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一项随机、对照试验,研究普卢利沙星作为三代头孢菌素耐药病原体引起的急性肾盂肾炎静脉用碳青霉烯类药物治疗后的转换治疗:一项初步研究。

A randomized, controlled trial of prulifloxacin as conversion therapy after intravenous carbapenem in the treatment of acute pyelonephritis caused by third generation cephalosporin resistant pathogens: A pilot study.

机构信息

Faculty of Pharmacy, Siam University, Bangkok, Thailand.

Department of Medicine, Taksin Hospital, Bangkok, Thailand.

出版信息

Clin Transl Sci. 2023 Dec;16(12):2709-2718. doi: 10.1111/cts.13665. Epub 2023 Oct 28.

Abstract

The efficacy of converting to oral fluoroquinolones after initial intravenous antibiotics for the treatment of acute pyelonephritis (APN) caused by the third-generation cephalosporin resistant Enterobacteriaceae (3-GCrEC) needs to be investigated. The objective was to compare the clinical and bacteriological outcome of oral prulifloxacin with intravenous ertapenem for the treatment of APN caused by 3-GCrEC. A pilot, randomized controlled trial of patients with APN caused by 3-GCrEC was conducted at two hospitals from August 2015 to December 2020. Any intravenous antimicrobial drug was initially permitted for empirical therapy. On day 4, adult patients (aged >18 years) with either non-bacteremic or bacteremic APN were eligible for the study if their infection was caused by 3-GCrEC susceptible to the study drugs. The patients were randomly assigned to receive either oral prulifloxacin or intravenous ertapenem. The total duration of antimicrobial therapy was 14 days. Of the 21 enrolled patients, 11 were treated with prulifloxacin, and 10 were treated with ertapenem. At the test of cure visit, there was no statistically significant difference between the patients with overall clinical success who were treated with prulifloxacin (90.9%) and those treated with ertapenem (100%, p = 0.999). In addition, there was no statistically significant difference in microbiological eradication between the prulifloxacin and ertapenem groups (100% vs. 100%, p = 0.999). The converting to oral prulifloxacin after intravenous antibiotics therapy appears to be an alternative option for treatment of APN caused by 3-GCrEC. A further large randomized controlled trial should be investigated.

摘要

对于初始静脉用抗生素治疗后转换为口服氟喹诺酮类药物治疗第三代头孢菌素耐药肠杆菌科(3-GCrEC)引起的急性肾盂肾炎(APN)的疗效,仍需进一步研究。本研究旨在比较口服普卢利沙星与静脉用厄他培南治疗 3-GCrEC 引起的 APN 的临床和细菌学结局。2015 年 8 月至 2020 年 12 月,在两家医院开展了一项针对由 3-GCrEC 引起的 APN 患者的试点、随机对照试验。初始经验性治疗时可使用任何静脉用抗菌药物。第 4 天,如果感染是由对研究药物敏感的 3-GCrEC 引起的、且为非菌血症或菌血症性 APN 的成年患者(年龄>18 岁),则符合入组条件。患者被随机分配接受口服普卢利沙星或静脉用厄他培南治疗。抗菌治疗的总疗程为 14 天。在 21 名入组患者中,11 名患者接受普卢利沙星治疗,10 名患者接受厄他培南治疗。在治愈测试访视时,接受普卢利沙星治疗的患者(90.9%)和接受厄他培南治疗的患者(100%)在总体临床成功率方面无统计学差异(p=0.999)。此外,普卢利沙星组和厄他培南组在微生物学清除率方面无统计学差异(100%vs.100%,p=0.999)。在静脉用抗生素治疗后转换为口服普卢利沙星治疗似乎是治疗由 3-GCrEC 引起的 APN 的一种替代选择。需要进一步开展大型随机对照试验进行研究。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5410/10719478/eec50c5f895d/CTS-16-2709-g002.jpg

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