特瑞普利单抗所致药物不良反应的临床特征分析

Analysis of Clinical Features of Adverse Drug Reactions Caused by Toripalimab

目的:分析特瑞普利单抗(toripalimab,TRPL)所致药物不良反应(adverse drug reactions,ADRs)的临床特点和规律,为该药的临床安全使用提供参考。方法:选取截至2021年9月全省医疗机构上报至河南省药品不良反应监测中心的TRPL所致ADRs 21例,以及以“特瑞普利单抗“”不良反应“”病例“”toripalimab“”adverse reaction”“case report”为关键词检索到的国内外文献中的TRPL所致ADRs 17例,从患者的年龄、性别、用药剂量、ADRs发生时间、累及器官等方面分析TRPL所致ADRs的临床特点和规律。结果:关联性评价结果显示,38例ADRs中与TRPL的相关性为“肯定”的有1例(占2.63%),“很可能”的有22例(占57.89%),“可能”的有15例(占39.47%);38例TRPL所致ADRs患者中性别主要为男性(23例,占60.53%),年龄主要集中在>50~80岁之间(27例,占71.76%);38例患者中,TRPL的使用符合当前其说明书适应证的仅15例,其中恶性黑色素瘤11例、尿路上皮癌4例;38例患者中TRPL的单次用药剂量以固定240 mg为主(30例,占78.95%);TRPL所致ADRs主要发生在患者用药后的90 d内(30例,占78.95%),而ADRs累及的器官主要为皮肤及其附件(11例,占28.95%)、内分泌系统(10例,占26.32%)和消化系统(10例,占26.32%);经过处置,38例患者的ADRs结局为治愈或好转的有31例(占81.58%)。结论:TRPL作为新近上市的抗肿瘤药物,其相关ADRs的报道仍较少,临床应持续观察和分析TRPL相关ADRs的临床特点,为其在临床的安全使用提供参考。

Objective:To investigate the clinical features and rules of adverse drug reactions(ADRs)caused by toripalimab(TRPL)and provide reference for the safe use of the drug in clinical practice.Methods:21 patients with ADRs caused by TRPL reported by the provincial medical institutions to the Henan Adverse Drug Reaction Monitoring Center as of September 2021 and 17 patients with ADRs caused by TRPL searched from the domestic and foreign literatures with the keywords such as"特瑞普利单抗","不良反应","病例”"toripalimab","adverse reaction"and"case report"were selected,and the clinical features and rules of ADRs caused by TRPL were analyzed in terms of age,gender,drug dose,ADRs occurrence time,and organs involved,etc.Results:The relevance evaluation showed that,among the 38 cases of ADRs,1 case(2.63%)was"definitely relevant"with TRPL,22 cases(57.89%)were"probably relevant"with TRPL,and 15 cases(39.47%)were"possibly relevant"with TRPL;the 38 cases of ADRs caused by TRPL were mainly male patients(23 cases,60.53%),and the age was mainly between 50+and 80 years old(27 cases,71.76%).Among the 38 cases,there were only 15 cases whose use of TRPL complied with the indications of the package insert,including 11 cases of malignant melanoma,and 4 cases of urothelial carcinoma.Among the 38 cases,the single dose of TRPL was mainly fixed at 240 mg(30 cases,78.95%);ADRs caused by TRPL mainly occurred within 90 days after drug administration(30 cases,78.95%),and the organs involved by ADRs were mainly the skin and its appendages(11 cases,28.95%),endocrine system(10 cases,26.32%)and digestive system(10 cases,26.32%);after treatment,31 of the 38 patients with ADRs were cured or improved(81.58%).Conclusion:TRPL is a newly marketed antineoplastic drug,and there are few reports on ADRs related to the drug.The clinical features of ADRs related to TRPL should be continuously observed and analyzed,so as to provide reference for its safe use in clinical practice.