Update on the safety and efficacy of commercial ultrasound contrast agents in cardiac applications.
Update on the safety and efficacy of commercial ultrasound contrast agents in cardiac applications.
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DOI：
10.1530/erp-15-0018
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发表时间：
2015-06-01
影响因子：
6.3
通讯作者：
Feinstein SB
中科院分区：
文献类型：
--
作者：
Appis AW;Tracy MJ;Feinstein SB
超声造影剂（UCA）目前在世界各地的临床和研究环境中使用。超声造影的概念起源于20世纪60年代末，第一批商业化的造影剂最初是在20世纪80年代开发的。今天的微泡被设计为更大的效用，并用于批准和标签外的适应症。2007年10月，美国食品药品监督管理局（FDA）强制实施了额外的产品标签警告，包括严重心肺反应、几种新的疾病状态禁忌症以及Optison和Depletion试剂的强制性术后30分钟监测期。 这些额外的警告是由心肺反应的报告引起的，这些反应与时间有关，但不能明确归因于这些UCA。随后几个月发表的报告不仅确定了UCA临床超声应用的安全性，而且提高了疗效。因此，FDA在2008年6月更新了产品标签，并减少了禁忌症，尽管它继续监测选定的患者。此外，向申办者提出了一项上市后计划，以进行一系列安全性研究，进一步评估UCA的风险。然后在2011年10月，FDA领导层在听取了上市后数据的结果后进一步降低了警告级别，这些数据显示了持续的安全性和改善的疗效。本文综述了UCA在当今临床实践中的应用，包括已批准的适应症，各种标签外用途以及最新数据，这些数据证实了UCA的安全性和有效性。
Ultrasound contrast agents (UCAs) are currently used throughout the world in both clinical and research settings. The concept of contrast-enhanced ultrasound imaging originated in the late 1960s, and the first commercially available agents were initially developed in the 1980s. Today's microbubbles are designed for greater utility and are used for both approved and off-label indications. In October 2007, the US Food and Drug Administration (FDA) imposed additional product label warnings that included serious cardiopulmonary reactions, several new disease-state contraindications, and a mandated 30 min post-procedure monitoring period for the agents Optison and Definity. These additional warnings were prompted by reports of cardiopulmonary reactions that were temporally related but were not clearly attributable to these UCAs. Subsequent published reports over the following months established not only the safety but also the improved efficacy of clinical ultrasound applications with UCAs. The FDA consequently updated the product labeling in June 2008 and reduced contraindications, although it continued to monitor select patients. In addition, a post-marketing program was proposed to the sponsors for a series of safety studies to further assess the risk of UCAs. Then in October 2011, the FDA leadership further downgraded the warnings after hearing the results of the post-marketing data, which revealed continued safety and improved efficacy. The present review focuses on the use of UCAs in today's clinical practice, including the approved indications, a variety of off-label uses, and the most recent data, which affirms the safety and efficacy of UCAs.