| Objective:1.The clinical characteristics of thrombocytopenia caused by different types of antibacterial drugs and the occurrence of bleeding events were systematically analyzed,in order to provide reference for clinical diagnosis and treatment of antibacteria-induced thrombocytopenia.2.Based on the FDA Adverse Event Reporting System(FAERS)database,to explore the degree of association between different antibacterial drugs and thrombocytopenia,and to evaluate the relative risk of thrombocytopenia,in order to provide evidence for the early recognition of antibacterial induced thrombocytopenia.3.To explore the clinical diagnosis and treatment status of antibacterial induced thrombocytopenia in order to enhance the clinical understanding of antibacterial induced thrombocytopenia.Methods:1.By referring to the domestic and foreign literature data platform,screening the case reports of antibacterial induced thrombocytopenia,collecting patients’ basic data,drug use,clinical manifestations,platelet values at different stages,therapeutic measures and outcomes,and conducting statistical analysis on their original diseases,suspicious drug categories,rational drug use,bleeding,etc.2.Download ADE reports from the FAERS database from the first quarter of 2018 to the second quarter of 2022,organize and de-weight the data,preferred term(PT),and use Case/non-case analysis method to analyze the gender,administration mode and medical outcome of patients with antibacterial related thrombocytopenia.The reporting odds ratio(ROR)and proportional reporting ratio(PRR)were used for signal mining.3.Consulted the case information of a third-class children’s hospital in Shanxi Province,screened the children with secondary thrombocytopenia after application of antibiotics,collected the detailed information of drug use,clinical manifestations,therapeutic measures and so on,conducted in-depth analysis of the etiology of secondary thrombocytopenia,and distinguished infection-related thrombocytopenia from antibacterial induced thrombocytopenia according to existing standards.The patients in different groups were compared and analyzed.Results:1.260 patients were included,involving 285 times of medication.The results of Naranjo’s were "confirm" in 25 cases,"possible" in 131 cases and "probable" in 104 cases.The median age of patients was 57(40-72)years old,and the elderly patients ≥60years old accounted for the largest proportion.The original disease involved 270 cases of infection,respiratory system infection was the most cases,mainly lung infection.Suspicious antibacterial drugs were classified into 10 categories,totaling 35 types,and161 cases showed bleeding symptoms.There were 64 cases of penicillin,involving 6types of drugs,22 cases of bleeding(34.38%),and 1 case of major bleeding;61 cases of cephalosporins,15 kinds of drugs,33 cases of bleeding(54.10%),1 case of massive bleeding;49 cases of glycopeptides,2 kinds of drugs,26 cases of bleeding(53.06%),3cases of massive bleeding;30 cases of sulfonamides,1 drug,27 cases of bleeding(90%),no massive bleeding;There were 30 quinolones,3 kinds of drugs,17 cases(56.67%)of bleeding,2 cases of massive bleeding;There were 13 carbapenems,2 drugs and 5bleeding cases(38.48%).31 cases of rifamycin,1 drug,31 cases of bleeding(100%),no massive bleeding;Other antibiotics were used 7 times without bleeding.In patients with bleeding events,there was a significant difference in the platelet value of different antimicrobial agents(P<0.05),and the median platelet value of Cefoperazone sulbactam was significantly higher than that of other antimicrobial agents.2.There were 27 clinically related PT’s in thrombocytopenia and 12 PT’s in the antibacterial-related thrombocytopenia report.The top three drugs suspected of inducing thrombocytopenia were antitumor agents and immunomodulators,blood and hematopoietic agents,and systemic antiinfective agents.The top three reporting countries of antibacterial induced thrombocytopenia were the United States,France and China,with the most reporting professional pharmacists.Case/no case statistical results show that the Relative risk of thrombocytopenia induced by male and intravenous administration is higher in patients of different ages.For adults and elderly patients,thrombocytopenia is an important cause of severe ADE and death events.Twenty-one antibacterial signals were positive by the Odds ratio method(ROR),and 15 were positive by the proportional ratio method(PRR).3.65 cases were included in the study,including 42 infection-related thrombocytopenia(TP),16 antibacterial drug-related TP,and 7 other cause-related TP.Newborns account for a large proportion,with males outnumbering females.There was a significant difference in the occurrence time of infection-related TP and antimicrobial drug-related TP.Patients in infection-related TP group ≤1 day accounted for a large proportion,while patients in antibacterial drug-related TP group concentrated on 1 to 5days.Among infection-associated TP,16 cases had bleeding,3 cases failed treatment,and 1 case died.Bleeding was found in 8 cases of antimicrobial associated TP,1 case failed treatment and 1 case died.Among newborn patients,the incidence of bleeding was41.51%.Conclusion:1.In literature case analysis,antimicrobial induced thrombocytopenia is prevalent in elderly patients,and there is currently no unified diagnostic standard.The results are mainly evaluated based on the association between adverse drug reactions.Patients with thrombocytopenia often use combination medication,resulting in unreasonable drug use.There are mainly 7 kinds of antibacterial drugs,35 of which are easy to cause thrombocytopenia.There is a big difference in the proportion of bleeding caused by various kinds of antibacterial drugs.Penicillin has the lowest proportion of bleeding.Sulfonamides and antituberculotics have a high proportion of bleeding,mainly minor bleeding.Glycopeptides and quinolones have a high proportion of small bleeding and large bleeding.In patients with bleeding events,the median platelet value of Cefoperazone sulbactam was significantly higher than that of other antibacterial drugs.2.In 2007,the ITP International Working Group standardized the naming of thrombocytopenia,but there are still non-standard terminology issues in the reporting process of adverse reactions to thrombocytopenia in the FAERS database.The statistical results show that male and intravenous administration may lead to an increased Relative risk of antibiotic induced thrombocytopenia.Antibacterial induced thrombocytopenia is an important factor leading to serious medical outcomes and even death in adult and elderly patients.The sensitivity of signal detection ROR in this study is higher than that of PRR.3.In a retrospective study of 65 pediatric cases,different methods were used to evaluate antimicrobial related TP,and there were significant differences in the results.The incidence of bleeding in newborns in this study is relatively high.There is a significant difference in the occurrence time of infection related TP and antibacterial drug related TP,but there is no unified diagnostic standard,which is not conducive to early recognition of antibacterial induced thrombocytopenia. |
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