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在英国一家三级传染病机构中使用达巴万星治疗未获许可适应症的经验。

Experience of use of dalbavancin for the treatment of unlicensed indications in a UK tertiary infectious diseases setting.

作者信息

Darlow Christopher A, Parsons Joseph, Lucy Danielle, Li Ang, Ratcliffe Libuse, Todd Stacy, Wong Nicholas

机构信息

Antimicrobial Therapeutics and Pharmacodynamics, University of Liverpool, Liverpool, UK.

Tropical and Infectious Diseases Unit, Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK.

出版信息

Infection. 2025 Jun 23. doi: 10.1007/s15010-025-02585-x.

DOI:10.1007/s15010-025-02585-x
PMID:40549326
Abstract

BACKGROUND

Dalbavancin is a long-acting lipoglycopeptide with Gram-positive activity, licensed for the treatment of acute bacterial skin and skin-structure infections (ABSSSIs), although off-licence use is increasingly prevalent. We describe our experience in Liverpool of using dalbavancin for off-licence indications and as a risk-reduction strategy in patients at risk of premature hospital discharge.

METHODS

Patients receiving dalbavancin in the period 1/9/2020-30/4/2024 in Liverpool were identified. Data was extracted by review of patient notes. Primary outcomes were clinical success (resolution of infection without re-admission or further antibiotics) and 90-day mortality.

RESULTS

Ninety-five individual dalbavancin courses were identified. 24/95 were for licensed indications (i.e., ABSSSI without bacteraemia). Off-licence indications included bone and joint infections (BJIs) (30/95), infective endocarditis (IE) (13/95) and Staphylococcus aureus bacteraemia (SAB) (27/95). The clinical success rate and 90-day mortality for ABSSSI without bacteraemia were 91.67% and 4.17%, respectively. BJI without bacteraemia and SAB outcomes were similar (p > 0.999). However, IE had worse rates of clinical success (61.5%, p = 0.072) and 90-day mortality (30.8%, p = 0.042). 10/18 PWIDs who were prematurely discharged achieved clinical success; 17/18 were alive at 90 days.

CONCLUSION

The data in this retrospective analysis adds to the growing body of evidence that dalbavancin is safe and effective for the treatment of BJIs and SABs. It also reinforces the uncertainty in the literature over the efficacy of use in IE. Additionally, these data demonstrate that dalbavancin may be used successfully as a risk mitigation strategy for PWIDs who may be prematurely discharged from an inpatient stay.

摘要

背景

达巴万星是一种具有革兰氏阳性活性的长效脂糖肽,已获许可用于治疗急性细菌性皮肤和皮肤结构感染(ABSSSI),尽管其超适应证使用越来越普遍。我们描述了在利物浦将达巴万星用于超适应证以及作为降低有提前出院风险患者风险的策略的经验。

方法

确定2020年9月1日至2024年4月30日期间在利物浦接受达巴万星治疗的患者。通过查阅患者病历提取数据。主要结局为临床成功(感染消退且未再次入院或未使用进一步的抗生素)和90天死亡率。

结果

确定了95个达巴万星治疗疗程。24/95用于适应证范围内的疾病(即无菌血症的ABSSSI)。超适应证包括骨和关节感染(BJI)(30/95)、感染性心内膜炎(IE)(13/95)和金黄色葡萄球菌菌血症(SAB)(27/95)。无菌血症的ABSSSI的临床成功率和90天死亡率分别为91.67%和4.17%。无菌血症的BJI和SAB的结局相似(p>0.999)。然而,IE的临床成功率较低(61.5%,p=0.072),90天死亡率较高(30.8%,p= 0.042)。10/18例提前出院的注射吸毒者取得了临床成功;17/18例在90天时存活。

结论

这项回顾性分析中的数据进一步证明,达巴万星治疗BJI和SAB安全有效。这也强化了文献中关于其在IE治疗中疗效的不确定性。此外,这些数据表明,达巴万星可成功用作可能提前出院的注射吸毒者的风险缓解策略。

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本文引用的文献

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A systematic review of dalbavancin efficacy as a sequential therapy for infective endocarditis.达巴万星作为感染性心内膜炎序贯治疗药物疗效的系统评价。
Infection. 2025 Feb;53(1):15-23. doi: 10.1007/s15010-024-02393-9. Epub 2024 Sep 26.
2
Real-life experience with IV dalbavancin in Canada; results from the CLEAR (Canadian LEadership on Antimicrobial Real-life usage) registry.加拿大 IV 达巴万星的真实临床应用经验;来自 CLEAR(加拿大抗菌药物真实世界应用领导力)登记研究的结果。
J Glob Antimicrob Resist. 2024 Sep;38:154-157. doi: 10.1016/j.jgar.2024.06.002. Epub 2024 Jun 20.
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Three-years of dalbavancin use at a UK tertiary referral hospital serving a population with high numbers of people who inject drugs.
在一家为大量注射吸毒者群体服务的英国三级转诊医院使用达巴万星三年。
JAC Antimicrob Resist. 2024 May 6;6(3):dlae066. doi: 10.1093/jacamr/dlae066. eCollection 2024 Jun.
4
Real-World Dalbavancin Use for Serious Gram-Positive Infections: Comparing Outcomes Between People Who Use and Do Not Use Drugs.达巴万星在真实世界中用于治疗严重革兰氏阳性感染:使用和未使用药物人群的疗效比较
Open Forum Infect Dis. 2024 Apr 5;11(4):ofae186. doi: 10.1093/ofid/ofae186. eCollection 2024 Apr.
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Dalbavancin Sequential Therapy for Gram-Positive Bloodstream Infection: A Multicenter Observational Study.达巴万星序贯疗法治疗革兰氏阳性血流感染:一项多中心观察性研究。
Infect Dis Ther. 2024 Mar;13(3):565-579. doi: 10.1007/s40121-024-00933-2. Epub 2024 Mar 1.
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In-label, off-label prescription, efficacy and tolerability of dalbavancin: report from a National Registry.达巴万星的标签内、标签外处方、疗效和耐受性:国家登记处的报告。
Infection. 2024 Aug;52(4):1297-1306. doi: 10.1007/s15010-024-02176-2. Epub 2024 Feb 7.
7
Experience with dalbavancin use in various gram-positive infections within Aberdeen Royal Infirmary OPAT service.在阿伯丁皇家医院门诊治疗服务中,使用达巴万星治疗各种革兰阳性感染的经验。
Infection. 2024 Apr;52(2):567-576. doi: 10.1007/s15010-023-02152-2. Epub 2024 Jan 2.
8
Dalbavancin plasma concentrations in 133 patients: a PK/PD observational study.133 例患者的达巴万星血浆浓度:一项 PK/PD 观察性研究。
J Antimicrob Chemother. 2023 Dec 1;78(12):2919-2925. doi: 10.1093/jac/dkad331.
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EN-DALBACEN 2.0 Cohort: real-life study of dalbavancin as sequential/consolidation therapy in patients with infective endocarditis due to Gram-positive cocci.EN-DALBACEN 2.0 队列:达巴万星作为革兰阳性球菌感染性心内膜炎患者序贯/巩固治疗的真实世界研究。
Int J Antimicrob Agents. 2023 Sep;62(3):106918. doi: 10.1016/j.ijantimicag.2023.106918. Epub 2023 Jul 11.
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Int J Antimicrob Agents. 2023 Jul;62(1):106842. doi: 10.1016/j.ijantimicag.2023.106842. Epub 2023 May 7.