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在一项评估耐甲氧西林金黄色葡萄球菌(MRSA)复杂性皮肤和软组织感染患者的临床试验中,利奈唑胺对经济结果及成本决定因素的影响。

Impact of linezolid on economic outcomes and determinants of cost in a clinical trial evaluating patients with MRSA complicated skin and soft-tissue infections.

作者信息

McKinnon Peggy S, Sorensen Sonja V, Liu Larry Z, Itani Kamal Mf

机构信息

Clinical Research/Infectious Diseases, Barnes-Jewish Hospital, St. Louis, MO 63110, USA.

出版信息

Ann Pharmacother. 2006 Jun;40(6):1017-23. doi: 10.1345/aph.1G728. Epub 2006 May 23.

Abstract

BACKGROUND

In clinical trials, linezolid has demonstrated higher clinical cure rates and shorter hospital duration for patients than has vancomycin for the treatment of complicated skin and soft-tissue infections (cSSTIs).

OBJECTIVE

To assess economic outcomes of linezolid versus vancomycin and evaluate determinants of treatment costs for cSSTIs.

METHODS

Economic data were obtained from US subjects enrolled in a multinational, open-label, clinical trial of cSSTIs caused by suspected or proven methicillin-resistant Staphylococcus aureus (MRSA). Subjects were randomized to receive intravenous or oral linezolid or intravenous vancomycin for 7-21 days. Costs for each patient were evaluated by applying nationally representative per diem hospital costs by hospital ward. Intravenous administration costs were applied to the duration of intravenous treatment. Factors contributing to the cost of therapy were evaluated using multivariate regression analysis.

RESULTS

Seven hundred seventeen US patients were included in the study. Demographics were similar between treatment groups. Length of stay and duration of intravenous therapy were shorter for linezolid-treated patients. Mean +/- SD cost for intent-to-treat population patients treated with linezolid versus vancomycin was 4865 US dollars +/- 4367 versus 5738 US dollars +/- 5190, respectively (p = 0.017), and in the MRSA population was 4881 US dollars +/- 3987 versus 6006 US dollars +/- 5039, respectively (p = 0.041). Factors significantly associated with increased cost included vancomycin therapy, age, and comorbidities, including diabetes. After adjusting for all other factors, treatment with linezolid was associated with significantly lower treatment costs compared with vancomycin.

CONCLUSIONS

Linezolid therapy was associated with improved clinical outcomes and significantly lower treatment costs than was vancomycin. The largest cost advantage was demonstrated in patients with documented MRSA cSSTIs.

摘要

背景

在临床试验中,与万古霉素相比,利奈唑胺治疗复杂性皮肤和软组织感染(cSSTIs)时,已证明其临床治愈率更高,患者住院时间更短。

目的

评估利奈唑胺与万古霉素的经济效果,并评估cSSTIs治疗成本的决定因素。

方法

经济数据来自参加一项由疑似或已证实的耐甲氧西林金黄色葡萄球菌(MRSA)引起的cSSTIs的多国、开放标签临床试验的美国受试者。受试者被随机分配接受静脉或口服利奈唑胺或静脉万古霉素治疗7 - 21天。通过应用各医院病房具有全国代表性的每日住院费用来评估每位患者的费用。静脉给药费用适用于静脉治疗的持续时间。使用多变量回归分析评估导致治疗费用的因素。

结果

717名美国患者纳入研究。各治疗组的人口统计学特征相似。利奈唑胺治疗的患者住院时间和静脉治疗持续时间较短。意向性治疗人群中,接受利奈唑胺治疗的患者的平均±标准差成本为4865美元±4367美元,而接受万古霉素治疗的患者为5738美元±5190美元(p = 0.017);在MRSA人群中,分别为4881美元±3987美元和6006美元±5039美元(p = 0.041)。与成本增加显著相关的因素包括万古霉素治疗、年龄以及合并症,包括糖尿病。在对所有其他因素进行调整后,与万古霉素相比,利奈唑胺治疗与显著更低的治疗成本相关。

结论

与万古霉素相比,利奈唑胺治疗具有更好的临床效果且治疗成本显著更低。在有记录的MRSA cSSTIs患者中显示出最大的成本优势。

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