Phản vệ liên quan đến thuốc cản quang chứa iod: Phân tích tín hiệu từ cơ sở dữ liệu báo cáo ADR Quốc gia trong giai đoạn 2015 - 2019

Abstract

Objective: To investigate the clinical characteristics and to identify the signals of anaphylaxis related to iodinated contrast media (ICM) in the period from 2015 to 2019. Subject and method: A cross-sectional retrospective study of spontaneous ADR reports registered at the National DI & ADR Center from 2015 to 2019. Result: Out of 1305 ADR reports with iodine-based contrast media as suspected drugs, 468 (35.9%) reports were selected as anaphylactic cases. Iobitridol was the most reported (50.1%), followed by iohexol (21.7%), and iobromid (20.5%). The majority of the cases (88.2%) occurred within minutes to 1 hour after exposure. Symptoms of anaphylaxis were observed in cardiovascular, respiratory, dermatologic and gastrointestinal systems, both of cardiovascular and respiratory reactions were the most common (> 70.0%). 241 (51.5%) cases were classified at severity level 3 and above, and 9 (1.9%) cases led to fatal outcome. Anaphylactic signals were detected including iopamidol (ROR = 2.61 [1.05 - 6.51] in 2015), iohexol (ROR = 2.21 [1.30 - 3.75] in 2016), and iobitridol (ROR = 1.39 [1.04 - 1.85] in 2018, ROR = 1.43 [1.13 - 1.80] in 2019). Conclusion: The risk of anaphylaxis attributed to ICM was demonstrated by this analysis of the Pharmacovigilance database. Routine evaluation so as to raise awareness among healthcare professionals is crucial for detecting signals and preventing the consequences of ICM-induced anaphylaxis.