| 构建注射用丹参多酚酸盐再评价证据体的研究 |
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| 引用本文： | 廖星,徐向阳,谢雁鸣,常艳鹏. 构建注射用丹参多酚酸盐再评价证据体的研究[J]. 中国中药杂志, 2014, 39(18): 3645-3649 |
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| 作者姓名： | 廖星 徐向阳 谢雁鸣 常艳鹏 |
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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 博士后流动站, 北京 100700;上海绿谷制药有限公司, 上海 201203;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（2009ZX09502-030）；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： | 该文围绕着中药注射剂创新药"注射用丹参多酚酸盐"上市后的再评价进行了系统的证据综合:药品质量控制;上市后药理学文献评价研究、临床疗效文献评价研究、临床安全性报道文献评价;非临床安全性如毒性实验研究、群体药代动力学再评价;有效性和安全性的多中心Ⅳ期临床试验;来自20家医院共14191例医院HIS数据的分析;739份ADR病例来自国家SRS系统中的报告分析;目前正在开展的上市后临床安全性监测注册登记研究等7个方面进行了全面阐述,使得"注射用丹参多酚酸盐"从研发到上市后的临床有效性和安全性研究拥有一套较为完整的证据链,能为该药规范性地开展再评价工作提供有利依据和信息。
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| 关 键 词： | 注射用丹参多酚酸盐 再评价报告 安全性 有效性 证据体 |
| 收稿时间： | 2014-07-04 |
Systematic report on re-evaluating parenterally administered salvianolate |
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| LIAO Xing,XU Xiang-yang,XIE Yan-ming and CHANG Yan-peng. Systematic report on re-evaluating parenterally administered salvianolate[J]. China Journal of Chinese Materia Medica, 2014, 39(18): 3645-3649 |
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| Authors: | LIAO Xing XU Xiang-yang XIE Yan-ming CHANG Yan-peng |
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| Affiliation: | Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China;Postdoctoral Research Station of China Academy of Chinese Medical Sciences, Beijing 100700, China;Shanhai Lvgu Pharmaceuticals Co., Ltd., Shanghai 201203, 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: | There are few articles or reports collecting evidence about parenterally administered salvianolate from premarketing and postmarketing research or studies systematically. This article is an exact miniature of a systematical report about parenterally administered salvianolate. We analyzed information from four aspects, such as quality control reports, non-clinical premarketing safety experiments, postmarketing research (efficacy studies, hospital information system data and national spontaneous reporting system data) and literature analysis. All the four aspects build an evidence body for Kudiezi Solution in order to inform its safety use in clinical practice and further study. |
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| Keywords: | parenterally administered salvianolate re-evaluation safety effectiveness evidence |
| 本文献已被 CNKI 等数据库收录！ |
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