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REDS研究:达巴万星与其他相同静脉注射抗生素类别的标准治疗方案对急性细菌性皮肤和皮肤结构感染(ABSSSI)患者的回顾性疗效研究。

REDS study: Retrospective effectiveness study of dalbavancin and other standard of care of the same IV antibiotic class in patients with ABSSSI.

作者信息

Papavramidis Theodossis, Gentile Ivan, Cattelan Anna Maria, Magnasco Laura, Viale Pierluigi, Francisci Daniela, Kofteridis Diamantis P, Tiseo Giusy, Giamarellos-Bourboulis Evangelos J, Lagi Filippo, Pinna Simone Mornese, D'Amico Federico, La Ferla Lucia, Panagopoulos Periklis, Gattuso Gianni, Sipsas Nikolaos V, Ruggieri Alessandro, Cattaneo Agnese, Corio Luciana, Comandini Alessandro, Mascagni Patrizia, Bassetti Matteo

机构信息

1st Propaedeutic Department of Surgery, University General Hospital of Thessaloniki AHEPA, Thessaloniki, Greece.

Department of Clinical Medicine and Surgery, Section of Infectious Diseases, University of Naples Federico II - Naples, Italy.

出版信息

Int J Antimicrob Agents. 2023 Apr;61(4):106746. doi: 10.1016/j.ijantimicag.2023.106746. Epub 2023 Feb 8.

DOI:
10.1016/j.ijantimicag.2023.106746
PMID:36758778
Abstract

OBJECTIVES

Acute bacterial skin and skin-structure infections (ABSSSIs) are a common source of morbidity in both the community and hospital settings. The current standard of care (SoC) requires multiple-dose intravenous (IV) regimens, which are associated with high hospitalisation rates, concomitant event risks and costs. Dalbavancin is a lipoglycopeptide, long-acting antibiotic that is effective against Gram-positive microorganisms, including methicillin-resistant Staphylococcus aureus (MRSA). Dalbavancin allows treatment of ABSSSIs with a single-shot IV administration or once weekly for 2 weeks, enabling clinicians to treat patients in an outpatient setting or to shorten the length of hospital stay.

METHODS

This multicentre, observational, retrospective study compared hospitalised patients who received dalbavancin and patients treated with the three most used IV antibiotics of the same or similar class: vancomycin, teicoplanin and daptomycin. The primary outcome was the time to discharge after starting the study antibiotics.

RESULTS

The primary endpoint, time to discharge from the study therapy start, was measured for both groups: the median number of days was 6.5 in the dalbavancin group vs. 11.0 days in the SoC group. Moreover, in subpopulations of patients receiving one or more concomitant antibiotics active for Gram-positives, MRSA and patients with the most prevalent comorbidity (i.e., diabetes), the advantage of dalbavancin in terms of length of stay was confirmed, with a halved time to discharge or more. Safety data on dalbavancin were consistent with data collected in clinical trials. No serious adverse drug reactions related to dalbavancin were reported and most of them were classified as skin and subcutaneous tissue disorders. One serious ADR was reported for daptomycin.

CONCLUSIONS

Although the analysis was only descriptive, it can be concluded that dalbavancin may enable a remarkable reduction in length of hospital stay, also confirming the clinical effectiveness and good safety profile demonstrated in clinical trials in a real-world setting.

摘要

目的

急性细菌性皮肤和皮肤结构感染(ABSSSIs)在社区和医院环境中都是常见的发病原因。当前的护理标准(SoC)需要多剂量静脉注射(IV)方案,这与高住院率、伴随事件风险和成本相关。达巴万星是一种脂糖肽长效抗生素,对革兰氏阳性微生物有效,包括耐甲氧西林金黄色葡萄球菌(MRSA)。达巴万星允许通过单次静脉注射或每周一次共两周的方式治疗ABSSSIs,使临床医生能够在门诊环境中治疗患者或缩短住院时间。

方法

这项多中心、观察性、回顾性研究比较了接受达巴万星治疗的住院患者和接受三种最常用的同类或类似类别的静脉抗生素治疗的患者:万古霉素、替考拉宁和达托霉素。主要结局是开始使用研究抗生素后出院的时间。

结果

对两组患者均测量了主要终点,即从研究治疗开始到出院的时间:达巴万星组的中位数天数为6.5天,而SoC组为11.0天。此外,在接受一种或多种对革兰氏阳性菌、MRSA有效的联合抗生素的患者亚组以及患有最常见合并症(即糖尿病)的患者中,达巴万星在住院时间方面的优势得到了证实,出院时间减半或更多。达巴万星的安全性数据与临床试验中收集的数据一致。未报告与达巴万星相关的严重药物不良反应,大多数不良反应被归类为皮肤和皮下组织疾病。达托霉素报告了一例严重不良反应。

结论

虽然该分析只是描述性的,但可以得出结论,达巴万星可能会显著缩短住院时间,这也证实了在现实环境中的临床试验中所证明的临床有效性和良好的安全性。

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