith R A

机构信息

Department of Mammography, Falun Central Hospital, Falun, Sweden.

出版信息

Cancer. 2001 May 1;91(9):1724-31. doi: 10.1002/1097-0142(20010501)91:9<1724::aid-cncr1190>3.0.co;2-v.

Abstract

BACKGROUND

The efficacy of mammographic screening in the reduction of breast carcinoma mortality has been demonstrated in randomized controlled trials. However, the evaluation of organized screening outside of research settings (so-called "service screening") faces unique methodologic and conceptual challenges. The current study describes the evaluation of organized mammography screening in a clinical setting and demonstrates the benefit obtained from service screening in two Swedish counties.

METHODS

In the group of subjects ages 20--69 years, there were 6807 women diagnosed with breast carcinoma over a 29-year period in 2 counties in Sweden and 1863 breast carcinoma deaths. All patients were classified from patient charts based on their screening status (i.e., whether they had been invited to undergo screening and whether they actually had undergone screening). The number of women who lived in the 2 counties during the 29-year study period was provided by the Central Bureau of Statistics. Breast carcinoma-specific mortality was compared across three time periods: 1) 1968--1977, when no screening was taking place because mammography had not been introduced; 2) 1978--1987, the approximate period of the Two-County randomized controlled trial of screening in women ages 40--74 years; and 3) 1988--1996, when all women in the 2 counties ages 40--69 years were invited to undergo screening (service screening). When comparing breast carcinoma mortality in screened women with that in women diagnosed before screening was introduced, a correction for self-selection bias was incorporated to prevent overestimation of the benefit of screening.

RESULTS

The mortality from incident breast carcinoma diagnosed in women ages 40-69 years who actually were screened during the service screening period (1988--1996) declined significantly by 63% (relative risk [RR] = 0.37; 95% CI, 0.30--0.46) compared with breast carcinoma mortality during the time period when no screening was available (1968--1977). The mortality decline was 50% (RR = 0.50; 95% CI, 0.41--0.60) when breast carcinoma mortality among all women who were invited to undergo screening (nonattendees included) was compared with breast cancer mortality during the time period when no screening was available (1968--1977). The reduction in mortality observed during the service screening period, adjusted for selection bias, was 48% (RR = 0.52; 95% CI, 0.43--0.63). No significant change in breast carcinoma mortality was observed over the three time periods in women who did not undergo screening. This group included women ages 20--39 years because these individuals were never invited to undergo screening, and women ages 40--69 years who did not undergo screening (not invited during the randomized trial or invited during the second and third time periods but declined).

CONCLUSIONS

Regular mammographic screening resulted in a 63% reduction in breast carcinoma death among women who actually underwent screening. The policy of invitation to organized screening with mammography appears to have reduced breast carcinoma mortality by 50% in these 2 counties.

摘要

背景

随机对照试验已证明乳腺钼靶筛查在降低乳腺癌死亡率方面的有效性。然而,对研究环境之外的有组织筛查(所谓的“服务筛查”)进行评估面临独特的方法学和概念性挑战。本研究描述了在临床环境中对有组织的乳腺钼靶筛查的评估,并证明了瑞典两个县从服务筛查中获得的益处。

方法

在年龄为20 - 69岁的受试者组中,瑞典两个县在29年期间有6807名女性被诊断为乳腺癌,1863人死于乳腺癌。所有患者根据其筛查状态(即是否被邀请进行筛查以及是否实际进行了筛查)从病历中进行分类。29年研究期间居住在这两个县的女性人数由中央统计局提供。比较了三个时间段的乳腺癌特异性死亡率:1)1968 - 1977年,当时由于未引入乳腺钼靶检查所以未进行筛查;2)1978 - 1987年,这是对40 - 74岁女性进行两县随机对照筛查试验的大致时间段;3)1988 - 1996年,当时两个县所有40 - 69岁的女性都被邀请进行筛查(服务筛查)。在比较筛查女性与在筛查引入之前被诊断的女性的乳腺癌死亡率时,纳入了对自我选择偏倚的校正,以防止高估筛查的益处。

结果

在服务筛查期间(1988 - 1996年)实际接受筛查的40 - 69岁女性中,新诊断的乳腺癌死亡率与无筛查时期(1968 - 1977年)相比显著下降了63%(相对风险[RR]=0.37;95%置信区间,0.30 - 0.46)。当将所有被邀请进行筛查的女性(包括未参与者)的乳腺癌死亡率与无筛查时期(1968 - (此处原文有误,应为1977)年)进行比较时,死亡率下降了50%(RR = 0.50;95%置信区间,0.41 - 0.60)。在调整选择偏倚后,服务筛查期间观察到的死亡率降低为48%(RR = 0.52;95%置信区间,0.43 - 0.63)。未接受筛查的女性在这三个时间段内乳腺癌死亡率未观察到显著变化。该组包括20 - 39岁的女性,因为这些人从未被邀请进行筛查,以及40 - 69岁未接受筛查的女性(在随机试验期间未被邀请,或在第二和第三时间段被邀请但拒绝)。

结论

定期乳腺钼靶筛查使实际接受筛查的女性乳腺癌死亡降低了63%。在这两个县,邀请进行有组织的乳腺钼靶筛查政策似乎使乳腺癌死亡率降低了50%。

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