摘要
目的 对阿兹夫定片上市后临床安全性的文献进行再评价,为临床安全用药提供参考。方法 检索2021—2024年中国知网、万方数据知识服务平台、维普资讯、中国生物医学文献数据库、PubMed中收载的阿兹夫定片的ADR文献,采用描述性分析方法,对ADR发生特点进行分析。结果 最终纳入14篇文献,其中临床研究/安全性监测8篇,个案报道6篇,共涉及1581例患者,276例患者发生了ADR。阿兹夫定片的ADR累及12个器官/组织/系统,合计378例次,主要集中在胃肠道疾病(132例次,占34.9%),表现为恶心、腹泻、呕吐等;其次是各类检查(94例次,占24.9%),表现为ALT升高、AST升高、WBC计数降低等;再次是各类神经系统疾病(64例次,占16.9%),表现为头晕、头痛等。78例患者记录了ADR的处理情况,多数好转或痊愈。发生≥3级的ADR的患者共6例,表现为转氨酶升高、呼吸困难等。结论 阿兹夫定的ADR临床表现多样,对消化系统和神经系统影响较为明显。在临床应用中建议持续扩大监测人群,尤其是老年人,促进阿兹夫定的用药安全。
Objective To conduct a post-marketing re-evaluation of the clinical safety of azulfidine tablets based on literature analysis,providing references for safe clinical use.Methods Literature on adverse drug reactions(ADRs)related to azulfidine tablets published between 2021 and 2024 was retrieved from CNKl,Wanfang Database,ViP Database,China Biomedical Literature Database,and PubMed.Descriptive analysis was employed to analyze ADR characteristics.Results A total of 14 studies were included(8 clinical studies/safety monitoring reports and 6 case reports),involving 276 patients.ADRs affected 12 organs/systems and manifested as 45 different clinical symptoms,with a total of 378 occurrences.The most common ADRs were gastrointestinal disorders(132 occurrences,34.9%),characterized by nausea,diarrhoea,vomiting,followed by abnormal laboratory test results(94 occurrences,24.9%),including elevated alanine aminotransferase,elevated aspartate aminotransferase,and decreased leukocyte counts;and neurological disorders(64 occurrences,16.9%),characterized by dizziness and headache.The management of ADRs was recorded in 78 patients,with most cases improved or recovered.Severe ADRs(grade≥3)were observed in 6 patients,presenting as elevated transaminases,dyspnoea.Conclusion The clinical manifestations of ADRs associated with azvudine are diverse,with significant impacts on the digestive and nervous system.It is recommended to continuously expand the monitoring population,particularly among the elderly,to enhance the safe use of azvudine.
作者
李更森
李鸿升
张亚同
孙雪林
LI Gengsen;LI Hongsheng;ZHANG Yatong;SUN Xuelin(Departmen of Internal Medicine, Ningbo University Affiliated Women and Children's Hospital;Department of Pharmacy,Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences)
出处
《临床药物治疗杂志》
2025年第7期63-67,共5页
Clinical Medication Journal
基金
中央高水平医院临床科研业务费资助项目(BJ-2023-200)。
关键词
阿兹夫定片
药品ADR
药品不良事件
安全性
再评价
文献分析
azulfidine tablets
adverse drug reactions
adverse drug events
safety
re-evaluation
literature analysis
