抗生素治疗小儿社区获得性皮肤脓肿的随机对照试验。

Randomized, controlled trial of antibiotics in the management of community-acquired skin abscesses in the pediatric patient.

机构信息

Cardinal Glennon Children's Medical Center, Saint Louis University School of Medicine, Pediatric Emergency Medicine Department, Division of Pediatrics, St. Louis, MO, USA.

出版信息

Ann Emerg Med. 2010 May;55(5):401-7. doi: 10.1016/j.annemergmed.2009.03.014. Epub 2009 May 5.

DOI:10.1016/j.annemergmed.2009.03.014

PMID:19409657

Abstract

STUDY OBJECTIVE

Emergency department visits for skin and soft tissue infections are increasing with the discovery of community-acquired methicillin-resistant Staphylococcus aureus. Whether abscesses treated surgically also require antibiotics is controversial. There are no published pediatric randomized controlled trials evaluating the need for antibiotics in skin abscess management. We determine the benefits of antibiotics in surgically managed pediatric skin abscesses.

METHODS

This was a double-blind, randomized, controlled trial. Pediatric patients were randomized to receive 10 days of placebo or trimethoprim-sulfamethoxazole after incision and draining. Follow-up consisted of a visit/call at 10 to 14 days and a call at 90 days. Primary outcome was treatment failure at the 10-day follow-up. Secondary outcome was new lesion development at the 10- and 90-day follow-ups. Noninferiority of placebo relative to trimethoprim-sulfamethoxazole for primary and secondary outcomes was assessed.

RESULTS

One hundred sixty-one patients were enrolled, with 12 lost to follow-up. The failure rates were 5.3% (n=4/76) and 4.1% (n=3/73) in the placebo and antibiotic groups, respectively, yielding a difference of 1.2%, with a 1-sided 95% confidence interval (CI) (-infinity to 6.8%). Noninferiority was established with an equivalence threshold of 7%. New lesions occurred at the 10-day follow-up: 19 on placebo (26.4%) and 9 on antibiotics (12.9%), yielding a difference of 13.5%, with 95% 1-sided CI (-infinity to 24.3%). At the 3-month follow-up, 15 of 52 (28.8%) in the placebo group and 13 of 46 (28.3%) in the antibiotic group developed new lesions. The difference was 0.5%, with 95% 1-sided CI (-infinity to 15.6%).

CONCLUSION

Antibiotics are not required for pediatric skin abscess resolution. Antibiotics may help prevent new lesions in the short term, but further studies are required.

摘要

研究目的

随着社区获得性耐甲氧西林金黄色葡萄球菌的发现，急诊科因皮肤和软组织感染就诊的人数不断增加。接受手术治疗的脓肿是否还需要使用抗生素存在争议。目前尚无关于评估儿童皮肤脓肿管理中抗生素使用必要性的已发表的儿科随机对照试验。本研究旨在确定抗生素在接受手术治疗的儿科皮肤脓肿中的作用。

方法

这是一项双盲、随机、对照试验。患儿在切开引流后随机分为接受 10 天安慰剂或复方磺胺甲噁唑治疗组。随访包括在第 10-14 天进行就诊/电话随访，并在第 90 天进行电话随访。主要结局为第 10 天随访时的治疗失败。次要结局为第 10 天和第 90 天随访时的新发皮损。采用单侧 95%置信区间（CI）下限（-infty）评估安慰剂相对于复方磺胺甲噁唑在主要和次要结局中的非劣效性。

结果

共纳入 161 例患儿，其中 12 例失访。安慰剂组和抗生素组的失败率分别为 5.3%（n=4/76）和 4.1%（n=3/73），差异为 1.2%，单侧 95%CI（-infty 至 6.8%）。等效性阈值为 7%，因此确立了非劣效性。第 10 天随访时新发皮损：安慰剂组 19 例（26.4%），抗生素组 9 例（12.9%），差异为 13.5%，95%单侧 CI（-infty 至 24.3%）。在 3 个月随访时，安慰剂组 52 例中有 15 例（28.8%）和抗生素组 46 例中有 13 例（28.3%）出现新发皮损。差异为 0.5%，95%单侧 CI（-infty 至 15.6%）。