| 药品不良反应个案报道的规范性报告 |
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| 引用本文： | 费宇彤,杨红,刘兆兰,张惠敏,刘建平. 药品不良反应个案报道的规范性报告[J]. 中国药物警戒, 2010, 7(4): 206-208 |
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| 作者姓名： | 费宇彤 杨红 刘兆兰 张惠敏 刘建平 |
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| 作者单位： | 1. 北京中医药大学循证医学中心,北京,100029
2. 北京中医药大学管理学院 |
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| 基金项目： | 国家重点基础研究发展计划(973计划)课题"循证医学在中医辩证论治疗效评价中应用的方法学研究"，科技部国际合作项目 |
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| 摘 要： | 个案报道是临床研究报告的一种重要形式,其在报告罕见或严重不良反应事件方面具有明显优越性。本文从个案报道的概念、分类及报告规范等方面分别进行了阐述;依据不良反应个案报告的方法学特点,参考国际个案报道的撰写规范,提出并制定了不良反应个案研究建议报告条目,以供医疗领域的临床工作者及研究者参考使用。
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| 关 键 词： | 个案报道 循证医学 不良反应 报告规范 |
Normative Reporting on Adverse Drug Reaction in Case Report |
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| FEI Yu-tong,YANG Hong,LIU Zhao-lan,ZHANG Hui-min,LIU Jian-ping. Normative Reporting on Adverse Drug Reaction in Case Report[J]. Chinese JOurnal of Pharmacovigilance, 2010, 7(4): 206-208 |
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| Authors: | FEI Yu-tong YANG Hong LIU Zhao-lan ZHANG Hui-min LIU Jian-ping |
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| Affiliation: | 1Center for Evidence-Based Chinese Medicine,Beijing University of Chinese Medicine,Beijing 100029,China;2School of Management,Beijing University of Chinese Medicine,Beijing 100029,China) |
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| Abstract: | Case report is an important model of clinical study reports,taking obvious advantages on unusual or serious adverse drug reaction reports.This paper introduces case report from the concept,classification and criterion of case reporting.Based on methodological characteristics of adverse drug reaction case reports and reference of the standard of international case reports,we also develop and propose suggested items of case reports as a reference for clinical workers and researchers in medical field. |
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| Keywords: | case report evidence-based adverse drug reaction reporting criterion |
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