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火针疗法治疗非节段型稳定期白癜风的疗效与安全性:一项随机自身对照临床试验

Efficacy and safety of fire needle therapy in treating non-segmental stable vitiligo: A randomized self-controlled clinical trial.

作者信息

Wang Yuyi, Lin Mao, Huang Fang, Jia Ruiling, Xu Wei, He Qi, Xiong Qiong, Hu Qin, Diao Qingchun, Liu Zhaolan

机构信息

Centre for Evidence Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China.

Department of Dermatology, Chongqing Hospital of Traditional Chinese Medicine, Chongqing, China.

出版信息

J Cosmet Dermatol. 2024 Oct;23(10):3335-3346. doi: 10.1111/jocd.16428. Epub 2024 Jun 18.

DOI:10.1111/jocd.16428
PMID:38894565
Abstract

BACKGROUND

Vitiligo remains a challenging condition to treat. Fire needle therapy, a traditional Chinese medicine technique, has potential as an alternative therapeutic strategy. However, rigorous evidence on its efficacy is lacking.

OBJECTIVE

We aimed to evaluate the efficacy and safety of fire needle therapy, alone and combined with topical tacrolimus ointment, for non-segmental stable vitiligo.

METHODS

In this 6-month randomized self-controlled trial, 35 vitiligo patients were enrolled, providing three similar lesions each. Lesions were randomly allocated to receive fire needle monotherapy, 0.1% tacrolimus ointment monotherapy, or combined fire needle and tacrolimus ointment therapy. The main outcome was change in vitiligo surface area.

RESULTS

In total, 29 patients completed the 6-month follow-up. The combination therapy group showed significantly greater reductions in vitiligo surface area compared to monotherapy groups starting at months 4 and 5. By the end of the study, combination therapy resulted in remarkably higher repigmentation responses, with 89.7% of lesions showing at least mild (≥25%) repigmentation and 51.7% showing good (≥50%) repigmentation. This significantly exceeded the outcomes with topical tacrolimus ointment alone, which only achieved 6.9% mild response and 6.9% good response. Fire needle monotherapy also demonstrated steady repigmentation over time, with 69% of lesions attaining a mild response by month 6. Importantly, no major adverse events occurred.

CONCLUSION

This study provides promising preliminary evidence supporting the use of fire needle therapy, alone or in combination with topical tacrolimus ointment, for inducing repigmentation in non-segmental stable vitiligo. As a non-pharmacological approach, fire needle therapy warrants further study as an alternative vitiligo treatment.

摘要

背景

白癜风的治疗仍然是一项具有挑战性的任务。火针疗法作为一种中医疗法,具有作为替代治疗策略的潜力。然而,目前缺乏关于其疗效的确切证据。

目的

我们旨在评估火针疗法单独使用以及联合外用他克莫司软膏治疗非节段性稳定期白癜风的疗效和安全性。

方法

在这项为期6个月的随机自身对照试验中,招募了35例白癜风患者,每位患者提供三个相似的皮损。皮损被随机分配接受火针单一疗法、0.1%他克莫司软膏单一疗法或火针联合他克莫司软膏疗法。主要观察指标是白癜风皮损面积的变化。

结果

共有29例患者完成了6个月的随访。联合治疗组从第4个月和第5个月开始,与单一治疗组相比,白癜风皮损面积的减少更为显著。到研究结束时,联合治疗导致色素再生反应明显更高,89.7%的皮损至少显示轻度(≥25%)色素再生,51.7%的皮损显示良好(≥50%)色素再生。这显著超过了单独使用外用他克莫司软膏的结果,后者仅达到6.9%的轻度反应和6.9%的良好反应。火针单一疗法也随着时间的推移显示出稳定的色素再生,到第6个月时,69%的皮损达到轻度反应。重要的是,未发生重大不良事件。

结论

本研究提供了有前景的初步证据,支持单独使用火针疗法或联合外用他克莫司软膏在非节段性稳定期白癜风中诱导色素再生。作为一种非药物方法,火针疗法作为白癜风的替代治疗值得进一步研究。

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