目的:探索清开灵注射液致药品不良反应(adverse drug reaction,ADR)发生的流行病学特点.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等数据库,收集清开灵注射液致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清开灵注射液致ADR的详细个案355例.与ADR相关的字段包括患者性别、年龄、ADR发生时间、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"ADR临床诊断为呼吸系统损害且ADR发生在开始给予清开灵注射液后前5 min内的案例占总研究案例的7.25％,其中92.00％案例的原发疾病为上呼吸道感染".结论:清开灵注射液致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,其发生规律尚需更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 Qingkailing injection .METHODS: Case reports on ADR induced by Qingkailing 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 .METHODS:A total of 335 cases of ADR induced by Qingkailing 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 of respiratory damage was diagnosed to be the ADR which occurred within 5 min after using Qingkailing injection accounted for 7.25％of the total cases , while the rest 92.00％were upper respiratory tract infection".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 .
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