基于多中心真实世界数据的集采注射用头孢曲松治疗细菌性感染的临床综合评价

Comprehensive clinical evaluation of centralized procurement ceftriaxone for injection in the treatment of bacterial infections based on multicenter real-world data

目的:通过真实世界研究比较集采与非集采注射用头孢曲松治疗细菌性感染患者的临床综合价值,为集采政策的更好落地执行提供参考。方法:回顾性收集17家中心集采与非集采注射用头孢曲松真实世界数据,借助倾向性评分匹配(PSM)方法平衡组间差异,从有效性、安全性、经济性和适宜性开展临床综合评价。结果:PSM后,集采组与非集采组各纳入510例患者进行分析。有效性评价:集采与非集采注射用头孢曲松的临床有效率、72 h有效率、细菌学疗效及感染相关指标(体温、WBC、NEUT、NEUT%、CRP、PCT)恢复至正常范围的患者比例组间均无统计学差异(P>0.05)。安全性评价:不良事件(AEs)发生率和AEs相关指标(WBC、Hb、PLT、EOS、ALT、Urea)异常率2组间均无显著性差异(P>0.05),且2组均未发生TBiL异常;而集采组NEUT、AST、Cr异常率低于非集采组(P<0.05)。经济性评价:最小成本法显示,集采注射用头孢曲松的住院总费用、住院期间总药品费用及总抗菌药物费用低于非集采组(P<0.01);且单因素敏感性分析与最小成本法分析结果一致。适宜性评价:集采注射用头孢曲松在适宜性评分高于非集采品种(95.5分vs.93分)。结论:集采注射用头孢曲松有效性不劣于非集采,安全性两者相当,集采较非集采更具经济学优势,且集采适宜性较非集采不同程度上体现一定优势。

OBJECTIVE To compare the comprehensive clinical value of injectable ceftriaxone from centralized and noncentralized procurement in the treatment of bacterial infection patients through real-world study,and to provide reference for better implementation of centralized procurement policy.METHODS Real-world data of injectable ceftriaxone from centralized and non-centralized procurement were retrospectively collected from 17 centers.The PSM analysis method was used to balance the differences between the groups,and a comprehensive clinical evaluation was carried out from the perspective of effectiveness,safety,economy,and suitability.RESULTS After PSM,510 patients were included in the centralized-procurement group and another 510 patients in the non-centralized-procurement group.Effectiveness evaluation:there were no significant differences in clinical effective rate,72 h effective rate,bacteriological efficacy,and the infection-related indicators(body temperature,WBC,NEUT,NEUT%,CRP,PCT)returned to the normal ranges between the two groups(P>0.05).Safety evaluation:the incidence of AEs and the abnormality rate of AEs-related indicators(WBC,Hb,PLT,EOS,ALT,Urea)were not significantly different between the two groups(P>0.05),and no TBiL abnormality occurred in either group;nonetheless,the abnormal rates of NEUT,AST and Cr in the centralized procurement group were lower than those in the non-centralized procurement group(P<0.05).Economic evaluation:the cost-minimization analysis showed that the total hospitalization cost,total drug cost during hospitalization,and total antibacterial drug cost of the centralized procurement group were lower than those of the non-centralized procurement group(P<0.01);and the results of univariate sensitivity analysis were consistent with those of cost-minimization analysis.Suitability evaluation:the suitability score of ceftriaxone from centralized procurement was higher than that from noncentralized procurement(95.5 vs.93).CONCLUSION The effectiveness of centralized procurement of ceftriaxone for injection is not inferior to non-centralized procurement,and the safety is equivalent as well.However,centralized procurement has more economic advantages than non-centralized procurement,and the suitability of centralized procurement reflects certain advantages to varying degrees compared to that of non-centralized procurement.