慢性鼻炎与鼻的超短波疗法:随机,双盲,假控制试验的协议
Ling Kong1, Jinlong Zhang2, Chuanmei Zhu3
1Department of Otolaryngology-Head & Neck Surgery, West China Hospital/West China School of Nursing, Sichuan University, Chengdu, Sichuan Province, 610041, People's Republic of China.
Trials
|October 8, 2025
概括
这项研究研究了超短波 (USW) 治疗具有鼻息肉 (CRSwNP) 的慢性鼻炎的治疗方法. 它旨在确定USW疗法是否为CRSwNP患者提供安全有效的非侵入性治疗选择.
科学领域:
- 耳鼻喉科 耳鼻喉科 耳鼻喉科
- 医疗技术 医疗技术 医学技术
- 临床试验 临床试验
背景情况:
- 带鼻息肉的慢性鼻炎 (CRSwNP) 导致持续的炎症,并显著影响生活质量.
- 目前的治疗方法,如皮质类固醇,手术和生物药物都有局限性,包括副作用和高复发率.
- 超短波 (USW) 疗法是一种潜在的非侵入性治疗方法,但缺乏证据证明CRSwNP的有效性.
研究的目的:
- 评估超短波 (USW) 疗法的疗效,以治疗具有鼻息肉的慢性鼻炎 (CRSwNP).
- 评估USW治疗作为非侵入性辅助治疗的潜力,可能减少对皮质类固醇,手术和生物制剂的依赖.
- 解决关于USW疗法的有效性在改善长期患者CRSwNP.结果的证据中的关键差距.
主要方法:
- 一个单中心,双盲,假控制试验,涉及150名CRSwNP患者.
- 参与者将每天接受积极的USW治疗或假治疗,持续两周,并接受标准的医疗护理.
- 主要结局是12个月后中鼻结局测试 (SNOT-22) 成绩的变化,而隆德-肯尼迪内镜成绩是关键的次要结局.
主要成果:
- 在试验结束和数据分析完成后,填写本部分.
- 主要结果将使用线性混合效应模型进行分析.
- 将进行敏感性分析,以管理缺失的数据.
结论:
- 该试验旨在提供关键证据,证明USW治疗CRSwNP的疗效.
- 积极的发现可以将USW疗法确立为一种有价值的非侵入性治疗选择.
- 结果将为临床指导方针提供信息,并指导CRSwNP管理的未来研究.
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