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蒽环类药物诱导的心脏毒性前瞻性多中心注册研究(AIC注册研究)的原理、设计与可行性

Rationale, Design, and Feasibility of a Prospective Multicenter Registry Study of Anthracycline-Induced Cardiotoxicity (AIC Registry).

作者信息

Inoue Keiko, Iida Noriko, Tajiri Kazuko, Bando Hiroko, Chiba Shigeru, Tasaka Nobutaka, Nagashio Kenji, Sasamura Rumi, Naito Hiroyuki, Murata Momoko, Li Siqi, Ishizu Tomoko, Nakazawa Yoko, Sekine Ikuo, Ieda Masaki

机构信息

Department of Cardiology, Faculty of Medicine, University of Tsukuba, Tsukuba 305-8575, Japan.

Clinical Laboratory, University of Tsukuba Hospital, Tsukuba 305-8576, Japan.

出版信息

J Clin Med. 2021 Mar 27;10(7):1370. doi: 10.3390/jcm10071370.

Abstract

As the number of cancer survivors increases, cardiac management in anthracycline-treated patients has become more important. We planned to conduct a prospective multicenter registry study for comprehensive echocardiographic and biomarker data collection and an evaluation of the current practice in terms of diagnosis and management of anthracycline-induced cardiotoxicity (AIC registry). To examine the feasibility of this registry study, we analyzed the 1-year follow-up data of 97 patients registered during the first year of this registry. The AIC registry was launched in July 2016. Data on echocardiographic parameters (e.g., two-and three-dimensional [(2- and 3-D) left ventricular ejection fraction (LVEF) and global longitudinal strain (GLS)) and biomarkers (e.g., troponin T and brain natriuretic peptide) were collected before anthracycline treatment, every 3 months during the first year after starting anthracycline, and every 6 months during the second year. Eighty-three patients (86%) completed a 1-year follow-up. The measurable rates of 2D LVEF, 3D LVEF, and GLS on each visit were nearly optimal (100%, 86-93%, and 84-94%, respectively). During the 1-year follow-up, 5 patients (6.0%) developed cardiotoxicity (a reduction in LVEF ≥ 10 percentage points from baseline and <55%). The AIC registry study is feasible and will be the first study to collect sizable echocardiographic and biomarker data on cardiotoxicity in Japanese patients treated with anthracycline in a real-world setting.

摘要

随着癌症幸存者数量的增加,蒽环类药物治疗患者的心脏管理变得愈发重要。我们计划开展一项前瞻性多中心注册研究,以全面收集超声心动图和生物标志物数据,并评估蒽环类药物所致心脏毒性(AIC注册研究)的诊断和管理方面的当前实践。为检验该注册研究的可行性,我们分析了该注册研究第一年登记的97例患者的1年随访数据。AIC注册研究于2016年7月启动。在蒽环类药物治疗前、开始使用蒽环类药物后的第一年每3个月以及第二年每6个月收集超声心动图参数(如二维和三维[(2维和3维)左心室射血分数(LVEF)和整体纵向应变(GLS)])和生物标志物(如肌钙蛋白T和脑钠肽)的数据。83例患者(86%)完成了1年随访。每次访视时二维LVEF、三维LVEF和GLS的可测量率几乎达到最佳(分别为100%、86 - 93%和84 - 94%)。在1年随访期间,5例患者(6.0%)发生了心脏毒性(LVEF较基线降低≥10个百分点且<55%)。AIC注册研究是可行的,并且将是第一项在真实世界环境中收集接受蒽环类药物治疗的日本患者心脏毒性的大量超声心动图和生物标志物数据的研究。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/caae/8036590/789a102c4b98/jcm-10-01370-g001.jpg

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