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| 北京地区2007～2011年1 416例莫西沙星不良反应/事件分析 |
| Analysis of 1 416 Cases of Moxifloxacin inducing Adverse Drug Reaction/event in Beijing Area from 2007 to 2011 |
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| DOI： |
| 中文关键词: 莫西沙星 药品不良反应 药品不良事件 严重不良反应 药物警戒 |
| 英文关键词:Moxifloxacin Adverse drug reactions Adverse drug events Serious adverse drug reactions Pharmacovigilance |
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| 中文摘要: |
| 摘 要 目的：统计分析北京地区近5年来莫西沙星不良反应/事件报告，为莫西沙星的安全合理应用提供依据。方法：收集整理2007年1月1日～2011年12月3日全国药品不良反应监测网络接收到的北京地区怀疑药品为莫西沙星的不良反应/事件报告，提取患者一般情况、用药情况、不良反应/事件发生情况及转归等信息，按照MedDRA系统将不良反应或不良事件进行系统分类，进行统计分析。结果：莫西沙星的不良反应/事件报告中，患者超说明书用药、超适应证用药较为突出，不良反应主要表现在皮下及皮下组织症状、神经系统症状、胃肠系统症状等。而严重不良反应以免疫系统症状、神经系统症状、肝胆系统症状为主。结论：莫西沙星的安全性是临床应关注的问题，应该在合理使用的基础上，监测并及时处理其不良反应/事件。 |
| 英文摘要: |
| ABSTRACT Objective:To analyze the reports of moxifloxacin inducing adverse drug reaction/ event(ADR/ADE) in Beijing area to provide reference for rational use of moxifloxacin. Methods:Collect reports of ADR/ADE induced by moxifloxacin received by the national drug adverse reaction monitoring center from January 1th in 2007 to December 31th in 2011，classify the adverse reactions according to MedDRA and make analysis of the patients'clinical characteristics and type and outcome of the ADR/ADE. Results:Off label use of moxifloxacin was prominent. The clinical manifestations of ADR/ADE were mostly skin and subcutaneous tissue damages, nervous system disorders and gastrointestinal disorders. And the serious ADR/ADE were mostly immune system disorders, nervous system disorders and hepatobiliary disorders.Conclusion:Safe to use with moxifloxacin is worth paying attention by clinicians, who should detect and deal with ADR/ADE of moxifloxacin in time on baisis of rational use. |
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