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头孢洛林酯治疗社区获得性肺炎和皮肤及皮肤结构感染:系统评价。

Ceftaroline fosamil for community-acquired pneumonia and skin and skin structure infections: a systematic review.

机构信息

College of Pharmacy, Qatar University, PO Box 2713, Doha, Qatar.

Vancouver General Hospital, Vancouver, BC, Canada.

出版信息

Int J Clin Pharm. 2017 Feb;39(1):26-32. doi: 10.1007/s11096-016-0417-z. Epub 2017 Jan 5.

DOI:10.1007/s11096-016-0417-z
PMID:28058593
Abstract

Background Ceftaroline is a parentally administered cephalosporin that has an in vitro expanded spectrum of activity compared with other cephalosporins yet data is conflicting regarding its place in therapy. Aim of the Review To compare the efficacy and safety of ceftaroline against standard antibiotic regimens for community-acquired pneumonia (CAP) and complicated skin and skin structure infections (cSSSIs). Method The databases of MEDLINE, EBSCO, and Embase were searched up to June 2016. Manual review of references was completed and experts in the field were contacted for unpublished data. Randomized controlled trials of ceftaroline in CAP or cSSSI populations were included. Outcomes included clinical cure, mortality, adverse events, serious adverse events, and discontinuation due to adverse events. Meta-analysis was used to pool results for these outcomes. We performed subgroup analyses for gram positive infections in CAP and infections caused by methicillin-resistant Staphylococcus aureus in cSSSIs. Risk of bias was assessed for all studies. Results Six trials (three for each indication) were included, each of which had an unclear or high risk of bias in at least one domain. For CAP, ceftaroline was significantly more efficacious in achieving clinical cure than ceftriaxone [risk ratio (RR) 1.11, 95% confidence interval (CI) 1.04-1.19; I = 47%]. For cSSSIs, there was no significant difference in clinical cure between ceftaroline and vancomycin plus aztreonam (RR 1.01, 95% CI 0.97-1.05; I = 0%). No differences were found for overall mortality, serious adverse events, discontinuation due to adverse events, and overall adverse events. Conclusion Ceftaroline is a viable therapeutic alternative for patients with CAP and cSSSIs, yet identified risks of bias and poor external validity preclude it from being recommended as a first-line agent.

摘要

背景

头孢洛林是一种可通过注射给药的头孢菌素,与其他头孢菌素相比,其体外活性谱有所扩大,但关于其在治疗中的地位的数据存在争议。

目的

比较头孢洛林与社区获得性肺炎(CAP)和复杂性皮肤和皮肤结构感染(cSSSIs)的标准抗生素治疗方案的疗效和安全性。

方法

检索 MEDLINE、EBSCO 和 Embase 数据库,检索截至 2016 年 6 月。对参考文献进行人工审查,并联系该领域的专家以获取未发表的数据。纳入头孢洛林治疗 CAP 或 cSSSI 人群的随机对照试验。主要结局包括临床治愈率、死亡率、不良事件、严重不良事件和因不良事件停药。对这些结局进行了荟萃分析。我们对 CAP 中的革兰氏阳性感染和 cSSSIs 中的耐甲氧西林金黄色葡萄球菌感染进行了亚组分析。对所有研究均进行了偏倚风险评估。

结果

纳入了 6 项试验(每种适应证各 3 项),每项研究均至少有一个领域存在不确定或高偏倚风险。对于 CAP,头孢洛林在实现临床治愈率方面明显优于头孢曲松[风险比(RR)1.11,95%置信区间(CI)1.04-1.19;I = 47%]。对于 cSSSIs,头孢洛林与万古霉素加氨曲南的临床治愈率无显著差异(RR 1.01,95%CI 0.97-1.05;I = 0%)。在总死亡率、严重不良事件、因不良事件停药和总不良事件方面,两组间均无差异。

结论

头孢洛林是 CAP 和 cSSSIs 患者的一种可行的治疗选择,但确定的偏倚风险和较差的外部有效性使其不能被推荐为一线药物。

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Ceftaroline Efficacy and Safety in Treatment of Complicated Skin and Soft Tissue Infection: A Systemic Review and Meta-Analysis of Randomized Controlled Trials.头孢洛林治疗复杂性皮肤和软组织感染的疗效与安全性:一项随机对照试验的系统评价和荟萃分析
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Efficacy and effectiveness of Ceftaroline Fosamil in patients with pneumonia: a systematic review and meta-analysis.头孢洛林酯治疗肺炎的疗效和有效性:系统评价和荟萃分析。
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Ceftaroline fosamil: a brief clinical review.头孢替唑钠:简要临床评价。
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FOCUS 2: a randomized, double-blinded, multicentre, Phase III trial of the efficacy and safety of ceftaroline fosamil versus ceftriaxone in community-acquired pneumonia.重点 2:头孢洛林酯氨噻肟与头孢曲松治疗社区获得性肺炎的疗效和安全性的随机、双盲、多中心 III 期临床试验。
J Antimicrob Chemother. 2011 Apr;66 Suppl 3:iii33-44. doi: 10.1093/jac/dkr097.
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FOCUS 1: a randomized, double-blinded, multicentre, Phase III trial of the efficacy and safety of ceftaroline fosamil versus ceftriaxone in community-acquired pneumonia.重点 1:头孢洛林酯氨噻肟与头孢曲松治疗社区获得性肺炎的疗效和安全性的随机、双盲、多中心、III 期临床试验。
J Antimicrob Chemother. 2011 Apr;66 Suppl 3:iii19-32. doi: 10.1093/jac/dkr096.
9
CANVAS 2: the second Phase III, randomized, double-blind study evaluating ceftaroline fosamil for the treatment of patients with complicated skin and skin structure infections.CANVAS 2:评价头孢洛林酯治疗复杂性皮肤和皮肤结构感染患者的第二项 III 期、随机、双盲研究。
J Antimicrob Chemother. 2010 Nov;65 Suppl 4:iv53-iv65. doi: 10.1093/jac/dkq255.
10
CANVAS 1: the first Phase III, randomized, double-blind study evaluating ceftaroline fosamil for the treatment of patients with complicated skin and skin structure infections.CANVAS 1 研究:首个评估头孢洛林酯治疗复杂性皮肤和皮肤软组织感染的 III 期、随机、双盲研究。
J Antimicrob Chemother. 2010 Nov;65 Suppl 4:iv41-51. doi: 10.1093/jac/dkq254.