Gartlehner Gerald, Thaler Kylie, Chapman Andrea, Kaminski-Hartenthaler Angela, Berzaczy Dominik, Van Noord Megan G, Helbich Thomas H
RTI International, Research Triangle Park, NC, USA.
Cochrane Database Syst Rev. 2013 Apr 30;2013(4):CD009632. doi: 10.1002/14651858.CD009632.pub2.
Breast cancer is the most common malignant disease diagnosed in women worldwide. Screening with mammography has the ability to detect breast cancer at an early stage. The diagnostic accuracy of mammography screening largely depends on the radiographic density of the imaged breasts. In radiographically dense breasts, non-calcified breast cancers are more likely to be missed than in fatty breasts. As a consequence, some cancers are not detected by mammography screening. Supporters of adjunct ultrasonography to the screening regimen for breast cancer argue that it might be a safe and inexpensive approach to reduce the false negative rates of the screening process. Critics, however, are concerned that performing supplemental ultrasonography on women at average risk will also increase the rate of false positive findings and can lead to unnecessary biopsies and treatments.
To assess the comparative effectiveness and safety of mammography in combination with breast ultrasonography versus mammography for breast cancer screening for women at average risk of breast cancer.
We searched the Cochrane Breast Cancer Group's Specialised Register, MEDLINE (via OvidSP) and EMBASE up until February 2012.To detect ongoing or unpublished studies, we searched the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP), ClinicalTrials.gov and the National Cancer Institute's clinical trial database until June 2012. In addition, we conducted grey literature searches using the following sources: OpenGrey; National Institute of Health RePORTER; Health Services Research Projects in Progress (HSRPROJ); Hayes, Inc. Health Technology Assessment; The New York Academy of Medicine's Grey Literature Index and Conference Papers Index.
For efficacy, we considered randomised controlled trials (RCTs), with either individual or cluster randomisation, and prospective, controlled non-randomised studies with a low risk of bias and a sample size of at least 500 participants.In addition to studies eligible for efficacy, we considered any controlled, non-randomised study with a low risk of bias and a study size of at least 500 participants for the assessment of harms.Our population of interest were women between the ages of 40 and 75 years who were at average risk for breast cancer.
Two review authors screened abstracts and full-text publications against the inclusion criteria. None of the studies met our inclusion criteria.
Our review did not detect any controlled studies on the use of adjunct ultrasonography for screening in women at average risk for breast cancer. One ongoing randomised controlled trial was identified (J-START, Japan).
AUTHORS' CONCLUSIONS: Presently, there is no methodologically sound evidence available justifying the routine use of ultrasonography as an adjunct screening tool in women at average risk for breast cancer.
乳腺癌是全球女性中诊断出的最常见恶性疾病。乳腺钼靶筛查有能力在早期检测出乳腺癌。乳腺钼靶筛查的诊断准确性很大程度上取决于成像乳房的放射密度。在放射密度高的乳房中，未钙化的乳腺癌比在脂肪型乳房中更易被漏诊。因此，一些癌症无法通过乳腺钼靶筛查检测出来。支持将超声检查作为乳腺癌筛查方案辅助手段的人认为，这可能是一种安全且廉价的方法，可降低筛查过程中的假阴性率。然而，批评者担心，对平均风险女性进行补充超声检查也会增加假阳性结果的发生率，并可能导致不必要的活检和治疗。
评估乳腺钼靶联合乳腺超声检查与单纯乳腺钼靶检查对平均患乳腺癌风险女性进行乳腺癌筛查的相对有效性和安全性。
我们检索了Cochrane乳腺癌小组的专业注册库、MEDLINE（通过OvidSP）和EMBASE，检索截至2012年2月。为了发现正在进行或未发表的研究，我们检索了世界卫生组织（WHO）国际临床试验注册平台（ICTRP）、ClinicalTrials.gov和美国国立癌症研究所的临床试验数据库，检索截至2012年6月。此外，我们使用以下来源进行了灰色文献检索：OpenGrey；美国国立卫生研究院报告人；正在进行的卫生服务研究项目（HSRPROJ）；海斯公司卫生技术评估；纽约医学院灰色文献索引和会议论文索引。
对于疗效，我们考虑了随机对照试验（RCT），包括个体随机或整群随机试验，以及前瞻性、对照非随机研究，偏倚风险低且样本量至少500名参与者。除了符合疗效标准的研究外，我们还考虑了任何偏倚风险低且研究规模至少500名参与者的对照非随机研究，用于评估危害。我们感兴趣的人群是年龄在40至75岁之间、平均患乳腺癌风险的女性。
两位综述作者根据纳入标准筛选摘要和全文出版物。没有一项研究符合我们的纳入标准。
我们的综述未发现任何关于对平均患乳腺癌风险女性使用超声检查作为筛查辅助手段的对照研究。确定了一项正在进行的随机对照试验（日本的J-START）。
目前，没有方法学上可靠的证据支持在平均患乳腺癌风险女性中常规使用超声检查作为辅助筛查工具。
