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| 基于关联规则的双黄连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 Shuanghuanglian Injection Based on Association Analysis |
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| DOI： |
| 中文关键词: 双黄连注射剂 数据挖掘 药品不良反应 关联规则 |
| 英文关键词:Shuanghuanglian injection Adverse drug reactions Data mining Apriori algorithm |
| 基金项目:国家自然科学基金项目(编号:81473547、81673829) |
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| 中文摘要: |
| 摘 要 目的：探索双黄连注射剂不良反应（ADR）发生的流行病学特点。 方法：通过系统检索1979~2015年文献，采集双黄连注射剂ADR详细个例报告，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：共检索符合纳入条件的双黄连注射剂ADR详细个案569例。其临床诊断大致有7类，皮肤损害案例占32.162%，过敏性休克案例占20.562%，呼吸系统损害案例占16.696%，消化系统损害案例占12.830%，神经系统损害案例占9.490%，循环系统损害案例占6.503%，泌尿系统损害案例占1.757%。其中有172例案例存在联合用药情况；155例ADR发生在给药开始后10 min之内。过敏性休克和循环系统损害的案例在男性患者和女性患者中构成比的差异有统计学意义（P<0.05），用药剂量规范与否、配液种类、ADR发生时间段在不同的ADR诊断中的分布的差异均有统计学意义（P<0.05）。置信度最高的关联规则是“肺炎患者占总研究案例的6.68%，其中52.63%的患者发生皮肤损害”。结论：双黄连注射剂ADR中过敏性休克的发生可能与患者性别、用药剂量、配液种类、ADR发生时间段等因素相关，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 Shuanghuanglian injection adverse reactions（ADR）. Methods:Analysis the collected detail Shuanghuanglian injection case reports from 1979 to 2015, apply Microsoft ACCESS database platform and Clementine 12.0 platform for data mining which include association rules Apriori algorithm. Results:569 Shuanghuanglian injection ADR cases were collected. There were about seven kinds of clinical diagnosis. Skin damage cases accounted for 32.162%; cases of allergic shock accounted for 20.562%; respiratory impairment cases accounted for 16.696%; the number of cases of digestive damage was 12.830%; neurological damage cases accounted for 9.490%; circulation system damage cases accounted for 6.503%; urinary damage cases accounted for 1.757%. There were 172 cases joint with other drug; The 155 cases of adverse reactions occurred within 10 minutes. The constituent ratio of allergic shock and circulatory damage between male and female patients showed significant differences (P<0.05). Statistical significances were also found in the correct dose, liquor types, toccurrence time of ADR among the different ADR diagnoses (P<0.05). Association rules Apriori algorithm show that Pneumonia patients accounted for 6.68% of the total study cases, and 52.63% of the patients had skin lesions. Conclusion:Occurrence of Shuanghuanglian injection’s ADR may be related to such factors as the gender of patients， drug does, the currence time of ADR and liquor types which complex under the action of performance still needs a larger sample size analysis of the data validation. |
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