清开灵注射液致过敏样反应风险因素的Logistics回归分析

Logistic Regression Analysisof Risk Factors for Anaphylaxis Caused by Qingkailing Injection

目的:探讨清开灵注射液引起过敏样反应的危险因素,为临床安全用药提参考。方法:收集2018年1月至2019年10月河北省药物警戒中心数据库中1052例清开灵注射液致过敏样不良反应个案报告,按照病例对照研究方法,采用单因素及多因素分析方法对患者年龄、性别、过敏发生时间、联合用药、溶媒等相关因素进行分析。结果:卡方检验显示清开灵注射液致过敏样不良反应值得关注;单因素分析显示,患者年龄、联合用药、过敏发生时间与过敏样反应相关。多因素分析显示,年龄(≤18y)、过敏发生时间(≤10min)是清开灵注射液致过敏样反应的独立危险因素,其OR值分别为1.744、2.287。结论:临床使用过程中应重点关注有风险因素的患者,保证用药安全,减少不良反应发生。

Objective:To explore the risk factors of anaphylaxis caused byQingkailing injection,and toprovidereference for clinical safe drug use.Methods:This study collected 1052 case reports of anaphylactoid adverse reactions caused by Qingkailing injection from the database of Hebei Center for Pharmacovigilance from January 2018 to October 2019.Based on the case-control study method,univariate and multivariate analysis approaches were used to analyze the patient′s age,gender,time of allergic occurrence,combined drug use,solvent and other related factors.Results:Chi-square test showed that thephenomenon of anaphylaxis caused by Qingkailing injection deserved our attention;Univariate analysisdemonstratedthat the age ofpatients,combined medication andthe time of allergyoccurrence were related to anaphylaxis.Multivariate analysis demonstrated that age(≤18y)and allergic time(≤10min)were independent risk factors of anaphylaxis caused by Qingkailing injection,and their OR values were 1.744 and 2.287 respectively.Conclusion:Patients with risk factors should be paid more attention in clinical use to ensure drug safety and reduce the incidence of anaphylaxis.