摘要
目的为临床合理用药提供参考。方法采用回顾性研究方法,对2011年1月1日至2017年12月31日河南省药品不良反应监测中心数据库中收集到的1 249例氟喹诺酮类口服制剂药品不良反应(ADR)/药品不良事件(ADE)报告进行统计和分析。结果 ADR/ADE涉及患者以19～64岁居多(87. 51%);多在用药后1 d内发生(65. 41%);主要累及胃肠道系统(54. 40%)、皮肤及其附件(22. 49%)、中枢及外周神经系统(11. 44%);主要表现为恶心、呕吐、皮疹、瘙痒、头晕等,并出现18例次心悸(1. 01%)和7例次视觉损害(0. 39%),但国产药品说明书中均无相关风险提示;国产药品说明书描述基本一致,但安全性信息特别是ADR项描述过于简单。结论临床应加强对氟喹诺酮类口服制剂心脏毒性和视觉异常的风险监测,避免严重ADR发生;药品生产企业应加强对本企业产品的安全性监测,根据监测结果及时修订产品说明书,特别是相关安全性信息;药品监管部门应加强药品说明书的管理,尽快规范和完善,以满足临床安全用药需求。
Objective To provide reference for rational drug use in the clinic.Methods A retrospective study was conducted to analyze 1249 reports of adverse drug reactions(ADR)/adverse drug events(ADE)induced by oral preparations of fluoroquinolone collected from the database of Center for ADR Monitoring of Henan from January 1,2011 to December 31,2017.Results Most of the patients with ADR/ADE were 19-64 years old(87.51%).Most of them occurred within 1 d after medication(65.41%).The ADR/ADE mainly in-volved gastrointestinal system(54.40%),skin and its attachment(22.49%),central and peripheral nervous system(11.44%).The main manifestations of ADR/ADE were nausea,vomiting,rash,itching,dizziness and so on,there were 18 cases of palpitations(1.01%)and 7 cases of visual impairments(0.39%).However,there was no risk indication in the instructions of the domestic drugs.The instructions of the domestic drugs were basically the same,but the safety information was too simple,especially the description of ADR items.Conclusion Clinic should strengthen the risk monitoring of cardiotoxicity and visual abnormality induced by oral preparations of fluoroquinolone to avoid the occurrence of severe ADR.Pharmaceutical manufacturing enterprises should strengthen the safety monitoring of their products and timely revise the product instructions according to the monitoring results,especially the safety-relevant informa-tion.Drug regulatory authorities should strengthen the management of instructions,standardize and improve them as soon as possible to meet the needs of clinical safe medication.
作者
龚立雄
王丽
王新茹
周晓杰
马雪皎
GONG Lixiong;WANG Li;WANG Xinru;ZHOU Xiaojie;MA Xuejiao(Center for Food and Drug Reevaluation of Henan,Zhengzhou,Henan,China 450018)
出处
《中国药业》
CAS
2019年第8期88-90,共3页
China Pharmaceuticals
关键词
氟喹诺酮
口服制剂
药品不良反应
药品不良事件
合理用药
fluoroquinolones
oral preparations
adverse drug reaction
adverse event reaction
rational drug use
