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中成药的不良反应分析及风险管理探讨 被引量:10

Adverse Reaction of Chinese Traditional Patent Medicine and Its Risk Early Warning Management
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摘要 目的通过介绍中成药不良反应的临床表现及其产生的原因,提高中成药临床应用的合理性与安全性。方法利用文献分析、专家访谈、描述性研究等方法,结合国家药品不良反应监测中心有关中成药不良反应事件情况进行统计和归纳分析。结果中成药在临床使用中存在很大误区,加之内在因素、外界环境及人为因素等多方面的影响,使中成药的不良反应逐年增多。其临床表现主要为变态反应,神经、血液、消化和泌尿等系统均受到损害。结论当前要加大对中成药不良反应知识的宣传力度,强化中成药组方、工艺流程等监管,鼓励企业深入对中成药的毒理、药理及有效成分等方面的安全性研究,减少中成药的不良反应,提高中成药的风险管理水平。 OBJECTIVE Clinical performance and the cause of adverse reactions were elucidated about Chinese traditionai patent medicine, which improved rationality and safety in clinical use. METHODS Some methods were applied, such as literatures' analysis method, experts'consults method, descriptive study method, and so on. Coupled with the Chinese patent medicines adverse events condition of the state drug adverse reaction monitoring centre, adverse events of Chinese traditional patent medicine were carried out statistical analysis and summary. RESULTS Chinese traditional patent medicines were misused in clinic. In addition, various factor affected on adverse events of Chinese traditional patent medicine, such as internal factors, the external environment and man-made factors etc., which made Chinese traditional patent medicine adverse increasing year by year. Clinical situation were allergy and nervous system, hematological system or urinary system were damaged. CONCLUSIONS In current, propaganda should be expanded about Chinese patent medicines adverse reaction information. It was important that medical personnel should supervise the composition of Chinese traditional patent medicine and technology process. Enterprises should be encouraged to investigate Chinese patent medicines' toxicology, pharmacology and active component etc., in order to reduce its adverse reaction and raise its risk management level.
出处 《中国初级卫生保健》 2008年第5期72-75,共4页 Chinese Primary Health Care
基金 湖北省重大科技成果(EK060566)
关键词 中成药 不良事件 风险管理 对策 adverse reaction of traditional Chinese medicine, risk event, warning management, countermeasure
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