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基于关联分析的穿琥宁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 Chuanhuning Injection Based on Association Analysis
  
DOI:
中文关键词:  穿琥宁注射剂  数据挖掘  药品不良反应  关联规则
英文关键词:Chuanhuning injection  Data mining  Adverse drug reactions  Association rules Apriori algorithm
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 蔺梦娟 张丹 谭迪 张晓朦 张冰 ①北京中医药大学中药学院(北京 100102) 
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中文摘要:
      摘 要 目的:探索穿琥宁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年文献,采集穿琥宁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为数据挖掘平台,应用关联规则Apriori算法开展数据挖掘研究。结果:共纳入穿琥宁注射剂所致不良反应案例183例,其临床表现大致有8类,有过敏性休克58例,血液系统损害46例,皮肤损害35例,呼吸系统损害16例;其中有60例存在联合用药情况; 46例不良反应发生在给药开始后5 min之内。置信度最高的关联规则是在“ADR发生时间段 = 0~5 min and 配液用量 = 250ml and 配液浓度= 5%”的情况下,88.24%的案例“不良反应临床表现=过敏性休克”;支持度最高的关联规则是“年龄段=20~29岁 and 配液浓度= 5%”与“不良反应临床表现 = 过敏性休克”同时出现的案例占纳入ADR案例的12.57%。结论:穿琥宁注射剂不良反应的特点与不良反应发生时间、联合用药情况、配液种类、患者年龄等因素相关,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 Chuanhuning injection adverse reactions.Methods: Analysis the collected detail Chuanhuning injection cases reported from 1979 to 2015, apply Microsoft Access database platform and Clementine 12.0 platform to data mining which include Apriori. Results:Chuanhuning injection adverse reaction 183 cases were included, and the adverse reaction cases were collected into 8 classes, including anaphylactic shock 58 cases, 46 cases of blood system damage, 35 cases of skin lesions, 16 cases of respiratory damage; there were 60 cases combination with other drugs, and 46 cases of adverse reactions occurred in the first five minutes, the highest Confidence association rule was that in the case of “ADR occurrence time=0 5 minutes, dosing volume=250 ml and dosing concentration=5%”, 88.24% of the cases take “Adverse clinical manifestations=anaphylactic shock”; the highest Support association rule was that case “Age=20 29 years old and dosing concentration=5%” and “adverse clinical manifestations=anaphylactic shock” simultaneously occurred take ADR cases accounted for 12.57%. Conclusion:The character of Chuanhuning injection’s ADR might be related to such factors as the ADR occurrence time, patient age, liquor types, combination with other drugs, which still needed a larger sample size analysis of the data validation.
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