以血凝酶为例的药品不良反应自动监测反馈系统体温异常数据分析

Analysis of Abnormal Body Temperature Data in the Automatic Monitoring and Feedback System for Adverse Drug Reactions:Taking Hemocoagulase as an Example

目的评价药品不良反应(ADR)自动监测反馈系统监测血凝酶致体温异常ADR的准确性,为建立基于自动监测反馈系统的血凝酶体温异常ADR监测方案提供参考。方法采用回顾性研究方法,提取医院ADR自动监测反馈系统2020年9月1日至2021年8月31日监测到的注射用尖吻蝮蛇血凝酶、注射用矛头蝮蛇血凝酶、注射用白眉蛇毒血凝酶致体温异常的ADR报告2434份(涉及患者2434例),以及该时段医院使用血凝酶的11602例患者的临床数据,以血凝酶药品说明书中的标准值作为该药ADR的判断标准,对数据进行多层次统计与分析,评价ADR自动监测反馈系统监测的准确性,并提出改进方案。结果ADR自动监测反馈系统监测到的上述3种血凝酶体温异常ADR发生率分别为19.05%,32.31%,17.51%,与设定的标准值存在较大差异;一过性低热(≤37.5℃)且无不适症状的发生率分别为64.46%,54.45%,73.86%,占比均较高;3种血凝酶引起体温异常ADR患者的年龄均存在显著差异(P<0.01);神经外科手术患者和肿瘤患者该ADR的判断不适合自动监测,其他患者的血凝酶单药引起中热、高热(>38℃)ADR的发生率分别为0.22%,0.20%,0.03%,与药品说明书中ADR发生率标准值接近。结论利用ADR自动监测反馈系统监测血凝酶单药引起的体温异常ADR发生率准确、快速,能较好地监测到一过性低热且无临床不适症状的ADR,漏报较少,但神经外科手术患者和肿瘤患者需药师结合临床判断。

Objective To evaluate the accuracy of the automatic monitoring and feedback system for adverse drug reactions(ADRs)in monitoring abnormal body temperature caused by hemocoagulase,and to provide a reference for establishing an ADR monitoring plan for abnormal body temperature ADRs caused by hemocoagulase based on the automatic monitoring and feedback system.Methods A retrospective study method was used to extract 2434 ADR reports(involving 2434 patients)on abnormal body temperature caused by Hemocoagulase Agkistrodon for Injection,Hemocoagulase Bothrops Atrox for Injection,and Hemocoagulase for Injection,as well as the data of 11602 patients treated with hemocoagulase in the hospital ADR automatic monitoring and feedback system from September 1,2020 to August 31,2021.The standard values in the drug instructions of hemocoagulase were taken as the judgment criteria for the ADR of the drug,and multi-level statistics and analysis were conducted to evaluate the accuracy of ADR automatic monitoring and feedback system monitoring,and to put forward improvement plans.Results The ADR incidence rates of abnormal body temperature caused by three types of hemocoagulase detected by the ADR automatic monitoring and feedback system were 19.05%,32.31%,and 17.51%,respectively,which were significantly different from the set standard values.The incidence rates of transient low fever(≤37.5℃)without discomfort symptoms were 64.46%,54.45%,and 73.86%,respectively,all of which accounted for a relatively high proportion.There were significant differences in the age of patients with abnormal body temperature ADRs caused by three types of hemocoagulase(P<0.01).The discrimination of these ADRs in neurosurgical patients and tumor patients was not suitable for automatic monitoring.In other patients,the incidence of moderate to high fever(>38℃)ADRs caused by the three types of hemocoagulase monotherapy was 0.22%,0.20%,and 0.03%,which was close to the standard value of ADR incidence in the drug instructions.Conclusion The use of ADR automatic monitoring and feedback system for monitoring the incidence of abnormal body temperature caused by hemocoagulase monotherapy is accurate and rapid,and can effectively monitor ADRs with transient low fever and no clinical discomfort symptoms,with fewer missed reports.However,adverse reactions caused by abnormal body temperature in neurosurgical patients or tumor patients need to be judged by Pharmace pharmacists in conjunction with clinical practice.