COVID-19治療藥品於台灣之不良反應通報分析

The Analysis of the Adverse Drug Reaction of COVID-19 Therapeutics in Taiwan

我國自2020年起陸續提供各不同機轉藥品以治療不同嚴重程度新型冠狀病毒感染（coronavirus disease 2019, COVID-19）之病人。本研究藉由分析全國藥物不良反應通報系統資料庫於2020/1/1-2023/6/30期間接獲之COVID-19治療藥品不良反應通報案件，以偵測此類藥品之潛在安全性訊號。研究共分析195例疑似使用COVID-19治療藥品後發生不良反應之通報案件，包括抗病毒藥品（183例）、複合單株式抗體（3例）及免疫調節藥品（9例），其中以抗病毒藥品remdesivir（65例）、molnupiravir（33例）、nirmatrelvir-ritonavir（85例）為多數。不良反應個案之男女占比相當，年齡分布介於3-99歲之間，並以其他具重要臨床意義之嚴重不良反應（46.2%）最多。經分析，多數不良反應通報症狀已刊載於仿單或中文用藥說明書，少數症狀如使用remdesivir後發生心搏過緩（bradycardia）或aspartate transaminase/alanine aminotransferase上升、使用nirmatrelvir-ritonavir後serum creatinine上升等則因通報資料不足、無法排除與COVID-19病程或併用藥品之關聯，而無法判斷與COVID-19治療藥品之相關性。建議醫療人員處方此類藥品時提醒病人可能之不良反應症狀，並留意病人用藥後之狀況。

Since 2020, Taiwan has introduced multiple medications to treat patients with different severities of COVID-19. This study aims to detect potential safety signal(s) while providing a comprehensive understanding of the safety profiles regarding COVID-19 medications by analyzing spontaneous adverse drug reaction (ADR) reports collected in Taiwan National ADR Reporting System from January 1, 2020, to June 30, 2023. This study examines 195 ADR reports following COVID-19 medication treatments, including 183 cases involving antiviral agents, 3 cases involving monoclonal antibody compounds and 9 cases involving immunomodulators. The most frequently reported suspect drugs are remdesivir, molnupiravir, and nirmatrelvir-ritonavir, with 65, 33, and 85 reports, respectively. The gender distribution among these reports is similar, with patient ages ranging from 3 to 99 years old. The majority of reports (46.2%) are classified as important medical events. According to our research, most symptoms reported in the ADRs are documented in the summary of product characteristics (SmPC) or medication instruction papers. However, some symptoms such as bradycardia or elevated aspartate transaminase/alanine aminotransferase levels after using remdesivir, and increased serum creatinine levels after using nirmatrelvir-ritonavir, cannot be conclusively associated with COVID-19 medications due to insufficient information or the inability to rule out connections with COVID-19 infection or concomitant medications. We recommend that healthcare professionals inform patients of these potential side effects and closely monitor their conditions following treatment with COVID-19 medications.