头孢他啶/阿维巴坦治疗革兰氏阴性菌感染的疗效和安全性荟萃分析  

Evaluation of the efficacy and safety of ceftazid-ime/avibactam in the treatment of Gramnegative bacterial infections:a metaanalysis

作　　者：李世琪 张颖 王淑君[2] LI Shiqi;ZHANG Ying;WANG Shujun(School of Life Sciences and Biopharmaceaticals,Shenyang Pharmacentical University,Shenyang 110016,China;School of Pharmacy,Shenyang Pharmaceatical University,Shenyang 110016,China)

机构地区：[1]沈阳药科大学生命科学与生物制药学院,辽宁沈阳110016 [2]沈阳药科大学药学院,辽宁沈阳110016

出　　处：《沈阳药科大学学报》2021年第11期1236-1247,1254,共13页Journal of Shenyang Pharmaceutical University

摘　　要：目的系统评估头孢他啶/阿维巴坦(CAZ/AVI)应用于革兰氏阴性菌感染患者的疗效和安全性。方法检索PubMed,EMBASE和Cochrane Library等数据库,查找涉及CAZ/AVI治疗革兰氏阴性菌感染的随机对照试验研究。筛选符合标准的文献,并进行质量评价,提取有效数据进行荟萃分析。结果共纳入14篇随机对照试验研究(7589例患者),荟萃分析结果显示:(1)在不考虑病原体、感染类型等情况下,对于临床反应TOC终点,CAZ/AVI的疗效与碳青霉烯类等对照药物相当(RR=0.986,95%CI:0.967~1.006);对于临床反应EOT终点,CAZ/AVI的疗效稍逊于碳青霉烯类等对照药物(RR=0.976,95%CI:0.957~0.996),P值0.019;亚组分析结果表明在不同感染类型中,CAZ/AVI的疗效与碳青霉烯类等其他对照药物相当,在儿童人群中,对于临床反应TOC终点CAZ/AVI的疗效与碳青霉烯类等对照药物相当。(2)在不考虑病原体、感染类型等情况下,对于微生物根除TOC终点,CAZ/AVI的疗效与碳青霉烯类等其他对照药物相当(RR=1.085,95%CI:0.981~1.199),P值0.113,亚组分析结果表明在复杂性尿路感染治疗中,CAZ/AVI的疗效优于碳青霉烯类等其他对照药物。(3)安全性分析:CAZ/AVI组和对照组不良事件发生率以及死亡率没有显著差异(RR=1.022,95%CI:0.973~1.074)和(RR=1.246,95%CI:0.940~1.651),但严重不良事件发生率CAZ/AVI组显著高于对照组(RR=1.317,95%CI:1.088~1.593),P值0.005。结论CAZ/AVI可用作治疗革兰氏阴性细菌感染时的替代方案,但在使用时应考虑到其较高的严重不良事件发生率。Objective To systematically evaluate the effectiveness and safety of ceftazidime/avibactam(CAZ/AVI)used in patients with Gram-negative bacteria infection.Methods The Pubmed,Embase,and the Cochrane Librar-y databases were searched up to December 2019.Screened the papers that meet the criteria,evaluate the quality of t-he papers,and extract valid data from them for meta analysis.Results 14 RCTs(7589 patien-ts)were included.Meta analysis results,(1)Regardless of the pathogen,the type of infection,etc.In terms of clinical response TOC e-ndpoint,the efficacy of CAZ/AVI was comparable to control drugs such as carbapenem(RR=0.986,95%CI:0.967~1.006);In terms of clinical response EOT endpoint,the efficacy of CAZ/AVI was less than control drugs such as carbapenem(RR=0.976,95%CI:0.957~0.996),P value 0.019.In terms of clinical response(subgroup analy-sis),in different infection types,the efficacy of CAZ/AVI was comparable to other control drugs such as carbapen-ems.For children,the efficacy of CAZ/AVI for the clinical response to the TOC endpoint was comparable to cont-rol drugs such as carbapenem.(2)Regardless of the pathogen,the type of infection,etc.In terms of microbial eradi-cation TOC endpoint,the efficacy of CAZ/AVI was comparable to control drugs such as carbapenem RR=1.085,95%CI:0.981~1.199),P value 0.113.The results of subgroup analysis showed that CAZ/AVI was more effective th-an carbapenems and other control drugs in the treatment of complex urinary tract infection.(3)In terms of safety a-bout adverse events and mortality,there was no significant difference between the CAZ/AVI group and the contro-l group(RR=1.022,95%CI:0.973~1.074)and(RR=1.246,95%CI:0.940~1.651),but the incidence of serious adverse events was significantly higher in the CAZ/AVI group than in the control group(RR=1.317,95%CI:1.088~1.593),P value 0.005.Conclusion CAZ/AVI can be used as an alternative for the treatment of gram-negative bacterial infections,but its higher SAE risk should be considered.

关 键 词：头孢他啶/阿维巴坦 革兰氏阴性菌感染 疗效 安全性 荟萃分析 

分 类 号：R917[医药卫生—药物分析学]