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指甲花(散沫花)局部制剂对大疱性表皮松解症患者瘙痒及伤口愈合的疗效:一项单臂试点临床试验

Efficacy of a Topical Formulation of Henna (Lawsonia Inermis Linnaeus) on the Itch and Wound Healing in Patients With Epidermolysis Bullosa: a Pilot Single-arm Clinical Trial.

作者信息

Niazi Mehdi, Parvizi Mohammad Mahdi, Saki Nasrin, Parvizi Zahra, Mehrbani Mehrzad, Heydari Mojtaba

机构信息

Department of Traditional Medicine, Faculty of Traditional Medicine, Kerman University of Medical Sciences, Kerman, Iran.

Molecular Dermatology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.

出版信息

Dermatol Pract Concept. 2022 Jul 1;12(3):e2022115. doi: 10.5826/dpc.1203a115. eCollection 2022 Jul.

Abstract

INTRODUCTION

Epidermolysis bullosa (EB) is a rare inherited genetic skin disorder with severe skin itching and recurrent blisters and erosion. There is no effective and specific therapy for all types of EB.

OBJECTIVES

The aim of this study was to evaluate a topical formulation of henna (Lawsonia inermis Linnaeus) in the management of wounds and the itching sensation in patients with EB.

METHODS

This is a pilot single-arm clinical trial. Nine patients with recessive dystrophic EB, with the age range of 5 to 32 years were enrolled in the study. The patients were instructed to apply the topical 1% henna ointment once daily on two erosions and on also two sites with moderate to a severe itching sensation. The total duration of the intervention was 4 weeks with weekly follow-up visits. Patient global impression of improvement, visual analog scale, and clinical global impression of improvement were used for assessing the wound healing process and itching discomfort.

RESULTS

There was a significant improvement in the skin symptoms of epidermolysis bullosa including skin redness, itching, burning, and local warmness (P < 0.05). Local pain decreased during the study period, but this was not statistically significant (P < 0.19). One patient reported moderate xerosis of skin after continuous usage.

CONCLUSIONS

It seems that the topical formulation of henna may be effective in the management of itching, burning, stringing, and cutaneous warmness sensation in patients with EB. Further controlled studies with larger sample sizes are recommended to better evaluate this formulation.

摘要

引言

大疱性表皮松解症(EB)是一种罕见的遗传性皮肤疾病,伴有严重的皮肤瘙痒以及反复出现的水疱和糜烂。目前尚无针对所有类型EB的有效且特异性的治疗方法。

目的

本研究旨在评估指甲花(散沫花)局部制剂对EB患者伤口及瘙痒感的治疗效果。

方法

这是一项单臂试点临床试验。纳入了9例年龄在5至32岁之间的隐性营养不良型EB患者。指导患者每天在两处糜烂部位以及两处有中度至重度瘙痒感的部位涂抹一次1%指甲花软膏。干预总时长为4周,每周进行随访。采用患者整体改善印象、视觉模拟量表以及临床整体改善印象来评估伤口愈合过程和瘙痒不适情况。

结果

大疱性表皮松解症的皮肤症状有显著改善,包括皮肤发红、瘙痒、灼痛和局部发热(P < 0.05)。在研究期间局部疼痛有所减轻,但差异无统计学意义(P < 0.19)。1例患者报告持续使用后出现中度皮肤干燥。

结论

指甲花局部制剂似乎对EB患者的瘙痒、灼痛、刺痛和皮肤发热感的治疗有效。建议开展进一步的大样本对照研究以更好地评估该制剂。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/88b1/9464551/7280b5567fca/dp1203a115g001.jpg

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