Safety analysis of azivudine tablets in the treatment of coronavirus disease 2019
10.3760/cma.j.cn114015-20220928-00881
- VernacularTitle:阿兹夫定片治疗新型冠状病毒感染的安全性分析
- Author:
Hongping HUANG
1
;
Qingxin CHEN
1
;
Tian YU
1
;
Huaman CHEN
1
Author Information
1. 厦门大学附属第一医院药剂科，厦门 361022
- Publication Type:Journal Article
- Keywords:
COVID-19;
Antiviral agents;
Safety;
Azivudine
- From:
Adverse Drug Reactions Journal
2023;25(1):17-20
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To explore the safety of azivudine tablets in the treatment of moderate coronavirus disease 2019 (COVID-19).Methods:Clinical data of adult COVID-19 patients who were hospitalized and treated with azivudine tablets at Xinglin Branch, the First Affiliated Hospital of Xiamen University from August 18 to September 18, 2022 were collected. The incidence, clinical manifestations, severity, and outcome of adverse reactions during treatment were analyzed descriptively and statistically.Results:A total of 117 patients were entered in the analysis, including 68 males (58.1%) and 49 females (41.9%); the age ranged from 18 to 76 years, with a median age of 44 years. The course of COVID-19 before taking azivudine tablets ranged from 2 to 25 days, with an average time of 13 days. Azivudine tablets were applicated for 2-14 days with an average time of 8 days. Among 117 patients, 10 patients (8.5%) had adverse reactions during taking azivudine tablets, including 5 patients with gastrointestinal reactions (2 had nausea, 2 had diarrhea, and 1 had abdominal distension), 2 patients with liver dysfunction and 2 patients with dizziness, 1 patient with elevated serum triglyceride level, and 1 with fatigue. Of them, one patient had 2 times of adverse reactions, which manifested as dizziness and abdominal distension. All patients recovered after discontinuation of azivudine tablets and/or symptomatic treatments. The severity of adverse reactions was grade 1 in 7 patients and grade 2 in 3 patients, and no grade 3 and above serious adverse reactions occurred. All adverse reactions observed in the study had been recorded in the drug label, and no new adverse reactions were found.Conclusions:Azivudine tablets is safe and well tolerated in the treatment of moderate COVID-19. The common adverse reactions were gastrointestinal reactions, abnormal liver function, and dizziness.
