| 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。 |
| 关键词: 真实世界研究 倾向评分匹配法 美罗培南 国产 原研 |
| DOI：10.13407/j.cnki.jpp.1672-108X.2024.06.002 |
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| 基金项目:江苏省药学会-天晴医院药学基金,编号 Q201902。 |
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| Efficacy and Safety of Generic and Original Meropenem for Injection in Children with Severe Pneumonia inthe Real World Based on Propensity Score Matching Method |
| Zhang Shengjie, Xu Jin, Xu Jing, Ji Xing, Miao Hongjun, Ge Xuhua, Liu Yao ( |
| (Children’s Hospital of Nanjing MedicalUniversity, Nanjing 210008, China) |
| Abstract: |
| Objective: To evaluate the efficacy and safety of generic and original meropenem for injection in children with severepneumonia, so as to provide evidence for selection of generic and generic drugs by clinicians. Methods: Clinical data were collectedfrom 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 generalinformation 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 theconfounding 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 evaluationshowed that there were no significant differences in clinical efficacy, bacteriological duration, 30-d all-cause mortality and dischargeoutcomes between the generic group and original group (P>0. 05). In the safety assessment, there was no significant difference in theproportion of hepatic and renal injury between the generic group and original group, except for the increased proportion of total bilirubinlevels (P>0. 05). Conclusion: For children with severe pneumonia, the generic meropenem for injection is basically comparable interms of clinical efficacy and hepatic and renal function safety |
| Key words: real world study propensity score matching method meropenem generic original |
