| 基于大型前瞻性安全性监测的参附注射液不良反应影响因素分析 |
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| 引用本文： | 王志飞,赵维,张寅,谢雁鸣.基于大型前瞻性安全性监测的参附注射液不良反应影响因素分析[J].中国中药杂志,2015,40(24):4746-4751. |
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| 作者姓名： | 王志飞 赵维 张寅 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： | 中央级公益性科研院所基本科研业务费专项(Z0406,PY1303);国家"重大新药创制"科技重大专项(2015ZX09501004-001-009);北京市中医药科技发展资金项目(JJ2015-58) |
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| 摘 要： | 采用前瞻性、多中心、大样本、登记注册式医院集中监测的方法采集不良反应人群的人口学资料、既往史、个人史、家族史、剂量、溶媒、合并用药等信息,采用交叉列联的方法分析其对ADR发生的影响及相互关系。结果发现,19~45岁的用药人群,有过敏史者ADR比例较高;46~65岁的用药人群中,有过敏史的男性ADR比例较高;合并用药人群中,未成年人ADR比例较高;无论是否符合说明书适应证,19~45岁患者,有合并用药、有过敏史者ADR比例较高;非适应证人群中合并用药且超说明书剂量用药者ADR比例较高;非适应证用药人群中有合并用药、高浓度、非说明书溶媒、非常规剂量者ADR比例较高。提示参附注射液ADR的发生主要与患者是否有药物过敏史,以及临床用药时是否按照说明书适应证、溶媒、剂量和浓度使用有关。
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| 关 键 词： | 参附注射液 不良反应 影响因素 医院集中监测 安全性监测 |
| 收稿时间： | 9/5/2015 12:00:00 AM |
Analysis of influencing factors on adverse reaction of Shengfu injection based on prospective active safety monitoring |
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| WANG Zhi-fei,ZHAO Wei,ZHANG Yin and XIE Yan-ming.Analysis of influencing factors on adverse reaction of Shengfu injection based on prospective active safety monitoring[J].China Journal of Chinese Materia Medica,2015,40(24):4746-4751. |
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| Authors: | WANG Zhi-fei ZHAO Wei ZHANG Yin and XIE Yan-ming |
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| Institution: | 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 and Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China |
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| Abstract: | This study collected demographic data, past history, personal history, family history, dosage, solvent, combined medication information of adverse reaction cases from a prospective, multi center, large sample intensive hospital monitoring, and found the influencing factors with cross-tab analysis. The results showed that in the medication group of 19-45, patients with allergic histories had a higher proportion in ADR; in the medication group of 46-65, male patients with allergic histories had a higher proportion in ADR; indication and non-indication group, patients of 19-45 years old, with combined medications and allergy histories had a higher proportion in ADR; Non-indication medication group, patients with combined medication, higher concentration, out-instruction solvent and dosage, had a higher proportion in ADR. So, the ADRs of Shenfu injection were related to the history of drug allergy, and also related to the indication, dosage, solvent, concentration when it was used. |
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| Keywords: | Shenfu injection adverse reaction influencing factors intensive hospital monitoring safety monitoring |
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