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达巴万星在实际应用中的安全性和有效性:对治疗皮肤/软组织及其他难治性感染的大型单中心病例系列的回顾性分析

Safety and Efficacy of Dalbavancin in Real Life: Retrospective Analysis of a Large Monocentric Case Series of Patients Treated for Skin/Soft Tissue and Other Difficult-to-Treat Infections.

作者信息

Parruti Giustino, Polilli Ennio, Coladonato Simona, Rapacchiale Giorgia, Trave Francesca, Mazzotta Elena, Bondanese Martina, Di Masi Francesco, Recinelli Davide, Corridoni Serena, Costantini Alberto, Ianniruberto Stefano, Cacciatore Pierluigi, Carinci Fabrizio

机构信息

Infectious Disease Unit, Santo Spirito General Hospital, 65124 Pescara, Italy.

Clinical Pathology, Santo Spirito General Hospital, 65124 Pescara, Italy.

出版信息

Antibiotics (Basel). 2024 Nov 8;13(11):1063. doi: 10.3390/antibiotics13111063.

Abstract

Dalbavancin is a long-acting lipoglycopeptide, approved for treatment of skin and skin structure infections. Its PK/PD profile and safety allow for short hospital stays even in the case of difficult-to-treat infections requiring long courses of therapy, e.g., osteomyelitis, cardiovascular, and prosthetic infections. We aimed to evaluate the safety and efficacy of dalbavancin in real life settings for both in-label and off-label indications. retrospective evaluation of all consecutive patients treated with dalbavancin at our site between May 2017 and September 2021. Results: A total of 100 patients treated with dalbavancin and followed up for 6 months after treatment (58% male; median age 63.5 years, median Charlson Comorbidity Index CCI = 2.7, 28% inpatients) were included with the following indications: acute bacterial skin and skin structure infections (22%), bone and prosthetic infections (57%), and cardiovascular infections (19%). Infections were caused by MSSA (30%), MRSA (5%), MR-CoNS (20%), and spp. (8%). In 32 cases, no isolate was obtained. The average number of infusions was 5 (s.d. = 3). Neither ensuing alteration of renal function nor neutropenia or thrombocytopenia were observed during treatment and follow-up. Two self-limiting skin rashes occurred. The overall clinical success rate was 84%-91% for registered and 82% for unregistered indications. The prescription of higher loading doses was the only predictor independently associated with better outcomes in multivariate models (OR: 5.2, 95%CI: 1.5-17.9, < 0.01). Dalbavancin proved to be effective for skin and skin structure infections, as well as for difficult-to-treat infections in highly comorbid patients. Regarding tolerability, our results support the use of dalbavancin for long-lasting treatments of deep-seated infections.

摘要

达巴万星是一种长效脂糖肽类药物,已被批准用于治疗皮肤及皮肤结构感染。其药代动力学/药效学特征及安全性使得即使在治疗需要长期疗程的难治性感染(如骨髓炎、心血管及假体感染)时,住院时间也可缩短。我们旨在评估达巴万星在现实环境中用于标签内及标签外适应症的安全性和有效性。对2017年5月至2021年9月期间在我们机构接受达巴万星治疗的所有连续患者进行回顾性评估。结果:共有100例接受达巴万星治疗并在治疗后随访6个月的患者(58%为男性;中位年龄63.5岁,中位查尔森合并症指数CCI = 2.7,28%为住院患者)纳入研究,其适应症如下:急性细菌性皮肤及皮肤结构感染(22%)、骨骼及假体感染(57%)和心血管感染(19%)。感染由甲氧西林敏感金黄色葡萄球菌(MSSA,30%)、耐甲氧西林金黄色葡萄球菌(MRSA,5%)、耐甲氧西林凝固酶阴性葡萄球菌(MR-CoNS,20%)及其他菌种(8%)引起。32例未获得分离菌株。平均输注次数为5次(标准差 = 3)。治疗及随访期间未观察到肾功能改变、中性粒细胞减少或血小板减少。出现两例自限性皮疹。注册适应症的总体临床成功率为84% - 91%,未注册适应症为82%。在多变量模型中,使用更高的负荷剂量是唯一与更好结局独立相关的预测因素(比值比:5.2,95%置信区间:1.5 - 17.9,P < 0.01)。达巴万星被证明对皮肤及皮肤结构感染以及高合并症患者的难治性感染有效。关于耐受性,我们的结果支持使用达巴万星进行深部感染的长期治疗。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a2cc/11591112/38c7fcca8480/antibiotics-13-01063-g001.jpg

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