80例注射用环磷腺苷葡胺致过敏性休克报告分析  

Analysis of 80 Cases of Anaphylactic Shock Caused by Meglumine Adenosine Cyclophosphate for Injection

作　　者：曹璐娟 甘戈 沈于兰 糜怡珺 Cao Lujuan;Gan Ge;Shen Yulan;Mi Yijun(Center fr ADR Monioring of Wauxi,Wuxi 14029,Jiangu,China;Wuxi Experimental Cente for Drug;Evaluation Center of Jiangsu Medical Products Administration)

机构地区：[1]无锡市药品不良反应监测中心,江苏无锡214029 [2]无锡市药品安全检验检测中心 [3]江苏省药品监督管理局审评中心

出　　处：《药物流行病学杂志》2022年第8期534-537,共4页Chinese Journal of Pharmacoepidemiology

摘　　要：目的:探讨注射用环磷腺苷葡胺导致过敏性休克的特点,为临床安全用药提供参考。方法:对2015~2020年无锡地区收到的80例注射用环磷腺苷葡胺致过敏性休克的药品不良反应(ADR)报告,按照患者性别、年龄、原患疾病及过敏史、可疑药物用法用量、稀释溶媒、不良反应诱导时间等进行回顾性分析。结果:80例报告中男女比例为1∶1,以65岁及以上的患者居多(58.75%),75.00%的过敏性休克发生在用药后30 min内。查阅企业最新药品说明书,不良反应项下未有过敏性休克的描述。结论:临床要加强注射用环磷腺苷葡胺的临床合理使用,重视其引起的过敏性休克。药品上市许可持有人应持续加强上市后产品不良反应监测,完善药品说明书信息。Objective:To investigate the features of allergic shock induced by meglumine adenosine cyclophosphate for injection,so as to provide reference for clinical rational drug use.Methods:Totally 80 cases of ADR reports of anaphylactic shock induced by meglumine cyclophosphate for injection in Jiangsu province from 2015 to 2020 were analyzed retrospectively in terms of genders,ages,original disease and allergy history,usage,dilution and adverse reaction induction time.Results:The ratio of male to female was 1∶1 in 80 cases,most patients aged more than 65 years old or above(58.75%),75.00%of anaphylactic shock occurred within 30 minutes during medication.No description of anaphylactic shock was found under the adverse reaction item according to the latest drug instructions of the company.Conclusion:More attention should be paid to the clinical rational use and the serious adverse reactions such as anaphylactic shock.Marketing authorization holders should strengthen the monitoring of post-marketing surveillance of drugs and promptly improve the safety information of drug instructions.

关 键 词：注射用环磷腺苷葡胺 过敏性休克 药品不良反应报告 回顾性分析 

分 类 号：R972.1[医药卫生—药品]