PDF(Pubmed)
Abstract：
Background: The patient benefit from a diagnostic nuclear medicine procedure far outweighs the associated radiation risk. This benefit/risk ratio assumes a properly administered radiopharmaceutical. However, a significant diagnostic radiopharmaceutical extravasation can confound the procedure in many ways. We identified three current extravasation hypotheses espoused by medical societies, advisory committees, and hundreds of individual members of the nuclear medicine community: diagnostic extravasations do not cause harm, do not result in high absorbed dose to tissue, and require complex dosimetry methods that are not readily available in nuclear medicine centers. We tested these hypotheses against a framework of current knowledge, recent developments, and original research. We conducted a literature review, searched regulatory databases, examined five clinical cases of extravasated patients, and performed dosimetry on those extravasations to test these globally accepted hypotheses. Results: A literature review found 58 peer-reviewed documents suggesting patient harm. Adverse event/vigilance report database reviews for extravasations were conducted and revealed 38 adverse events which listed diagnostic radiopharmaceutical extravasation as a factor, despite a regulatory exemption for required reporting. In our own case material, assessment of care was evaluated for five extravasated patients who underwent repeat imaging. Findings reflected results of literature review and included mis- or non-identification of lesions, underestimation of Standardized Uptake Values (SUVs) by 19-73%, classification of scans as non-diagnostic, and the need to repeat imaging with the associated additional radiation exposure, inconvenience, or delays in care. Dosimetry was performed for the same five cases of diagnostic radiopharmaceutical extravasation. Absorbed doses to 5 cm3 of tissue were between 1.1 and 8.7 Gy, and shallow dose equivalent for 10 cm2 of skin was as high as 4.2 Sv. Conclusions: Our findings suggest that significant extravasations can or have caused patient harm and can irradiate patients\' tissue with doses that exceed medical event reporting limits and deterministic effect thresholds. Therefore, diagnostic radiopharmaceutical injections should be monitored, and dosimetry of extravasated tissue should be performed in certain cases where thresholds are thought to have been exceeded. Process improvement efforts should be implemented to reduce the frequency of extravasation in nuclear medicine.
摘要：
背景：患者从诊断核医学程序中获益远远超过相关的辐射风险。这种益处/风险比假定是正确施用的放射性药物。然而,一个显著的诊断放射性药物外渗可以混淆在许多方面的程序。我们确定了医学界支持的三个当前的外渗假设，咨询委员会,和数百名核医学界的个人成员:诊断外渗不会造成伤害，不会导致组织的高吸收剂量，并且需要复杂的剂量测定方法，这些方法在核医学中心并不容易获得。我们根据当前知识的框架测试了这些假设，最近的事态发展,原创性研究。我们进行了文献综述，搜索监管数据库，检查了5例外渗患者的临床病例，并对这些外渗进行剂量测定，以测试这些全球公认的假设。结果：文献综述发现58份同行评审的文献表明患者受到伤害。对外渗的不良事件/警戒报告数据库进行了审查，发现了38起不良事件，其中将诊断性放射性药物外渗列为一个因素。尽管监管豁免了所需的报告。在我们自己的案例材料中，对5例接受重复成像检查的外渗患者的护理评估进行了评估.研究结果反映了文献综述的结果，包括病变的错误或未识别，对标准化摄取值(SUV)的低估19-73%，将扫描分类为非诊断性，以及需要重复成像与相关的额外辐射暴露，不便,或延迟护理。对相同的5例诊断放射性药物外渗进行了剂量学。对5cm3组织的吸收剂量在1.1和8.7Gy之间，10cm2皮肤的浅剂量当量高达4.2Sv。结论：我们的研究结果表明，显著的外渗可以或已经造成患者伤害，并且可以用超过医学事件报告限值和确定性效应阈值的剂量照射患者组织。因此,应监测诊断放射性药物注射，和外渗组织的剂量测定应在某些情况下被认为已超过阈值。应实施过程改进工作，以减少核医学中外渗的频率。
