常见严重药品不良.pptVIP

* * （优选）常见严重药品不良 当前第1页\共有41页\编于星期六\5点 什么是严重药品不良反应？What is a Serious Adverse Event? An adverse event is any undesirable experience associated with the use of a medical product in a patient. The event is serious and should be reported when the patient outcome is: Death----死亡 Report if the patients death is suspected as being a direct outcome of the adverse event. Life-Threatening------威胁生命 Report if the patient was at substantial risk of dying at the time of the adverse event or it is suspected that the use or continued use of the product would result in the patients death. Examples: Pacemaker failure; gastrointestinal hemorrhage; bone marrow suppression; infusion pump failure which permits uncontrolled free flow resulting in excessive drug dosing. 当前第2页\共有41页\编于星期六\5点 Hospitalization (initial or prolonged)------需要和延长住院 Report if admission to the hospital or prolongation of a hospital stay results because of the adverse event. Examples：pseudomembranous colitis; or bleeding causing or prolonging hospitalization. Disability-----致残 Report if the adverse event resulted in a significant, persistent, or permanent change, impairment, damage or disruption in the patients body function/structure, physical activities or quality of life. Examples: Cerebrovascular accident due to drug-induced hypercoagulability; toxicity; peripheral neuropathy. Congenital Anomaly-----遗传、致畸性 Report if there are suspicions that exposure to a medical product prior to conception or during pregnancy resulted in an adverse outcome in the child. 当前第3页\共有41页\编于星期六\5点 过敏性休克药品不良反应判定评价标准 定义： 过敏性休克是外界某些抗原性物质进入机体后，主要通过免疫机制在短时间内发生的强烈全身变态反应综合征，由于抗体与抗原结合使机体释放一些生物活性物质如组胺、缓激肽、5-羟色胺和血小板激活因子等，导致全身毛细血管扩张和通透性增加，心排血量急剧下降，血压下降达休克水平。 当前第4页\共有41页\编于星期六\5点 一、发生机制 1、药理性组胺释放机制 ： 组胺存在于MC和BAS的颗粒内，是类过敏反应的主要介质之一，可与机体不同部位的受体结合，产生类过敏反应症状。类过敏反应原进入机体与MC直接接触，引发MC脱颗粒，导致组胺释放。组胺进入细胞外液内，使毛细血管后小静脉扩张、血管通透性增加、平滑肌收缩和粘液腺分泌增多等过敏样症状[3]。其病理作用与其血浓度有关，组胺≤1ng/ml时并不引起症状，1～2ng/ml时仅有皮肤反应，6ng/ml发生全身反应，100ng/ml以上则发生严重反应。