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目的:对香丹注射液的不良反应进行调查,探索基于医院信息系统开展药品不良反应的监测方法。方法:分别利用计算机“触发器”技术,从医院住院患者数据库中提取出现触发信号的患者的资料及病历回顾性研究方法,对我院322份使用香丹注射液的住院患者不良反应进行调查,采用SPSS 11.5统计软件进行统计分析。结果:利用计算机触发信号筛查出香丹注射液不良反应的病例数有34例,病历回顾性研究查出25例不良反应,对两种方法进行一致性分析,Kappa值等于0.76,提示两种方法具有高度的一致性。结论:基于HIS系统进行药品不良反应集中监测的方法是可行的,在与病历回顾性研究筛选出相同的发生ADR病历的条件下,该方法较病历回顾性研究省时、省力。
OBJECTIVE: To investigate the adverse reactions of Xiangdan Injection and explore the monitoring methods of adverse drug reactions based on hospital information system. Methods: Using computer “trigger ” technology, we extracted the data of patients with trigger signal from the hospital inpatient database and the retrospective study of medical records. Adverse reactions of hospitalized 322 patients who used Xiangdan injection in our hospital Survey, using SPSS 11.5 statistical software for statistical analysis. Results: There were 34 cases of adverse events detected by computerized triggering in Xiangdan injection, 25 cases of adverse reactions were retrospectively analyzed by medical records, and the consistency of the two methods was analyzed. The Kappa value was equal to 0.76, suggesting that two The method is highly consistent. Conclusion: It is feasible to use HIS system for centralized monitoring of adverse drug reactions. Under the condition of the same ADR records screened out by the retrospective analysis of medical records, this method is more time-saving and labor-saving than the retrospective study.