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全身蓝光照射治疗特应性皮炎:一项随机假对照临床试验(AD-Blue)

Full-body blue light irradiation as treatment for atopic dermatitis: a randomized sham-controlled clinical trial (AD-Blue).

作者信息

Buhl Timo, Santibanez Santana Marisol, Forkel Susann, Kromer Christian, Seidel Julia, Möbs Christian, Pfützner Wolfgang, Pfeiffer Sebastian, Laubach Hans-Joachim, Boehncke Wolf-Henning, Liebmann Joerg, Born Matthias, Schön Michael Peter

机构信息

University Medical Centre Göttingen, Department of Dermatology, Venereology, and Allergology, Göttingen, Germany.

Lower Saxony Institute of Occupational Dermatology, University Medical Centre Göttingen, Göttingen, Germany.

出版信息

J Dtsch Dermatol Ges. 2023 Dec;21(12):1500-1510. doi: 10.1111/ddg.15211. Epub 2023 Oct 9.

Abstract

BACKGROUND

Visible blue light (wavelength 400-495 nm) is a promising new treatment option for both psoriasis and atopic dermatitis (AD). Whilst previous clinical trials featured various devices and blue light at a variety of wavelengths, none of these interventions were challenged in objective clinical criteria.

PATIENTS AND METHODS

Eighty-seven patients diagnosed with AD were enrolled in AD-Blue, an international, prospective, double-blinded, three-armed (415 nm vs. 450 nm vs. sham control), randomized trial designed to investigate the safety and efficacy of prototype full-body blue light devices.

RESULTS

Full-body irradiation with 450 nm blue light but not 415 nm had a significant impact on itch (Itch-VAS, -1.6 ± 2.3; p  =  0.023 vs. sham irradiation). PO-SCORAD values also decreased significantly in response to irradiation at 415 nm (-11.5 ± 18.4; p = 0.028 vs. sham irradiation). None of the other outcome measures (EASI, SCORAD, IGA, DLQI) changed significantly. No safety signals were observed. Evaluation of skin transcriptomes, cytokine levels in serum, and ELISpots from peripheral blood mononuclear cells isolated from a subset of patients revealed moderate decreases in IL-31 in response to irradiation with blue light.

CONCLUSIONS

Despite its favorable safety profile and moderate reductions in itch and IL-31 levels, full-body blue light irradiation did not lead to an amelioration of any of the objective measures of AD.

摘要

背景

可见蓝光(波长400 - 495纳米)是治疗银屑病和特应性皮炎(AD)的一种很有前景的新方法。尽管之前的临床试验采用了各种设备和不同波长的蓝光,但这些干预措施均未按照客观临床标准进行验证。

患者与方法

87名被诊断为特应性皮炎的患者参与了AD - Blue研究,这是一项国际性、前瞻性、双盲、三臂(415纳米 vs. 450纳米 vs. 假对照)随机试验,旨在研究全身蓝光原型设备的安全性和有效性。

结果

450纳米蓝光全身照射而非415纳米蓝光对瘙痒有显著影响(瘙痒视觉模拟评分,-1.6 ± 2.3;与假照射相比,p = 0.023)。415纳米照射后PO - SCORAD值也显著下降(-11.5 ± 18.4;与假照射相比,p = 0.028)。其他结局指标(EASI、SCORAD、IGA、DLQI)均无显著变化。未观察到安全信号。对皮肤转录组、血清细胞因子水平以及从部分患者分离的外周血单个核细胞进行的酶联免疫斑点分析显示,蓝光照射后IL - 31水平有适度下降。

结论

尽管全身蓝光照射安全性良好,且能适度减轻瘙痒和降低IL - 31水平,但并未改善特应性皮炎的任何客观指标。

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