头孢他啶/阿维巴坦治疗碳青霉烯类耐药肠杆菌感染疗效和安全性的Meta分析

The efficacy and safety of ceftazidime/avibactam therapy on carbapenem-resistant Enterobacteriaceae infections:a Meta-analysis

目的系统评价头孢他啶/阿维巴坦(ceftazidime/avibactam,CAZ/AVI)治疗耐碳青霉烯类肠杆菌/肺炎克雷伯菌(CRE/CRKP)感染的疗效和安全性,以期为临床治疗提供循证依据。方法计算机检索PubMed、Embase、The Cochrane Library、CBM、CNKI、VIP电子数据库,收集从建库起至2020年5月公开发表的使用CAZ/AVI治疗CRE/CRKP感染的研究,由2名评价员独立按纳入与排除标准筛选文献、提取资料并评价纳入研究的方法学质量后,采用RevMan 5.3统计软件对结果进行分析。结果共纳入5篇英文文献,合计392例患者。结果显示有效性方面:CAZ/AVI组患者临床治愈率[OR=3.57,95%CI(2.03,6.26),P<0.00001]显著高于对照组。CAZ/AVI组患者28 d/30 d全因病死率[OR=0.27,95%CI(0.14,0.50),P<0.0001]显著低于对照组。两组患者临床缓解率[OR=1.92,95%CI(0.93,3.97),P=0.08]和感染复发率[OR=0.44,95%CI(0.11,1.85),P=0.26]无显著性差异。安全性方面:CAZ/AVI组患者不良事件(AEs)[OR=0.29,95%CI(0.10,0.80),P=0.02]显著低于对照组,两组患者严重不良事件(SAEs)[OR=0.33,95%CI(0.09,1.19),P=0.09]无显著性差异。结论当前证据表明,CAZ/AVI治疗碳青霉烯类耐药菌感染具有生存优势且并不增加SAEs,安全性好。受纳入研究质量和数量限制,上述结论有待更多高质量的RCT加以验证。

Objective To systematically evaluate the efficacy and safety of ceftazidime/avibactam(CAZ/AVI)in the treatment of carbapenem-resistant Enterobacteriaceae(CRE)or carbapenem-resistance Klebsiella pneumonia(CRKP),and to provide evidence-cased reference for clinic therapy.Methods A comprehensive literature search from PubMed,Embase,the Cochrane Library,CBM,CNKI and VIP database was conducted for the CAZ/AVI therapy on CRE/CRKP infections published before May.2020.Two reviewers independently screened literatures according to the inclusion and exclusion criteria,extracted data,and assessed the methodological quality of the included studies.The results were analyzed by RevMan 5.3 statistical software.Results Five studies in English involving 392 patients were included for the analysis.In terms of effectiveness,the results showed CAZ/AVI group significantly increased the clinical cure rate[OR=3.57,95%CI(2.03,6.26),P<0.00001]compared with the control group.Also CAZ/AVI group significantly decreased the 28/30 day all-cause mortality[OR=0.27,95%CI(0.14,0.50),P<0.0001].There were no significant difference between the two groups in the clinical remission rate[OR=1.92,95%CI(0.93,3.97),P=0.08]and the infection recurrence rate[OR=0.44,95%CI(0.11,1.85),P=0.26].In terms of safety,the incidence of adverse events in CAZ/AVI group were lower than those in control group[OR=0.29,95%CI(0.10,0.80),P=0.02].There was no significant difference between two groups in the incidence of serious adverse events[OR=0.33,95%CI(0.09,1.19),P=0.09].Conclusion The current evidence shows that CAZ/AVI therapy has advantage in survival rate for the treatment of CRE/CRKP infections without increase of SAEs.Limited by the quality and quantity of the included studies,the above conclusions need to be verified with more high-quality RCTs.