Clindamycin versus trimethoprim-sulfamethoxazole for uncomplicated skin infections.
Clindamycin versus trimethoprim-sulfamethoxazole for uncomplicated skin infections.
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DOI：
10.1056/nejmoa1403789
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发表时间：
2015-03-19
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影响因子：
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通讯作者：
DMID 07-0051 Team
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作者：
Miller LG;Daum RS;Creech CB;Young D;Downing MD;Eells SJ;Pettibone S;Hoagland RJ;Chambers HF;DMID 07-0051 Team
皮肤和皮肤结构感染在门诊环境中很常见。然而，各种抗生素治疗方案在社区获得性耐甲氧西林金黄色葡萄球菌（MRSA）时代的疗效尚不清楚。我们招募了门诊患者，这些患者患有单纯性皮肤感染，蜂窝织炎，直径大于5 cm的脓肿（对于年龄较小的儿童来说较小），或两者兼而有之。患者在4个研究中心入组。所有患者均行切开引流术。患者以1：1的比例随机分配接受克林霉素或甲氧苄啶-磺胺甲恶唑（TMP-SMX）治疗10天。患者和研究者不知道治疗分配和微生物检测结果。主要转归为治疗结束后7 ~ 10天临床治愈。共入组524例患者（克林霉素组264例，TMP-SMX组260例），包括155例儿童（29.6%）。160例患者（30.5%）有脓肿，280例（53.4%）有蜂窝织炎，82例（15.6%）有混合感染，定义为至少一处脓肿病变和一处蜂窝织炎病变。S. 217例患者（41.4%）的病变中分离出金黄色葡萄球菌，其中167例（77.0%）为MRSA。在意向治疗人群中，两个治疗组的治愈患者比例相似（克林霉素组为80.3%，TMP-SMX组为77.7%;差异，-2.6个百分点; 95%置信区间[CI]，-10.2至4.9; P = 0.52）和可评价的患者人群（466例患者;克林霉素组为89.5%，TMP-SMX组为88.2%;差异为-1.2个百分点; 95%CI为-7.6至5.1; P = 0.77）。在儿童、成人和脓肿与蜂窝织炎患者亚组中，两种治疗的治愈率无显著差异。两组发生不良事件的患者比例相似。我们发现克林霉素和TMP-SMX在治疗单纯性皮肤感染（包括蜂窝织炎和脓肿）的疗效或副作用方面无显著差异。（由国家过敏和传染病研究所和国家卫生研究院国家转化科学推进中心资助; ClinicalTrials.gov编号，NCT 00730028。
Skin and skin-structure infections are common in ambulatory settings. However, the efficacy of various antibiotic regimens in the era of community-acquired methicillin-resistant Staphylococcus aureus (MRSA) is unclear. We enrolled outpatients with uncomplicated skin infections who had cellulitis, abscesses larger than 5 cm in diameter (smaller for younger children), or both. Patients were enrolled at four study sites. All abscesses underwent incision and drainage. Patients were randomly assigned in a 1:1 ratio to receive either clindamycin or trimethoprim–sulfamethoxazole (TMP-SMX) for 10 days. Patients and investigators were unaware of the treatment assignments and microbiologic test results. The primary outcome was clinical cure 7 to 10 days after the end of treatment. A total of 524 patients were enrolled (264 in the clindamycin group and 260 in the TMP-SMX group), including 155 children (29.6%). One hundred sixty patients (30.5%) had an abscess, 280 (53.4%) had cellulitis, and 82 (15.6%) had mixed infection, defined as at least one abscess lesion and one cellulitis lesion. S. aureus was isolated from the lesions of 217 patients (41.4%); the isolates in 167 (77.0%) of these patients were MRSA. The proportion of patients cured was similar in the two treatment groups in the intention-to-treat population (80.3% in the clindamycin group and 77.7% in the TMP-SMX group; difference, −2.6 percentage points; 95% confidence interval [CI], −10.2 to 4.9; P = 0.52) and in the populations of patients who could be evaluated (466 patients; 89.5% in the clindamycin group and 88.2% in the TMP-SMX group; difference, −1.2 percentage points; 95% CI, −7.6 to 5.1; P = 0.77). Cure rates did not differ significantly between the two treatments in the subgroups of children, adults, and patients with abscess versus cellulitis. The proportion of patients with adverse events was similar in the two groups. We found no significant difference between clindamycin and TMP-SMX, with respect to either efficacy or side-effect profile, for the treatment of uncomplicated skin infections, including both cellulitis and abscesses. (Funded by the National Institute of Allergy and Infectious Diseases and the National Center for Advancing Translational Sciences, National Institutes of Health; ClinicalTrials.gov number, NCT00730028.)