Muskula Preetham R, Main Michael L
From Saint Luke's Mid America Heart Institute, Kansas City, MO.
Circ Cardiovasc Imaging. 2017 Apr;10(4). doi: 10.1161/CIRCIMAGING.116.005459.
In October 2007, the Food and Drug Administration mandated significant revisions to product labeling for the commercially available echocardiographic contrast agents (ECA) Definity and Optison after spontaneous healthcare provider reports of 4 patient deaths and ≈190 severe cardiopulmonary reactions occurring in close temporal relationship to ECA administration. Since then, multiple large ECA safety studies have been published and have included outpatients, hospitalized patients (including the critically ill), patients undergoing stress echocardiography, and patients with pulmonary hypertension. In addition, the Food and Drug Administration has convened 2 Advisory Committee meetings and the product labels for Optison and Definity have been substantially revised with a softening of safety restrictions. In this review, we will address the safety of ECA use in patients with serious cardiopulmonary conditions, patients with intracardiac shunts, and special patient populations including pulmonary hypertension, pediatrics, and pregnancy. In addition, we will discuss the confounding role of pseudocomplication in attribution of adverse events during diagnostic testing, the current status of the ECA Black Box Warning, and recommended safety precautions during ECA administration.
2007年10月，在医疗服务提供者自发报告4例患者死亡以及约190例与超声心动图造影剂（ECA）Definity和Optison给药时间密切相关的严重心肺反应后，美国食品药品监督管理局强制要求对市售ECA的产品标签进行重大修订。从那时起，已发表了多项大型ECA安全性研究，这些研究涵盖了门诊患者、住院患者（包括重症患者）、接受负荷超声心动图检查的患者以及患有肺动脉高压的患者。此外，美国食品药品监督管理局召开了2次咨询委员会会议，Optison和Definity的产品标签已进行了大幅修订，安全限制有所放宽。在本综述中，我们将探讨在患有严重心肺疾病的患者、有心内分流的患者以及包括肺动脉高压、儿科和妊娠在内的特殊患者群体中使用ECA的安全性。此外，我们将讨论伪并发症在诊断测试期间不良事件归因中的混淆作用、ECA黑框警告的现状以及ECA给药期间推荐的安全预防措施。
