Lancashire Cardiac Centre, Blackpool Teaching Hospitals NHS Foundation Trust, Blackpool, UK.
A.O.R.N. Monaldi-U.O.C. Medicina Infettivologica e dei Trapianti, Via L. Bianchi, Naples, Italy.
Infect Dis Ther. 2015 Sep;4(3):283-96. doi: 10.1007/s40121-015-0075-9. Epub 2015 Jul 14.
The European Cubicin(®) Outcomes Registry and Experience (EU-CORE(SM)) was a retrospective, non-interventional, multicenter study which evaluated the safety and effectiveness of daptomycin therapy in patients with Gram-positive infections including infective endocarditis (IE).
Data from the EU-CORE registry were collected for patients with IE who had received at least one dose of daptomycin between January 2006 and April 2012, across 18 countries in Europe (12), Latin America (5) and Asia (1). Clinical outcomes were assessed as success (cured or improved), failure or non-evaluable. Adverse events (AEs) were recorded during treatment and for up to 30 days post-treatment; follow-up data were collected for 2 years.
Of 6075 patients included in the EU-CORE registry, 610 were diagnosed with IE as primary infection; 149 (24.4%) right-sided IE (RIE), 414 (67.9%) left-sided IE (LIE), and 47 (7.7%) with both right- and left-sided IE (BRLIE). Overall clinical success was achieved in 80.0% of patients (RIE 88.6%, LIE 76.6% and BRLIE 82.9%). Success rates for methicillin-resistant Staphylococcus aureus (MRSA) infections were 90.9%, 71.7% and 66.6% in patients with RIE, LIE and BRLIE, respectively. The overall sustained clinical success rate in patients followed for up to 2 years was 86.7% (RIE 93.5%, LIE 88.3% and BRLIE 77.8%). AEs deemed possibly related to daptomycin in the investigator's opinion were reported in 2 (1.3%) RIE, 18 (4.3%) LIE and 1 (2.1%) BRLIE patients. There were 11 (1.8%) patients (2 with RIE, 8 with LIE and 1 with BRLIE) with AEs of creatine phosphokinase elevation reported as possibly related to daptomycin.
Data from this real-world clinical setting showed that daptomycin was well tolerated and effective for the treatment of LIE and BRLIE in addition to RIE caused by Gram-positive bacteria, including MRSA. Two-year follow-up data showed that a high proportion of patients had a sustained response.
欧洲 Cubicin（®）结局和经验注册研究（EU-CORE（SM））是一项回顾性、非干预性、多中心研究，评估了达托霉素治疗革兰阳性感染（包括感染性心内膜炎（IE））患者的安全性和有效性。
从 2006 年 1 月至 2012 年 4 月，在欧洲（12 个国家）、拉丁美洲（5 个国家）和亚洲（1 个国家）的 18 个国家收集了至少接受过一次达托霉素治疗的 IE 患者的 EU-CORE 登记数据。临床结局评估为治愈或改善、失败或无法评估。治疗期间和治疗后 30 天内记录不良事件（AE）；收集了 2 年的随访数据。
在 EU-CORE 登记册中纳入的 6075 例患者中，有 610 例被诊断为原发性 IE；149 例（24.4%）为右侧 IE（RIE），414 例（67.9%）为左侧 IE（LIE），47 例（7.7%）为右侧和左侧 IE（BRLIE）。80.0%的患者达到了总体临床成功（RIE 为 88.6%，LIE 为 76.6%，BRLIE 为 82.9%）。RIE、LIE 和 BRLIE 患者中耐甲氧西林金黄色葡萄球菌（MRSA）感染的成功率分别为 90.9%、71.7%和 66.6%。随访长达 2 年的患者中，总持续临床成功率为 86.7%（RIE 为 93.5%，LIE 为 88.3%，BRLIE 为 77.8%）。研究者认为可能与达托霉素有关的 AEs 报告在 2 例 RIE 患者（1.3%）、18 例 LIE 患者（4.3%）和 1 例 BRLIE 患者（2.1%）中。有 11 例（1.8%）患者（2 例 RIE，8 例 LIE，1 例 BRLIE）出现肌酸磷酸激酶升高的 AEs，研究者认为可能与达托霉素有关。
来自这一真实临床环境的数据表明，达托霉素在治疗革兰阳性菌引起的 RIE 以及 LIE 和 BRLIE 方面耐受性良好且有效，包括耐甲氧西林金黄色葡萄球菌。2 年随访数据显示，很大比例的患者有持续反应。
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