Simonetti Oriana, Rizzetto Giulio, Molinelli Elisa, Cirioni Oscar, Offidani Annamaria
Clinic of Dermatology, Department of Clinical and Molecular Sciences, Polytechnic University of Marche, Ancona, Italy.
Clinic of Infectious Diseases, Department of Biomedical Sciences and Public Health, Polytechnic University of Marche, Ancona, Italy.
Ther Clin Risk Manag. 2021 Mar 22;17:223-232. doi: 10.2147/TCRM.S271445. eCollection 2021.
Dalbavancin is a bactericidal lipoglycopeptide active against gram-positives. Its use has been approved for the treatment of acute bacterial skin and skin structure infections (ABSSSI).
We conducted a narrative review of the literature on the safety profile of dalbavancin. The bibliographic research was carried out on the PubMed database on 6 November 2020 by seeking combinations of the following keywords: dalbavancin, adverse effects, safety, drug interactions, and skin infections.
Five double-blind Phase 3 randomized clinical trials, 2 open-label randomized trials, and 4 retrospective studies were identified. No statistically significant differences were found between dalbavancin and comparators in the incidence of adverse events. Retrospective studies confirm the low incidence of adverse events.
Dalbavancin is a therapeutic option that has demonstrated an excellent safety profile, also in relation to the other MRSA therapies available. Its use represents a cost-effective solution for the treatment of those patients with ABSSSI who would need hospitalization. One limitation of this study is that most of the available data are from Phase III clinical trials. Further real-life studies with a larger sample size are therefore needed to better assess the safety profile of the dalbavancin, especially to investigate the true incidence of rare adverse events.
达巴万星是一种对革兰氏阳性菌有活性的杀菌性脂糖肽。其已被批准用于治疗急性细菌性皮肤和皮肤结构感染（ABSSSI）。
我们对关于达巴万星安全性的文献进行了叙述性综述。2020年11月6日在PubMed数据库上进行文献检索，通过搜索以下关键词的组合：达巴万星、不良反应、安全性、药物相互作用和皮肤感染。
确定了5项双盲3期随机临床试验、2项开放标签随机试验和4项回顾性研究。在不良事件发生率方面，达巴万星与对照药物之间未发现统计学上的显著差异。回顾性研究证实不良事件发生率较低。
达巴万星是一种已证明具有出色安全性的治疗选择，与现有的其他耐甲氧西林金黄色葡萄球菌（MRSA）治疗方法相比也是如此。对于需要住院治疗的ABSSSI患者，其使用是一种具有成本效益的解决方案。本研究的一个局限性是，大多数现有数据来自3期临床试验。因此，需要进一步开展样本量更大的实际研究，以更好地评估达巴万星的安全性，特别是调查罕见不良事件的真实发生率。
