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达巴万星和奥利万星治疗革兰阳性感染的适应证内和适应证外使用。

On- and off-label utilization of dalbavancin and oritavancin for Gram-positive infections.

机构信息

Department of Clinical Pharmacy, University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences, Aurora, CO, USA.

Department of Pharmacy-Infectious Diseases, University of Colorado Hospital, Aurora, CO, USA.

出版信息

J Antimicrob Chemother. 2019 Aug 1;74(8):2405-2416. doi: 10.1093/jac/dkz162.

DOI:10.1093/jac/dkz162
PMID:31322694
Abstract

BACKGROUND

Long-acting lipoglycopeptides (laLGPs) are FDA approved only for acute bacterial skin and skin structure infections (ABSSSIs). However, these antibiotics show promise for off-label use, reductions in hospital length of stay (LOS) and healthcare cost savings.

OBJECTIVES

To assess the effectiveness, safety, impact on LOS and estimated cost savings from laLGP treatment for Gram-positive infections.

METHODS

Retrospective cohort of adult patients who received at least one dose of laLGPs at the University of Colorado Health system. Descriptive statistics were utilized for analysis.

RESULTS

Of 59 patients screened, 56 were included: mean age 47 years, 59% male and 30% injection drug users/polysubstance abusers (dalbavancin, 71%; oritavancin, 25%; both, 4%). Most common indications for laLGP: ABSSSIs (36%), osteomyelitis (27%) and endocarditis (9%). Most common isolated pathogens: MSSA and MRSA (25% and 19%, respectively), Enterococcus faecalis (11%) and CoNS (11%). Previous antibiotics were administered for a median of 13 days (IQR = 7.0-24.5 days) and laLGPs for a median of one dose (IQR = 1-2 doses). Ten (18%) patients were lost to follow-up. Clinical failure was found in 7/47 (15%) cases with adequate follow-up. Mild adverse effects occurred in six (11%) patients. Projected reduction in hospital LOS and health-system costs were 514 days (9.18 days/person average) and $963456.72 ($17204.58/person average), respectively.

CONCLUSIONS

Prospective trials are needed to validate the use of these antibiotics for Gram-positive infections in practice, with the hope that they will reduce hospital LOS and the need for daily antibiotic infusions to provide alternative options for patients not qualifying for outpatient parenteral antimicrobial therapy.

摘要

背景

长效糖肽类抗生素(laLGPs)仅获得美国食品药品监督管理局(FDA)批准用于治疗急性细菌性皮肤和皮肤结构感染(ABSSSIs)。然而,这些抗生素具有成为非适应证用药的潜力,可以减少住院时间(LOS)和节省医疗保健成本。

目的

评估 laLGP 治疗革兰氏阳性感染的疗效、安全性、对 LOS 的影响以及估计的成本节约。

方法

回顾性分析在科罗拉多大学健康系统接受至少一剂 laLGPs 的成年患者队列。采用描述性统计分析方法进行数据分析。

结果

在筛选的 59 名患者中,有 56 名患者入组:平均年龄 47 岁,59%为男性,30%为注射吸毒者/药物滥用者(达巴万星,71%;或利伐万古霉素,25%;两者均用,4%)。laLGP 的主要适应证为 ABSSSIs(36%)、骨髓炎(27%)和心内膜炎(9%)。最常见的分离病原体:金黄色葡萄球菌和耐甲氧西林金黄色葡萄球菌(分别为 25%和 19%)、粪肠球菌(11%)和凝固酶阴性葡萄球菌(11%)。之前使用的抗生素中位治疗时间为 13 天(IQR = 7.0-24.5 天),laLGPs 的中位治疗剂量为 1 剂(IQR = 1-2 剂)。10 名(18%)患者失访。在 47 名(15%)有充分随访的患者中,发现 7 例(15%)临床治疗失败。6 名(11%)患者出现轻度不良反应。预计住院 LOS 和医疗系统成本分别减少 514 天(9.18 天/人)和 963456.72 美元(17204.58 美元/人)。

结论

需要前瞻性试验来验证这些抗生素在实践中治疗革兰氏阳性感染的效果,希望它们能减少住院 LOS 和每日抗生素输注的需求,为不符合门诊肠外抗菌治疗条件的患者提供替代治疗方案。

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