目的 通過對既往托珠單抗在臨床應用的安全性信息進行總結，分析其所致不良反應（ADR）的規(guī)律和特點，以期為后續(xù)臨床合理應用提供參考。方法 檢索中國學術期刊（網(wǎng)絡版）、萬方數(shù)字化期刊全文庫、中文科技期刊全文數(shù)據(jù)庫（維普）和PubMed、Web of Science數(shù)據(jù)庫自建庫至2020年3月關于托珠單抗致ADR的病例報道，對患者的年齡、性別、原患疾病以及托珠單抗的用法用量、不良反應發(fā)生時間、臨床表現(xiàn)等進行回顧性分析。結果 共計47例不良反應病例被納入，男性9例，女性38例，年齡主要集中在≤ 30歲和61~70歲，構成比分別為21.3%、23.4%；原患疾病主要為類風濕性關節(jié)炎，構成比為51.1%；有4例明確指出ADR的發(fā)生與藥物相互作用有關；ADR累及多個系統(tǒng)/器官，主要以皮膚及附件（26.0%）、血液系統(tǒng)（18.0%）為主。結論 臨床使用托珠單抗時應加強用藥安全性監(jiān)測，減少ADR的發(fā)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

國家自然科學基金資助項目（21676187）