Clinic of Infectious Diseases, San Paolo Hospital, ASST Santi Paolo E Carlo, University of Milan , Milan, Italy.
Clinic of Infectious Diseases, Department of Internal Medicine, University Hospital of Padua , Padua, Italy.
Expert Rev Anti Infect Ther. 2020 Dec;18(12):1271-1279. doi: 10.1080/14787210.2020.1798227. Epub 2020 Aug 14.
We evaluated the efficacy and safety of dalbavancin in ABSSSI and 'other sites' infections' (OTA).
Observational study involving 11 Italian hospitals including patients that received ≥1 dose of dalbavancin in 2016-2019. The outcome was end-of-treatment efficacy and safety in ABSSSI and OTA in a real-life setting.
206 patients enrolled (males 50%, median age 62 [IQR 50-76] years), 60.2% ABSSSI, 39.8% OTA. 69.7% ABSSSI 90.7% OTA (p = 0.003) and 46.3% ABSSSI 37.2% OTA (p = 0.786) received previous and concomitant antibiotics, respectively. 82.5% reached clinical cure . Eleven (5.4%) patients had non-serious adverse events (AE). OTA patients showed longer hospitalization (13.5 days, 5.5-22 3, 0-11.7; p<0.0001) and received longer previous (18 days, 9-30 11, 7-19; p = 0.007)/concomitant antibiotic treatments (21 days, 14-52 11, 8-14; p < 0.0001), compared to ABSSSI. ABSSSI and OTA showed similar efficacy (85.5% 75%, p = 0.459) and safety (no AE: 81.5% 64.3%, p = 0.258); efficacy was independent of previous/concomitant therapies.
Dalbavancin demonstrated a success rate of >80%, with similar efficacy/safety in ABSSSI and off-label indications. The preferential use of dalbavancin as second-line or combination therapy would seem to suggest the need for in-depth studies focused on its off-label use.
我们评估达巴万星治疗 ABSSSI 和“其他部位”感染（OTA）的疗效和安全性。
这是一项涉及意大利 11 家医院的观察性研究，纳入了 2016 年至 2019 年期间接受至少一剂达巴万星治疗的患者。主要结局为真实环境下 ABSSSI 和 OTA 的治疗结束时的疗效和安全性。
共纳入 206 例患者（男性占 50%，中位年龄 62[50-76]岁），60.2%为 ABSSSI，39.8%为 OTA。69.7%的 ABSSSI 和 90.7%的 OTA（p=0.003）患者和 46.3%的 ABSSSI 和 37.2%的 OTA（p=0.786）患者分别接受了既往和同时应用的抗生素治疗。82.5%的患者达到临床治愈。11 例（5.4%）患者出现非严重不良事件（AE）。OTA 患者的住院时间更长（13.5 天，5.5-22 天；3.0-11.7 天；p<0.0001），且接受了更长时间的既往（18 天，9-30 天；11 天，7-19 天；p=0.007）/同时应用的抗生素治疗（21 天，14-52 天；11 天，8-14 天；p<0.0001），与 ABSSSI 相比。ABSSSI 和 OTA 的疗效相似（85.5% vs. 75%；p=0.459），安全性相当（无 AE：81.5% vs. 64.3%；p=0.258）；疗效不依赖于既往/同时应用的治疗。
达巴万星的有效率>80%，在 ABSSSI 和适应证外的疗效和安全性相似。达巴万星作为二线或联合治疗药物的优先使用似乎表明需要开展深入研究，重点关注其适应证外的应用。
