首页|期刊导航|中国临床药理学杂志|集采头孢菌素类注射剂真实世界研究进展

集采头孢菌素类注射剂真实世界研究进展OA

Real world research progress on centralized purchasing of cephalosporin injections

中文摘要英文摘要

目的 在药品集中带量采购(简称"集采")政策全面推进的背景下,本研究旨在系统梳理与整合集采头孢菌素类注射剂在真实世界研究中所呈现的有效性、安全性与经济性等相关证据,比较其与原研药/进口仿制药的临床表现,以期为集采中选仿制药的合理应用、临床评价和政策优化提供循证依据.方法 检索2021年4月至2026年2月公开发表的集采头孢菌素类注射剂真实世界研究文献,以QATSM-RWS对纳入研究进行质量评价,从临床疗效、安全性、经济性等维度展开综合分析.结果 经筛选,共纳入17篇文献.研究品种主要包括头孢呋辛、头孢曲松与头孢哌酮-舒巴坦钠,覆盖成人与儿童不同感染人群及围手术期预防、临床抗感染治疗两大场景.结果显示,有效性上,多数研究显示集采头孢菌素注射剂与原研/进口仿制药在围手术期预防感染及治疗性抗感染中整体疗效相当,仅个别研究在次要指标上存在差异;安全性上,围手术期预防用药两组安全性无显著差异,治疗性应用场景中,多数研究证实两组安全性水平相当,仅部分研究的个别安全性指标结果存在差异;在经济性方面,集采药物可明显降低治疗相关费用,经济优势突出.结论 总体来看,集采头孢菌素类注射剂在临床有效性、安全性方面与原研药/进口仿制药基本一致,同时具有较优的经济性,可减轻患者就医负担.受纳入研究覆盖品种有限、多为单中心研究,样本量偏小等因素限制,相关研究证据仍有待完善,后续需开展大样本、多中心临床研究进一步夯实循证依据.

Objective Against the backdrop of the comprehensive promotion of the policy of centralized bulk procurement of drugs(referred to as"centralized procurement"),this study aims to systematically review and integrate relevant evidence on the effectiveness,safety,and cost-effectiveness of cephalosporin injectables under centralized procurement as presented in real-world studies,and compare their clinical performance with that of original research drugs/imported generic drugs.The goal is to provide an evidence-based basis for the rational use,clinical evaluation,and policy optimization of selected generic drugs in centralized procurement.Methods Retrieval of real-world research literature on centralized collection cephalosporin injections published from April 2021 to February 2026,comprehensive analysis was conducted from the dimensions of clinical efficacy,safety,and economy,and QATSM-RWS was used to evaluate the quality of the included studies.Results After screening,a total of 17 studies were included.The investigated medications primarily comprised cefuroxime,ceftriaxone,and cefoperazone-sulbactam sodium,covering diverse infectious populations in both adults and children,as well as two key clinical scenarios:perioperative infection prevention and therapeutic anti-infective treatment.The results demonstrated that,in terms of efficacy,most studies indicated comparable overall effectiveness between centrally procured cephalosporin injections and original/imported generic drugs for perioperative infection prevention and therapeutic anti-infective therapy,with only individual studies showing differences in secondary endpoints.Regarding safety,no significant differences were observed between the two groups for perioperative prophylaxis;in therapeutic applications,most studies confirmed equivalent safety profiles across both groups,with only certain safety indicators differing in specific studies.In terms of economy,centrally procured medications significantly reduced treatment-related expenses,demonstrating notable economic advantages.Conclusion Overall,centrally procured cephalosporin injections are basically consistent with original drugs/imported generic drugs in terms of clinical effectiveness and safety,while also offering superior cost-effectiveness,which can reduce patients' medical burden.Limited by factors such as the limited coverage of included research varieties,mostly single-center studies,and small sample sizes,relevant research evidence still needs to be improved.Large-sample,multi-center clinical studies need to be conducted in the future to further consolidate the evidence-based basis.

王美灵;王滕;郭玉金;孔维香

济宁市第一人民医院临床药学科,山东济宁 272000济宁市第一人民医院临床药学科,山东济宁 272000济宁市第一人民医院临床药学科,山东济宁 272000济宁市第一人民医院临床药学科,山东济宁 272000

医药卫生

药品集中带量采购头孢菌素类注射剂仿制药真实世界研究临床评价

centralized bulk procurement of drugscephalosporin injectionsgeneric drugsreal world researchclinical evaluation

《中国临床药理学杂志》 2026 (10)

1417-1423,7

山东省围手术期临床用药多领域科研公益项目(BH003159-CT202408020051)

10.13699/j.cnki.1001-6821.2026.10.011

评论