目的 通过对既往托珠单抗在临床应用的安全性信息进行总结，分析其所致不良反应（ADR）的规律和特点，以期为后续临床合理应用提供参考。方法 检索中国学术期刊（网络版）、万方数字化期刊全文库、中文科技期刊全文数据库（维普）和PubMed、Web of Science数据库自建库至2020年3月关于托珠单抗致ADR的病例报道，对患者的年龄、性别、原患疾病以及托珠单抗的用法用量、不良反应发生时间、临床表现等进行回顾性分析。结果 共计47例不良反应病例被纳入，男性9例，女性38例，年龄主要集中在≤ 30岁和61~70岁，构成比分别为21.3%、23.4%；原患疾病主要为类风湿性关节炎，构成比为51.1%；有4例明确指出ADR的发生与药物相互作用有关；ADR累及多个系统/器官，主要以皮肤及附件（26.0%）、血液系统（18.0%）为主。结论 临床使用托珠单抗时应加强用药安全性监测，减少ADR的发生。

Objective To summarizthe existing clinical safety evidences on the use of tocilizumab, and to analyze the general regularity and characteristics of adverse reactions induced by tocilizumab, and to provide reference for rational drug use in clinic. Methods Literatures about adverse reactions induced by tocilizumab were collected from Chinese Academic Journal (online), Wangfang Database, Chinese Science and Technology Journal Full-text Database (VIP), Pubmed, and Web of Science from creating database to March 2019 were searched for case reports about tocilizumab, and the patients information including gender, age, primary disease, and dosage combined medication, occurrence time, and clinical manifestations were extracted and analyzed. Results A total of 47 ADR cases induced by tocilizumab were collected, including 9 males and 38 females, and the age of patients were mainly ≤ 30 and 61-70 years old with the constituent ratio of 21.3% and 23.4%, respectively. The primary disease was rheumatoid arthritis, accounted for 51.1%. The occurrence of ADR was clearly indicated to be related to drug interaction in 4 cases. Organs/systems involved in tocilizumab induced ADRs were mainly disorders of skin and appendages damage (26.0%) and blood system (18.0%). Conclusion In the clinical use of tocilizumab, attention should be paid to ADR monitoring, safety monitoring of tocilizumab should be strengthened to reduce the occurrence of adverse reactions.

R977

国家自然科学基金资助项目（21676187）