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美罗培南仿制药与原研药治疗重症肺炎的有效性、安全性与经济性比较

Comparison of efficacy,safety and cost-effectiveness of generic drugs and original meropenem in the treatment of severe pneumonia
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摘要 目的 评价美罗培南仿制药与原研药治疗重症肺炎的有效性、安全性和经济性,为美罗培南的临床合理使用和带量采购政策的实施提供参考。方法 回顾性收集2021年1月至2024年6月使用注射用美罗培南的住院病例506例,根据使用美罗培南种类分为仿制组(n=209)和原研组(n=297),采用倾向性评分匹配法调整组间差异后,比较2组有效性、安全性和经济性。结果 倾向性评分匹配法匹配后,2组各纳入病例193例。有效性评价方面,仿制组治愈率为86.01%,原研组治愈率为91.19%,2组比较差异无统计学意义(P>0.05)。安全性评价方面,仿制组的不良反应总发生率为7.25%,原研组的不良反应总发生率为5.70%,2组比较差异无统计学意义(P>0.05)。经济性评价方面,仿制组住院期间总费用、药品总费用、抗菌药物费用低于原研组,差异有统计学意义(P<0.05)。结论 对于重症肺炎患者,美罗培南仿制药与原研药的有效性和安全性相当,但与原研药比较,美罗培南仿制药具有明显的经济优势。 AIM To evaluate the efficacy,safety,and economic outcomes of generic and original meropenem in the treatment of severe pneumonia,thereby providing references for the rational clinical use of meropenem and the implementation of centralized volume-based procurement policies.METHODSSAretrospectivestudywas conductedon 506 hospitalized patients who received injection of meropenem from January 2021 to June 2024.Patients were divided into the generic drug group(n=209)and original drug group(n=297)based on the type of meropenem used.After adjusting for intergroup differences using the propensity score matching(PsM)method,the efficacy,safety,and cost-effectiveness of the 2 groups were compared.RESULTS After matching by the PSM method,193 patients were included in each group.All observation indicators were analyzed,showing that the recovery rate for the generic drug group was 86.01%,while the recovery rate for the original drug group was 91.19%.There was no statistically significant difference between 2 groups(P>0.05).In the safety evaluation,the incidence of adverse reactions in the generic drug group was 7.25%,compared to 5.70%in the original drug group.There was no statistically significant difference between 2 groups(P>0.05).In the economic evaluation,the generic drug group demonstrated significantly lower total hospitalization costs,total medication costs,and total antibiotic expenses compared to the original group,with all differences showing statistical significance(P<0.05).CONCLUSION For patients with severe pneumonia,generic meropenem is equally effective and safe as the original meropenem,but generic meropenem offers significant economic advantages.
作者 李红桥 夏雯 李兰 柯敏 饶志威 LI Hongqiao;XIA Wen;LI Lan;KE Min;RAO Zhiwei(Department of Pharmacy,Huangshi Central Hospital,Afiliated Hospital of Hubei Polytechnic University,Huangshi 435000,China;Department of Pediatric Clinic,,Huangshi Central Hospital,Afiliated Hospital of Hubei Polytechnic University,Huangshi 435000,China;Department of Abdominal Tumor Surgery,Huangshi Central Hospital,Afiliated Hospital of Hubei Polytechnic University,Huangshi 435000,China;Hubei Key Laboratory of Kidney Disease Pathogenesis and Intervention,Huangshi 435000,China;Department of Pharmacy,Xianning Central Hospital,The First Affliated Hospital of Hubei University of Science and Technology,Xianning 437100,China)
出处 《中国临床药学杂志》 2025年第7期488-492,共5页 Chinese Journal of Clinical Pharmacy
基金 湖北理工学院科学研究计划资助项目(编号25xjz04Y) 黄石市社会科学研究项目(编号2024sk303) 湖北省自然科学基金面上项目(编号2020CFB868)。
关键词 真实世界研究 倾向性评分匹配 美罗培南 有效性 安全性 带量采购 仿制药 成本-效果 real world data propensity score matching meropenem efficacy safety volume-based procurement genericdrug cost-effectiveness
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