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  

Efficacy and Safety of Generic and Original Meropenem for Injection in Children with Severe Pneumonia in the Real World Based on Propensity Score Matching Method

作　　者：张圣洁 徐进[1] 许静[1] 季兴[1] 缪红军[1] 葛许华[1] 刘瑶[1] Zhang Shengjie;Xu Jin;Xu Jing;Ji Xing;Miao Hongjun;Ge Xuhua;Liu Yao(Children’s Hospital of Nanjing Medical University,Nanjing 210008,China)

机构地区：[1]南京医科大学附属儿童医院,南京210008

出　　处：《儿科药学杂志》2024年第6期5-9,共5页Journal of Pediatric Pharmacy

基　　金：江苏省药学会-天晴医院药学基金,编号Q201902。

摘　　要：目的:评价国产与原研注射用美罗培南在重症肺炎患儿中疗效和安全性的一致性,为医师对原研和仿制药的选择提供参考。方法:本研究数据来源于2019-2021年南京医科大学附属儿童医院信息系统电子档案数据库。住院期间使用国产或原研注射用美罗培南的重症肺炎患儿被纳入本研究,采集患儿基本信息及用药信息。采用倾向评分匹配(PSM)法将两组患儿按性别、体质量进行匹配,获得组间协变量均衡的样本;运用Logistics多因素回归法对国产或原研注射用美罗培南匹配后两组患儿的混杂因素进行分析,校正混杂因素后对两组患儿临床疗效指标和用药安全性指标进行比较。结果:疗效评估的4个指标显示,国产组与原研组的抗菌药物临床疗效、细菌学疗程、30天全因死亡率及出院转归情况比较差异均无统计学意义(P均>0.05)。在安全性评估中,国产组患儿肝功能损伤和肾功能损伤比例与原研组相比,除总胆红素水平升高比例外其他指标比较差异均无统计学意义(P>0.05)。结论:对于重症肺炎患儿,国产与原研注射用美罗培南在临床疗效和肝肾功能方面的安全性基本相当。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.

关 键 词：真实世界研究 倾向评分匹配法 美罗培南 国产 原研 

分 类 号：R97[医药卫生—药品]