真实世界中国产与进口替加环素治疗泛耐药鲍曼不动杆菌感染的有效性、安全性、经济性研究

Cohort study on efficacy,safety and economics of domestic and imported tigecycline in treatment of extensively drug resistant Acinetobacter baumannii infection in real world

目的比较国产与进口替加环素治疗泛耐药鲍曼不动杆菌感染的有效性、安全性和经济性,为临床药物选择提供依据。方法回顾性分析南部战区总医院2018年7月1日至2020年6月30日确诊为泛耐药鲍曼不动杆菌感染并使用国产或进口替加环素治疗的342例患者资料,其中国产组186例,进口组156例,采用1∶1最近邻匹配法进行倾向评分匹配,获得组间协变量较均衡的2组样本,以临床有效率和细菌学清除率评估疗效,以不良反应发生率评估安全性,以增量成本-效果分析进行经济性评价。结果倾向评分匹配后国产组和进口组最终各纳入122例患者。国产组和进口组的临床有效率分别为85.2%和86.9%,细菌学清除率分别为50.0%和54.1%,不良反应发生率分别为3.3%和2.5%,组间均无显著差异(P> 0.05)。增量成本效果分析显示,每使1例患者临床获益,进口组需要的增量药物治疗成本为105 233.52元。结论国产与进口替加环素在治疗泛耐药鲍曼不动杆菌感染的疗效和安全性相似,国产替加环素经济性优于进口替加环素。

AIM To compare the efficacy, safety and economics of domestic and imported tigecycline in the treatment of extensively drug resistant Acinetobacter baumannii(XDRAB) infection, so as to provide basis for clinical drug selection. METHODS The data of 342 patients diagnosed with XDRAB infection and treated with domestic(186 cases) or imported(156 cases) tigecycline in the General Hospital of Southern Theater Command from July 1, 2018 to June 30, 2020 were analyzed retrospectively. The two groups were subjected to propensity score matching(PSM) using the 1∶1 nearest neighbor matching method to obtain two groups of samples with balanced covariates. The curative effect was evaluated by clinical effective rate and bacteriological clearance rate, the safety was evaluated by the incidence of adverse reactions, and the economy was evaluated by incremental cost-effectiveness analysis. RESULTS After PSM, the domestic group and the imported group eventually included 122 patients respectively. The clinical effective rates were 85.2% and 86.9%, the bacteriological clearance rates were 50.0% and 54.1%, and the adverse reaction rates were 3.3% and 2.5% in the domestic group and the imported group respectively, without significant difference between the two groups(P > 0.05).The incremental cost-effectiveness analysis showed that the incremental drug treatment cost required by the imported group was 105 233.52 yuan for every patient clinically benefited. CONCLUSION Domestic and imported tigecycline have similar efficacy and safety in the treatment of XDRAB infection, and domestic tigecycline is more economical than imported tigecycline.