Analysis of Abnormal Body Temperature Data in the Automatic Monitoring and Feedback System for Adverse Drug Reactions:Taking Hemocoagulase as an Example
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 2 434 ADR reports(involving 2 434 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 11 602 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 pharmacists in conjunction with clinical practice.
informatizationautomatic monitoring and feedback systemadverse drug reactionsbody temperaturehemocoagulase
万方数据
维普
