基于关联规则的血塞通注射液致药品不良反应发生规律的研究

Research on The Regularity of Adverse Drug Reactions Induced by Xuesaitong Injection Based on Association Rules

目的:探索血塞通注射液致药品不良反应(adverse drug reaction,ADR)的流行病学特点。方法:系统检索1979—2015年中国期刊全文数据库、中文科技期刊数据库、中文生物医学期刊数据库和万方数据库,收集血塞通注射液致ADR的详细个案报告,采用Microsoft ACCESS软件构建数据库,以Clementine 12.0软件为数据挖掘平台,应用关联规则Apriori算法开展数据挖掘研究。结果:共搜索符合纳入条件的血塞通注射液致ADR的详细个案108例,与ADR相关的字段包括患者年龄段、ADR发生时间段、原发疾病类别和配液浓度。关联规则Apriori算法中置信度最高的规则为"临床配液种类为葡萄糖注射液、配液用量为250 ml且临床给药途径为静脉滴注的患者占总体研究的31.48%,其中91.18%的案例的配液浓度为5%"。结论:血塞通注射液致ADR的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,其发生规律尚需大样本量的数据分析验证。

OBJECTIVE： To probe into the epidemiological characteristics of adverse drug reactions （ADR） induced by Xuesaitong injection. METHODS： Case reports on ADR induced by Xuesaitong injection during 1979-2015 were collected by retrieving CNKI, VIP, CBM and Wanfang, Microsoft ACCESS was adopted to construct database, and the Clementine 12. 0 was set as the platform to perform data mining with the application of Apriori algorithm. RESULTS： A total of 108 cases of ADR induced by Xuesaitong injection were selected to be matched with the including criteria, ADR related fields including patients＇ genders, ages, occurrence time of ADR, categories of primary diseases and the concentration of dosing fluid. Apriori algorithm indicated that the rule with the highest confidence degree was ＂the cases with the dosing fluid of glucose injection, dosage of 250 ml and administration route of intravenous drip accounted for 31.48% of the total cases, of which 91.18% with the concentration of dosing fluid of 5% ＂. CONCLUSIONS： ADR induced by Qingkailing injection is a complicated result caused under the combined effects of factors of clinical medication, patients＇ physical condition and the nature of drugs, yet its occurrence regularities still needs analysis and verification with the data of larger sample size.