关键词: font-size:medium, ">清开灵注射液；过敏样不良反应；危险因素；Logistic回归分析

Abstract: 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.

Key words: Qingkailing injection, Anaphylaxis, Risk factors, Logistic regression analysis