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临床试验:头孢氨苄联合甲氧苄啶-磺胺甲噁唑与头孢氨苄单药治疗单纯性蜂窝织炎的比较效果:一项随机对照试验。

Clinical trial: comparative effectiveness of cephalexin plus trimethoprim-sulfamethoxazole versus cephalexin alone for treatment of uncomplicated cellulitis: a randomized controlled trial.

机构信息

Department of Emergency Medicine, Brigham and Women's Hospital, Boston, MA, USA.

出版信息

Clin Infect Dis. 2013 Jun;56(12):1754-62. doi: 10.1093/cid/cit122. Epub 2013 Mar 1.

DOI:10.1093/cid/cit122
PMID:23457080
Abstract

BACKGROUND

Community-associated methicillin-resistant S. aureus (CA-MRSA) is the most common organism isolated from purulent skin infections. Antibiotics are usually not beneficial for skin abscess, and national guidelines do not recommend CA-MRSA coverage for cellulitis, except purulent cellulitis, which is uncommon. Despite this, antibiotics targeting CA-MRSA are prescribed commonly and increasingly for skin infections, perhaps due, in part, to lack of experimental evidence among cellulitis patients. We test the hypothesis that antibiotics targeting CA-MRSA are beneficial in the treatment of cellulitis.

METHODS

We performed a randomized, multicenter, double-blind, placebo-controlled trial from 2007 to 2011. We enrolled patients with cellulitis, no abscesses, symptoms for <1 week, and no diabetes, immunosuppression, peripheral vascular disease, or hospitalization (clinicaltrials.gov NCT00676130). All participants received cephalexin. Additionally, each was randomized to trimethoprim-sulfamethoxazole or placebo. We provided 14 days of antibiotics and instructed participants to continue therapy for ≥1 week, then stop 3 days after they felt the infection to be cured. Our main outcome measure was the risk difference for treatment success, determined in person at 2 weeks, with telephone and medical record confirmation at 1 month.

RESULTS

We enrolled 153 participants, and 146 had outcome data for intent-to-treat analysis. Median age was 29, range 3-74. Of intervention participants, 62/73 (85%) were cured versus 60/73 controls (82%), a risk difference of 2.7% (95% confidence interval, -9.3% to 15%; P = .66). No covariates predicted treatment response, including nasal MRSA colonization and purulence at enrollment.

CONCLUSIONS

Among patients diagnosed with cellulitis without abscess, the addition of trimethoprim-sulfamethoxazole to cephalexin did not improve outcomes overall or by subgroup.

CLINICAL TRIALS REGISTRATION

NCT00676130.

摘要

背景

社区相关性耐甲氧西林金黄色葡萄球菌(CA-MRSA)是从脓性皮肤感染中分离出的最常见的病原体。抗生素通常对皮肤脓肿无益,且国家指南不建议对蜂窝织炎使用 CA-MRSA 覆盖,除非是不常见的脓性蜂窝织炎。尽管如此,针对 CA-MRSA 的抗生素仍被广泛且越来越多地用于皮肤感染的治疗,这可能部分归因于蜂窝织炎患者缺乏实验证据。我们检验了这样一个假设,即针对 CA-MRSA 的抗生素在治疗蜂窝织炎方面是有益的。

方法

我们于 2007 年至 2011 年进行了一项随机、多中心、双盲、安慰剂对照试验。我们招募了患有蜂窝织炎、无脓肿、症状持续时间<1 周且无糖尿病、免疫抑制、外周血管疾病或住院治疗的患者(clinicaltrials.gov NCT00676130)。所有参与者均接受头孢氨苄治疗。此外,每位参与者还随机分为甲氧苄啶-磺胺甲噁唑或安慰剂组。我们提供了 14 天的抗生素,并指导参与者继续治疗至少 1 周,然后在他们感到感染已治愈的 3 天后停止治疗。我们的主要结局指标是治疗成功的风险差异,在 2 周时进行面对面评估,并在 1 个月时通过电话和病历确认。

结果

我们共纳入了 153 名参与者,其中 146 名参与者的意向治疗分析数据完整。中位年龄为 29 岁,范围为 3-74 岁。在干预组中,73 名参与者中有 62 名(85%)治愈,而对照组中有 73 名参与者中的 60 名(82%)治愈,风险差异为 2.7%(95%置信区间为-9.3%至 15%;P=.66)。没有协变量可以预测治疗反应,包括鼻 MRSA 定植和入组时的脓性分泌物。

结论

在诊断为无脓肿的蜂窝织炎患者中,头孢氨苄联合甲氧苄啶-磺胺甲噁唑并不能改善整体或亚组的结局。

临床试验注册

NCT00676130。

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