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目的使药学工作者提高对药物警戒及药物不良反应监测重要性的认识。方法对药物警戒与药物不良反应定义及内涵进行比较,辨析二者的联系与区别。结果药物警戒不同于药物不良反应监测,药物不良反应是药物警戒的基础工作,但不是药物警戒的全部,药物警戒包含着上市后药品的再评价和药品不良反应的预警。药物在临床前的研制阶段及在临床实验阶段都应纳入药物警戒的范畴,即药物警戒涵括了药物从研发到上市使用的整个过程,而药物不良反应监测仅指药品上市后的监测。结论药物警戒与药物不良反应监测工作应紧密结合,药物警戒工作是药物不良反应监测的发展趋势,应予以重视。
Purpose To enable pharmacologists to raise awareness of the importance of drug alerting and adverse drug reaction monitoring. Methods The definition and connotation of drug alert and adverse drug reaction were compared, and the connection and difference between the two were analyzed. Results Pharmacological alert is different from ADR monitoring. Adverse drug reaction is the basic work of drug alert, but not the whole of drug alert. Pharmacovigilance includes the pre-warning of post-market drug re-evaluation and adverse drug reaction. Drugs in the preclinical development phase and in the clinical trial phase should be included in the scope of drug alert, that is, drug alert covers the entire process of drug development from the market to use, and adverse drug reaction monitoring refers to the drug after the market monitoring. Conclusion The pharmacovigilance and adverse drug reaction monitoring should be closely integrated. The pharmacovigilance is the development trend of the adverse drug reaction monitoring, which should be paid attention to.