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药物性心肌功能障碍——临床和临床前研究评估建议。

Drug-induced myocardial dysfunction - recommendations for assessment in clinical and pre-clinical studies.

机构信息

AstraZeneca R&D, Gothenburg, Sweden.

AstraZeneca R&D, Gaithersburg, MD, US.

出版信息

Expert Opin Drug Saf. 2020 Mar;19(3):281-294. doi: 10.1080/14740338.2020.1731471. Epub 2020 Feb 25.

DOI:10.1080/14740338.2020.1731471
PMID:32064957
Abstract

: Drug-induced myocardial dysfunction is an important safety concern during drug development. Oncology compounds can cause myocardial dysfunction, leading to decreased left ventricular ejection fraction and heart failure via several mechanisms. Cardiovascular imaging has a major role in the early detection and monitoring of cardiotoxicity. Echocardiography is the method of choice because of its widespread availability, low cost, and absence of radiation exposure. Cardiac magnetic resonance imaging can provide better reliability, reproducibility, and accuracy in the detection of drug-induced myocardial dysfunction. In addition, it enables assessment of myocardial edema, fibrosis, and necrosis. Cardiac serologic biomarkers such as troponins and B-type natriuretic peptides are used in combination with imaging during drug development. This article provides a general overview of each imaging modality and practical guidance for early detection and monitoring of cardiotoxicity.: Cardiovascular imaging modalities and cardiac biomarkers for monitoring of cardiac function and early detection of drug-induced myocardial dysfunction in drug development.: Some new drugs especially in the oncology field, can cause myocardial dysfunction. Depending on the strength of pre-clinical or clinical data, CV imaging modalities and cardiac biomarkers play an important role in the early detection and mitigation plans for such drugs during their development.

摘要

药物性心肌功能障碍是药物开发过程中的一个重要安全关注点。肿瘤化合物可通过多种机制导致心肌功能障碍,导致左心室射血分数降低和心力衰竭。心血管成像在早期检测和监测心脏毒性方面具有重要作用。由于其广泛的可用性、低成本和无辐射暴露,超声心动图是首选方法。心脏磁共振成像在检测药物引起的心肌功能障碍方面具有更好的可靠性、可重复性和准确性。此外,它还可以评估心肌水肿、纤维化和坏死。在药物开发过程中,心脏血清生物标志物(如肌钙蛋白和 B 型利钠肽)与成像结合使用。本文概述了每种成像方式,并提供了早期检测和监测心脏毒性的实用指导。

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