基于关联规则分析我院新的和严重药品不良反应发生规律

Analysis of new and severe adverse drug reactions in our hospital based on association rules

目的 分析我院新的和严重药品不良反应的特点及规律,为用药安全提供参考。方法 收集我院2020年1月至2021年10月上报至国家药品不良反应监测系统的新的和严重的药品不良反应报告,并对报告基本情况和用药情况等进行统计及关联规则分析。结果 共188例新的和严重的药品不良反应,其中新的一般药品不良反应113例(60.11%),严重的药品不良反应75例(39.89%)。基本情况单因素关联分析发现,关联性评价-可能、心血管疾病、年龄≥70岁、皮肤及附件和神经系统损害等因素中发生新的药品不良反应置信度均>70%。基本情况多因素关联分析发现,血液系统损害、肿瘤疾病、女性、年龄46~69岁、体重≥45 kg及关联性评价-很可能等关联因素中发生严重药品不良反应的置信度为100%。用药情况关联分析发现,口服给药、中成药、静脉滴注的抗肿瘤药物等因素发生新的和严重药品不良反应置信度>80%。结论 我院新的和严重药品不良反应发生具有一定特征,有特定疾病的特殊人群与新的和严重药品不良反应发生具有相关性,应重点加强中成药和静脉用抗肿瘤药物的使用监测。

Objective To analyze the characteristics and laws of new/severe ADR in our hospital,so as to provide reference for safe medication.Methods The new/severe ADR reported by our hospital to the national ADR monitoring system from January 2020 to October 2021 were collected to make statistical and association rule analysis of the basic information and medication in the reports.Results There were 188 new and severe ADR,including 113 new general adverse drug reactions(60.11%)and 75 severe adverse drug reactions(39.89%).The univariate correlation analysis of basic information revealed that the confidence of new adverse drug reactions in relevance evaluation-possible,cardiovascular disease,age≥70 years old,and damage in skin,accessories and nervous system was more than 70%.The multivariate correlation analysis of basic information revealed that the confidence of severe adverse drug reactions in the related factors such as blood system damage,tumor disease,female,aged 46~69 years old,weight≥45 kg and relevance evaluation-very likely was 100%.The correlation analysis of drug use showed that the confidence of new/severe adverse drug reactions caused by oral administration,Chinese patent medicine,intravenous anti-tumor drugs and other factors was more than 80%.Conclusion The occurrence of new/severe ADR in our hospital has certain characteristics,and the specific populations with specific diseases are related to the occurrence of new/severe ADR.The monitoring of the use of Chinese patent medicine and intravenous antitumor drugs should be strengthened.