LumiMed, 106 Noroton Ave Suite 101, Darien, CT, 06820, USA.
J Med Case Rep. 2023 Jun 14;17(1):263. doi: 10.1186/s13256-023-03980-4.
Allergic rhinitis is the most common allergic disease, with a prevalence up to 40% in the general population. Allergic rhinitis requires daily treatment to block inflammatory mediators and suppress the inflammatory response. However, these medications may have harmful side effects. Photobiomodulation as a treatment modality to reduce inflammation has been beneficial in many chronic disorders, yet therapy has not been US Food and Drug Administration approved for the treatment of allergic rhinitis. The LumiMed Nasal Device was designed to address the limitations associated with the treatment of allergic rhinitis with photobiomodulation. This in-office study hopes to show efficacy, usability, and comfortability of the LumiMed Nasal Device.
Twenty patients with allergic rhinitis were treated during high allergy season with LumiMed Nasal Device. The average age of patients was 35 years (10-75); 11 were female and 9 were male. The population's ethnicities were white (n = 11), Black (n = 6), Oriental (n = 2), and Iranian (n = 1). Patients were treated with twice-daily dosing, 10 seconds in each nostril, for 10 consecutive days. After 10 days, patients were evaluated for symptom relief, device comfort and device ease of use. The Total Nasal Symptom Score was used to assess severity of main symptoms of allergic rhinitis. The sum of Total Nasal Symptom Scores for each symptom category was calculated (total possible scores per patient were 0-9). Rhinorrhea/nasal secretions, nasal congestion, and nasal itching/sneezing were evaluated on a scale of 0-3 (0 no symptoms, 1 mild symptoms, 2 moderate symptoms, 3 severe symptoms). Device comfort was evaluated on a scale of 0-3 (0 no discomfort, 1 mild discomfort, 2 moderate discomfort, 3 severe discomfort). Device ease of use was evaluated on a scale of 0-3 (0 very easy, 1 somewhat difficult, 2 difficult, 3 very difficult).
The results from these case studies indicated that of the 20 patients in this case study, 100% of patients experienced improvement in overall Total Nasal Symptom Score after using LumiMed Nasal Device. Of those patients, 40% brought their Total Nasal Symptom Score down to 0. Furthermore, 95% felt the LumiMed Nasal Device was comfortable to use, while 85% of patients felt the LumiMed Nasal Device was easy to use.
过敏性鼻炎是最常见的过敏性疾病,在普通人群中的患病率高达 40%。过敏性鼻炎需要每天进行治疗以阻断炎症介质并抑制炎症反应。然而,这些药物可能会有有害的副作用。光生物调节作为一种减轻炎症的治疗方法,已在许多慢性疾病中显示出益处,但尚未获得美国食品和药物管理局批准用于治疗过敏性鼻炎。LumiMed 鼻腔装置的设计旨在解决与光生物调节治疗过敏性鼻炎相关的局限性。这项门诊研究旨在展示 LumiMed 鼻腔装置的疗效、可用性和舒适性。
在过敏高发季节,20 名过敏性鼻炎患者使用 LumiMed 鼻腔装置进行治疗。患者的平均年龄为 35 岁(10-75 岁);11 名女性,9 名男性。患者的种族为白人(n=11)、黑人(n=6)、东方人(n=2)和伊朗人(n=1)。患者接受每日两次治疗,每次 10 秒,连续 10 天。10 天后,对患者的症状缓解、设备舒适性和易用性进行评估。总鼻部症状评分用于评估过敏性鼻炎主要症状的严重程度。计算每个症状类别的总鼻部症状评分总和(每位患者的总评分为 0-9)。鼻漏/鼻分泌物、鼻塞和鼻痒/打喷嚏均按 0-3 级(0 无症状,1 轻度症状,2 中度症状,3 重度症状)进行评估。设备舒适性按 0-3 级(0 无不适,1 轻度不适,2 中度不适,3 重度不适)进行评估。设备易用性按 0-3 级(0 非常容易,1 有点困难,2 困难,3 非常困难)进行评估。
这些病例研究的结果表明,在这项病例研究中的 20 名患者中,100%的患者在使用 LumiMed 鼻腔装置后总鼻部症状评分得到改善。在这些患者中,40%的患者将总鼻部症状评分降至 0。此外,95%的患者认为 LumiMed 鼻腔装置使用舒适,85%的患者认为 LumiMed 鼻腔装置易于使用。