1249例氟喹诺酮类口服制剂不良反应/不良事件及说明书对比分析
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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 1 249 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 involved 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 information. 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.
Objective To provide reference for rational drug use in the clinic. Methods A retrospective study was conducted to analyze 1 249 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 involved 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 information. 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.
引文
[1]王晓红.氟喹诺酮类药物临床应用[J].中国实用医药,2008,3(17):86-87.
[2]侯鹏高,吕长淮.氟喹诺酮类药物不良反应的临床分析[J].齐齐哈尔医学院学报,2015,21(1):23-24.
[3]李星如,毕凤兰.浅析氟喹诺酮类药物的安全性现状[J].中国药物警戒,2013,10(1):44-46.
[4]杜洋.氟喹诺酮类药品不良反应的临床表现特点及分布规律[J].中外医学研究,2017,15(14):154-155.
[5]刘芳群. 87例喹诺酮类药品不良反应的相关因素分析[J].中国药物警戒,2009,6(3):165-167.
[6]孙忠实,朱珠.氟喹诺酮类药物与其所致QT间期延长[J].中国药物警戒,2004,1(2):38-39.
[7] LAPI F,WILCHESKY M,KEZOUH A,et al. Fluoroquinolones and the risk of serious arrhythmia:a population-based study[J].Clin Infect Dis,2012,55(11):1457-1465.
[8]袁瑾懿,王明贵.氟喹诺酮类和严重心律失常危险:基于人群的研究[J].中国感染与化疗杂志,2013,13(6):449.
[9]张青霞,侯凯旋.药师对住院患者氟喹诺酮类药物相关严重心律失常的干预研究[J].实用药物与临床,2017,20(1):84-87.
[10] KUO SC,CHEN YT,LEE YT,et al. Association between recent use of fluoroquinolones and rhegmatogenous retinal detachment:a population-based cohort study[J]. Clin Infect Dis,2014,58(2):197-203.
[11]刘琛.氟喹诺酮类药物或可增加视网膜脱落的风险[J].药物不良反应杂志,2012,14(2):87.
[12]刘芳,马香芹,杨丽娜,等.我院常用喹诺酮类药物的心脏不良反应分析[J].中国药房,2017,28(5):625-629.
[2]侯鹏高,吕长淮.氟喹诺酮类药物不良反应的临床分析[J].齐齐哈尔医学院学报,2015,21(1):23-24.
[3]李星如,毕凤兰.浅析氟喹诺酮类药物的安全性现状[J].中国药物警戒,2013,10(1):44-46.
[4]杜洋.氟喹诺酮类药品不良反应的临床表现特点及分布规律[J].中外医学研究,2017,15(14):154-155.
[5]刘芳群. 87例喹诺酮类药品不良反应的相关因素分析[J].中国药物警戒,2009,6(3):165-167.
[6]孙忠实,朱珠.氟喹诺酮类药物与其所致QT间期延长[J].中国药物警戒,2004,1(2):38-39.
[7] LAPI F,WILCHESKY M,KEZOUH A,et al. Fluoroquinolones and the risk of serious arrhythmia:a population-based study[J].Clin Infect Dis,2012,55(11):1457-1465.
[8]袁瑾懿,王明贵.氟喹诺酮类和严重心律失常危险:基于人群的研究[J].中国感染与化疗杂志,2013,13(6):449.
[9]张青霞,侯凯旋.药师对住院患者氟喹诺酮类药物相关严重心律失常的干预研究[J].实用药物与临床,2017,20(1):84-87.
[10] KUO SC,CHEN YT,LEE YT,et al. Association between recent use of fluoroquinolones and rhegmatogenous retinal detachment:a population-based cohort study[J]. Clin Infect Dis,2014,58(2):197-203.
[11]刘琛.氟喹诺酮类药物或可增加视网膜脱落的风险[J].药物不良反应杂志,2012,14(2):87.
[12]刘芳,马香芹,杨丽娜,等.我院常用喹诺酮类药物的心脏不良反应分析[J].中国药房,2017,28(5):625-629.