单克隆抗体药物致不良反应132例文献分析  

Literature Analysis of 132 Cases of Adverse Drug Reaction Induced by Monoclonal Antibody

作　　者：杨澍[1] 史海雯[1] 高秀清[1] 洪阁[2] 高杉[3] 

机构地区：[1]天津市第四中心医院,天津300140 [2]中国医学科学院生物医学工程研究所/天津市生物医学材料重点实验室,天津300192 [3]天津中医药大学,天津300193

出　　处：《中国药房》2015年第23期3223-3225,共3页China Pharmacy

基　　金：国家自然科学基金资助项目(No.81403198);天津市生物医学材料重点实验室开放课题

摘　　要：目的:探讨单克隆抗体药物致不良反应(ADR)发生的规律及特点,为临床合理用药提供参考。方法:以"单克隆抗体"或"单抗"为检索词,检索并对中国生物医学文献服务系统、中国知网、万方数据库、维普中文科技期刊数据库1979年1月-2014年12月报道的单克隆抗体药物致ADR的文献34篇、132例并进行分析。结果:132例单克隆抗体药物致ADR中,男性57例(43.18%),女性75例(56.82%),男、女比例为1∶1.3;年龄最小者2岁,最大者111岁;引发ADR的单克隆抗体药物中以阿达木单抗最多,有70例(53.03%);用药在1d内出现ADR的例数最多,为44例(33.33%);单克隆抗体药物致ADR主要为皮肤及其附件损害(20.72%)、全身性反应(18.42%)、心血管系统损害(16.78%)等,具体表现为皮疹、瘙痒、寒战、发热、心慌、心跳加快等。结论:单克隆抗体致ADR较为常见,临床使用时应加强对患者的监护,尤其是儿童和老年患者,以确保患者用药安全,提高临床治疗水平。OBJECTIVE：To investigate rules and characteristics of the adverse drug reactions（ADR）induced by monoclonal antibodies,and provide reference for rational drug use. METHODS：The literatures of ADR induced by monoclonal antibodies from Jan. 1979 to Dec. 2014 were retrieved and analyzed. RESULTS：Among the 132 ADRs induced by monoclonal antibodies,57 were male（43.18%）,75 were female（56.82%）,the ratio of male to female was 1∶1.3,the youngest was 2 years old,and oldest was 111 years old;Adalimumab dominated monoclonal antibody drugs（70 cases,53.03%）;there were a maximum of ADR（44）within 1 d,accounting for 33.33%;ADR induced by monoclonal antibodies mainly were skin lesions（20.72%）,systemic reactions（18.42%）and cardiovascular system damage（16.78%）,with the specific performance of rash,itching,chills,fever,palpitation,rapid heartbeat and so on. CONCLUSIONS：ADR induced by monoclonal antibodies is more common in the clinic. The clinic should timely promote and strengthen the patients＇ care to ensure safe drug use and improve level of clinical treatment.

关 键 词：单克隆抗体 药品不良反应 分析 

分 类 号：R978.1[医药卫生—药品] R378[医药卫生—药学]