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药品不良反应伤害分级的初步研究
引用本文:盛红彬,黄登笑,陆逸雁,蒋国华,黄淇敏. 药品不良反应伤害分级的初步研究[J]. 上海交通大学学报(医学版), 2009, 29(12): 1515
作者姓名:盛红彬  黄登笑  陆逸雁  蒋国华  黄淇敏
作者单位:1. 上海交通大学,医学院第三人民医院药剂科,上海,201900
2. 上海市食品药品监督管理局宝山分局,上海,200439
基金项目:上海市宝山区科委基金,上海市教育委员会基金,上海交通大学医学院基金
摘    要:目的 设计药品不良反应(ADR)伤害的量化分级标准和分级方法,为构建ADR补偿体系提供参考依据。方法 在借鉴我国其他伤害事故分级的基础上,选取上海市范围内的27位医药卫生专家,通过两轮专家咨询,对不同器官和不同层级的ADR伤害进行独立评分和序化分级。结果 ADR伤害由重到轻初步分为1~10级,1级为死亡,10级为最轻微伤害。结论 以ADR伤害的特点为基础的量化分级方法基本符合我国现有国情,可以作为ADR补偿救济制度鉴定标准的参考。

关 键 词:药品不良反应  伤害  分级

Preliminary study on grading of injury from adverse drug reaction
SHENG Hong-bin,HUANG Deng-xiao,LU Yi-yan,JIANG Guo-hua,HUANG Qi-min. Preliminary study on grading of injury from adverse drug reaction[J]. Journal of Shanghai Jiaotong University:Medical Science, 2009, 29(12): 1515
Authors:SHENG Hong-bin  HUANG Deng-xiao  LU Yi-yan  JIANG Guo-hua  HUANG Qi-min
Affiliation:1. Department of Pharmacy, The Third People's Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai 201900, China;2. Baoshan Branch of Shanghai Food and Drug Administration, Shanghai 200439, China
Abstract:Objective To design a quantitative criterion and grading system for injury from adverse drug reaction (ADR) in order to serve the compensation system of injury from ADR. Methods Based on the other grading system of injury cases, the independent scores and serial grades were given to the ADR injury of different organs or different levels through two turns of consultation to 27 experts from Shanghai. Results Injury from ADR was graded from stage 1 to stage 10 according to the damage degree, with 1 stand for death and 10 for slightest injury. Conclusion The grading method of ADR based on the characteristics of injury accords with the condition of China, and can provide reference for making up the compensation system of ADR injury.
Keywords:adverse drug reaction  injury  grade
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