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基于数据挖掘的清热类中药注射剂不良反应流行病学特点研究
Study on the Epidemiological Characteristics of Adverse Reaction Caused by Heat clearing Injection Based on Data Mining
  
DOI:
中文关键词:  清热类中药注射剂  数据挖掘  药品不良反应  流行病学特点
英文关键词:Heat clearing injection  Data mining  Adverse drug reactions  Epidemiological characteristics
基金项目:国家自然科学基金项目(编号:81473547、81673829)
作者单位
崔盈盈 吴嘉瑞 张丹 谭迪 张晓朦 张冰 ①北京中医药大学中药学院临床中药系(北京 100102) 
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中文摘要:
      摘 要 目的:探索清热类中药注射剂不良反应发生的流行病学特点。方法:通过系统检索1979~2015年期刊文献,采集清热类中药注射剂不良反应详细个案报告,在此基础上应用Microsoft ACCESS构建数据库,进而以Clementine 12.0数据挖掘平台,综合应用贝叶斯网络、神经网络、关联规则Apriori算法和决策树(CART)算法开展数据挖掘研究。结果:共检索符合纳入条件的清热类中药注射剂不良反应详细个案1 315例,其中321例不良反应发生在用药开始5min内,有993例不良反应发生在用药开始30min内。不良反应涉及人体多个系统,皮肤损害占29.27%,过敏性休克占27.30%,呼吸系统损害占16.42%,神经系统损害占9.80%,消化系统损害占8.59%,循环系统损害占3.57%,眼部损害占3.42%等。数据挖掘结果显示不同的注射剂不良反应临床表现相似,不良反应临床表现也与原发疾病类、过敏史、配液用量有关。结论:清热类中药注射剂不良反应发生是在临床用药因素、患者体质因素和药品自身因素共同作用下的复杂表现,其发生规律尚需更大样本量的数据分析验证。
英文摘要:
      ABSTRACT Objective:To explore the epidemiological characteristics of Heat clearing injection adverse reactions.Methods:Analysis the collected detail Heat clearing injection case reported from 1979 to 2015, apply Microsoft ACCESS database platform and Clementine 12.0 to study. Integrating application of bayesian network, neural network and association rules Apriori algorithm and decision tree (CART) algorithm in data mining research. Results:1 315 cases of traditional Chinese medicine injection adverse reaction met the conditions and were retrieved. Among them, 321 cases of adverse reactions occurred in 5 minutes after medication, there were 993 cases of adverse drug reactions happened in 30 minutes after medication. Adverse reactions to multiple systems involved in the human body, skin lesions (29.27%), anaphylactic shock (27.30%), respiratory damage (16.42%), nervous system damage (9.80%), digestive system damage (8.59%), circulatory system damage accounted for 3.57%, eye damage (3.42%), etc. Data mining results showed that adverse clinical manifestation is similar, which may relate to the primary disease, allergy, liquor consumption.Conclusion: Occurrence of Heat clearing injection’s ADR might be related to such factors as clinical drug factors, patients’ physical factors and drug themselves which complex under the action of performance still needed a larger sample size analysis of the data validation.
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