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夫西地酸乳膏在全科医疗中治疗脓疱病的双盲随机安慰剂对照试验。

Fusidic acid cream in the treatment of impetigo in general practice: double blind randomised placebo controlled trial.

作者信息

Koning Sander, van Suijlekom-Smit Lisette W A, Nouwen Jan L, Verduin Cees M, Bernsen Roos M D, Oranje Arnold P, Thomas Siep, van der Wouden Johannes C

机构信息

Department of General Practice, University Hospital Rotterdam, Room Ff325, PO Box 1738, Erasmus University, 3000 DR Rotterdam, Netherlands.

出版信息

BMJ. 2002 Jan 26;324(7331):203-6. doi: 10.1136/bmj.324.7331.203.

Abstract

OBJECTIVE

To test the hypothesis that fusidic acid would not increase the treatment effect of disinfecting with povidone-iodine alone in children with impetigo.

DESIGN

Randomised placebo controlled trial.

SETTING

General practices in Greater Rotterdam.

PARTICIPANTS

184 children aged 0-12 years with impetigo.

MAIN OUTCOME MEASURES

Clinical cure and bacterial cure after one week.

RESULTS

After one week of treatment 55% of the patients in the fusidic acid group were clinically cured compared with 13% in the placebo group (odds ratio 12.6, 95% confidence interval 5.0 to 31.5, number needed to treat 2.3). After two weeks and four weeks the differences in cure rates between the two groups had become smaller. More children in the placebo group were non-compliant (12 v 5) and received extra antibiotic treatment (11 v 3), and more children in the placebo group reported adverse effects (19 v 7). Staphylococcus aureus was found in 96% of the positive cultures; no strains were resistant to fusidic acid.

CONCLUSIONS

Fusidic acid is much more effective than placebo (when both are given in combination with povidone-iodine shampoo) in the treatment of impetigo. Because of the low rate of cure and high rate of adverse events in the placebo group, the value of povidone-iodine in impetigo can be questioned.

摘要

目的

验证夫西地酸不会增加单用聚维酮碘对脓疱病患儿的治疗效果这一假设。

设计

随机安慰剂对照试验。

地点

大鹿特丹的普通诊所。

参与者

184名0至12岁的脓疱病患儿。

主要观察指标

一周后的临床治愈情况和细菌学治愈情况。

结果

治疗一周后,夫西地酸组55%的患者临床治愈,而安慰剂组为13%(优势比12.6,95%置信区间5.0至31.5,需治疗人数2.3)。两周和四周后,两组治愈率的差异变小。安慰剂组有更多儿童不依从(12例对5例)并接受了额外的抗生素治疗(11例对3例),且安慰剂组有更多儿童报告了不良反应(19例对7例)。在96%的阳性培养物中发现了金黄色葡萄球菌;没有菌株对夫西地酸耐药。

结论

在脓疱病治疗中,夫西地酸比安慰剂(二者均与聚维酮碘洗发水联合使用时)有效得多。由于安慰剂组治愈率低且不良事件发生率高,聚维酮碘在脓疱病中的价值值得质疑。

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