| Objective:Compound aminophylline barbital injection is one of the commonly used antipyretic and analgesic drugs in acute hyperthermia.The adverse reactions caused by the drug involve multiple organs and systems of body,and include anaphylactic shock,agranulocytosis and other serious adverse reactions.At present,the monitoring of adverse events mainly relies on the spontaneous reporting system of adverse drug reactions and case reports of medical institutions,and there is no study using real-world data to evaluate the safety of the drug.The purpose of this study is to describe the epidemic situation of compound amilin barbital injection in 7medical institutions by using real world data,analyze the influence of the drug on blood cell test indexes,and explore the influencing factors of its suspected allergic reaction,so as to provide reference for clinical rational drug use and research ideas for drug safety evaluation based on the real world.Methods:(1)Collect case data from 7 medical institutions that have recorded the use of compound ammoniobarbital injection from June 2016 to June 2019,statistically describe the demographic and clinical information of the drug population,and analyze their clinical truth Application situation.(2)Collect case data of hospitalized patients with fever symptoms in 7 medical institutions from June 2016 to June 2019,and divide them into exposed and control groups according to whether they used compound amidobarbital injection,and exclude medical records.Incomplete patients,malignant tumor patients,patients who died during hospitalization,patients aged ≥ 80 years and hospitalization days more than 30 days;based on exposed patients,use propensity score matching method according to gender,age,allergy history,admission diagnosis,admission department,Discharge diagnosis and discharge department conducted 1:1 matching from the control population,obtained 905 subjects in the exposure group and the control group,and collected the blood cell test results of the two groups of patients before and after the medication;the paired t test was used to analyze the medication use of the two groups of patients The change level of blood cell test results before and after,to explore the effect of compound ammoniobarbital injection on blood cell test indicators.(3)Collect the cases of hospitalized patients with compound amidobarbital injection from June 2015 to June 2019 in 7 medical institutions,and use prescription sequence analysis to obtain patients with suspected allergic reactions to compound amidobarbital injection 165 cases,using propensity score matching method to match 1:4 according to gender,age and hospitalization department to obtain 660 control subjects;conditional Logistic regression was used to analyze the effects of allergic history,single dose and combination medication on suspected allergic reactions.Results:(1)The clinical use of compound amidobarbital injection complied with the instructions for use as a whole,but there were irrational drug use phenomena such as over-dose,long-term administration,use of the drug population involving infants and young children,and contraindications.(2)The red blood cell count(P=0.006),the percentage of mononuclear cells(P=0.017),the percentage of lymphocytes(P=0.001),the average red blood cell volume(P=0.001),and the basophils of the exposed group and the control group The percentage of cells(P=0.001),the percentage of eosinophils(P=0.001),the percentage of neutrophils(P=0.001)and the average erythrocyte hemoglobin concentration(P=0.001)8 test indicators before and after the application of the test results change level The difference was statistically significant.(3)There was no statistically significant difference between the suspected allergy group and the control group in allergy history and single dose(P>0.05),and some drugs had statistically significant differences in combination medication(P<0.05).Compound ammonia Limbarbital injection and magnesium sulfate(OR=3.132,P=0.0057),mannitol(OR=2.180,P=0.0202),compound electrolyte injection(OR=2.792,P=0.004),Bupleurum injection(OR=4.442,P=0.0009)The combined use of 4 drugs may increase the risk of allergic reactions in patients.Conclusion:(1)The clinical application of compound amidobarbital injection is basically consistent with the instructions,but there are some irrational medications.The clinical application should be used in strict accordance with the instructions,and the latest clinical guidelines and expert consensus should be combined to ensure the safety of patients’ medication..(2)The use of compound amidobarbital injection may be related to the reduction in the level of granulocytes in patients,and it also suggests that it is related to changes in cell count,average red blood cell volume and average red blood cell hemoglobin content,but the results obtained need to be further prospective Research and verification.(3)The combined use of compound amidobarbital injection and magnesium sulfate,mannitol,compound electrolyte injection and Bupleurum injection may increase the risk of allergic reactions in patients,but the results of the study need to be further prospective Research and verification. |
