康柏西普眼用注射液治疗眼部新生血管性疾病出现不良反应的病例分析  

Analysis of adverse drug reaction of conbercept ophthalmic injection for ocular neovascular diseases

作　　者：赵茂竹[1] 张杰 万灵[3] 钟捷[3] 

机构地区：[1]四川省医学科学院四川省人民医院城东病区眼科,四川省成都市610101 [2]成都市药物不良反应监测中心,四川省成都市610042 [3]四川省医学科学院四川省人民医院眼科,610072

出　　处：《眼科新进展》2017年第7期677-679,683,共4页Recent Advances in Ophthalmology

摘　　要：目的统计分析全国2014年至2016年玻璃体内注射康柏西普眼用注射液的不良反应报告,以提高康柏西普眼用注射液临床应用的安全性。方法对2014年至2016年国家药品不良反应监测中心数据库中全国62家医疗机构使用康柏西普眼用注射液出现的248例不良反应病例进行统计分析。结果康柏西普眼用注射液临床使用中出现的药物不良反应主要累及眼部、心血管系统、骨骼肌系统及皮肤系统。药物不良反应主要发生于注射早期。248例不良反应的处理转归结果上报情况为痊愈126例,好转120例,未好转1例,1例预后不详,无死亡病例。结论应对康柏西普眼用注射液玻璃体内注射引起的眼内炎、视网膜脱离、玻璃体积血等严重不良反应加以重视,该药的严重不良反应及新的不良反应需作为上市后评价的关注要点。需加强对各医疗机构药物不良反应报告质量进行评估和管理。Objective To analyze the adverse drug reaction of intravitreal conbercept injection for the security of conbercept injection in clinical application. Methotis From 2014 to 2015,248 cases of adverse drug reaction caused by intravitreal conbercept injection were monitored by 52 medical institutions from National Center for Adverse Drug Reaction Monitoring China, and analyzed in this study. Results The adverse drug reactions caused by conbercept were mainly observed in the ophthalmology system, skin system, mnsculoskeletal system and cardiovascular system. The adverse drug reactions mainly occurred in the early stage of injection. Among those patients,the reported treatment results were cured in 126 cases ,improved in 120 cases ,unchanged in 1 case, unknown in 1 case, and no anyone died. Conelusion It should give a great attention to the serious adverse reaction that caused by conbercept injection, especially for endophthalmitis, retinal detachment and vitreous hemorrhage. The incidence of serious and newly observed adverse drug reaction should be two important portions of post-marketing safety surveillance. Moreover, the quality of adverse drug reaction reports from different medical institutions needs to be improved. Their assessment and management should be enhanced.

关 键 词：康柏西普眼用注射液 药物不良反应 分析 

分 类 号：R773[医药卫生—眼科]