Sun Ji, Deng Xuanyu, Huang Juanjuan, He Gefei, Huang Shiqiong
The Affiliated Changsha Hospital of Xiangya School of Medicine, Central South University, Changsha, China.
The First Hospital of Changsha, Changsha, PR China.
PLoS One. 2024 Dec 31;19(12):e0316573. doi: 10.1371/journal.pone.0316573. eCollection 2024.
Nirmatrelvir/Ritonavir, acting as an effective agent against COVID-19, has achieved considerable results in clinical studies in terms of drug efficacy. However, there is little research about its medication safety. Based on the FDA adverse event reporting system (FAERS) database, this study aims to mine the adverse reaction signals of the latest major recommended drug Nirmatrelvir/Ritonavir for the antiviral treatment of COVID-19, so as to provide a basis for safe and rational drug use. The reporting odds ratio (ROR) was used to explore the adverse event report data of all COVID-19 emergency use authorization (EUA) products in the FAERS database with the deadline of third quarter of 2023. In the analysis, 135427 adverse drug event (ADE) reports were found, and 35250 ADEs were reported with Nirmatrelvir/Ritonavir as the primary suspected drug, which was involved in multiple system. There was a high signal intensity of dysgeusia (ROR = 72.98), diarrhea (ROR = 3.03) and headache (ROR = 1.25), which was compatible with the adverse reactions recorded in the manual for Nirmatrelvir/Ritonavir. In addition, it was suggested that Nirmatrelvir/Ritonavir might cause pale-colored stools (ROR = 45.53), chromaturia (ROR = 3.07), yellow skin (ROR = 3.62), tongue coating (ROR = 35.55) and other new adverse reactions (not included in the instructions manual for Nirmatrelvir/Ritonavir). The ADEs of Nirmatrelvir/Ritonavir that are not in the instructions and are highly relevant in the real world are supplemented, prompting clinical attention to the ADEs of the drug, and providing a theoretical basis for the safe and effective application of the drug.
奈玛特韦/利托那韦作为一种抗新冠病毒的有效药物，在临床研究中已取得了显著的疗效。然而，关于其用药安全性的研究却很少。基于美国食品药品监督管理局不良事件报告系统（FAERS）数据库，本研究旨在挖掘新冠病毒抗病毒治疗的最新主要推荐药物奈玛特韦/利托那韦的不良反应信号，为安全合理用药提供依据。采用报告比值比（ROR）对截至2023年第三季度的FAERS数据库中所有新冠紧急使用授权（EUA）产品的不良事件报告数据进行探索。分析发现135427份药品不良事件（ADE）报告，其中以奈玛特韦/利托那韦为主要怀疑药物的ADE报告有35250份，涉及多个系统。味觉障碍（ROR = 72.98）、腹泻（ROR = 3.03）和头痛（ROR = 1.25）的信号强度较高，这与奈玛特韦/利托那韦说明书中记录的不良反应相符。此外，提示奈玛特韦/利托那韦可能会引起浅色粪便（ROR = 45.53）、血尿（ROR = 3.07）、皮肤发黄（ROR = 3.62）、舌苔（ROR = 35.55）等新的不良反应（未包含在奈玛特韦/利托那韦说明书中）。补充了奈玛特韦/利托那韦说明书中未提及且在现实世界中高度相关的ADE，促使临床关注该药物的ADE，为该药物的安全有效应用提供理论依据。
