College of Medicine, Korea University, Seoul, Republic of Korea; Genomics and Digital Health, Samsung Advanced Institute for Health Sciences and Technology, Sungkyunkwan University, Seoul, Republic of Korea.
Department of Pediatrics, Yonsei University College of Medicine, Seoul, Republic of Korea.
Clin Gastroenterol Hepatol. 2021 Sep;19(9):1970-1972.e3. doi: 10.1016/j.cgh.2021.04.039. Epub 2021 Apr 30.
Remdesivir has demonstrated clinical benefits in randomized placebo-controlled trials (RCTs) in patients with coronavirus disease 2019 (COVID-19) and was first approved for COVID-19 patients. However, whether remdesivir causes gastrointestinal adverse drug reaction (GI-ADRs) including hepatotoxicity is less clear. Therefore, we aimed to detect a diverse spectrum of GI-ADRs associated with remdesivir using VigiBase, the World Health Organization's international pharmacovigilance database of individual case safety reports.
瑞德西韦在 2019 冠状病毒病（COVID-19）患者的随机安慰剂对照试验（RCT）中显示出临床益处，并首次获准用于 COVID-19 患者。然而，瑞德西韦是否会引起包括肝毒性在内的胃肠道不良药物反应（GI-ADR）尚不清楚。因此，我们旨在使用世界卫生组织的个体病例安全报告国际药物警戒数据库 VigiBase 来检测与瑞德西韦相关的广泛的 GI-ADR。
