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重症监护患者中达托霉素的应用经验:来自一项注册研究的结果。

Daptomycin experience in critical care patients: results from a registry.

机构信息

School of Pharmacy and Pharmaceutical Science, State University of New York at Buffalo, Buffalo, NY, USA.

出版信息

Ann Pharmacother. 2012 Apr;46(4):495-502. doi: 10.1345/aph.1Q490. Epub 2012 Mar 27.

Abstract

BACKGROUND

Vancomycin is often the drug of choice in critically ill patients with gram-positive infections, although circumstances often prevent its use. In these situations, clinicians are frequently left with limited data regarding alternative agents.

OBJECTIVE

To describe patients with reported sepsis receiving daptomycin in a critical care unit.

METHODS

This multicenter, noncomparative, noninterventional study identified patients in critical care units, using the Cubicin Outcomes Registry and Experience (CORE) 2005-2009 registry. A descriptive account of patient characteristics, infectious etiology, outcomes at the end of daptomycin therapy, and 30-day mortality is reported. Nonevaluable patients were excluded from the efficacy analysis but included in the safety analysis.

RESULTS

We identified 128 patients, 98 (77%) of whom were evaluable for efficacy. Patient characteristics for the efficacy population were 55 (56%) males, 30 (31%) aged 66 years or older, 38 (39%) had creatinine clearance less than 30 mL/min, and 27 (28%) were on dialysis. Common underlying diseases included acute or chronic renal failure 44 (45%), hypertension 40 (41%), and diabetes 27 (28%). Seventy-two (73%) patients were bacteremic. The most common pathogens found were methicillin-resistant Staphylococcus aureus (32%), vancomycin-resistant Enterococcus faecium (21%), and coagulase-negative staphylococci (20%). Prior to daptomycin, antibiotics were used in 84 (86%) patients, most commonly vancomycin (65/84; 77%). The median (range) initial daptomycin dose was 6 mg/kg (3-10) and duration of 10 days (1-58). Overall success rate was 70% (31% cured; 39% improved). Twelve adverse events possibly related to daptomycin were reported in 9 of 128 (7%) patients in the safety population; 4 of these in 4 (3%) patients were serious. The mortality rate within 30 days of completing daptomycin was 42 of 128 (33%) patients.

CONCLUSIONS

These data provide preliminary results on the use of daptomycin in critically ill patients with complicated conditions. Controlled studies are needed to best evaluate daptomycin use in these patients.

摘要

背景

在患有革兰阳性感染的危重症患者中,万古霉素通常是首选药物,尽管在某些情况下无法使用。在这些情况下,临床医生往往缺乏替代药物的数据。

目的

描述在重症监护病房中接受达托霉素治疗的报告为败血症的患者。

方法

这项多中心、非对照、非干预性研究使用 Cubicin Outcomes Registry and Experience(CORE)2005-2009 登记册,在重症监护病房中确定患者。报告了患者特征、感染病因、达托霉素治疗结束时的结局以及 30 天死亡率的描述性数据。无法评估的患者被排除在疗效分析之外,但被纳入安全性分析。

结果

我们确定了 128 名患者,其中 98 名(77%)可进行疗效评估。疗效人群的患者特征为:55 名(56%)男性,30 名(31%)年龄在 66 岁或以上,38 名(39%)肌酐清除率<30ml/min,27 名(28%)接受透析。常见的基础疾病包括急性或慢性肾衰竭 44 例(45%)、高血压 40 例(41%)和糖尿病 27 例(28%)。72 名(73%)患者菌血症。最常见的病原体是耐甲氧西林金黄色葡萄球菌(32%)、万古霉素耐药粪肠球菌(21%)和凝固酶阴性葡萄球菌(20%)。在使用达托霉素之前,84 名(86%)患者使用了抗生素,最常见的是万古霉素(65/84;77%)。初始达托霉素剂量中位数(范围)为 6mg/kg(3-10),疗程为 10 天(1-58)。总体成功率为 70%(31%治愈;39%改善)。在安全性人群的 128 名患者中,报告了 9 名(7%)患者的 12 起可能与达托霉素有关的不良事件;其中 4 名(3%)患者为严重不良事件。在完成达托霉素治疗后的 30 天内,128 名患者中有 42 名(33%)死亡。

结论

这些数据提供了关于重症患者使用达托霉素治疗复杂感染的初步结果。需要进行对照研究以最好地评估这些患者使用达托霉素的情况。

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