| 灯盏细辛注射液疑似类过敏反应病例相关影响因素分析——巢式病例对照研究 |
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| 引用本文： | 杨薇,程豪,谢雁鸣,杨虎,庄严.灯盏细辛注射液疑似类过敏反应病例相关影响因素分析——巢式病例对照研究[J].中国中药杂志,2013,38(18):3024-3027. |
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| 作者姓名： | 杨薇 程豪 谢雁鸣 杨虎 庄严 |
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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;中国人民大学 统计学院, 北京 100872;中国中医科学院 中医临床基础医学研究所, 北京 100700;中国人民大学 统计学院, 北京 100872;中国人民解放军 海军总医院, 北京 100048 |
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| 基金项目： | 国家"重大新药创制"科技重大专项(2009ZX09502-030);国家自然科学基金青年基金项目(81202776);中国中医科学院客座联合创新研究项目(ZZ070817) |
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| 摘 要： | 灯盏细辛注射液临床不良反应主要为过敏反应,该研究基于全国20家三甲医院信息系统(hospital information system,HIS)数据库,采用巢式病例对照设计,将使用灯盏细辛注射液后使用地塞米松注射液的患者判断为 发生可疑类过敏反应者,与可能未发生过敏反应人群进行对比,应用单因素及多因素Logistic回归的方法,探讨入院病情、过敏史、单次用药剂量、疾病及合并用药与可疑类过敏反应发生的相关性。通过分析发现,入院病情对可疑类过敏反应有极显著影响,P为0.008 3, OR为5.642,在使用灯盏细辛注射液同时使用维生素B6注射液、注射用氨溴索时也可能发生可疑类过敏反应,P分别为0.000 2,0.016 7,OR分别为9.545,3.194。基于现有HIS数据及研究方法发现,患者入院病情、使用维生素B6注射液或注射用氨溴索可能为使用灯盏细辛注射液发生类过敏反应的危险因素,但仍需进一步研究加以验证。该研究结果可以为灯盏细辛注射液临床安全使用提供一定指导,也可为灯盏细辛注射液上市后临床安全性评价研究提供新方法。
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| 关 键 词： | 灯盏细辛注射液 HIS 巢式病例对照 Logistic回归分析 可疑类过敏反应 真实世界研究 |
| 收稿时间： | 2013/5/22 0:00:00 |
Nested case control study to analyze suspected cases and their related factors of allargic reactions to parenterally administered Dengzhan Xixin |
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| YANG Wei,CHENG Hao,XIE Yan-ming,YANG Hu and ZHUANG Yan.Nested case control study to analyze suspected cases and their related factors of allargic reactions to parenterally administered Dengzhan Xixin[J].China Journal of Chinese Materia Medica,2013,38(18):3024-3027. |
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| Authors: | YANG Wei CHENG Hao XIE Yan-ming YANG Hu and ZHUANG Yan |
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| Affiliation: | Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China;School of Statistics, Renmin University of China, Beijing 100872, China;Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China;School of Statistics, Renmin University of China, Beijing 100872, China;Navy General Hospital, Beijing 100048, China |
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| Abstract: | To assess if adverse drug reactions (ADR)s to parenterally administered Dengzhan Xixin are allergic in origin. Hospital information system (HIS) data from 20 hospitals in China were used to carry out a nested case control design study. Included were patients who received dexamethasone for suspected allergic reactions after receiving parenterally administered Dengzhan Xixin. These were compared with non-allergic reaction people. Single factor logistic regression and multiple factor logistic regression were used to analyze data. Condition on admission,allergic history,dosage, disease status and drug combinations were taken into account in cases of suspected allergic reactions. After analysis we found that the condition on admission had a significant effect, P=0.008 3, OR value=5.642 on suspected cases of allergic reactions. Using vitamin B6 injection or ambroxol at the same time as parenterally administered Dengzhan Xixin were significant, P=0.000 2 and 0.016 7, OR value=9.545 and 3.194, risk factors in this group. Based on this current research, condition on admission as well as the concomitant use of vitamin B6 or ambroxol may be the risk factors in suspected cases of allergic reactions. However, further research for verification is required. This study can provide guidance for safe clinical practice in using parenterally administered. It can also provide a new method for the pharmcovigilance of parenterally administered Dengzhan Xixin. |
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| Keywords: | parenterally administered Dengzhan Xixin hospital information system nested case control Logistic regression analysis suspected cases of allergic reactions real world study |
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