真实世界中清开灵注射液发生疑似过敏反应的相关影响因素研究

Study on The Related Factors of Suspected Allergic Reaction in Qingkailing Injection in The Real World

目的:基于巢式病例对照设计,探讨真实世界清开灵注射液发生疑似过敏反应的影响因素。方法:本文基于全国16家大型三甲医院信息系统中使用过清开灵注射液患者的信息,采用巢式病例对照研究方法,对比过敏组与对照组的合并疾病、合并用药、住院天数分段、用药剂量等信息,运用Logistic回归分析导致过敏反应发生的可疑因素。结果:分析发现,泌尿系感染和神经肌肉系统疾病是发生可疑类过敏反应的危险因素,使用清开灵注射液的同时服用维生素C或泼尼松龙片会增加可疑类过敏反应发生的机会,利多卡因注射液与清开灵注射液同用发生可疑类过敏反应的危险性更大,单次使用剂量在20mL及以上增加了发生可疑类过敏反应的可能,住院天数、疗程及日剂量不是发生可疑类过敏反应的危险因素。结论:本研究在方法上可行,为临床安全用药提供了一定的线索,但还需要更多的临床研究和药学实验探讨其原因及机制。

Objective:Based on nested case-control design,to explore the influencing factors of suspected allergic reaction of Qingkailing injection in the real world.Methods:Based on the hospital information system of 16 large hospitals in China,Qingkailing injection was used in the information system.A nested case-control study was used to compare the information on the combination of diseases,combined medication,hospital days,dosage and so on between the allergy group and the control group.Results:The results showed that urinary tract infection and neuromuscular system diseases were the risk factors for suspicious allergic reactions.Take vitamin C or prednisolone tablets together with Qingkailing injection could increase the chance of suspicious allergic reaction,and the risk of suspicious allergic reaction of lidocaine injection and Qingkailing injection was higher than that of Qingkailing injection.The single dose of 20 m L or could increased the possibility of suspicious allergic reaction.The days of hospitalization,course of treatment and daily dose were not the risk factors for suspicious allergic reactions.Conclusion:This study is feasible and provides some clues for clinical safety of drug use,but more clinical studies and pharmacological experiments are needed to explore the causes and mechanisms.