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0.1%他克莫司软膏治疗白色糠疹:一项开放标签、随机、安慰剂对照研究。

Tacrolimus ointment 0.1% in pityriasis alba: an open-label, randomized, placebo-controlled study.

作者信息

Rigopoulos D, Gregoriou S, Charissi C, Kontochristopoulos G, Kalogeromitros D, Georgala S

机构信息

Department of Dermatology, Andreas Sygros Hospital, University of Athens, 5 Ionos Dragoumi Str, 16121 Athens, Greece.

出版信息

Br J Dermatol. 2006 Jul;155(1):152-5. doi: 10.1111/j.1365-2133.2006.07181.x.

DOI:10.1111/j.1365-2133.2006.07181.x
PMID:16792767
Abstract

BACKGROUND

Pityriasis alba (PA) is a frequent reason for dermatological consultation because of its chronic course, tendency to relapse and aesthetic impact.

OBJECTIVES

In view of its strong association with atopic dermatitis, the objective of this open-label study was to assess the efficacy and safety of tacrolimus ointment in the treatment of PA compared with the efficacy of moisturizers.

PATIENTS/METHODS: The study population consisted of 60 individuals of phototype III or IV according to Fitzpatrick's classification, aged 6-21 years. Patients were randomly assigned to one of two groups. Subjects in group A were instructed to apply tacrolimus ointment 0.1% twice daily, 12 h apart, on all hypopigmented macules. Standard moisturizers with SPF 20 sunscreen were used on all lesions applied at least 30 min apart from the tacrolimus ointment. Subjects in group B used solely the same moisturizers with sunscreen. Hypopigmented areas were evaluated at baseline and weeks 0, 3, 6 and 9 by investigators for scaling, hypopigmentation and pruritus on a scale of 0-3. Patient satisfaction was also recorded on a scale of 0-3. All adverse effects were recorded.

RESULTS

A statistically significant improvement through time, in hypopigmentation, pruritus and scaling was observed in both groups during the course of 9 weeks. Hypopigmentation resolved from a baseline score of 2.38+/-0.64 to 1.15+/-0.54 at week 3, 0.46+/-0.51 at week 6 and 0.00+/-0.00 at week 9 for the group applying tacrolimus ointment 0.1%. The difference in improvement between the two groups was statistically significant on all three assessments for hypopigmentation (P<0.001), and for pruritus on week 6 and 9 assessments (P<0.05). Three patients (11.5%) in the tacrolimus group reported a mild transient sensation of burning. All patients in the tacrolimus group reported they were completely satisfied or just satisfied with the treatment compared with only 50% of patients using the placebo.

CONCLUSIONS

Tacrolimus ointment 0.1% appears to be an effective and safe treatment for PA.

摘要

背景

白色糠疹(PA)因其病程慢性、易复发及对美观有影响,是皮肤科会诊的常见原因。

目的

鉴于其与特应性皮炎密切相关,本开放标签研究的目的是评估他克莫司软膏治疗PA的疗效和安全性,并与保湿剂的疗效进行比较。

患者/方法:研究人群包括60名根据菲茨帕特里克分类法属于III型或IV型皮肤类型、年龄在6至21岁之间的个体。患者被随机分为两组。A组受试者被指示每天两次、间隔12小时在所有色素减退斑上涂抹0.1%他克莫司软膏。在所有皮损上使用含SPF 20防晒剂的标准保湿剂,与他克莫司软膏间隔至少30分钟涂抹。B组受试者仅使用相同的含防晒剂的保湿剂。研究者在基线、第0、3、6和9周对色素减退区域的脱屑、色素减退和瘙痒情况进行0至3级评估。患者满意度也采用0至3级记录。记录所有不良反应。

结果

在9周的疗程中,两组的色素减退、瘙痒和脱屑情况均随时间有统计学显著改善。对于涂抹0.1%他克莫司软膏的组,色素减退从基线评分2.38±0.64在第3周降至1.15±0.54,第6周降至0.46±0.51,第9周降至0.00±0.00。两组在色素减退的所有三项评估中改善情况的差异有统计学意义(P<0.001),在第6周和第9周瘙痒评估中差异有统计学意义(P<0.05)。他克莫司组有3名患者(11.5%)报告有轻微短暂的烧灼感。他克莫司组所有患者报告对治疗完全满意或只是满意,而使用安慰剂的患者中只有50%如此。

结论

0.1%他克莫司软膏似乎是治疗PA的一种有效且安全的方法。

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