双波长发光二极管光疗治疗慢性外耳道炎的疗效：一项随机对照初步研究

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中文摘要

背景与目的： 慢性外耳道炎（CEO）是外耳道的一种持续性炎症性疾病，以瘙痒、耳痛和耳漏为特征，且常难以治疗。本研究评估了一种新型便携式双波长发光二极管（LED）光疗装置（波长为660和940 nm）的临床疗效和安全性。
受试者与方法： 这项前瞻性、随机、对照初步研究于2024年8月至11月在一家三级医院进行。21名病程持续超过1个月的CEO成人被随机分配到三组（每组n=7）。随机化采用计算机生成的区组随机化序列进行。第1组单独接受LED光疗，第2组单独接受局部氧氟沙星治疗，第3组接受LED光疗联合抗生素治疗，为期2周。在基线和治疗后通过耳镜检查、纯音测听以及疼痛和不适的视觉模拟量表评分评估结局。
结果： 所有21名参与者均完成了研究。耳镜检查显示，第2组的耳漏消退率最高，完全消退率为75.0%，而第1组为25.0%，第3组为20.0%（p=0.194）。在红斑和水肿方面未观察到显著的组间差异。关于主观症状，LED治疗（第1组和第3组）带来了明显改善。第1组的不适评分从7.00显著降至3.00（p<0.05），而第3组也从6.43显著降至2.14（p<0.01）。第2组的基线疼痛评分显著较低（0.60±1.34），因此由于地板效应限制了有意义的比较。纯音测听显示各治疗组均无显著变化。未观察到严重不良事件、光敏反应或热损伤。
结论： 这项初步研究显示，双波长LED光疗是安全的，并能显著减轻CEO患者的疼痛和不适，而局部抗生素在耳漏消退方面仍更优。总体而言，LED光疗可作为辅助或替代选择，尤其适用于寻求非抗菌治疗的患者。

英文摘要

BACKGROUND AND OBJECTIVES: Chronic external otitis (CEO) is a persistent inflammatory condition of the external auditory canal characterized by pruritus, otalgia, and otorrhea and is often difficult to treat. This study evaluated the clinical efficacy and safety of a novel portable dual-wavelength light-emitting diode (LED) phototherapy device at wavelengths of 660 and 940 nm.
SUBJECTS AND METHODS: This prospective, randomized, controlled pilot study was conducted at a tertiary hospital between August and November 2024. Twenty-one adults with CEO persisting for more than 1 month were randomly assigned to three groups (n=7 per group). Randomization was performed using a computer-generated block randomization sequence. Group 1 received LED phototherapy alone, Group 2 received topical ofloxacin alone, and Group 3 received combined LED phototherapy and antibiotic therapy for 2 weeks. Outcomes were evaluated at baseline and after treatment using otoscopic findings, pure-tone audiometry, and visual analog scale scores for pain and discomfort.
RESULTS: All 21 participants completed the study. Otoscopic examination showed that Group 2 showed the highest resolution of otorrhea, with 75.0% complete resolution compared with 25.0% in Group 1 and 20.0% in Group 3 (p=0.194). No significant between-group differences were observed in erythema and edema. Regarding subjective symptoms, LED therapy (Groups 1 and 3) resulted in a marked improvement. Group 1 showed a significant reduction in discomfort from 7.00 to 3.00 (p<0.05), whereas Group 3 also showed a significant reduction from 6.43 to 2.14 (p<0.01). Group 2 had a substantially lower baseline pain score (0.60±1.34), thereby limiting meaningful comparison due to a floor effect. Pure-tone audiometry revealed no significant changes across treatment groups. No serious adverse events, photosensitivity reactions, or thermal injuries were observed.
CONCLUSIONS: This pilot study revealed that dual-wavelength LED phototherapy is safe and significantly reduces pain and discomfort in CEO, whereas topical antibiotics remain superior for otorrhea resolution. Collectively, LED phototherapy may serve as an adjunctive or alternative option, particularly for patients seeking non-antimicrobial treatment.