阿兹夫定片治疗新型冠状病毒感染的安全性分析

Safety analysis of azivudine tablets in the treatment of coronavirus disease 2019

目的探讨阿兹夫定片治疗普通型新型冠状病毒感染(COVID-19)的安全性。方法收集2022年8月18日至9月18日在厦门大学附属第一医院杏林分院住院并应用阿兹夫定片治疗的成年COVID-19患者临床资料,对治疗期间不良反应的发生率、临床表现、严重程度和转归等进行描述性统计分析。结果纳入分析的患者共117例,男性68例(58.1%),女性49例(41.9%);年龄18~76岁,中位年龄44岁;服用阿兹夫定片前COVID-19病程为2~25 d,平均13 d;阿兹夫定片疗程为2~14 d,平均8 d。117例患者中10例(8.5%)在服用阿兹夫定片期间发生不良反应,包括胃肠道反应5例(恶心2例、腹泻2例、腹胀1例),肝功能异常和头晕各2例,血清三酰甘油水平升高和乏力各1例;其中1例发生不良反应2例次,表现为头晕+腹胀。停用阿兹夫定片和/或对症治疗后均恢复正常。不良反应严重程度为1级者7例,2级3例,无3级及以上严重不良反应发生。所观察到的不良反应在药品说明书中均有记载,未发现新的不良反应。结论阿兹夫定片治疗普通型COVID-19安全性较好,患者耐受性较好;常见的不良反应为胃肠道反应、肝功能异常和头晕。

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,