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在日本,利奈唑胺与万古霉素治疗耐甲氧西林金黄色葡萄球菌引起的感染的对比研究

Linezolid versus vancomycin for the treatment of infections caused by methicillin-resistant Staphylococcus aureus in Japan.

作者信息

Kohno S, Yamaguchi K, Aikawa N, Sumiyama Y, Odagiri S, Aoki N, Niki Y, Watanabe S, Furue M, Ito T, Croos-Dabrera R, Tack K J

机构信息

Second Department of Internal Medicine, Nagasaki University Graduate School of Pharmaceutical Sciences, Nagasaki, Japan.

出版信息

J Antimicrob Chemother. 2007 Dec;60(6):1361-9. doi: 10.1093/jac/dkm369. Epub 2007 Oct 3.

Abstract

OBJECTIVES

To compare the efficacy and safety of linezolid and vancomycin for the treatment of methicillin-resistant Staphylococcus aureus (MRSA) infections in Japan.

METHODS

Patients with nosocomial pneumonia, complicated skin and soft-tissue infections or sepsis caused by MRSA were randomized to receive linezolid (600 mg every 12 h) or vancomycin (1 g every 12 h).

RESULTS

One hundred patients received linezolid and 51 received vancomycin with outcomes evaluated at the end of therapy (EOT) and at the follow-up (FU), 7-14 days later. At EOT, clinical success rates in the MRSA microbiologically evaluable population were 62.9% and 50.0% for the linezolid and vancomycin groups, respectively; and microbiological eradication rates were 79.0% and 30.0% in the two groups, respectively (P < 0.0001). At FU, the clinical success rates were 36.7% for both groups and the microbiological eradication rates were 46.8% and 36.7%, respectively. Reversible anaemia (13%) and thrombocytopenia (19%) were reported more frequently in linezolid patients; laboratory analysis showed mild decrease in platelet counts with full recovery by FU. The mean platelet count in linezolid patients with thrombocytopenia was 101,000/mm(3). Significantly low platelet counts (<50,000/mm(3)) were observed more frequently in patients receiving vancomycin than in linezolid patients (6% versus 3%). Mean changes in haemoglobin levels between the two groups were not different.

CONCLUSIONS

Linezolid is as effective as vancomycin for the treatment of MRSA infections and may be more effective than vancomycin in achieving microbiological eradication. Haematological adverse events were reported more frequently in linezolid-treated patients; analysis of laboratory data showed a mild reversible trend towards lower platelet counts.

摘要

目的

比较利奈唑胺和万古霉素在日本治疗耐甲氧西林金黄色葡萄球菌(MRSA)感染的疗效和安全性。

方法

将由MRSA引起的医院获得性肺炎、复杂性皮肤和软组织感染或败血症患者随机分为两组,分别接受利奈唑胺(每12小时600毫克)或万古霉素(每12小时1克)治疗。

结果

100例患者接受利奈唑胺治疗,51例患者接受万古霉素治疗,在治疗结束时(EOT)以及7 - 14天后的随访(FU)时评估疗效。在EOT时,利奈唑胺组和万古霉素组中MRSA微生物学可评估人群的临床成功率分别为62.9%和50.0%;两组的微生物学根除率分别为79.0%和30.0%(P < 0.0001)。在FU时,两组的临床成功率均为36.7%,微生物学根除率分别为46.8%和36.7%。利奈唑胺治疗的患者中可逆性贫血(13%)和血小板减少症(19%)的报告更为频繁;实验室分析显示血小板计数轻度下降,但在随访时完全恢复。血小板减少的利奈唑胺治疗患者的平均血小板计数为101,000/mm³。接受万古霉素治疗的患者中血小板计数显著降低(<50,000/mm³)的情况比接受利奈唑胺治疗的患者更频繁(6%对3%)。两组之间血红蛋白水平的平均变化无差异。

结论

利奈唑胺治疗MRSA感染的疗效与万古霉素相当,在实现微生物学根除方面可能比利奈唑胺更有效。利奈唑胺治疗的患者血液学不良事件报告更为频繁;实验室数据分析显示血小板计数有轻度可逆性降低趋势。

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