| 参芪扶正注射液上市后安全性再评价研究 |
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| 引用本文： | 艾青华,黎元元,谢雁鸣. 参芪扶正注射液上市后安全性再评价研究[J]. 中国中药杂志, 2014, 39(18): 3633-3636 |
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| 作者姓名： | 艾青华 黎元元 谢雁鸣 |
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| 作者单位： | 中国中医科学院 中医临床基础医学研究所, 北京 100700;中国中医科学院 中医临床基础医学研究所, 北京 100700;中国中医科学院 中医临床基础医学研究所, 北京 100700 |
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| 基金项目： | 国家自然科学基金项目（81202776）;国家“重大新药创制”科技重大专项（2015ZX09501004-001-002）;中国中医科学院客座研究员联合创新研究项目（ZZ070817） |
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| 摘 要： | 为促进参芪扶正注射液(以下简称参芪扶正)的临床安全用药,该文对参芪扶正的上市后安全性研究进行了系统梳理。其中包括多中心、大样本、注册登记式的安全性监测研究、基于国家自发呈报系统(spontaneous reporting system,SRS)数据分析、基于全国20家三甲医院的医院信息系统(hospital information system,HIS)数据分析和国内外文献研究。该研究认为参芪扶正具有较好的安全性,其不良反应多为过敏反应,主要累及皮肤及其附件损害、全身性损害,严重者可出现过敏性休克。不良反应/事件(adverse drug reaction/event,ADR/E)多发于中老年人,可能与用药(肿瘤)人群有关。基于SRS数据的预警分析与文献研究均认为"静脉炎"的发生与参芪扶正用药有较强关联。
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| 关 键 词： | 参芪扶正注射液 上市后再评价 安全性研究 |
| 收稿时间： | 2014-07-18 |
Study of post marketing safety reevaluation of Shenqi Fuzheng injection |
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| AI Qing-hu,LI Yuan-yuan and XIE Yan-ming. Study of post marketing safety reevaluation of Shenqi Fuzheng injection[J]. China Journal of Chinese Materia Medica, 2014, 39(18): 3633-3636 |
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| Authors: | AI Qing-hu LI Yuan-yuan XIE Yan-ming |
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| Affiliation: | Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China;Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China;Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China |
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| Abstract: | In order to promote the Shenqifuzheng injection (SQFZ) clinical medication safety, this study reevaluate on SQFZ post marketing safety study systematically. Including multi center large sample registration type safety monitoring research, the analysis based on national spontaneous reporting system data, the analysis based on the 20 national hospital information system data and literature research. Above the analysis, it suggests that SQFZ has good security. The more adverse drug reaction(ADR) as allergic reactions, mainly involved in the damage of skin, appendages and its systemic damage, serious person can appear allergic shock. ADR/E is more common in the elderly, may be related to medication (tumor) populations. Early warning analysis based on SRS data and literature research are of the view that "phlebitis" has a strong association with SQFZ used. |
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| Keywords: | Shenqi Fuzheng injection post marketing reevaluation safety research |
| 本文献已被 CNKI 等数据库收录！ |
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