摘要
目的:了解抗体药物在我国的应用现状及其药学监护知识。方法:采用回顾性分析,对我国现已批准上市的抗体药物进行统计、分析,并与美国应用的适应证进行比较。结果:我国现有抗体药物16种,其中单克隆抗体药物15种,抗体融合蛋白1种,按药理学分为抗肿瘤药物(7种)、治疗自身免疫性疾病药物(5种)、器官移植抗排异反应药物(3种)、抗视网膜黄斑变性药物(1种)。我国的抗体药物大多数为进口药品,美国批准的适应证多于中国。抗体药物的免疫原性可导致严重的临床后果。结论:近年来我国抗体药物的应用发展迅速,对其不良反应要十分重视,应着重加强ADR或ADE的监测、分析和上报。
Objective： To acquire information on clinical applicaiton of antibody drugs in China and its pharmaceutical care situation. Methods： Making statistics and analysis of the antibody drugs in China by retrospective analysis, comparing their indications in China and US. Results：16 antibody dugs have already been approved in China, including 15 monoclonal antibody drugs and 1 dimeric fusion protein. Conclusions：In recent years the development of domestic application of antibody drugs is very fast and we should pay great attention to their adverse reactions.
出处
《药品评价》
CAS
2014年第6期12-16,共5页
Drug Evaluation
关键词
抗体药物
单克隆抗体药物
不良反应
药学监护
Antibody Drug
Monoclonal Antibody Drug
Adverse Drug Reactions
Pharmaceutical Care
