| 中西药联用临床安全性评价应引入核心指标集 |
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| 引用本文： | 邱瑞瑾,钟长鸣,关曼柯,胡嘉元,赵晨,陈昭,李敏,韩松洁,何天麦,黄涯,陈静,商洪才. 中西药联用临床安全性评价应引入核心指标集[J]. 中国循证医学杂志, 2020, 0(5): 511-514 |
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| 作者姓名： | 邱瑞瑾 钟长鸣 关曼柯 胡嘉元 赵晨 陈昭 李敏 韩松洁 何天麦 黄涯 陈静 商洪才 |
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| 作者单位： | 北京中医药大学东直门医院中医内科学教育部和北京市重点实验室;中国中医科学院中医临床基础医学研究所;北京中医药大学第三附属医院;天津中医药大学附属保康医院 |
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| 基金项目： | 国家自然科学基金项目(编号:81904051);中央高校基本科研业务费专项(编号:2019-JYB-JS-033)。 |
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| 摘 要： | 保障患者安全是临床研究和实践的关键。目前,中医临床安全性评价存在诸多问题,如中西药联用难以真实反映中药临床安全性、症状性不良事件/反应的报告缺乏可靠性、同类临床研究中安全性指标报告差异大等。在西药临床研究应用不良事件/反应术语集及核心指标集的基础上,应将核心指标集概念引入到中西药联用临床安全性评价中,以提高中药临床安全性评价水平。
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| 关 键 词： | 中西药联用 安全性 临床评价 核心指标集 |
Core outcome set should be introduced to safety evaluation in clinical research of integrated traditional Chinese and western medicine |
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| QIU Ruijin,ZHONG Changming,GUAN Manke,HU Jiayuan,ZHAO Chen,CHEN Zhao,LI Min,HAN Songjie,HE Tianmai,HUANG Ya,CHEN Jing,SHANG Hongcai. Core outcome set should be introduced to safety evaluation in clinical research of integrated traditional Chinese and western medicine[J]. Chinese Journal of Evidence-based Medicine, 2020, 0(5): 511-514 |
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| Authors: | QIU Ruijin ZHONG Changming GUAN Manke HU Jiayuan ZHAO Chen CHEN Zhao LI Min HAN Songjie HE Tianmai HUANG Ya CHEN Jing SHANG Hongcai |
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| Affiliation: | (Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing,Dongzhimen Hospital,Beijing University of Chinese Medicine,Beijing 100700,P.R.China;Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,P.R.China;Beijing University of Chinese Medicine Third Affiliated Hospital,Beijing 100029,P.R.China;Baokang Hospital of Tianjin University of Traditional Chinese Medicine,Tianjin 300193,P.R.China) |
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| Abstract: | Safeguarding patient’s safety is important in clinical research and practice. At present, there are many problems in the clinical safety evaluation of traditional Chinese medicine. For instance, combination of Chinese and western medicines provides difficulty for definite reflection of clinical safety of Chinese medicine, lack of reliability of reporting of symptomatic adverse events/reactions, as well as discrepancy in safety outcomes reporting in similar clinical studies. Based on the application of adverse events/reactions term sets and core outcomes sets in clinical trials of western medicine, it is proposed that the concept of core outcome sets should be introduced to the clinical safety evaluation of integrated Chinese and western medicines in order to improve the clinical safety evaluation. |
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| Keywords: | Integrated traditional Chinese and western medicine Safety Clinical evaluation Core outcome set |
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