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目的:探索参麦注射剂不良反应(ADR)发生的流行病学特点.方法:通过系统检索1979～2015年文献,采集参麦注射剂ADR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:共检索符合纳入条件的参麦注射剂ADR详细个案118例.其临床诊断大致有6类,呼吸系统损害20例(16.95％),皮肤及其附件损害19例(16.10％),全身性损害26例(22.03％),神经紊乱23例(19.49％),胃肠系统损害18例(15.25％),心率及心律紊乱12例(10.17％).后项包含ADR诊断的关联规则有“ADR发生在0～5 min之内的男性患者占总体研究案例的14.41％,其中41.18％的患者的ADR诊断为全身性损害”.结论:参麦注射剂ADR诊断种类可能与患者性别、配液种类等因素相关,尚需更大样本量的数据分析验证.","Objective:To explore the epidemiological characteristics of Shenmai injection adverse reactions.Methods:Analysis the collected detail 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:118 Shenmai injection adverse reaction cases were collected.There were about six kinds of clinical diagnosis.Respiratory damage accounted for 16.95 ％;the damage to the skin and its accessories accounted for 16.10％;total body damage accounted for 22.03％;neurological disorders accounted for 19.49 percent;Gastrointestinal damage was 15.25％;heart rate and heart rhythm disorders accounted for 10.17 percent.The association rules of ADR diagnostic includes the following list:"Adverse reaction cases of male patients occurred in 0-5min accounted 14.41 percent of the total studied cases,and 41.18 percent of these cases with ADR diagnosed as systemic lesions."Conclusion:Occurrence of Shenmai injection's ADR may be related to such factors as the gender of patients and liquor types which complex under the action of performance still needs a larger sample size analysis of the data validation.