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观察者盲法随机对照初步临床试验比较局限性浸浴补骨脂素-长波紫外线与局限性窄谱中波紫外线治疗手掌部湿疹。

An observer-blinded randomized controlled pilot trial comparing localized immersion psoralen-ultraviolet A with localized narrowband ultraviolet B for the treatment of palmar hand eczema.

机构信息

Newcastle Dermatology, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, U.K.

Biostatistics Research Group, Institute of Health and Society, Newcastle University, Newcastle upon Tyne, U.K.

出版信息

Br J Dermatol. 2018 Jul;179(1):63-71. doi: 10.1111/bjd.16238. Epub 2018 Mar 14.

Abstract

BACKGROUND

Hand eczema is a common inflammatory dermatosis that causes significant patient morbidity. Previous studies comparing psoralen-ultraviolet A (PUVA) with narrowband ultraviolet B (NB-UVB) have been small, nonrandomized and retrospective.

OBJECTIVES

To conduct an observer-blinded randomized controlled pilot study using validated scoring criteria to compare immersion PUVA with NB-UVB for the treatment of chronic hand eczema unresponsive to topical steroids.

METHODS

Sixty patients with hand eczema unresponsive to clobetasol propionate 0·05% were randomized to receive either immersion PUVA or NB-UVB twice weekly for 12 weeks with assessments at intervals of 4 weeks. The primary outcome measure was the proportion of patients achieving 'clear' or 'almost clear' Physician's Global Assessment (PGA) response at 12 weeks. Secondary outcome measures included assessment of the modified Total Lesion and Symptom Score (mTLSS) and the Dermatology Life Quality index (DLQI).

RESULTS

In both treatment arms, 23 patients completed the 12-week assessment for the primary outcome measure. In the PUVA group, five patients achieved 'clear' and eight 'almost clear' [intention-to-treat (ITT) response rate 43%]. In the NB-UVB group, two achieved 'clear' and five 'almost clear' (ITT response rate 23%). For the secondary outcomes, median mTLSS scores were similar between groups at baseline (PUVA 9·5, NB-UVB 9) and at 12 weeks (PUVA 3, NB-UVB 4). Changes in DLQI were similar, with improvements in both groups.

CONCLUSIONS

In this randomized pilot trial recruitment was challenging. After randomization, there were acceptable levels of compliance and safety in each treatment schedule, but lower levels of retention. Using validated scoring systems - PGA, mTLSS and DLQI - as measures of treatment response, the trial demonstrated that both PUVA and NB-UVB reduced the severity of chronic palmar hand eczema.

摘要

背景

手部湿疹是一种常见的炎症性皮肤病,会导致患者出现明显的疾病负担。之前比较补骨脂素加紫外线 A(PUVA)与窄谱中波紫外线 B(NB-UVB)治疗手部慢性湿疹的研究规模较小、非随机且为回顾性研究。

目的

采用盲法观察者评估和已验证的评分标准,进行一项比较浸浴式 PUVA 与 NB-UVB 治疗外用皮质类固醇治疗无效的慢性手部湿疹的前瞻性随机对照研究。

方法

60 例外用卤米松丙酸 0.05%治疗无效的手部湿疹患者被随机分为两组,分别接受每周 2 次的浸浴式 PUVA 或 NB-UVB 治疗,共 12 周,每 4 周评估一次。主要结局指标为治疗 12 周时达到“痊愈”或“几乎痊愈”的医师总体评估(PGA)应答的患者比例。次要结局指标包括改良总损伤和症状评分(mTLSS)和皮肤病生活质量指数(DLQI)的评估。

结果

在两组治疗中,23 例患者完成了主要结局指标的 12 周评估。在 PUVA 组中,5 例患者达到“痊愈”,8 例患者达到“几乎痊愈”[意向治疗(ITT)应答率为 43%]。在 NB-UVB 组中,2 例患者达到“痊愈”,5 例患者达到“几乎痊愈”(ITT 应答率为 23%)。对于次要结局,两组基线时(PUVA 9.5,NB-UVB 9)和 12 周时(PUVA 3,NB-UVB 4)的 mTLSS 中位数评分相似。两组的 DLQI 评分均有改善,且变化相似。

结论

在这项随机试点研究中,入组具有挑战性。随机分组后,两种治疗方案均具有可接受的依从性和安全性,但保留率较低。使用 PGA、mTLSS 和 DLQI 等评分系统作为治疗反应的衡量标准,该试验表明 PUVA 和 NB-UVB 均能减轻慢性手掌部手部湿疹的严重程度。

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