中药注射剂不良反应的影响因素与发生机制分析

不良反应是中药注射剂安全性研究的重点,目前文献研究中不良反应的影响因素尚未明确,发生机制研究相对较少,合格药品和正常用法用量是不良反应判断的前提条件。患者年龄、性别、基础疾病、过敏体质或药物过敏史是常见的影响因素,而溶媒种类、药物浓度、药液配制后的存放时间、给药速度、与临床常用药品的配伍禁忌是不良反应主要研究的影响因素。不良反应的发生机制需结合临床前研究、临床表现、药物流行病学试验结果来判断。为正确判断与研究不良反应,提出应明确中药注射剂不良事件/反应影响因素,完善中药注射剂药品说明书,重视中药注射剂不良反应发生机制,推进中药注射剂上市后安全性再评价。

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

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.