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单剂量口服氟康唑与克霉唑局部治疗花斑癣的疗效比较:一项双盲随机对照试验。

Single-dose oral fluconazole versus topical clotrimazole in patients with pityriasis versicolor: A double-blind randomized controlled trial.

机构信息

Department of Dermatology, 5th Azar Hospital, Golestan University of Medical Sciences, Gorgan, Iran.

出版信息

J Dermatol. 2010 Aug;37(8):699-702. doi: 10.1111/j.1346-8138.2010.00908.x.

DOI:10.1111/j.1346-8138.2010.00908.x
PMID:20649710
Abstract

This study was designed to compare the therapeutic effects of topical clotrimazole and systemic fluconazole in pityriasis versicolor. A double-blind randomized controlled trial was carried out in the dermatological clinic of Gorgan, northern Iran, between April 2006 and May 2007. All consecutive patients with pityriasis versicolor were included and randomly divided into two groups. In the first group (G1), patients underwent treatment with a single dose of fluconazole capsule (400 mg) and placebo cream. In the second group (G2), patients underwent treatment with clotrimazole cream (twice daily) and placebo capsule. The course of treatment was 2 weeks. All subjects were re-evaluated 2, 4 and 12 weeks after the end of the therapeutic course. After 2 weeks, the rate of complete resolution of disease was significantly higher in G2 than G1 (49.1% vs 30%). After 4 weeks, 41 patients (81.2%) of G1 and 52 patients (94.9%) of G2 showed complete resolution. After 12 weeks, 46 patients (92%) in G1 and 45 patients (81.8%) in G2 showed complete resolution. Recurrence rate in G1 and G2 were 6% and 18.2%, respectively. No complications were seen in either group. In this study, clinical response at week 4 was greater in the clotrimazole group than the fluconazole group. Recurrence at week 12 after treatment was less with oral fluconazole than clotrimazole cream. So, for better evaluation, more studies need to be done.

摘要

本研究旨在比较克霉唑外用和氟康唑系统治疗花斑癣的疗效。2006 年 4 月至 2007 年 5 月在伊朗北部戈尔甘皮肤科诊所进行了一项双盲随机对照试验。所有连续的花斑癣患者均纳入并随机分为两组。第一组(G1)患者接受氟康唑胶囊(400mg)单次剂量和安慰剂乳膏治疗。第二组(G2)患者接受克霉唑乳膏(每日两次)和安慰剂胶囊治疗。疗程为 2 周。所有受试者在治疗结束后 2、4 和 12 周时重新评估。治疗 2 周后,G2 组的疾病完全缓解率明显高于 G1 组(49.1% vs 30%)。4 周后,G1 组 41 例(81.2%)和 G2 组 52 例(94.9%)患者完全缓解。治疗 12 周后,G1 组 46 例(92%)和 G2 组 45 例(81.8%)患者完全缓解。G1 和 G2 组的复发率分别为 6%和 18.2%。两组均未出现并发症。本研究中,克霉唑组在第 4 周的临床反应大于氟康唑组。治疗后 12 周时,氟康唑的复发率低于克霉唑乳膏。因此,为了更好地评估,还需要进行更多的研究。

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