Detection Of Suspected Allergic Reaction Signal And Influencing Factors Of Tanreqing Injection Based On Electronic Medical Record

Objective: As a kind of drug dosage type widely used in clinical practice,it has the characteristics of quick effect and remarkable effect,but with the wide application of Chinese medicine,the safety problem of Chinese medicine has gradually increased and attracted the attention of the drug regulatory department.In this study,under the background of big data,we actively carried out the research on the influencing factors of suspected sllergic reaction of Tanreqing injection based on real world data,providing reference for the rational use of drugs in the clinic,and also providing reasonable suggestions for real world guidelines and research design.Methods: The use of medical records for patients with Tanreqing injections from the Institute of Medical Data of Chongqing Medical University.Using Apriori algorithm to analyze the drug combination of Chinese and medicine.A total of 175 patients with suspected allergic reactions were screened by pre-scription sequence analysis.700 control cases were obtained by 1:4 matching according to age,gender and inpatient department.Conditional logistic regression was used to analyze Tanreqing Injection in terms of single dose,history of allergy,vehicle,basic diseases,combination of drugs and laboratory examination.Results: Tanreqing injection is frequently used in combination withLianhua Qingwen granules,Danmu extract syrup,Qiangli loquat dew,kanglai injection and Xueshuantong for injection.It is also frequently used in combination with medicine,such as carbosulfan sodium,hemagglutinase,doxofylline,bromohexin,budesonide,salbutamol,penicillin and ceftizoxime.Through statistical analysis of suspected allergy group and control group,Type 2 diabetes mellitus(OR = 9.374,P = 0.013),electrolyte disorder(OR = 1.938,P = 0.032),hypertensive heart disease(OR = 2.662,P = 0.011),secondary malignant tumor of bone(or = 6.838,P= 0.015),and oral infection(OR = 7.293,P = 0.033)had no effects on the suspected allergic reaction of Tanreqing Injection;The 9 combination drugs of Tanreqing Injection increased the risk of suspected allergic reaction of Tanreqing Injection,including metoclopramide(OR = 3.499,P = 0.0005),budesonide(OR = 2.778,P = 0.0026),sodium bicarbonate(OR = 3.557,P= 0.0009),Yanhuning(OR = 2.803,P = 0.0131),montelukast sodium(OR= 3.283,P = 0.0009),moxifloxacin(OR = 1.848,P = 0.0404),penicillin(OR = 2.388,P = 0.0131),hemagglutinase(OR = 3.749,P = 0.0013),and pantoprazole(OR = 2.152,P = 0.0081);in terms of laboratory test indicators,there were statistical differences between the two groups in blood calcium(P = 0.0308),blood sodium(P = 0.0358),neutrophil percentage(P < 0.0001)and leukocyte(P < 0.0001),and in blood potassium(P = 0.9538).The single dosage allergy history and vehicle had no effects on the suspected allergic reaction of Tanreqing Injection.Conclusion:(1)Tanreqing injection is mainly used in middle-aged and elderly patients and also widely used in clinical applications,and its application is basically consistent with the drug instructions;(2)Tanreqing injection is frequently used in combination with traditional Chinese medicine,including clearing heat and detoxification,promoting blood circulation.In medicine,the frequency of combined use of epinephrinereceptor agonists,jaundice,phlegm drug cortisol and antiviral drugs is higher;(3)the nine drugs of type 2 diabetic nephropathy,electrolyte disorder,hypertensive heart disease,secondary malignant tumor of bone and oral infection in the patients’ basic diseases,and the combination drugs of metoclopramide,budesonide,sodium bicarbonate,Yanhuning,montelukast,moxifloxacin,penicillin,hemagglutinase and pantoprazole may increase the risk of allergic reaction of Reqing injection.At the same time,it may be accompanied by changes in blood test indicators such as sodium,blood calcium,neutrophils,but the conclusions of this study need to be confirmed by further prospective studies;(4)The study of suspected allergic reactions based on real-world Tanreqing injection is an exploration of the re-evaluation of safety after post marketing,and it can provide reference and suggestions for the formulation of a guide to adverse drug reactions of real-world data.