冷冻疗法治疗慢性鼻炎：一项前瞻性、多中心注册研究的长期结果。
Cryotherapy as Treatment for Chronic Rhinitis: Long-Term Results of a Prospective, Multicenter Registry.
文献信息
| PMID | 42841538 |
|---|---|
| 原文 | 在 PubMed 查看原文 ↗ |
| 发表日期 | 2026 |
| 作者 | Amber U Luong |
| 作者单位 | Otorhinolaryngology, McGovern Medical School of the University of Texas Health Science Center at Houston, Houston, Texas, USA. |
| 期刊 | Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery |
| SCI 分区 | Q1 |
| IF | 2.9 |
| 研究类型 | 临床研究 · 临床 |
| 所属专科 | 鼻科 |
中文摘要
目的： 本注册研究的目的是收集接受ClariFix冷冻治疗装置治疗慢性鼻炎的大型且多样化队列的观察性数据。
研究设计： 前瞻性、多中心、非随机、观察性注册研究。
地点： 22家三级医疗和私立耳鼻咽喉科诊所。
方法： 对患有过敏性或不过敏性慢性鼻炎的成年患者实施ClariFix治疗。结局指标包括反射性总鼻症状评分、迷你鼻结膜炎生活质量问卷、患者总体印象变化、临床医生总体印象改善，以及至24个月随访时与装置或操作相关的不良事件。
结果： 共有354名参与者接受了932次治疗。从基线到所有随访，反射性总鼻症状评分的平均变化均显著（P < .001）；超过73%的参与者为应答者，在所有随访中均达到≥1分的降低。基线反射性总鼻症状评分≥7的参与者比基线评分<7的参与者改善更大（P < .001）。在所有随访中，超过74%的参与者为生活质量应答者（迷你鼻结膜炎生活质量问卷≥0.4分）。超过73%的参与者在所有随访中报告PGIC改善。临床医生在3个月随访时注意到87.1%的参与者有改善。未报告与装置或治疗相关的严重不良事件。与装置和治疗相关的不良事件为短暂、非严重，通常通过非处方药物和温热饮品缓解。
结论： 本注册研究提供了额外的长期证据，证明冷冻疗法在多样化人群中治疗慢性鼻炎至24个月的安全性和有效性。
英文摘要
OBJECTIVE: The purpose of this registry was to capture observational data on a large and diverse cohort treated with the ClariFix Cryotherapy device for chronic rhinitis.
STUDY DESIGN: Prospective, multicenter, nonrandomized, observational registry.
SETTING: Twenty-two tertiary care and private otolaryngology practices.
METHODS: ClariFix treatment was administered to adult patients with allergic or nonallergic chronic rhinitis. Outcome measures included the reflective Total Nasal Symptom Score, mini Rhinoconjunctivitis Quality of Life Questionnaire, Patient Global Impression of Change, Clinician Global Impression-Improvement, and adverse events related to the device or procedure through 24-month follow-up.
RESULTS: A total of 354 participants received 932 treatments. The mean change in total reflective Total Nasal Symptom Score from baseline to all follow-ups was significant (P < .001); greater than 73% of participants were responders, achieving ≥1 point reduction at all follow-ups. Participants with baseline reflective Total Nasal Symptom scores ≥ 7 had greater improvement than those with baseline scores < 7 (P < .001). Greater than 74% of participants were quality of life responders (≥0.4 points) at all follow-ups with the mini Rhinoconjunctivitis Quality of Life Questionnaire. More than 73% of participants reported PGIC improvement at all follow-ups. Clinicians noted improvement in 87.1% of participants at 3-month follow-up. No device- or treatment-related serious adverse events were reported. Device- and treatment-related adverse events were transient, nonserious, and typically resolved by over-the-counter medication and warm beverages.
CONCLUSION: This registry provides additional long-term evidence of the safety and efficacy of cryotherapy for the treatment of chronic rhinitis in a diverse population through 24 months.