中国临床药理学杂志2026,Vol.42Issue(10):1417-1423,7.DOI:10.13699/j.cnki.1001-6821.2026.10.011
集采头孢菌素类注射剂真实世界研究进展
Real world research progress on centralized purchasing of cephalosporin injections
摘要
Abstract
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.关键词
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Key words
centralized bulk procurement of drugs/cephalosporin injections/generic drugs/real world research/clinical evaluation分类
医药卫生引用本文复制引用
王美灵,王滕,郭玉金,孔维香..集采头孢菌素类注射剂真实世界研究进展[J].中国临床药理学杂志,2026,42(10):1417-1423,7.基金项目
山东省围手术期临床用药多领域科研公益项目(BH003159-CT202408020051) (BH003159-CT202408020051)