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舍他康唑 2%乳膏与咪康唑 2%乳膏治疗皮肤真菌病的双盲临床试验。

Sertaconazole 2% cream vs. miconazole 2% cream for cutaneous mycoses: a double-blind clinical trial.

机构信息

Department of Dermatology, Tehran University of Medical Sciences, Tehran, Iran.

出版信息

Clin Exp Dermatol. 2009 Dec;34(8):e837-9. doi: 10.1111/j.1365-2230.2009.03579.x. Epub 2009 Sep 28.

Abstract

The efficacy of 2% creams of miconazole nitrate and sertaconazole were compared in a double-blind clinical trial carried out on 100 patients with an established diagnosis of cutaneous dermatophytosis. Assessments were performed on days 0, 15, 29 and 43 in our dermatology clinic. Cure was defined according to clinical assessment confirmed by microscopical examination and culture. The groups were similar in age, gender, weight and clinical presentation. The reported side-effects, most commonly pruritus, occurred in 22 (40.0%) and 15 (33.3%) patients in the sertaconazole and miconazole groups, respectively (P = 0.28), but were not serious enough to stop the treatment. The only significant difference between the groups was in per-protocol cure rate by day 15, when patients in the sertaconazole group had a higher cure rate than the miconazole group (P < 0.01). In conclusion, sertaconazole was superior to miconazole in producing an early response in our patients. Given the higher price of sertaconazole and the ability of the considerably less expensive miconazole to produce equally good response after a month, the usefulness of sertaconazole as an alternative to miconazole in Iran requires further study.

摘要

我们在 100 例已确诊的皮肤真菌病患者中进行了一项双盲临床试验,比较了硝酸咪康唑和舍他康唑 2%乳膏的疗效。在我们的皮肤科诊所,于第 0、15、29 和 43 天进行评估。治愈的定义是根据临床评估并经显微镜检查和培养确认。两组在年龄、性别、体重和临床表现方面相似。报告的副作用,最常见的是瘙痒,在舍他康唑组和咪康唑组中分别有 22(40.0%)和 15(33.3%)例患者发生(P = 0.28),但并不严重到足以停止治疗。两组之间唯一的显著差异是在第 15 天的按方案治愈率,舍他康唑组的治愈率高于咪康唑组(P < 0.01)。总之,舍他康唑在我们的患者中早期反应优于咪康唑。鉴于舍他康唑价格较高,而相对便宜的咪康唑在一个月后也能产生同样良好的反应,因此,在伊朗,舍他康唑作为咪康唑的替代药物的用途需要进一步研究。

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