Park Soo-Yeon, Song Ji-Hoon, Duc Nguyen Cong, Lee Gihyun
Department of Ophthalmology, Otolaryngology & Dermatology, College of Korean Medicine, Dongshin University, Naju, Republic of Korea.
College of Korean Medicine, Dongshin University, Naju, Republic of Korea.
J Pharmacopuncture. 2025 Mar 31;28(1):69-79. doi: 10.3831/KPI.2025.28.1.69.
The need for alternative therapies for atopic dermatitis (AD) has emerged due to the side effects of conventional therapies. Biodegradable microneedle acupuncture (BMA) is a novel medical device that overcame the shortcomings of traditional intradermal acupuncture (IDA), such as foreign body feeling and allergic dermatitis. This study aimed to evaluate the efficacy and safety of BMA for patients with Mild to Moderate AD compared with the IDA.
An assessor-blinded, parallel, non-superiority, randomized controlled pilot trial was conducted. Thirty adult participants were recruited from a single hospital and were equally divided into the experimental or control group. They were treated with BMA or IDA on both sides of LI11, ST36, and PC6 for four hours. Over four weeks, both interventions were performed eight times in total. The primary endpoint was the objective scoring AD (O-SCORAD) index. The secondary endpoints were visual analog scale (VAS) for itch and sleep disturbance, dermatology life quality index (DLQI), skin hydration, and transepidermal water loss (TEWL).
Enrolled thirty participants completed the trial. After the trial, all endpoints remarkably improved compared with the baseline in both groups, except for the TEWL. Between the two interventions, there were no remarkable differences in the fourth week, except for the VAS score for itch and DLQI. No serious adverse events occurred during the study period.
Both BMA and IDA were effective in improving Mild to Moderate AD, and they were safe. BMA can be an alternative to conventional acupuncture for patients with sensitive skin, including metal allergies.
由于传统疗法的副作用，对特应性皮炎（AD）替代疗法的需求应运而生。可生物降解微针针刺（BMA）是一种新型医疗器械，克服了传统皮内针刺（IDA）的缺点，如异物感和过敏性皮炎。本研究旨在评估与IDA相比，BMA治疗轻至中度AD患者的疗效和安全性。
进行了一项评估者盲法、平行、非劣效性随机对照试验。从一家医院招募了30名成年参与者，将他们平均分为实验组或对照组。在双侧的LI11、ST36和PC6进行BMA或IDA治疗4小时。在四周内，两种干预措施总共进行8次。主要终点是客观评分AD（O-SCORAD）指数。次要终点是瘙痒和睡眠障碍的视觉模拟量表（VAS）、皮肤病生活质量指数（DLQI）、皮肤水合作用和经表皮水分流失（TEWL）。
30名入组参与者完成了试验。试验后，除TEWL外，两组所有终点与基线相比均有显著改善。在两种干预措施之间，除瘙痒的VAS评分和DLQI外，第四周没有显著差异。研究期间未发生严重不良事件。
BMA和IDA在改善轻至中度AD方面均有效，且安全。对于包括金属过敏在内的皮肤敏感患者，BMA可作为传统针刺的替代方法。
