抗肿瘤单克隆抗体早期临床试验中超敏反应规范化处置策略探讨  

Discussion of standardized assessment and emergency treatment for hypersensitivity reactions in early clinical trials of anti-tumor monoclonal antibody drugs

作　　者：方莹莹 刘龙 李银娟 王兴河 FANG Ying-ying;LIU Long;LI Yin-juan;WANG Xing-he(Phase I Clinical Trial Center,Beijing Shijitan Hospital,Capital Medical University,Beijing 100038,China)

机构地区：[1]首都医科大学附属北京世纪坛医院药物Ⅰ期临床试验研究室,北京100038

出　　处：《中国新药杂志》2021年第24期2295-2299,共5页Chinese Journal of New Drugs

摘　　要：目的:对抗肿瘤单克隆抗体(简称抗肿瘤单抗)超敏反应规范化处置策略(判断、评估和处理)进行分析探讨。方法:在中国知网和Pubmed等数据库中,以"抗肿瘤药物"、"单克隆抗体"和"超敏反应"为关键词检索相关文献,检索时间为2010年1月1日至2021年10月1日,对超敏反应类型、风险因素以及处理治疗进行汇总分析。结果:共纳入文献63篇,其中有22.1%的文献没有明确定义超敏反应类型。完全人源化抗肿瘤单抗和人源化抗肿瘤单抗被报道出现输液反应的频率分别为56.7%和43.1%。静脉输液抗肿瘤单抗被报道超敏反应的频率明显高于皮下注射药物(88.5%vs 11.5%)。患者出现超敏反应的报道频率高于健康受试者(58.7%vs 20.2%)。结论:超敏反应需要规范化判断,超敏反应的风险程度与药物特点、给药方式、给药人群等有关;急性超敏反应处理流程需要规范化、系统化、个体化,对于部分抗肿瘤单抗药物可考虑进行快速药物脱敏治疗。Objective:To explore the roles of standardized judgement,risk assessment and emergency treatment of hypersensitivity reactions(HSRs)of anti-tumor monoclonal antibody drugs.Methods:The literature of anti-tumor drugs,monoclonal antibodies and HSRs was retrieved from China National Knowledge Infrastructure(CNKI)and PubMed from January 1,2010 to October 1,2021.The definition and classification of HSRs,risk factors and novel treatment were analyzed.Results:A total of 63 pieces of literature were included,of which 22.1%did not clearly define the type of HSRs.The frequencies of infusion reactions of Fully Human Mab and Humanized Mab were reported to be 56.7%and 43.1%,respectively.The frequency of reported HSRs in intravenous drugs was significantly higher than that in subcutaneous ones(88.5%vs 11.5%);the frequency of HSRs reported in patients was significantly higher than that in healthy subjects(58.7%vs 20.2%).Conclusion:The terminology of HSRs needs to be standardized.The degree of risk could be related to the drug characteristic,the method of administration,and the population of medication.The treatment of acute HSRs needs to be standardized,systematized and individualized.Rapid drug desensitization(RDD)might be novel and beneficial treatment for tumor patients.

关 键 词：抗肿瘤药物 单克隆抗体 早期临床试验 超敏反应 规范化判断 风险评估 规范化处理 

分 类 号：R979.1[医药卫生—药品]