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口服和外用抗生素治疗儿童临床感染性湿疹:门诊护理中的一项实用随机对照试验

Oral and Topical Antibiotics for Clinically Infected Eczema in Children: A Pragmatic Randomized Controlled Trial in Ambulatory Care.

作者信息

Francis Nick A, Ridd Matthew J, Thomas-Jones Emma, Butler Christopher C, Hood Kerenza, Shepherd Victoria, Marwick Charis A, Huang Chao, Longo Mirella, Wootton Mandy, Sullivan Frank

机构信息

Division of Population Medicine, School of Medicine, Cardiff University, Cardiff, Wales

School of Social and Community Medicine, University of Bristol, Bristol, England.

出版信息

Ann Fam Med. 2017 Mar;15(2):124-130. doi: 10.1370/afm.2038.

Abstract

PURPOSE

Eczema may flare because of bacterial infection, but evidence supporting antibiotic treatment is of low quality. We aimed to determine the effect of oral and topical antibiotics in addition to topical emollient and corticosteroids in children with clinically infected eczema.

METHODS

We employed a 3-arm, blinded, randomized controlled trial in UK ambulatory care. Children with clinical, non-severely infected eczema were randomized to receive oral and topical placebos (control), oral antibiotic (flucloxacillin) and topical placebo, or topical antibiotic (fusidic acid) and oral placebo, for 1 week. We compared Patient Oriented Eczema Measure (POEM) scores at 2 weeks using analysis of covariance (ANCOVA).

RESULTS

We randomized 113 children (40 to control, 36 to oral antibiotic, and 37 to topical antibiotic). Mean (SD) baseline Patient Oriented Eczema Measure scores were 13.4 (5.1) for the control group, 14.6 (5.3) for the oral antibiotic group, and 16.9 (5.5) for the topical antibiotic group. At baseline, 104 children (93%) had 1 or more of the following findings: weeping, crusting, pustules, or painful skin. Mean (SD) POEM scores at 2 weeks were 6.2 (6.0) for control, 8.3 (7.3) for the oral antibiotic group, and 9.3 (6.2) for the topical antibiotic group. Controlling for baseline POEM score, neither oral nor topical antibiotics produced a significant difference in mean (95% CI) POEM scores (1.5 [-1.4 to 4.4] and 1.5 [-1.6 to 4.5] respectively). There were no significant differences in adverse effects and no serious adverse events.

CONCLUSIONS

We found rapid resolution in response to topical steroid and emollient treatment and ruled out a clinically meaningful benefit from the addition of either oral or topical antibiotics. Children seen in ambulatory care with mild clinically infected eczema do not need treatment with antibiotics.

摘要

目的

湿疹可能因细菌感染而发作,但支持抗生素治疗的证据质量较低。我们旨在确定在患有临床感染性湿疹的儿童中,除局部润肤剂和皮质类固醇外,口服和局部使用抗生素的效果。

方法

我们在英国门诊护理中进行了一项三臂、双盲、随机对照试验。患有临床非严重感染性湿疹的儿童被随机分配接受口服和局部安慰剂(对照组)、口服抗生素(氟氯西林)和局部安慰剂,或局部抗生素(夫西地酸)和口服安慰剂,为期1周。我们使用协方差分析(ANCOVA)比较了2周时的患者导向性湿疹测量(POEM)分数。

结果

我们将113名儿童随机分组(40名进入对照组,36名进入口服抗生素组,37名进入局部抗生素组)。对照组的平均(标准差)基线患者导向性湿疹测量分数为13.4(5.1),口服抗生素组为14.6(5.3),局部抗生素组为16.9(5.5)。基线时,104名儿童(93%)有以下一项或多项表现:渗液、结痂、脓疱或皮肤疼痛。2周时对照组平均(标准差)POEM分数为6.2(6.0),口服抗生素组为8.3(7.3),局部抗生素组为9.3(6.2)。在控制基线POEM分数后,口服和局部抗生素在平均(95%CI)POEM分数上均未产生显著差异(分别为1.5[-1.4至4.4]和1.5[-1.6至4.5])。不良反应无显著差异,也无严重不良事件。

结论

我们发现局部类固醇和润肤剂治疗反应迅速,并排除了添加口服或局部抗生素的临床显著益处。在门诊护理中就诊的轻度临床感染性湿疹儿童不需要抗生素治疗。

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