189例新型冠状病毒感染患者应用先诺特韦/利托那韦治疗的安全性分析  

Safety analysis of simnotrelvir/ritonavir treatment in 189 patients with coronavirus disease 2019

作　　者：张红梅[1] 邓嘉玉 王相峰 宋燕青[1] Zhang Hongmei;Deng Jiayu;Wang Xiangfeng;Song Yanqing(Department of Pharmacy,Lequn Branch,the First Hospital of Jilin University,Changchun 130031,China)

机构地区：[1]吉林大学第一医院乐群院区药学部,长春130031

出　　处：《药物不良反应杂志》2024年第5期285-290,共6页Adverse Drug Reactions Journal

摘　　要：目的探讨先诺特韦/利托那韦治疗新型冠状病毒感染(COVID⁃19)的安全性。方法收集2023年6月9日至9月30日在吉林大学第一医院乐群院区住院并应用先诺特韦/利托那韦治疗的成年COVID⁃19患者的病历资料,根据是否发生先诺特韦/利托那韦相关药物不良反应(ADR)将患者分为ADR组与无ADR组。对患者发生ADR时间、临床表现、严重程度以及治疗和转归进行回顾性分析。结果纳入本研究的患者189例,男性92例(48.7%)、女性97例(51.3%),年龄69(60.5,74.0)岁。先诺特韦/利托那韦用法用量均遵照说明书规定(先诺特韦0.75 g+利托那韦0.1 g口服、1次/12 h,连续5 d)。189例患者中18例(9.5%)发生先诺特韦/利托那韦相关ADR。ADR组(18例)和无ADR组(171例)患者的性别、年龄、吸烟状况、COVID⁃19分型和基础疾病为高血压病、糖尿病、心血管疾病、脑血管疾病、肺部疾病、肿瘤术后者占比的差异均无统计学意义(均P>0.05),2组患者基础疾病为肝损伤和肾损伤者占比的差异有统计学意义(均P<0.05)。ADR组共发生ADR 23例次,发生时间为服用先诺特韦/利托那韦后1~8 d;临床表现包括消化系统症状、转氨酶升高、血清肌酐升高、血尿酸升高、血小板计数降低、白细胞和中性粒细胞计数降低、头晕、头痛等,5例患者同时出现2种症状。ADR严重程度为1、2级者分别为12和6例,无≥3级严重ADR发生。除1例因血小板减少停药外,其他患者均完成5 d治疗。停用先诺特韦/利托那韦和/或对症治疗1~5 d后ADR均消失。结论先诺特韦/利托那韦治疗COVID⁃19有较好的安全性,主要的ADR为腹泻、转氨酶升高等,严重程度均为1~2级,停药后ADR消失;基础疾病为肝、肾损伤者应用先诺特韦/利托那韦时更需警惕ADR的发生。Objective To explore the safety of simnotrelvir/ritonavir in the treatment of coronavi⁃rus disease 2019(COVID⁃19).Methods The medical records of adult patients with COVID⁃19 who were hospitalized in Lequn Branch,Hospital of the First Hospital of Jilin University from June 9 to September 30,2023 and treated with simnotrelvir/ritonavir were collected.According to whether adverse drug reactions(ADR)related to simnotrelvir/ritonavir occurred,the patients were divided into ADR group and non⁃ADR group.The clinical data,occurrence time of ADR,clinical manifestations,severity,treatment and outcome of patients were analyzed retrospectively.Results A total of 189 patients were enrolled in this study,including 92 males(48.7%)and 97 females(51.3%),with a median age of 69(60.5,74.0)years.The usage and dosage of simnotrelvir/ritonavir were in accordance with the instructions(0.75 g of simnotrelvir and 0.1 g of ritonavir orally,once every 12 hours for 5 days).ADR related to simnotrelvir/ritonavir occurred in 18 of 189 patients(9.5%).There were no significant differences(all P>0.05)in gender,age,smoking status,COVID⁃19 classification and the proportion of patients with basic diseases such as hypertension,diabetes,cardiovascu⁃lar disease,cerebrovascular disease,lung disease,and tumor after surgery between the ADR group(18 patients)and non⁃ADR group(171 patients).The difference in the propation of patients with liver injury and kidney injury between the 2 groups were statistically significant(both P<0.05).A total of 23 cases of ADR occurred in the ADR group.The occurrence time of ADR was 1 to 8 days after taking simnotrelvir/ritonavir.The clinical manifestations of ADR included digestive system symptoms,elevated transaminases,elevated serum creatinine,elevated serum uric acid,decreased platelet count,decreased white blood cell and neutro⁃phil counts,dizziness,headache,etc.Five patients had 2 kinds of symptoms at the same time.The severity of ADR was grade 1 in 12 patients and grade 2 in 6 patients,and no≥grade 3

关 键 词：冠状病毒感染 抗病毒药 安全 先诺特韦 利托那韦 

分 类 号：R511[医药卫生—内科学]