Signal Mining And Risk Factor Analysis Of Adverse Reactions To Iodinated Contrast Media

Iodinated contrast media(ICM)is a kind of X-ray contrast media commonly used in clinic,which is widely used in angiography,subarachnoid angiography and intracavitary angiography.With the rapid development of clinical imaging examination and interventional therapy,the usage amount of iodinated contrast media in China has been increasing rapidly.Based on the research of the real world data,compared with the traditional drug epidemiology methods monitoring adverse drug reactions can quickly come to the conclusion,this article aims to explore using real world data monitoring iodinated contrast media adverse reactions,to guide clinical rational drug use,are based on real data of injection post-marketing clinical safety evaluation provides research train of thought.Methods:(1)The report ratio method(ROR)and proportional report ratio method(PRR)were used to analyze the adverse reaction reports of the U.S.food and drug administration reporting system(FARES)fromJanuary 2004 to December 2019,to mine the adverse reaction signals of iodinated contrast media and to analyze and evaluate the results.(2)Inpatient records of iohexol injection use were collected from 7 hospitals from January 2007 to June 2018.190 patients with suspected allergic reaction to iohexol injection were obtained by prescription sequence analysis,and 760 patients in the control group were obtained by 1:4matching according to gender,age and inpatient departments with propensity score matching method.Conditional Logistic regression was used to analyze the effect of administration method,allergy history,single dose and combination on suspected allergic reaction.(3)To collect7 hospitals in January 2007-July 2018 elderly inpatients medical records using iohexol injection,three days before and after the drug screening bleeding tube are creatinine check records of patients,according to the diagnostic criteria of PC-AKI are divided into PC-AKI group and non PC-AKI,using Logistic regression analysis basic diseases,laboratory diagnosis,use of contrast media,and disease diagnosis for the influence of elderly acute kidney injury.Results:(1)The FAERS database was extracted to obtain 4732 reports of adverse drug event related to iohexol,3527 reports of adverse drug event related to iopromide,1008 reports of adverse drug event related to iopamidol,and 914 reports of adverse drug event related to iodixanol.After detection,176 cases,206 cases,126 cases and 148 casesof ADR signals were obtained respectively.ADR signals of iodinated contrast media mainly accumulate in skin system,nervous system,respiratory system and kidney system.The strongest signal of iohexol ADR signals included intravascular osmosis,contrast media reaction,encephalopathy caused by contrast media,abnormal radioisotope scanning and meningitis.The strongest signal of iopromide ADR signals included encephalopathy caused by contrast media,contrast media reaction,myocardial hemorrhage,convulsion and contrast media allergy.The strongest signal of iopamidol ADR signals included encephalopathy,hepatic artery stenosis,spinal cord ischemia,contrast media allergy and contrast media reaction.The strongest signal of iodixanol ADR signals include coronary artery occlusion,encephalopathy caused by contrast media,anaphylactic shock,contrast media reactions,and hypersensitivity.Compared with other iodinated contrast media,iohexol has a lower risk of nephrotoxicity,a lower risk of severe skin damage and a higher risk of mild skin damage,and a lower risk of respiratory damage.In the use of iohexol in the population,women are more prone to chest distress,men are more prone to acute kidney injury,cardiac arrest,and chills.Older people are more likely to suffer from extravasation,loss of consciousness,and decreased blood pressure.(2)There were statistically significant differences between the two groups in administration method,dosage and allergy history(P < 0.05),part of the drug in combination difference wasstatistically significant(P < 0.05),iohexol injection with pantoprazole(OR = 2.201,P = 0.0001),mannitol(OR = 3.406,P = 0.0001),penicillin(OR = 1.839,P = 0.0142),tramadol(OR = 2.050,P = 0.0036)used in combination with four drugs may increase the risk of an allergic reaction in patients.(3)a total of 749 cases were screened,among which 39 cases met the diagnostic criteria of PC-AKI,and the incidence of PC-AKI was5.21%(39/749).Logistic regression analysis results showed that creatinine ? 133 ?mol/L(OR = 2.619,P = 0.045)and blood uric acid ?400?mol/L(OR = 3.153,P = 0.014),hemoptysis(OR = 9.031,P = 0.009),chronic renal insufficiency uremia stage(OR=14.297,P=0.018),diffuse peritonitis(OR = 33.418,P = 0.001),shock(OR = 14.456,P = 0.014),atherosclerosis(OR = 9.547,P = 0.002),and cerebral embolism(OR =29.063,P = 0.005)were independent risk factors for PC-AKI.Conclusion: The adverse reactions of iodinated contrast media mainly involve the skin system,respiratory system and circulatory system.Its adverse reaction signal is numerous,mainly concentrates in the respiratory system,the skin system,the nervous system disease as well as the kidney and the urinary system.The adverse reaction of iodinated contrast media in clinical use is affected by many factors.Attention should be paid to the combination of drug use and primary disease to ensure the safety of drug use.