口服新霉素用于耐碳青霉烯类细菌去定植的疗效与安全性：一项开放标签随机对照试验

Efficacy and Safety of Oral Neomycin for the Decolonization of Carbapenem-Resistant : An Open-Label Randomized Controlled Trial.

作者信息

Tancharoen Lalita, Srisomnuek Ananya, Tiengrim Surapee, Thamthaweechok Narisara, Tangkorskul Teerawit, Thamlikitkul Visanu

机构信息

Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok 10700, Thailand.

Department of Research, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok 10700, Thailand.

出版信息

Antibiotics (Basel). 2024 Aug 20;13(8):781. doi: 10.3390/antibiotics13080781.

DOI:10.3390/antibiotics13080781

PMID:39200081

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11351571/

Abstract

BACKGROUND

Patients with carbapenem-resistant (CRE) in the gastrointestinal (GI) tract are at risk for subsequent infections and transmission, necessitating contact precautions. Neomycin has shown in vitro activity against CRE in 66-85% of isolates. This study evaluated the efficacy and safety of neomycin for CRE decolonization.

METHODS

In this open-label randomized controlled trial, stool/rectal swab samples from high-risk patients were collected and tested for CRE colonization in the GI tract. Patients who had CRE and met eligible criteria were divided into a neomycin group ( = 26; treated with 4.2 g/day neomycin for 5 days) and a control group ( = 26). CRE detection in stool/rectal swabs was performed on days 7 ± 2 and 14 ± 2.

RESULTS

The two groups' baseline characteristics were similar. CRE presence on day 7 ± 2 was significantly lower in the neomycin group (46.2%) than in the control group (80.8%, = 0.01). Efficacy of neomycin (4.2 g/day for 5 days) for CRE decolonization was 42.8-53.8% by day 7. By day 14 ± 2, the CRE rate in the neomycin group had risen to align with the control group's rate (73.1% vs. 61.5%, = 0.56). The neomycin group experienced mild, temporary, gastrointestinal side-effects.

CONCLUSIONS

Neomycin effectively reduced CRE colonization on day 7 ± 2, but its impact waned by day 14 ± 2. This suggests that neomycin dosage was too low and the duration of treatment was too short for lasting CRE decolonization.

摘要

背景

胃肠道中携带耐碳青霉烯类肠杆菌科细菌（CRE）的患者有发生后续感染及传播的风险，因此需要采取接触预防措施。新霉素对66%-85%的CRE分离株显示出体外活性。本研究评估了新霉素用于CRE去定植的疗效和安全性。

方法

在这项开放标签随机对照试验中，收集高危患者的粪便/直肠拭子样本，检测胃肠道中的CRE定植情况。携带CRE且符合入选标准的患者被分为新霉素组（n = 26；接受4.2 g/天新霉素治疗5天）和对照组（n = 26）。在第7±2天和第14±2天对粪便/直肠拭子进行CRE检测。

结果

两组的基线特征相似。新霉素组在第7±2天的CRE携带率（46.2%）显著低于对照组（80.8%，P = 0.01）。到第7天，新霉素（4.2 g/天，共5天）对CRE去定植的疗效为42.8%-53.8%。到第14±2天，新霉素组的CRE携带率上升至与对照组相当（73.1%对61.5%，P = 0.56）。新霉素组出现了轻度、短暂的胃肠道副作用。