Yue Jirong, Dong Bi Rong, Yang Ming, Chen Xiaomei, Wu Taixiang, Liu Guan J
Department of Geriatrics,West China Hospital, Sichuan University, Chengdu, China.
Cochrane Database Syst Rev. 2013 Jul 12(7):CD008056. doi: 10.1002/14651858.CD008056.pub2.
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).
To compare the effects and safety of linezolid and vancomycin for treating people with SSTIs.
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 We also contacted manufacturers for details of unpublished and ongoing trials.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.
We included all randomised controlled trials (RCTs) comparing linezolid with vancomycin in the treatment of SSTIs.
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.
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.
皮肤和软组织感染(SSTIs)的发病率及治疗成本都很高。利奈唑胺和万古霉素是常用于治疗皮肤和软组织感染的抗生素,尤其是耐甲氧西林金黄色葡萄球菌(MRSA)引起的感染。
比较利奈唑胺和万古霉素治疗SSTIs患者的疗效和安全性。
2013年5月,我们检索了以下数据库:Cochrane伤口组专业注册库;Cochrane对照试验中心注册库(CENTRAL)(Cochrane图书馆);Ovid MEDLINE;Ovid MEDLINE(在研及其他未索引引文);Ovid EMBASE;以及EBSCO CINAHL。我们还联系了制造商以获取未发表和正在进行的试验的详细信息。我们仔细审查了所有纳入试验和主要综述文章中的参考文献,以识别任何其他试验。
我们纳入了所有比较利奈唑胺和万古霉素治疗SSTIs的随机对照试验(RCTs)。
两位综述作者独立选择试验、评估偏倚风险并提取数据。主要结局包括临床治愈、微生物学治愈以及与SSTI相关和与治疗相关的死亡率。我们根据年龄以及感染是否由MRSA引起进行了亚组分析。
我们纳入了9项RCTs(3144名参与者)。利奈唑胺与成人更好的临床治愈率(RR 1.09,95%CI 1.03至1.16)和微生物学治愈率(RR 1.08,95%CI 1.01至1.16)相关。对于由MRSA引起的那些感染,利奈唑胺在临床治愈率(RR 1.09,95%CI 1.03至1.17)和微生物学治愈率(RR 1.17,95%CI 1.04至1.32)方面显著优于万古霉素。没有RCT报告与SSTI相关和与治疗相关的死亡率。利奈唑胺和万古霉素之间的全因死亡率没有显著差异(RR 1.44,95%CI 0.75至2.80)。与万古霉素组相比,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)的发生率更低,然而,接受利奈唑胺治疗的患者更多报告有血小板减少(RR 13.06,95%CI 1.72至99.22)和恶心(RR 2.45,95%CI 1.52至3.94)。从现有数据来看,利奈唑胺组患者的住院时间似乎比万古霉素组短。口服利奈唑胺的门诊治疗每日费用低于静脉注射万古霉素。虽然利奈唑胺的住院治疗每日费用高于万古霉素的住院治疗,但利奈唑胺组的住院中位时间短三天。因此,利奈唑胺治疗的每位患者的总住院费用低于万古霉素治疗。
利奈唑胺在治疗SSTIs患者(包括由MRSA引起的SSTIs)方面似乎比万古霉素更有效。现有证据存在较高的偏倚风险,且基于由生产利奈唑胺的制药公司资助的研究。需要进一步进行设计良好、独立资助的RCTs来证实现有证据。