2%酮康唑洗发水治疗花斑癣：一项多中心、随机、双盲、安慰剂对照试验。

Ketoconazole 2% shampoo in the treatment of tinea versicolor: a multicenter, randomized, double-blind, placebo-controlled trial.

作者信息

Lange D S, Richards H M, Guarnieri J, Humeniuk J M, Savin R C, Reyes B A, Hickman J, Pariser D M, Pariser R J, Sherertz E F, Grossman R M, Gisoldi E M, Klausner M A

机构信息

Janssen Pharmaceutica, Titusville, NJ 08560, USA.

出版信息

J Am Acad Dermatol. 1998 Dec;39(6):944-50. doi: 10.1016/s0190-9622(98)70267-1.

DOI:10.1016/s0190-9622(98)70267-1

PMID:9843006

Abstract

BACKGROUND

Tinea versicolor is a common superficial fungal infection caused by a lipophilic yeast. This chronically recurring opportunistic infection is especially prevalent in tropical and semitropical regions. The topical short-term application of ketoconazole 2% shampoo may provide effective and safe therapy for tinea versicolor.

OBJECTIVE

The purpose of this study was to evaluate the efficacy and safety of a single application (1 day) versus three daily applications (3 days) of ketoconazole 2% shampoo versus placebo shampoo in the treatment of mycologically confirmed tinea versicolor.

METHODS

Three hundred twelve patients were included in the primary analyses for this 31-day study. Global evaluation scores were measured on days 10 and 31 with a 5-point scale (1 = healed to 5 = worsening), and a cellophane tape test was done at baseline and days 3, 10, and 31. Efficacy was assessed by clinical response, defined as both a global evaluation score of 1 (healed) and a negative cellophane tape test on day 31. Signs and symptoms of tinea versicolor (scaling, itching, erythema, hypopigmentation, hyperpigmentation) also were evaluated at baseline, day 10, and day 31 with a 4-point scale (0 = absent to 3 = severe).

RESULTS

Both regimens of ketoconazole shampoo were significantly (P < .001) more effective than placebo for rate of clinical response, global evaluation scores, and mycologic outcomes (cellophane tape test). The clinical response rates at day 31 were 73%, 69%, and 5% for the 3-day ketoconazole, 1-day ketoconazole, and placebo groups, respectively. The difference in the efficacy of the two ketoconazole treatment regimens was not statistically significant. There were no significant differences between any of the treatment groups in the number of patients who experienced adverse events. No serious adverse events occurred and no patient withdrew from the trial prematurely because of an adverse event.

CONCLUSION

Ketoconazole 2% shampoo, used as a single application or daily for 3 days, is safe and highly effective in the treatment of tinea versicolor.

摘要

背景

花斑癣是一种由亲脂性酵母菌引起的常见浅表真菌感染。这种慢性复发性机会性感染在热带和亚热带地区尤为普遍。局部短期应用2%酮康唑洗发水可为花斑癣提供有效且安全的治疗方法。

目的

本研究的目的是评估2%酮康唑洗发水单次应用（1天）与每日应用三次（3天）对比安慰剂洗发水治疗真菌学确诊的花斑癣的疗效和安全性。

方法

312名患者纳入了这项为期31天研究的主要分析。在第10天和第31天用5分制（1 = 痊愈至5 = 恶化）测量整体评估分数，并在基线、第3天、第10天和第31天进行透明胶带试验。疗效通过临床反应评估，定义为第31天整体评估分数为1（痊愈）且透明胶带试验为阴性。花斑癣的体征和症状（鳞屑、瘙痒、红斑、色素减退、色素沉着）也在基线、第10天和第31天用4分制（0 = 无至3 = 严重）进行评估。

结果

酮康唑洗发水的两种治疗方案在临床反应率、整体评估分数和真菌学结果（透明胶带试验）方面均显著（P <.001）优于安慰剂。第31天，3天酮康唑组、1天酮康唑组和安慰剂组的临床反应率分别为73%、69%和5%。两种酮康唑治疗方案的疗效差异无统计学意义。各治疗组中发生不良事件的患者数量无显著差异。未发生严重不良事件，也没有患者因不良事件提前退出试验。