文档介绍：?? qoirvnoqihwcoinhfvwobufhonichvfkhfchnfvui qoirvnoqihwcoinhfvwobufhonichvfkhfchnfvui ghwuhgnvuwighbcfwuiobrvguowienhfqoiwchfmweoihqmwicrhyiowbr ghwuhgnvuwighbcfwuiobrvguowienhfqoiwchfmweoihqmwicrhyiowbr q q药品不良反应监测基本概念与基础知识药品不良反应监测基本概念与基础知识吴桂芝吴桂芝成都成都 国家药品不良反应监测中心国家药品不良反应监测中心?? qoirvnoqihwcoinhfvwobufhonichvfkhfchnfvui qoirvnoqihwcoinhfvwobufhonichvfkhfchnfvui ghwuhgnvuwighbcfwuiobrvguowienhfqoiwchfmweoihqmwicrhyiowbr ghwuhgnvuwighbcfwuiobrvguowienhfqoiwchfmweoihqmwicrhyiowbr q q??指合格药品在正常用法用量下出现的与用药指合格药品在正常用法用量下出现的与用药目的无关的或意外的有害反应。目的无关的或意外的有害反应。??排除了治疗失败、药物过量、药物滥用、不排除了治疗失败、药物过量、药物滥用、不依从用药和用药差错的情况依从用药和用药差错的情况药品不良反应 Adverse (Drug) Reaction, ADR 药品不良反应 Adverse (Drug) Reaction, ADR ?? qoirvnoqihwcoinhfvwobufhonichvfkhfchnfvui qoirvnoqihwcoinhfvwobufhonichvfkhfchnfvui ghwuhgnvuwighbcfwuiobrvguowienhfqoiwchfmweoihqmwicrhyiowbr ghwuhgnvuwighbcfwuiobrvguowienhfqoiwchfmweoihqmwicrhyiowbr q q药品不良反应 Adverse (Drug) Reaction, ADR 药品不良反应 Adverse (Drug) Reaction, ADR ? A response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological functions. —— WHO Technical Report No. 498 (1972) ?? qoirvnoqihwcoinhfvwobufhonichvfkhfchnfvui qoirvnoqihwcoinhfvwobufhonichvfkhfchnfvui ghwuhgnvuwighbcfwuiobrvguowienhfqoiwchfmweoihqmwicrhyiowbr ghwuhgnvuwighbcfwuiobrvguowienhfqoiwchfmweoihqmwicrhyiowbr q q副作用(Side Effect) 副作用(Side Effect) ?是指药品按正常用法用量使用时所出现的与药品的药理学活性相关,但与用药目的无关的作用。? Any unintended effect of a pharmaceutical product occurring at normal dosage which is related to the pharmacological properties of the drug. ?? qoirvnoqihwcoinhfvwobufhonichvfkhfchnfvui qoirvnoqihwcoinhfvwobufhonichvfkhfchnfvui ghwuhgnvuwighbcfwuiobrvguowienhfqoiwchfmweoihqmwicrhyiowbr ghwuhgnvuwighbcfwuiobrvguowienhfqoiwchfmweoihqmwicrhyiowbr q q非预期不良反应 Unexpected Adverse Reaction 非预期不良反应非预期不良反应 Unexpected Adverse Reaction Unexpected Adverse Reaction ?不良反应的性质和严重程度与国内药品