基于倾向评分匹配法的国产与原研注射用美罗培南治疗儿童重症肺炎疗效与安全性评价的真实世界研究OACSTPCD

Objective:To evaluate the efficacy and safety of generic and original meropenem for injection in children with severe pneumonia,so as to provide evidence for selection of generic and generic drugs by clinicians.Methods:Clinical data were collected from the electronic archive database of information system of Children's Hospital of Nanjing Medical University from 2019 to 2021.Children with severe pneumonia who used generic or original meropenem for injection during hospitalization were included,the general information and medication information were collected.Two groups were matched by gender and body mass by propensity score matching(PSM)method,and the samples with balanced covariates were obtained.Logistic multifactorial regression was used to analyze the confounding factors of two groups after matching with generic or original meropenem for injection,the clinical efficacy and safety indicators were compared between two groups after correcting for the confounding factors.Results:Four indicators of efficacy evaluation showed that there were no significant differences in clinical efficacy,bacteriological duration,30-d all-cause mortality and discharge outcomes between the generic group and original group(P＞0.05).In the safety assessment,there was no significant difference in the proportion of hepatic and renal injury between the generic group and original group,except for the increased proportion of total bilirubin levels(P＞0.05).Conclusion:For children with severe pneumonia,the generic meropenem for injection is basically comparable in terms of clinical efficacy and hepatic and renal function safety.