Endrikat Jan, Khater Hassan, Boreham Alexander Dp, Fritze Sabine, Schwenke Carsten, Bhatti Aasia, Trnkova Zuzana Jirakova, Seidensticker Peter
Radiology R&D, Bayer AG, Berlin, Germany.
Department of Gynecology, Obstetrics and Reproductive Medicine, University Medical School of Saarland, Homburg, Germany.
Breast Cancer (Auckl). 2023 Aug 16;17:11782234231189467. doi: 10.1177/11782234231189467. eCollection 2023.
Contrast-enhanced mammography (CEM) is an emerging breast imaging modality. Clinical data is scarce.
To summarize clinical evidence on the use of iopromide in CEM for the detection or by systematically analyzing the available literature on efficacy and safety.
Systematic review and meta-analysis.
Iopromide-specific publications reporting its use in CEM were identified by a systematic search within Bayer's Product Literature Information (PLI) database and by levering a recent review publication. The literature search in PLI was performed up to January 2023. The confirmatory-supporting review publication was based on a MEDLINE/EMBASE + full text search for publications issued between September 2003 and January 2019. Relevant literature was selected based on pre-defined criteria by 2 reviewers. The comparison of CEM vs traditional mammography (XRM) was performed on published results of sensitivity and specificity. Differences in diagnostic parameters were assessed within a meta-analysis.
Literature search: A total of 31 studies were identified reporting data on 5194 patients. Thereof, 19 studies on efficacy and 3 studies on safety. Efficacy: in 11 studies comparing iopromide CEM vs XRM, sensitivity was up to 43% higher (range 1%-43%) for CEM. Differences in specificity were found to be in a range of -4% to 46% for CEM compared with XRM. The overall gain in sensitivity for CEM vs XRM was 7% (95% CI [4%, 11%]) with no statistically significant loss in specificity in any study assessed. In most studies, accuracy, positive predictive value, and negative predictive value were found to be in favor of CEM. In 2 studies comparing CEM with breast magnetic resonance imaging (bMRI), both imaging modalities performed either equally well or CEM tended to show better results with respect to sensitivity and specificity. Safety: eight cases of iopromide-related adverse drug reactions were reported in 1022 patients (0.8%).
Pertinent literature provides evidence for clinical utility of iopromide in CEM for the detection or confirmation of breast cancer. The overall gain in sensitivity for iopromide CEM vs XRM was 7% with no statistically significant loss in specificity.
对比增强乳腺X线摄影（CEM）是一种新兴的乳腺成像方式。临床数据稀缺。
通过系统分析有关碘普罗胺在CEM中用于检测的疗效和安全性的现有文献，总结其临床证据。
系统评价和荟萃分析。
通过在拜耳产品文献信息（PLI）数据库中进行系统检索，并借助最近的一篇综述性出版物，确定了报告碘普罗胺在CEM中应用的特定出版物。在PLI中进行的文献检索截至2023年1月。验证性支持性综述性出版物基于对2003年9月至2019年1月发表的出版物进行的MEDLINE/EMBASE +全文检索。由2名评审员根据预先定义的标准选择相关文献。根据已发表的敏感性和特异性结果对CEM与传统乳腺X线摄影（XRM）进行比较。在荟萃分析中评估诊断参数的差异。
文献检索：共确定31项研究，报告了5194例患者的数据。其中，19项关于疗效的研究和3项关于安全性的研究。疗效：在11项比较碘普罗胺CEM与XRM的研究中，CEM的敏感性高达43%（范围1%-43%）。与XRM相比，CEM的特异性差异在-4%至46%之间。CEM与XRM相比，敏感性的总体提高为7%（95%CI[4%，11%]），在任何评估的研究中特异性均无统计学意义上的降低。在大多数研究中，准确性、阳性预测值和阴性预测值均有利于CEM。在2项比较CEM与乳腺磁共振成像（bMRI）的研究中，两种成像方式表现相当，或者CEM在敏感性和特异性方面往往显示出更好的结果。安全性：在1022例患者中报告了8例与碘普罗胺相关的药物不良反应（0.8%）。
相关文献为碘普罗胺在CEM中用于检测或确诊乳腺癌的临床应用提供了证据。碘普罗胺CEM与XRM相比，敏感性总体提高7%，特异性无统计学意义上的降低。
