利用实验室危急值对严重药物不良反应的主动监测研究  

Research on active monitoring of serious adverse drug reactions using laboratory critical values

作　　者：李科南 时绘绘 王雪莹 宇文利霞 王丽华 冯亚楠 陈文娟 Li Ke'nan;Shi Huihui;Wang Xueying;Yuwen Lixia;Wang Lihua;Feng Ya'nan;Chen Wenjuan(Xingtai Center for Adverse Drug Reaction Monitoring,Hebei Province,Xingtai 054002,China;Department of Pharmacy,Xingtai Central Hospital,Hebei Province,Xingtai 054099,China;Department of Medical Affairs,Xingtai Central Hospital,Hebei Province,Xingtai 054099,China;Center for Drug Evaluation of Hebei,Shijiazhuang 050011,China)

机构地区：[1]河北省邢台市药品不良反应和药物滥用监测中心,邢台054002 [2]河北省邢台市中心医院药剂科,邢台054099 [3]河北省邢台市中心医院医务科,邢台054099 [4]河北省药品审评中心,石家庄050011

出　　处：《药物不良反应杂志》2024年第12期732-736,共5页Adverse Drug Reactions Journal

基　　金：河北省药品监督管理局科技计划(2022ZC1055)。

摘　　要：目的探讨利用实验室危急值对严重药物不良反应(SADR)实施主动监测在药物警戒中的作用。方法将邢台市中心医院作为哨点医院,收集该医院2022年7月至2022年12月实验室信息系统中血常规、血生化、血气分析、凝血功能的危急值报告。逐一查阅报告中涉及患者的电子病历,评价治疗药物与危急值间的关联性。对涉及药物不良反应(ADR)和SADR的危急值及可疑药物进行描述性统计分析,比较门急诊及住院患者中ADR和SADR的发生情况。结果共有1597份危急值报告纳入分析,174份(10.90%)被判定为与ADR相关,其中68份(39.1%)被判定为与SADR相关。住院部危急值报告占比明显多于门急诊[0.39%(1114/288541)比0.16%(483/307176),P<0.001],但门急诊的危急值报告中与ADR相关者占比明显高于住院部[14.29%(69/483)比9.43%(105/1114),P=0.004],门急诊和住院部报告中与SADR相关者在所有ADR相关危急值报告中占比[31.88%(22/69)比43.81%(46/105)]和在所有危急值报告中的占比[4.55%(22/483)比4.13%(46/1114)]相似,差异均无统计学意义(均P>0.05)。68份SADR报告涉及80项危急值,排在前3位的为白细胞减少(主要与抗肿瘤药物有关)、凝血功能异常(主要与抗凝药有关)和电解质紊乱(主要与降血压药有关),部分危急值的发生与用药错误或不当有关。结论利用实验室危急值可有效地对药物引起的血细胞、血生化和凝血功能等方面的SADR实施主动监测,有利于及时发现门急诊和住院患者中的SADR以及用药错误和不适当治疗导致的严重不良事件。Objective To explore the role of using laboratory critical values for active monitoring of serious adverse drug reactions(SADRs)in pharmacovigilance.Methods Xingtai Central Hospital was used as a sentinel hospital.The reports containing critical value in blood routine,blood biochemistry,blood gas analysis,and coagulation function from July 2022 to December 2022 were collected by the laboratory information system in the hospital.The electronic medical records of patients involved in the reports were reviewed,and the correlation between therapeutic drugs and the critical values was evaluated.The critical values related to adverse drug reactions(ADRs)and SADRs,and the suspicious drugs were analyzed by descriptive statistics.The occurrence of ADRs and SADRs in outpatients/emergency patients and hospitalized patients were compared.Results A total of 1597 reports containing critical values were included in the analysis.In these reports,174(10.90%)were judged to be related to ADRs,of which 68(39.1%)were related to SADRs.The proportion of reports containing critical values in the Inpatient Department was significantly higher than that in the Outpatient/Emergency Department[0.39%(1114/288541)vs.0.16%(483/307176),P<0.001];the proportion of reports related to ADR in all laboratory reports of the Outpatient/Emergency Department was significantly higher than that of the Inpatient Department[14.29%(69/483)vs.9.43%(105/1114),P=0.004];the proportion of reports involving SADRs in those involving ADRs[31.88%(22/69)vs.43.81%(46/105)]and that in all reports[4.55%(22/483)vs.4.13%(46/1114)]both were similar between Outpatient/Emergency Department and Inpatient Department,and the differences were not statistically significant(all P>0.05).Six-eight reports of SADR involved 80 critical values,and the top 3 were leukopenia(mainly involving anticancer drugs),coagulation dysfunction(mainly involving anticoagulants)and electrolyte disorder(mainly involving antihypertensive drugs),some of which were induced by medication errors or improper dr

关 键 词：实验室危急值 药物相关副作用和不良反应 药物警戒 主动监测 

分 类 号：R969.3[医药卫生—药理学]