头孢洛扎/他唑巴坦治疗革兰氏阴性菌感染的meta分析  

Meta-analysis of randomized controlled trials of ceftolozane-tazobactam for gram-negative bacteria infections

作　　者：胡琴 唐博文[4] 刘韶 陈敬兰[1] 门鹏 邓晟[1] HU Qin;TANG Bo-wen;LIU Shao;CHEN Jing-lan;MEN Peng;DENG Sheng(Department of Pharmacy,Xiangya Hospital,Central South University,Changsha 410008;Institute of Hospital Administration,Central South University,Changsha 410008;Xiangya Health Development Research Center,Changsha 410008;Xiangya School of Pharmaceutical Sciences,Central South University,Changsha 410013;Department of Pharmacy,Third Hospital of Peking University,Beijing 100191)

机构地区：[1]中南大学湘雅医院药学部,长沙410008 [2]中南大学医院管理研究所,长沙410008 [3]湘雅卫生与健康发展研究中心,长沙410008 [4]中南大学湘雅药学院,长沙410013 [5]北京大学第三医院药剂科,北京100191

出　　处：《中南药学》2022年第8期1736-1742,共7页Central South Pharmacy

基　　金：湖南省自然科学基金科药联合基金(No.2022JJ80045);中南大学湘雅医院管理科研基金(No.2019GL08)。

摘　　要：目的评价头孢洛扎/他唑巴坦治疗革兰氏阴性菌感染的临床疗效、微生物学反应和安全性。方法利用计算机检索Cochrane Library、Embase、PubMed三个外文数据库和万方数据知识服务平台、知网、维普中文科技期刊全文数据库三个中文数据库,纳入比较头孢洛扎/他唑巴坦与对照组治疗细菌感染的有效性和安全性的随机对照试验(RCTs)。主要结局指标为临床治愈率和细菌清除率,次要结局指标为不良事件发生率、严重不良事件发生率和全因病死率。两名研究员独立提取并分析数据,评价偏倚风险并使用Review Manager 5.3进行meta分析。结果共纳入4项研究,涉及2924例患者。Meta分析结果表明,在微生物学改良意向治疗(mMITT)人群(OR=0.92,95%CI:0.68~1.23,P=0.55)和临床可评价人群(OR=1.07,95%CI:0.80~1.43,P=0.63)中,头孢洛扎/他唑巴坦治疗细菌感染的临床治愈率不亚于对照组。头孢洛扎/他唑巴坦对肠杆菌科(OR=1.55,95%CI:1.18~2.03,P=0.002)和大肠埃希菌属亚组(OR=1.91,95%CI:1.27~2.88,P=0.002)有较强的微生物清除能力。此外,头孢洛扎/他唑巴坦与对照组在不良事件发生率(OR=1.07,95%CI:0.91~1.26,P=0.41)、严重不良事件发生率(OR=1.25,95%CI:0.87~1.78,P=0.22)以及全因病死率(OR=1.02,95%CI:0.75~1.39,P=0.91)方面没有显著差异。结论在治疗革兰氏阴性菌感染时,头孢洛扎/他唑巴坦与一线治疗方案相比在临床治愈率方面具有非劣效性,并具有更好的细菌清除率,且安全性良好。Objective To assess the clinical efficacy,safety and microbiological responses of ceftolozane-tazobactam for gram-negative bacteria infections by meta-analysis.Methods The systematic review and meta-analysis of randomized controlled trials(RCTs)was conducted to determine the efficacy and safety of ceftolozane-tazobactam for bacterial infections.Electronic databases such as the Cochrane library,Embase,PubMed,and three Chinese databases were searched for RCTs of ceftolozane-tazobactam for bacterial infections(infection sites not limited).The primary outcomes included the clinical cure rate and bacterial clearance rate,whereas the secondary outcomes covered the risk of adverse events(AEs),risk of serious adverse events and all-cause mortality.Two reviewers independently assessed the risk of bias,collected and analyzed the data.The meta-analysis was performed with Review Manager 5.3.Results Four RCTs involving 2924 patients were ultimately included.The ceftolozane-tazobactam combination obtained a clinical outcome non-inferior to that of the control group in the treatment of bacterial infection in both the microbiologically modified intention-to-treat(mMITT)population group(OR=0.92,95%CI:0.68-1.23,P=0.55)and the clinically evaluable population group(OR=1.07,95%CI:0.80-1.43,P=0.63).Besides,ceftolozane-tazobactam had a stronger microbiological eradication rate for Enterobacteriaceae(OR=1.55,95%CI:1.18-2.03,P=0.002)and the subgroup of Escherichia coli(OR=1.91,95%CI:1.27-2.88,P=0.002).Furthermore,no significant differences were found between ceftolozane-tazobactam and the control group in the risk of AEs(OR=1.07,95%CI:0.91-1.26,P=0.41),serious AEs(OR=1.25,95%CI:0.87-1.78,P=0.22)or all-cause mortality(OR=1.02,95%CI:0.75-1.39,P=0.91).Conclusion In the treatment of bacterial infections,the efficacy of ceftolozane-tazobactam is as good as that of first-line drugs,with better microbiological responses safety and tolerance.

关 键 词：头孢洛扎/他唑巴坦 有效性 细菌清除率 安全性 META分析 

分 类 号：R96[医药卫生—药理学]