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瑞典一家三级医院使用达巴万星进行超说明书治疗复杂革兰氏阳性感染的五年真实世界经验。

Five-year real-world experience with off-label dalbavancin treatment for complex gram-positive infections at a Swedish tertiary hospital.

作者信息

Hall Anna, Månsson Emeli, Krifors Anders

机构信息

Department of Infectious Diseases, Hospital of Västmanland, Västerås, Sweden.

Centre for Clinical Research, Västmanland Hospital Västerås, RegionVästmanland-Uppsala University, Västerås, Sweden.

出版信息

Infect Dis (Lond). 2025 Jul 31:1-7. doi: 10.1080/23744235.2025.2541853.

Abstract

BACKGROUND

Dalbavancin is a long-acting lipoglycopeptide approved for acute bacterial skin and soft-tissue infections. Its prolonged half-life enables outpatient treatment, reducing the burden of hospitalisation. Despite increasing off-label use for complex Gram-positive infections, real-world effectiveness data remain limited.

OBJECTIVE

This study aimed to evaluate the clinical effectiveness and safety of dalbavancin in a real-world tertiary care setting in Sweden.

METHODS

We retrospectively analysed the medical records of all patients ( = 66) who received dalbavancin in Region Västmanland, Sweden, from 2019 to 2023. Patient characteristics, source of infection, identified pathogens, treatment regimens, and outcomes were extracted from medical records. The primary outcome was clinical cure at 6 months; secondary outcomes included mortality, need for suppressive therapy, and adverse events.

RESULTS

Sixty-six patients (median age 73 years; 47% female) received dalbavancin for orthopaedic/bone infections (56%), endocarditis (23%), vascular graft infections (6%), bacteraemia (6%), sacral ulcer infections (6%), and other infections (3%). The patients had significant comorbidities: diabetes (38%), malignancy (33%), chronic kidney disease (44%), and substance use disorders (17%)."Methicillin-susceptible" Staphylococcus aureus was the predominant pathogen (31% of isolates). Dalbavancin was prescribed to facilitate outpatient therapy (53%), address poor compliance (17%), or manage antibiotic intolerances (17%). Patients received a median of 2 doses (range 1-17). At 6-month follow-up, 62% achieved clinical cure, 18% remained on suppressive therapy, and 20% died, primarily from underlying conditions. Adverse events were infrequent (6%) and generally mild.

CONCLUSIONS

Dalbavancin achieved a 62% cure rate despite significant comorbidities, offering a safe alternative to inpatient care for elderly, comorbid patients.

摘要

背景

达巴万星是一种长效脂糖肽类药物,已被批准用于治疗急性细菌性皮肤和软组织感染。其较长的半衰期使门诊治疗成为可能,减轻了住院负担。尽管达巴万星在治疗复杂革兰氏阳性菌感染方面的非标签使用日益增多,但实际疗效数据仍然有限。

目的

本研究旨在评估达巴万星在瑞典一家三级医疗中心的实际临床疗效和安全性。

方法

我们回顾性分析了2019年至2023年在瑞典韦斯特曼兰地区接受达巴万星治疗的所有患者(n = 66)的病历。从病历中提取患者特征、感染源、鉴定出的病原体、治疗方案和治疗结果。主要结局是6个月时的临床治愈;次要结局包括死亡率、是否需要抑制性治疗以及不良事件。

结果

66例患者(中位年龄73岁;47%为女性)接受达巴万星治疗,用于骨科/骨感染(56%)、心内膜炎(23%)、血管移植感染(6%)、菌血症(6%)、骶骨溃疡感染(6%)和其他感染(3%)。患者有显著的合并症:糖尿病(38%)、恶性肿瘤(33%)、慢性肾脏病(44%)和物质使用障碍(17%)。“甲氧西林敏感”金黄色葡萄球菌是主要病原体(分离株的31%)。使用达巴万星是为了便于门诊治疗(53%)、解决依从性差的问题(17%)或处理抗生素不耐受情况(17%)。患者接受的中位剂量为2剂(范围1 - 17剂)。在6个月的随访中,62%的患者实现了临床治愈,18%的患者仍在接受抑制性治疗,20%的患者死亡,主要死于基础疾病。不良事件发生率较低(6%),且一般较轻。

结论

尽管存在显著的合并症,达巴万星的治愈率仍达到62%,为老年合并症患者提供了一种安全的住院治疗替代方案。

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