摘要
目的:全面了解我省培氟沙星不良反应发生情况,为临床合理用药提供参考。方法:检索2003年1月-2010年4月泛珠三角不良反应监测网络平台湖南省数据库收集的培氟沙星不良反应资料,从患者性别和年龄分布、报告来源、剂型分布、ADR累及器官或系统及临床表现、ADR严重程度及转归等方面进行分析。结果:培氟沙星不良反应累及器官或系统,以说明书明确的胃肠系统损害、中枢神经系统反应、过敏反应居多,也有说明书未注明的呼吸系统损害、心率及心律紊乱等,说明书注明为偶见的不良反应神经紊乱占4.06%;静脉注射出现不良反应几率最大;女性患者所占比例略高于男性。结论:不良反应监测数据为培氟沙星上市后安全性评价积累了第一手临床资料,可为临床合理使用和安全监管提供参考。
Objective：To comprehensively understand the adverse drug reactions（ADRs） of pefloxacin in Hunan province,and provide references for clinical rational medication.Methods：The data of ADRs caused by pefloxacin were collected in Hunan province between January 2003 and April 2010 from the ADR network platform of Pan-Pearl River Delta,and analyzed statistically in respect of the distribution of age and gender,source of reports,dosage form,organs and systems involved and clinical manifestation,the degree of ADRs,consequence and prognosis.Results：The main adverse reactions of pefloxacin involved multiple organ systems,such as gastrointestinal system damage,aberrant central nervous system responses,allergic reactions which were clearly pointed out in the instruction of pefloxacin;while the respiratory system damage,heart rate and rhythm disorders which were not pointed out in the instruction were also reported.The neurological disorder which was rare in the instruction accounted for 4.06% of the total reports.The adverse reactions caused by intravenous administration were the most common;the proportion of female was higher than that of male.Conclusion：It accumulated the first-hand clinical information for post-marketing safety evaluation on pefloxacin,which could be used for providing references for clinical rational medication and safety control.
出处
《中国药物应用与监测》
CAS
2010年第6期357-360,共4页
Chinese Journal of Drug Application and Monitoring
关键词
培氟沙星
药品不良反应
监测
Pefloxacin
Adverse drug reaction
Monitoring
