目的 分析马来酸桂哌齐特注射液相关皮肤类的药品不良反应(ADR)与过敏样反应/过敏性休克的可靠发生率及发生特征,为临床提供参考资料.方法 设置"医疗机构药品不良事件(ADE)主动监测系统与智能评估警示系统"在"皮肤变态反应"与"过敏性休克"模块回顾性提取我院2015年1月-2016年12月使用马来酸桂哌齐特注射液住院患者的病例,人工分析系统报警病例获得ADR发生率及发生特征,并利用巢式病例对照研究方法研究ADR发生的可能风险因素.结果 系统共回顾监测11052例马来酸桂哌齐特使用患者,15例皮肤类ADR,发生率0.14%,2例过敏样反应,发生率0.018%,无严重皮肤ADR病例,无过敏性性休克病例,巢式病例对照研究显示在性别、年龄、BMI、药物过敏史、严重疾病方面阳性病例组与对照组无显著统计学差异.结论 桂哌齐特引起皮肤类ADR和过敏样反应的发生率分别在偶见和罕见范围,程度较轻.应用专项软件极大提高了文本信息研究的效率.%Objective To study the reliable incidence and occurrence characteristics of the cutaneous adverse reaction and anaphylactic reaction and anaphylactic shock caused by cinepazide maleate, so as to provide reference information for clinic. Methods The adverse drug events' active surveillance and assessment system, on cutaneous allergy reaction module and anaphylactic shock module, was used to automatic surveillance for the hospitalized patients in General Hospital of PLA who received cinepazide maleate between January 2015 and December 2016. Suspected cases submitted by system were evaluated by professionals to obtain the incidence and occurrence characteristics. The risk factors were analysed by nested case-control study. Results A total of 11052 patients using cinepazide maleate were retrospectively surveilled, 15 cases of cutaneous adverse reaction and its incidence was 0.14%, while 2 cases of anaphylactic reaction and its incidence was 0.018%, no severe cutaneous adverse reaction or anaphylactic shock was surveilled. Risk factor analysis indicated there was no significant statistical difference in age, gender, BMI, allergic history and severe diseases between positive group and matched group. Conclusion The incidence of cutaneous adverse reaction and anaphylactic reaction induced by cinepazide maleate were in occasional and rare ranges, respectively, and the symptoms are mild. The application of special software greatly improves the efficiency of text information research.
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