利奈唑胺与万古霉素治疗皮肤和软组织感染

Jirong Yue, Bi Rong Dong, Ming Yang, Xiaomei Chen, Taixiang Wu, Guan J Liu
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Linezolid and vancomycin are antibiotics that are commonly used in treating skin and soft-tissue infections, specifically those infections due to methicillin-resistant <i>Staphylococcus aureus (</i>MRSA).</p>\n </section>\n \n <section>\n \n <h3> Objectives</h3>\n \n <p>To compare the effects and safety of linezolid and vancomycin for treating people with SSTIs.</p>\n </section>\n \n <section>\n \n <h3> Search methods</h3>\n \n <p>In May 2013 we conducted searches of the following databases: Cochrane Wounds Group Specialised Register; The Cochrane Central Register of Controlled Trials (CENTRAL) (<i>The Cochrane Library</i>); Ovid MEDLINE; Ovid MEDLINE (In-Process &amp; Other Non-Indexed Citations); Ovid EMBASE; and EBSCO CINAHL. We also contacted manufacturers for details of unpublished and ongoing trials. 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For those infections due to MRSA, linezolid was significantly more effective than vancomycin in clinical (RR 1.09, 95% CI 1.03 to 1.17) and microbiological cure rates (RR 1.17, 95% CI 1.04 to 1.32). No RCT reported SSTI-related and treatment-related mortality. There was no significant difference in all-cause mortality between linezolid and vancomycin (RR 1.44, 95% CI 0.75 to 2.80). There were fewer incidents of red man syndrome (RR 0.04, 95% CI 0.01 to 0.29), pruritus (RR 0.36, 95% CI 0.17 to 0.75) and rash (RR 0.27, 95% CI 0.12 to 0.58) in the linezolid group compared with vancomycin, however, more people reported thrombocytopenia (RR 13.06, 95% CI 1.72 to 99.22), and nausea (RR 2.45, 95% CI 1.52 to 3.94) when treated with linezolid. It seems, from the available data, that length of stay in hospital was shorter for those in the linezolid group than the vancomycin group. The daily cost of outpatient therapy was less with oral linezolid than with intravenous vancomycin. 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引用次数: 6

摘要

背景皮肤和软组织感染(SSTIs)的发病率和治疗费用很高。利奈唑胺和万古霉素是通常用于治疗皮肤和软组织感染的抗生素,特别是那些由耐甲氧西林金黄色葡萄球菌(MRSA)引起的感染。目的比较利奈唑胺与万古霉素治疗性传播感染的疗效和安全性。检索方法2013年5月,我们对以下数据库进行了检索:Cochrane Wounds Group specialized Register;Cochrane中央对照试验登记(Central) (Cochrane图书馆);奥维德MEDLINE;Ovid MEDLINE(进程中&其他非索引引文);奥维德EMBASE;EBSCO CINAHL。我们还联系了制造商,了解未发表和正在进行的试验的细节。我们仔细检查了所有获得的试验和主要综述文章的引用,以确定任何额外的试验。我们纳入了比较利奈唑胺和万古霉素治疗ssti的所有随机对照试验(RCTs)。数据收集和分析两位综述作者独立选择试验,评估偏倚风险并提取数据。主要结局是临床治愈、微生物治愈、ssti相关死亡率和治疗相关死亡率。我们根据年龄和感染是否由MRSA引起进行了亚组分析。我们纳入了9项rct(3144名受试者)。利奈唑胺与较好的临床(RR 1.09, 95% CI 1.03 ~ 1.16)和成人微生物治愈率(RR 1.08, 95% CI 1.01 ~ 1.16)相关。对于MRSA引起的感染,利奈唑胺在临床(RR 1.09, 95% CI 1.03 ~ 1.17)和微生物治愈率(RR 1.17, 95% CI 1.04 ~ 1.32)上明显优于万古霉素。没有随机对照试验报告性传播感染相关和治疗相关的死亡率。利奈唑胺和万古霉素的全因死亡率无显著差异(RR 1.44, 95% CI 0.75 ~ 2.80)。与万古霉素相比,利奈唑胺组红人综合征(RR 0.04, 95% CI 0.01至0.29)、瘙痒(RR 0.36, 95% CI 0.17至0.75)和皮疹(RR 0.27, 95% CI 0.12至0.58)的发生率较低,然而,利奈唑胺组报告血小板减少(RR 13.06, 95% CI 1.72至99.22)和恶心(RR 2.45, 95% CI 1.52至3.94)的发生率较高。从现有的数据来看,利奈唑胺组的住院时间似乎比万古霉素组短。每日门诊治疗费用口服利奈唑胺低于静脉注射万古霉素。虽然每天使用利奈唑胺的住院治疗费用高于使用万古霉素的住院治疗费用,但利奈唑胺的中位住院时间比使用万古霉素的住院时间短3天。因此,利奈唑胺治疗每位患者的总医院费用低于万古霉素治疗。作者的结论:利奈唑胺似乎比万古霉素更有效地治疗ssti患者,包括由MRSA引起的ssti。现有的证据有很高的偏倚风险,而且是基于生产利奈唑胺的制药公司支持的研究。需要进一步精心设计、独立资助的随机对照试验来证实现有证据。治疗皮肤和软组织感染的抗生素药物皮肤和软组织感染如脓疱疮、脓肿、溃疡和手术部位感染是常见的皮肤感染。对于涉及深层组织的严重皮肤和软组织感染,死亡率和治疗费用很高。利奈唑胺和万古霉素是有效治疗皮肤和软组织感染的抗生素,特别是由对某些抗生素产生耐药性的细菌引起的感染。本综述确定了9项随机对照试验,共3144名受试者,比较了利奈唑胺治疗和万古霉素治疗皮肤和软组织感染的效果。利奈唑胺被发现比万古霉素更有效地治疗这些感染。利奈唑胺组皮肤并发症较少。两组之间报告的死亡人数没有差异,用利奈唑胺治疗的患者比用万古霉素治疗的患者住院时间短。 门诊每日治疗费用口服利奈唑胺低于静脉注射万古霉素,但住院治疗费用利奈唑胺高于万古霉素。未来需要设计良好的试验来证实这些结果,因为得出这些结论的试验方法学质量很差,有很高的偏倚风险,而且是由制造利奈唑胺的制药公司资助的。
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Linezolid versus vancomycin for skin and soft tissue infections

Background

The morbidity and treatment costs associated with skin and soft tissue infections (SSTIs) are high. Linezolid and vancomycin are antibiotics that are commonly used in treating skin and soft-tissue infections, specifically those infections due to methicillin-resistant Staphylococcus aureus (MRSA).

Objectives

To compare the effects and safety of linezolid and vancomycin for treating people with SSTIs.

Search methods

In May 2013 we conducted searches of the following databases: Cochrane Wounds Group Specialised Register; The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library); Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid EMBASE; and EBSCO CINAHL. We also contacted manufacturers for details of unpublished and ongoing trials. We scrutinised citations within all obtained trials and major review articles to identify any additional trials.

Selection criteria

We included all randomised controlled trials (RCTs) comparing linezolid with vancomycin in the treatment of SSTIs.

Data collection and analysis

Two review authors independently selected trials, assessed risk of bias and extracted data. The primary outcomes were clinical cure, microbiological cure, and SSTI-related and treatment-related mortality. We performed subgroup analyses according to age, and whether the infection was due to MRSA.

Main results

We included nine RCTs (3144 participants). Linezolid was associated with a significantly better clinical (RR 1.09, 95% CI 1.03 to 1.16) and microbiological cure rate in adults (RR 1.08, 95% CI 1.01 to 1.16). For those infections due to MRSA, linezolid was significantly more effective than vancomycin in clinical (RR 1.09, 95% CI 1.03 to 1.17) and microbiological cure rates (RR 1.17, 95% CI 1.04 to 1.32). No RCT reported SSTI-related and treatment-related mortality. There was no significant difference in all-cause mortality between linezolid and vancomycin (RR 1.44, 95% CI 0.75 to 2.80). There were fewer incidents of red man syndrome (RR 0.04, 95% CI 0.01 to 0.29), pruritus (RR 0.36, 95% CI 0.17 to 0.75) and rash (RR 0.27, 95% CI 0.12 to 0.58) in the linezolid group compared with vancomycin, however, more people reported thrombocytopenia (RR 13.06, 95% CI 1.72 to 99.22), and nausea (RR 2.45, 95% CI 1.52 to 3.94) when treated with linezolid. It seems, from the available data, that length of stay in hospital was shorter for those in the linezolid group than the vancomycin group. The daily cost of outpatient therapy was less with oral linezolid than with intravenous vancomycin. Although inpatient treatment with linezolid cost more than inpatient treatment with vancomycin per day, the median length of hospital stay was three days shorter with linezolid. Thus, total hospital charges per patient were less with linezolid treatment than with vancomycin treatment.

Authors' conclusions

Linezolid seems to be more effective than vancomycin for treating people with SSTIs, including SSTIs caused by MRSA. The available evidence is at high risk of bias and is based on studies that were supported by the pharmaceutical company that makes linezolid. Further well-designed, independently-funded, RCTs are needed to confirm the available evidence.

Plain Language Summary

Antibiotic drugs for treating skin and soft tissue infections

Skin and soft tissue infections such as impetigo, abscesses, ulcers, and surgical site infections are common infections of the skin. For serious skin and soft tissue infections involving the deeper tissues, the death rate and treatment costs are high. Linezolid and vancomycin are antibiotics that are effective in treating skin and soft tissue infections, particularly infections caused by bacteria that have developed resistance to some antibiotics. This review identified nine RCTs, with a total of 3144 participants, and compared treatment with linezolid against treatment with vancomycin for skin and soft tissue infections. Linezolid was found to be more effective than vancomycin for treating these infections. There were fewer skin complications in the group that were treated with linezolid. There were no differences between the two groups in the number of reported deaths, and those treated with linezolid had shorter lengths of hospital stay than those treated with vancomycin. The daily cost of outpatient therapy was less with oral linezolid than with intravenous vancomycin, although for inpatient treatment, linezolid was more expensive than vancomycin. Well-designed trials will be required in future to confirm these results, as the trials from which these conclusions were drawn were of poor methodological quality, at high risk of bias, and were funded by the pharmaceutical company that makes linezolid.

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