哌拉西林-他唑巴坦、头孢吡肟和厄他培南治疗产超广谱β-内酰胺酶大肠埃希菌所致尿路感染的随机对照试验
Randomized controlled trial of piperacillin-tazobactam, cefepime and ertapenem for the treatment of urinary tract infection caused by extended-spectrum beta-lactamase-producing Escherichia coli.
作者信息
Seo Yu Bin, Lee Jacob, Kim Young Keun, Lee Seung Soon, Lee Jeong-A, Kim Hyo Youl, Uh Young, Kim Han-Sung, Song Wonkeun
机构信息
Division of Infectious Diseases, Department of Internal Medicine, Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Republic of Korea.
Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Republic of Korea.
出版信息
BMC Infect Dis. 2017 Jun 7;17(1):404. doi: 10.1186/s12879-017-2502-x.
BACKGROUND
Due to limited therapeutic options, the spread of extended-spectrum beta-lactamases (ESBLs) have become a major public health concern. We conducted a prospective, randomized, open-label comparison of the therapeutic efficacy of piperacillin-tazobactam (PTZ), cefepime, and ertapenem in febrile nosocomial urinary tract infection with ESBL-producing Escherichia coli (ESBL-EC).
METHODS
This study was conducted at three university hospitals between January 2013 and August 2015. Hospitalized adult patients presenting with fever were screened for healthcare-associated urinary tract infection (HA-UTI). When ESBL-EC was solely detected and susceptible to a randomized antibiotic in vitro, the case was included in the final analysis. Participants were treated for 10-14 days with PTZ, cefepime, or ertapenem.
RESULTS
A total of 66 participants were evenly assigned to the PTZ and ertapenem treatment groups. After the recruitment of six participants, assignment to the cefepime treatment group was stopped because of an unexpectedly high treatment failure rate. The baseline characteristics of these participants did not differ from participants in other treatment groups. The clinical and microbiological response to PTZ treatment was estimated to be 94% and was similar to the response to ertapenem treatment. The efficacy of cefepime was 33.3%. In the cefepime group, age, Charlson comorbidity index, genotype, and minimal inhibitory concentration (MIC) did not significantly affect the success of treatment. Similarly, genotype seemed to be irrelevant with respect to clinical outcome in the PTZ group. Expired cases tended to involve septic shock with a high Charlson comorbidity index and high MIC.
CONCLUSION
Results from this study suggest that PTZ is effective in the treatment of urinary tract infection caused by ESBL-EC when the in vitro test indicates susceptibility. In addition, cefepime should not be used as an alternative treatment for urinary tract infection caused by ESBL-EC.
TRIAL REGISTRATION
The trial was registered with the Clinical Research Information Service of Korea Centers for Disease Control and Prevention. (KCT0001895).
背景
由于治疗选择有限，超广谱β-内酰胺酶（ESBLs）的传播已成为一个主要的公共卫生问题。我们进行了一项前瞻性、随机、开放标签的比较研究，以评估哌拉西林-他唑巴坦（PTZ）、头孢吡肟和厄他培南治疗产ESBLs的大肠埃希菌（ESBL-EC）所致发热性医院获得性尿路感染的疗效。
方法
本研究于2013年1月至2015年8月在三家大学医院进行。对出现发热的住院成年患者进行医疗相关尿路感染（HA-UTI）筛查。当仅检测到ESBL-EC且在体外对随机分配的抗生素敏感时，该病例纳入最终分析。参与者接受PTZ、头孢吡肟或厄他培南治疗10-14天。
结果
共有66名参与者被平均分配到PTZ和厄他培南治疗组。招募6名参与者后，由于治疗失败率意外高，停止了头孢吡肟治疗组的分配。这些参与者的基线特征与其他治疗组的参与者没有差异。PTZ治疗的临床和微生物学反应估计为94%，与厄他培南治疗的反应相似。头孢吡肟的疗效为33.3%。在头孢吡肟组中，年龄、Charlson合并症指数、基因型和最低抑菌浓度（MIC）对治疗成功没有显著影响。同样，在PTZ组中，基因型似乎与临床结局无关。死亡病例往往涉及败血症性休克，Charlson合并症指数高且MIC高。
结论
本研究结果表明，当体外试验显示敏感时，PTZ对治疗ESBL-EC所致尿路感染有效。此外，头孢吡肟不应作为ESBL-EC所致尿路感染的替代治疗药物。
试验注册
该试验已在韩国疾病控制与预防中心临床研究信息服务中心注册。（KCT0001895）
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