Keil Felix, Daikos George L, Skoutelis Athanasios, Dominguez Jose Ignacio Barranco, Pathan Rashidkhan, Hamed Kamal
Hanusch Krankenhaus der Wiener Gebietskrankenkasse-Medizinische Abteilung, Heinrich Collin-Strasse, Vienna, Austria.
National University of Athens-Laiko General Hospital, Athens, Greece.
Adv Ther. 2015 Aug;32(8):715-26. doi: 10.1007/s12325-015-0231-3. Epub 2015 Aug 4.
The aim of this analysis was to describe in real-world settings the clinical outcomes and safety associated with daptomycin treatment in patients with neutropenia and Gram-positive infections.
Patients with an absolute neutrophil count (ANC) ≤1000 cells/mm(3) who received at least one dose of daptomycin between 2006 and 2012 were selected from a non-interventional, multicenter, retrospective registry (European Cubicin(®) Outcome Registry and Experience; EU-CORE(SM)).
Of the 6075 patients enrolled in EU-CORE, 446 (7.3%) had an ANC ≤ 1000 cells/mm(3) at baseline or during daptomycin therapy; they were all included in efficacy and safety populations. Half of the patients had severe neutropenia (ANC ≤ 100 cells/mm(3)). Most patients had hematologic malignancy (60.5%), an immunosuppressed state (39.7%) or had undergone a transplant (27.8%). The most common primary infections were bacteremia (42.2%) and complicated skin and soft tissue infection (13.9%). Cultures were positive for 68.6% (254/370) of patients with available culture results; coagulase-negative staphylococci (43.7%; 111/254) and Staphylococcus aureus (18.9%; 48/254) were the most commonly isolated primary pathogens. Median duration of daptomycin therapy was 10.0 (range 1-98) days. Most patients (82.8%) received antibiotics concomitantly with daptomycin; the most common were carbapenems (51.2%), penicillins (42.1%), and aminoglycosides (19.9%). The overall clinical success rate (cured or improved) associated with daptomycin was 77.1%. Adverse events possibly related to daptomycin treatment were reported in seven (1.6%) patients and led to drug discontinuation in 27 (6.1%) patients.
The study results suggest that daptomycin is an effective therapeutic option for the treatment of a broad range of Gram-positive infections in patients with neutropenia, and has a good safety profile.
This study was funded by Novartis Pharma AG.
本分析的目的是在真实世界环境中描述达托霉素治疗中性粒细胞减少症合并革兰氏阳性菌感染患者的临床结局和安全性。
从一项非干预性、多中心、回顾性登记研究（欧洲 Cubicin® 结局登记与经验研究；EU-CORE(SM)）中选取 2006 年至 2012 年期间接受至少一剂达托霉素治疗且绝对中性粒细胞计数（ANC）≤1000 个细胞/mm³ 的患者。
在 EU-CORE 登记的 6075 例患者中，446 例（7.3%）在基线或达托霉素治疗期间 ANC≤1000 个细胞/mm³；他们均被纳入疗效和安全性分析人群。半数患者患有严重中性粒细胞减少症（ANC≤100 个细胞/mm³）。大多数患者患有血液系统恶性肿瘤（60.5%）、处于免疫抑制状态（39.7%）或接受过移植（27.8%）。最常见的原发性感染为菌血症（42.2%）和复杂性皮肤及软组织感染（13.9%）。在有可用培养结果的患者中，68.6%（254/370）培养结果呈阳性；凝固酶阴性葡萄球菌（43.7%；111/254）和金黄色葡萄球菌（18.9%；
