基于多中心真实世界数据的集采有效性、安全性和经济性评价——以替加环素为例  

Evaluation of Efficacy,Safety and Economics of Centralized Procurement Based on Multicentre Real-World Data——Taking Tigecycline as an Example

作　　者：邓雨琴 毛盼盼[1] 刘璐 李香荷 罗青 刘苗苗 何姣 李兴德[1] 王胤佳[1] 程瑶瑶 宋沧桑[1] 

机构地区：[1]昆明市第一人民医院,昆明650011 [2]普洱市人民医院,普洱665000 [3]昆明同仁医院,昆明650228 [4]昆明医科大学附属甘美医院,昆明650000

出　　处：《中国医疗保险》2024年第5期109-115,共7页China Health Insurance

基　　金：云南省卫生健康委员会“临床药学中心建设项目”;云南省卫生健康委员会“医学领军人才培养计划项目”(L-2018012);昆明市卫生健康委员会卫生科研课题项目“基于多中心真实世界数据的原研药与仿制药注射用替加环素临床综合评价”(2022-13-01-013)。

摘　　要：目的:比较集采与原研替加环素治疗细菌性感染患者的有效性、安全性和经济性,为临床药物选择提供依据。方法:回顾性收集三家医疗机构2019年7月—2023年7月使用集采与原研替加环素治疗的318例患者资料,其中原研组109例、集采组209例,采用倾向性评分匹配获得组间协变量均衡的2组样本,以临床有效率、28d死亡率、细菌学清除率和感染相关指标评估疗效,以不良反应发生率和不良事件异常率评估安全性,以最小成本分析法评价经济性。结果:经过倾向性评分匹配后,集采与原研组各86例。集采与原研组的临床有效率、28d死亡率、细菌学清除率、WBC、NEUT、NEUT%、hsCRP/CRP、IL-6、PCT恢复效果无统计学差异(P>0.05);原研组体温恢复至正常范围的患者比例较集采组高(P<0.05)。集采与原研组不良反应发生率组间无统计学差异(P>0.05)。集采组凝血酶原时间延长的发生率高于原研组(P<0.05),其余不良事件相关指标异常发生率组间均无统计学意义(P>0.05)。最小成本法显示,集采组的替加环素费用、住院期间总抗菌药物费用、住院期间总药品费用及住院总费用低于原研组(P<0.01);且在敏感性分析的参数浮动范围内,与最小成本法分析结果一致。结论:集采与原研替加环素抗细菌感染的疗效和安全性总体相似,集采较原研替加环素更具经济学优势。Objective:The paper compares the efficacy,safety and economics of centralized procurement and original tigecycline in the treatment of patients with bacterial infection to provide evidence for clinical drug selection.Methods:Data of 318 patients treated with centralized procurement(209 cases)and original(109 cases)tigacycline from 3 hospitals from July 2019 to July 2023 were retrospectively collected.The two groups of samples with balanced covariates were obtained by propensity score matching(PSM).The efficacy was evaluated by clinical effective rate,28d mortality rate,bacteriological clearance rate and infection-related indicators,the safety was evaluated by the incidence of adverse reactions and abnormal rate of adverse events,and the economics was evaluated by the cost-minimization analysis.Results:After PSM,the centralized procurement group and the original group included 86 patients respectively.There was no significant difference in clinical effective rate,28d mortality rate,bacteriological clearance rate,WBC,NEUT,NEUT%,hsCRP/CRP,IL-6 and PCT recovery between the two groups(P>0.05).The proportion of patients whose body temperature returned to the normal range in the original group was higher than that in the centralized procurement group(P<0.05).There was no statistically significant difference in the incidence of adverse reactions between the centralized procurement and original research groups(P>0.05).The incidence of PT extension in the centralized procurement group was higher than that in the original group(P<0.05),and there was no significant difference in the abnormal rate of other adverse event-related indicators between the groups(P>0.05).The cost-minimization analysis showed that the cost of tigacycline,total antibacterial drug cost,total drug cost and total hospitalization cost in the centralized procurement group were lower than those in the original group(P<0.01).Moreover,within the range of parameters for sensitivity analysis,the results were consistent with those of cost-minimization analysis.

关 键 词：替加环素 集中采购 真实世界数据 

分 类 号：F840.684[经济管理—保险]