广泛地理区域内达托霉素的真实世界使用情况：CORE和欧盟CORE汇总分析结果
Real-world daptomycin use across wide geographical regions: results from a pooled analysis of CORE and EU-CORE.
作者信息
Seaton R Andrew, Gonzalez-Ruiz Armando, Cleveland Kerry O, Couch Kimberly A, Pathan Rashidkhan, Hamed Kamal
机构信息
Queen Elizabeth University Hospital, Glasgow, UK.
Darent Valley Hospital, Dartford, UK.
出版信息
Ann Clin Microbiol Antimicrob. 2016 Mar 15;15:18. doi: 10.1186/s12941-016-0130-8.
BACKGROUND
Pooled data from two large registries, Cubicin(®) Outcomes Registry and Experience (CORE; USA) and European Cubicin(®) Outcomes Registry and Experience (EU-CORE; Europe, Latin America, and Asia), were analyzed to determine the characteristics and clinical outcomes of daptomycin therapy in patients with Gram-positive infections across wide geographical regions.
METHODS
Patients receiving at least one dose of daptomycin between 2004 and 2012 for the treatment of Gram-positive infections were included. Clinical success was defined as an outcome of 'cured' or 'improved'. Post-treatment follow-up data were collected for a subset of patients (CORE: osteomyelitis and orthopedic foreign body device infection; EU-CORE: endocarditis, intracardiac/intravascular device infection, osteomyelitis, and orthopedic device infection). Safety was assessed for up to 30 days after daptomycin treatment.
RESULTS
In 11,557 patients (CORE, 5482; EU-CORE, 6075) treated with daptomycin (median age, 62 [range, 1-103] years), the most frequent underlying conditions were cardiovascular disease (54.7 %) and diabetes mellitus (28.0 %). The most commonly treated primary infections were complicated skin and soft tissue infection (cSSTI; 31.2 %) and bacteremia (21.8 %). The overall clinical success rate was 77.2 % (uncomplicated SSTI, 88.3 %; cSSTI, 81.0 %; osteomyelitis, 77.7 %; foreign body/prosthetic infection (FBPI), 75.9 %; endocarditis, 75.4 %; and bacteremia, 69.5 %). The clinical success rate was 79.1 % in patients with Staphylococcus aureus infections (MRSA, 78.1 %). An increasing trend of high-dose daptomycin (>6 mg/kg/day) prescribing pattern was observed over time. Clinical success rates were higher with high-dose daptomycin treatment for endocarditis and FBPI. Adverse events (AEs) and serious AEs possibly related to daptomycin therapy were reported in 628 (5.4 %) and 133 (1.2 %) patients, respectively.
CONCLUSIONS
The real-world data showed that daptomycin was effective and safe in the treatment of various Gram-positive infections, including those caused by resistant pathogens, across wide geographical regions.
背景
分析了来自两个大型注册研究库的数据，即 Cubicin（®）结果注册研究与经验研究（CORE；美国）以及欧洲 Cubicin（®）结果注册研究与经验研究（EU-CORE；欧洲、拉丁美洲和亚洲），以确定达托霉素治疗广泛地理区域内革兰氏阳性感染患者的特征和临床结局。
方法
纳入 2004 年至 2012 年间接受至少一剂达托霉素治疗革兰氏阳性感染的患者。临床成功定义为“治愈”或“改善”的结局。收集了一部分患者的治疗后随访数据（CORE：骨髓炎和骨科异物装置感染；EU-CORE：心内膜炎、心内/血管内装置感染、骨髓炎和骨科装置感染）。在达托霉素治疗后长达 30 天评估安全性。
结果
在 11557 例接受达托霉素治疗的患者中（CORE 组 5482 例，EU-CORE 组 6075 例）（中位年龄 62 岁[范围 1 - 103 岁]），最常见的基础疾病是心血管疾病（54.7%）和糖尿病（28.0%）。最常治疗的原发性感染是复杂性皮肤和软组织感染（cSSTI；31.2%）和菌血症（21.8%）。总体临床成功率为 77.2%（非复杂性 SSTI，88.3%；cSSTI，81.0%；骨髓炎，77.7%；异物/假体感染（FBPI），75.9%；心内膜炎，75.4%；菌血症，69.5%）。金黄色葡萄球菌感染患者的临床成功率为 79.1%（耐甲氧西林金黄色葡萄球菌（MRSA），78.1%）。随着时间推移，观察到达托霉素高剂量（>6mg/kg/天）处方模式呈上升趋势。高剂量达托霉素治疗心内膜炎和 FBPI 的临床成功率更高。分别有 628 例（5.4%）和 133 例（1.2%）患者报告了可能与达托霉素治疗相关的不良事件（AE）和严重 AE。
结论
真实世界数据表明，达托霉素在治疗广泛地理区域内的各种革兰氏阳性感染（包括由耐药病原体引起的感染）方面有效且安全。
Zotero 插件