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[中药注射剂不良反应的影响因素及机制分析]

[Influencing factor and mechanism analysis of adverse drug reaction in traditional Chinese medicine injection].

作者信息

Wei Xu, Xie Yan-Ming

机构信息

Institute of Basic Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China.

出版信息

Zhongguo Zhong Yao Za Zhi. 2012 Sep;37(18):2748-51.

Abstract

Adverse drug reaction (ADR) is the key contents in traditional Chinese medicine (TCM) injection safety research. However, influencing factors of ADR is not clearly, mechanism research is relatively rare, which are to be found in the literature to date. Qualified drugs and normal usage and dosage are the premise condition of ADR judgment. Age, sex, basic diseases, allergic constitution or drug allergy history are common factors. Kinds of solvent, drug concentration, storage time after liquid drug preparation, dripping speed, incompatibility of TCM injection and clinical commonly used medicine are the major ADR research factors. Adverse events mechanism should be synthetically judged by pre-clinical research, clinical manifestation, drug epidemiological trials results. In order to judge and study ADR correctly, It should be acquainted with TCM injection adverse events or ADR influencing factors,improve injection specification, and pay attention to the ADR mechanism, promote post-marketed reevaluation of safety in TCM injection.

摘要

药品不良反应(ADR)是中药注射剂安全性研究的关键内容。然而,ADR的影响因素尚不明确,机制研究相对较少,迄今为止在文献中有待发现。合格的药品以及正常的用法用量是ADR判断的前提条件。年龄、性别、基础疾病、过敏体质或药物过敏史是常见因素。溶剂种类、药物浓度、液体药物配制后的储存时间、滴注速度、中药注射剂与临床常用药物的配伍禁忌是ADR研究的主要因素。不良事件机制应通过临床前研究、临床表现、药物流行病学试验结果进行综合判断。为了正确判断和研究ADR,应熟悉中药注射剂不良事件或ADR影响因素,完善注射规范,并关注ADR机制,推进中药注射剂上市后安全性再评价。

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