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治疗难治性皮肤癣菌病:一项随机、双盲、安慰剂对照研究的结果。

Treatment of difficult-to-treat-dermatophytosis: results of a randomized, double-blind, placebo-controlled study.

机构信息

Department of Pharmacology, Faculty of Medicine, University of Peradeniya, Sri Lanka.

Department of Community Medicine, Faculty of Medicine, University of Peradeniya, Sri Lanka.

出版信息

J Infect Dev Ctries. 2021 Nov 30;15(11):1731-1737. doi: 10.3855/jidc.14666.

Abstract

INTRODUCTION

Difficult-to-treat dermatophytosis is an emerging public health problem in Sri Lanka. Safe, effective and affordable treatment is needed to solve this problem. Therefore this study has assessed the effectiveness and safety of modified Whitfield ointment applied twice daily with oral griseofulvin 500 mg daily given over 8 weeks in patients with difficult-to-treat dermatophytosis.

METHODOLOGY

A randomized, double-blind, within-patient-placebo-controlled trial was conducted in patients with clinico- mycologically (history, physical examination, direct light microscopy examination of scales in potassium hydroxide mount) confirmed difficult-to-treat dermatophytosis. Lesions were randomized to receive modified Whitfield ointment (5% benzoic acid and 5% salicylic acid) or emulsifying ointment. All patients were given oral griseofulvin 500mg once daily. The outcome measures were clinical assessment of disease severity, the total surface area of the lesions and the patient's perception of the disease severity at baseline and every two weeks up to a maximum of 8 weeks.

RESULTS

Thirty patients completed the study. At two weeks, there was a statistically significant improvement in modified Whitfield ointment arm in the clinical assessment of disease severity and the patients' perception. There was a 7.59% reduction in the surface area of lesions in modified Whitfield ointment arm and a 5.83% increase in the surface area of lesions in the emulsifying ointment arm at two weeks. The difference between the two arms in surface area changes was not statistically significant (p = 0.107, df = 29).

CONCLUSIONS

A combination of modified Whitfield ointment with griseofulvin is significantly effective, safe and affordable option for treating difficult-to-treat dermatophytosis in the tropics.

摘要

简介

在斯里兰卡,难治性皮肤癣菌病是一个新出现的公共卫生问题。需要安全、有效和负担得起的治疗方法来解决这个问题。因此,本研究评估了在热带地区使用改良的 Whitfield 软膏(含 5%苯甲酸和 5%水杨酸),每日两次,同时口服灰黄霉素 500mg,每日一次,共 8 周,治疗难治性皮肤癣菌病的疗效和安全性。

方法

对临床和真菌学(病史、体格检查、直接镜检检查氢氧化钾载片上的鳞屑)确诊的难治性皮肤癣菌病患者进行了一项随机、双盲、自身对照安慰剂对照试验。将病变随机分配至接受改良 Whitfield 软膏或乳化软膏治疗。所有患者均给予灰黄霉素 500mg 每日一次。主要疗效评估指标为疾病严重程度的临床评估、病变的总表面积以及患者在基线和每两周(最多 8 周)时对疾病严重程度的感知。

结果

30 例患者完成了研究。在第 2 周时,改良 Whitfield 软膏组在疾病严重程度的临床评估和患者感知方面有统计学显著改善。改良 Whitfield 软膏组的病变面积减少了 7.59%,而乳化软膏组的病变面积增加了 5.83%。两组在病变面积变化方面的差异无统计学意义(p=0.107,df=29)。

结论

改良 Whitfield 软膏联合灰黄霉素治疗热带地区难治性皮肤癣菌病是一种安全、有效且负担得起的选择。

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