目的:分析托珠单抗治疗新型冠状病毒肺炎(COVID-19)中发生不良反应(adverse drug reactions，ADRs)的临床表现和特点，为临床合理用药提供参考。方法:检索中国知网(CNKI)、万方医学网、PubMed和Web of Science数据库，2019年12月至2023年4月收载的托珠单抗治疗COVID-19时发生ADRs的病例报道，进行总结分析。结果:检索到35篇共52例托珠单抗治疗COVID-19中ADRs的病例报道，男42例(80。77％)，女10例(19。23％);年龄分布以40～69岁(36例，69。23％)居多;ADRs多发生在用药后1～20d(40例，76。92％)，主要为感染及侵染类疾病(16例，21。05％)、肝胆系统疾病(12例，15。08％)以及胃肠系统疾病(11例，14。47％);其中深静脉血栓、继发性噬血细胞性淋巴组织细胞增生症等为药品说明书未记载的ADRs。结论:临床应加强对托珠单抗ADRs的监测，特别是在用药20d内发生的感染及侵染类、胃肠系统以及肝胆系统的疾病，以保证患者用药安全。
Literature analysis of adverse reactions of tocilizumab in the treatment of COVID-19
OBJECTIVE To explore the clinical manifestations and characteristics of adverse drug reactions(ADRs)of tocilizumab in the treatment of COVID-19 and provide references for clinical rational medication.METHODS The case reports of ADRs occurring during the treatment of COVID-19 with tocilizumab were retrieved from the databases of China National Knowledge Infrastructure(CNKI),Wanfang Medical Network,PubMed and Web of Science,from December 2019 to April 2023.RESULTS A total of 52 cases of ADRs in the treatment of COVID-19 with tocilizumab were included within 35 case reports.There were 42 males(80.77％)and 10 females(19.23％).Patients aged 40-69 years had the highest percentage(n=36,69.23％).The incidence of ADRs was higher within 1 to 20 days of medication(n=40,76.92％).Major ADRs occurred in infection and invasive diseases(n=16,21.05％),hepatobiliary system diseases(n=12,15.08％)and gastrointestinal system dis-eases(n=11,14.47％).Deep venous thrombosis and secondary hemophagocytic lymphohistiocytosis belonged to ADRs not men-tioned in package insert.CONCLUSION Clinical monitoring of ADRs of tocilizumab should be strengthened.Infections and invasive diseases,gastrointestinal system and hepatobiliary system diseases occurring within 20 days of medication should be closely watched for ensuring drug safety.
tocilizumabCOVID-19adverse drug reactionsliterature analysis
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