上海交通大学学报（医学版）

›› 2010, Vol. 30 ›› Issue (8): 951-.doi: 10.3969/j.issn.1674-8115.2010.08.020

• 论著（卫生事业管理） • 上一篇    下一篇

药品不良反应因果关系判定研究

林建莹1, 黄登笑2, 盛红彬1, 陆逸雁3, 黄淇敏1   

  1. 1.上海交通大学 |医学院第三人民医院卫生管理教研室, 上海 201900；2.上海交通大学 医学院第三人民医院医务部, 上海 201900；3.上海市食品药品监督管理局宝山分局, 上海 200439
  • 出版日期:2010-08-25 发布日期:2010-08-27
  • 通讯作者: 黄淇敏, 电子信箱: qiminh@126.com。
  • 作者简介:林建莹（1966—）, 女, 硕士；电子信箱: jane_linsh99@yahoo.com。
  • 基金资助:

    上海市宝山区科委基金（08-E-2）和上海市教委基金（09YS109）

Study on causality assessment of adverse drug reactions

LIN Jian-ying1, HUANG Deng-xiao2, SHENG Hong-bin1, LU Yi-yan3, HUANG Qi-min1   

  1. 1.Department of Health Management, 2.Department of Medical Administration, The Third People's Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai 201900, China；3.Baoshan Branch of Shanghai Food and Drug Administration, Shanghai 200439, China
  • Online:2010-08-25 Published:2010-08-27
  • Supported by:

    Science and Technology Committee Foundation of Baoshan District, Shanghai, 08-E-2；Shanghai Education Committee Foundation, 09YS109

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摘要：

目的 构建一种新的药品不良反应（ADR）因果关系判定的量化标准。方法 通过文献检索和专家咨询，得到准则层指标14项，每项又根据实际情况分为不同的判断情况，构成子准则层，形成问卷。对65名上海市食品药品监督管理局、各级医疗相关单位专业ADR损害判断人员进行相关调查，由他们根据自己的理论与经验填写。通过层次分析法和综合指数法构建一个指数型的ADR因果判断的量化标准。随机抽取某公司10例已上报国家ADR监测中心的资料进行实证。结果 通过计算，判断出准则层、子准则层指标权重系数，然后再计算出ADR因果关系判定值范围，获得五级ADR因果判断标准。经过10例实证，2例被判断为不可能，8例被判断为怀疑，与实际情况相吻合。结论 提出的五级ADR因果判断标准可以作为ADR补偿救济制度因果关系判定的参考。

关键词: 药品不良反应, 因果关系, 判定

Abstract:

Objective To explore a quantitative method of causality assessment of adverse drug reactions (ADR). Methods By means of literature review and expert consulatation, 14 indexes of criteria level in ADR causality assessment were obtained, sub-criteria level was established for each parameter accordingly, and a questionnaire was designed. Sixty-five professionals in ADR assessment from Shanghai Food and Drug Administration and medical institutions of all levels in Shanghai were surveyed and asked to complete the questionnaires based on their knowledge and experience. Analytic hierarchy process and synthetic index method were employed to establish the quantization standard of ADR causality assessment. Ten cases of ADR reporting to national ADR monitoring center from a given company were randomly selected for demonstration. Results Index weights at criterion level and sub-criterion level were drawn after calculation, and a five-grade quantitative criterion of ADR causality assessment was proposed. The results of demonstration with 10 cases were consistent with the available findings. Conclusion The proposed fivegrade quantitative method of ADR causality assessment can serve as referrences for ADR compensation mechanism.

Key words: adverse drug reaction, causality, assessment