Zhang Yue, Tao Li-Na, Qu Xiao-Yu, Niu Jun-Qi, Ding Yan-Hua, Zhang Si-Xi
Department of Pharmacy, The First Hospital, Jilin University, Changchun, China.
Department of Hepatology, The First Hospital, Jilin University, Changchun, China.
Rev Assoc Med Bras (1992). 2018 Mar;64(3):253-263. doi: 10.1590/1806-9282.64.03.253.
The aim of this study was to assess the efficacy and safety of ceftazidime-avibactam in the treatment of complicated intra-abdominal infections (CIAIs) and complicated urinary tract infections (CUTIs) with meta-analysis method.
We included six randomized clinical trials identified from Medline, Embase, Cochrane Library, "ISRCTN Register" and "ClinicalTrials.gov" which compared ceftazidime-avibactam with comparison group. The meta-analysis was performed using Review Manager software version 5.3.
Ceftazidime-avibactam versus active comparisons demonstrated a statistically significant higher rate of microbiological response success on microbiological evaluable populations at the test-of-cure visit (95CI 1.10-2.38, p=0.02) and late-follow-up visit (95CI 1.09-2.23, p=0.02) for the treatment of CUTIs. Ceftazidime-avibactam versus active comparisons demonstrated a statistically significant higher rate of microbiological response success on EME populations at the test-of-cure visit (95CI 1.08-4.27, p=0.03) and late-follow-up visit (OR=1.75, 95CI 1.33-2.29, p<0.0001) for the treatment of CUTIs. Similar results were obtained at the late-follow-up visit (OR = 1.58, 95CI 1.26-1.97, p<0.0001) on microbiologically modified intent-to-treat (mMITT) populations for the treatment of CUTIs. We can find better eradication rates for E. coli and Klebsiella pneumoniae based on mMITT populations. In terms of AEs, SAEs and mortality, ceftazidime-avibactam had a safety and tolerability profile broadly similar to the comparison group.
This meta-analysis provides evidence of the efficacy of ceftazidime-avibactam as a potential alternative for the treatment of patients with CUTIs, and CIAIs.
本研究旨在采用荟萃分析方法评估头孢他啶-阿维巴坦治疗复杂性腹腔内感染（CIAIs）和复杂性尿路感染（CUTIs）的疗效和安全性。
我们纳入了从Medline、Embase、Cochrane图书馆、“ISRCTN注册库”和“ClinicalTrials.gov”中识别出的六项随机临床试验，这些试验将头孢他啶-阿维巴坦与对照组进行了比较。使用Review Manager 5.3版软件进行荟萃分析。
在治疗CUTIs方面，与活性对照相比，头孢他啶-阿维巴坦在治疗结束访视时（95%CI 1.10 - 2.38，p = 0.02）和后期随访时（95%CI 1.09 - 2.23，p = 0.02），在微生物可评估人群中显示出微生物学反应成功的比例在统计学上显著更高。在治疗CUTIs方面，与活性对照相比，头孢他啶-阿维巴坦在治疗结束访视时（95%CI 1.08 - 4.27，p = 0.03）和后期随访时（OR = 1.75，95%CI 1.33 - 2.29，p < 0.0001）在可评价微生物学证据（EME）人群中显示出微生物学反应成功的比例在统计学上显著更高。在后期随访时（OR = 1.58，95%CI 1.26 - 1.97，p < 0.0001），在微生物学改良意向性治疗（mMITT）人群中治疗CUTIs也获得了类似结果。基于mMITT人群，我们发现大肠杆菌和肺炎克雷伯菌的根除率更高。在不良事件（AEs）、严重不良事件（SAEs）和死亡率方面，头孢他啶-阿维巴坦的安全性和耐受性与对照组大致相似。
这项荟萃分析为头孢他啶-阿维巴坦作为治疗CUTIs和CIAIs患者的潜在替代药物的疗效提供了证据。
