注射用头孢噻肟钠的真实世界安全性研究OACSTPCD

Objective To improve the safety of clinical use of Cefotaxime Sodium for Injection,especially in special populations.Methods A total of 1984 cases of individual case safety report(ICSR)on Cefotaxime Sodium for Injection spontaneously reported nationwide collected by a pharmaceutical company from January 2019 to December 2022 were included,and the types and influencing factors of adverse drug reactions(ADRs)were analyzed.Results Among 1984 cases of ICSR,1279 cases(64.47%)were included in the special population group,and 705 cases(35.53%)were included in the non-special population group.A total of 3001 case times of ADR were involved.The ADR types were similar between the two groups(P>0.05),and those were mainly general ADRs(1388 cases,69.96%).The system organ classification(SOC)with most case times of preferred term(PT)was skin and subcutaneous tissue diseases(1715 case times),followed by gastrointestinal system diseases(369 case times),systemic diseases and various reactions at administration site(228 case times),involving 1135,228,124 case times in the special population group respectively.The occurrence time of ADRs and outcome were significantly different between the two groups(P<0.05),the occurrence time of ADRs was mainly within 30 min after medication,and the outcome was mainly recovery or improvement.The Logistic regression analysis showed that patients'age group,whether special population or not,population category,combined medication,overdose,duration of administration,skin test results,clinical irrational drug use,past allergy history and ADR history were all the risk factors for Cefotaxime Sodium for Injection-related ADRs(P<0.05);among them,whether special population or not and population category were the independent risk factors for the ADRs involving systemic diseases,various reactions at the administration site,and various neurological diseases.Conclusion There are many risk factors for Cefotaxime Sodium for Injection-related ADRs.In clinical practice,we should pay attention to identifying the influencing factors related to ADRs,and focus on medication monitoring in special populations to avoid the medication risks of patients as much as possible and improve the medication safety.