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随机临床试验:家庭肠外营养患者长期金黄色葡萄球菌去定植

Randomized clinical trial: Long-term Staphylococcus aureus decolonization in patients on home parenteral nutrition.

作者信息

Gompelman Michelle, Wezendonk Guus T J, Wouters Yannick, Beurskens-Meijerink Judith, Fragkos Konstantinos C, Rahman Farooq Z, Coolen Jordy P M, van Weerdenburg Ingrid J M, Wertheim Heiman F L, Kievit Wietske, Akkermans Reinier P, Serlie Mireille J, Bleeker-Rovers Chantal P, Wanten Geert J A

机构信息

Intestinal Failure Unit, Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, the Netherlands.

Intestinal Failure Unit, Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, the Netherlands.

出版信息

Clin Nutr. 2023 May;42(5):706-716. doi: 10.1016/j.clnu.2023.03.010. Epub 2023 Mar 17.

Abstract

BACKGROUND & AIMS: Staphylococcus aureus decolonization has proven successful in prevention of S. aureus infections and is a key strategy to maintain venous access and avoid hospitalization in patients receiving home parenteral nutrition (HPN). We aimed to determine the most effective and safe long-term S. aureus decolonization regimen.

METHODS

A randomized, open-label, multicenter clinical trial was conducted. Adult intestinal failure patients with HPN support and carrying S. aureus were randomly assigned to a 'continuous suppression' (CS) strategy, a repeated chronic topical antibiotic treatment or a 'search and destroy' (SD) strategy, a short and systemic antibiotic treatment. Primary outcome was the proportion of patients in whom S. aureus was totally eradicated during a 1-year period. Secondary outcomes included risk factors for decolonization failure and S. aureus infections, antimicrobial resistance, adverse events, patient compliance and cost-effectivity.

RESULTS

63 participants were included (CS 31; SD 32). The mean 1-year S. aureus decolonization rate was 61% (95% CI 44, 75) for the CS group and 39% (95% CI 25, 56) for the SD group with an OR of 2.38 (95% CI 0.92, 6.11, P = 0.07). More adverse effects occurred in the SD group (P = 0.01). Predictors for eradication failure were a S. aureus positive caregiver and presence of a (gastro)enterostomy.

CONCLUSION

We did not demonstrate an increased efficacy of a short and systemic S. aureus decolonization strategy over a continuous topical suppression treatment. The latter may be the best option for HPN patients as it achieved a higher long-term decolonization rate and was well-tolerated (NCT03173053).

摘要

背景与目的

金黄色葡萄球菌去定植已被证明在预防金黄色葡萄球菌感染方面是成功的,并且是维持接受家庭肠外营养(HPN)患者的静脉通路和避免住院的关键策略。我们旨在确定最有效且安全的长期金黄色葡萄球菌去定植方案。

方法

进行了一项随机、开放标签、多中心临床试验。成年肠衰竭且接受HPN支持并携带金黄色葡萄球菌的患者被随机分配至“持续抑制”(CS)策略组,即重复的慢性局部抗生素治疗;或“搜查并清除”(SD)策略组,即短期全身性抗生素治疗。主要结局是在1年期间金黄色葡萄球菌被完全根除的患者比例。次要结局包括去定植失败和金黄色葡萄球菌感染的危险因素、抗菌药物耐药性、不良事件、患者依从性和成本效益。

结果

纳入63名参与者(CS组31名;SD组32名)。CS组1年的金黄色葡萄球菌去定植率平均为61%(95%CI 44, 75),SD组为39%(95%CI 25, 56),比值比为2.38(95%CI 0.92, 6.11,P = 0.07)。SD组发生更多不良事件(P = 0.01)。根除失败的预测因素是护理人员金黄色葡萄球菌检测呈阳性以及存在(胃)肠造口术。

结论

我们未证明短期全身性金黄色葡萄球菌去定植策略比持续局部抑制治疗有更高的疗效。后者可能是HPN患者的最佳选择,因为它实现了更高的长期去定植率且耐受性良好(NCT03173053)。

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