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鼻用草药蒸汽疗法治疗拔管后呼吸道症状的有效性和安全性:一项实用随机对照平行分组研究的方法

Effectiveness and Safety of Nasal Herbal Steam Therapy for Post-Extubation Respiratory Symptoms: A Methodology of Pragmatic Randomized Controlled, Parallel Grouped Study.

作者信息

Hong Sung-Eun, Hyun Myung Han, Lee Sang Hyung, Kim Bup-Woo, Kim Hee Jun, Ko Eun Ju, Lee Jee Young

机构信息

Integrative Cancer Center, CHA Ilsan Medical Center, CHA University School of Medicine, Goyang-si, Gyeonggi-do, Rep of Korea.

Department of Surgery, CHA Ilsan Medical Center, CHA University School of Medicine, Goyang-si, Gyeonggi-do, Rep of Korea.

出版信息

Integr Cancer Ther. 2025 Jan-Dec;24:15347354251375469. doi: 10.1177/15347354251375469. Epub 2025 Sep 16.

DOI:10.1177/15347354251375469
PMID:40955847
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12441290/
Abstract

Post-extubastion respiratory symptoms (PERS) are a common sequelae of endotracheal intubation, impeding postoperative recovery. Despite the widespread use of prophylactic corticosteroids and symptomatic management, these approaches have limitations in alleviating PERS. In this study, we aim to evaluate the efficacy and safety of nasal herbal steam therapy (NHST), a traditional Korean medicine intervention, in managing PERS among patients with thyroid cancer following endotracheal intubation. In this pragmatic, parallel-group randomized controlled trial, 66 post-thyroidectomy patients with thyroid cancer who underwent endotracheal intubation will be randomly assigned in a 1:1 ratio to either the NHST group or the standard care group. The intervention group will receive personalized NHST for 5 consecutive days, whereas the control group will follow conventional postoperative care protocols. The primary endpoint is the change in Wisconsin Upper Respiratory Symptom Survey scores from baseline to day 5. Secondary endpoints included patient-reported symptom relief, safety assessments, and adherence rates. By investigating the therapeutic potential of NHST, this study will establish its role as a non-invasive, adjunctive intervention for improving intubation-related complications, potentially contributing to broadening integrative treatment strategies and optimizing recovery outcomes for patients with PERS. The study will be conducted in accordance with the Declaration of Helsinki and approved by the Institutional Review Board of CHA Ilsan Medical Center (ICHA 2024-011-006, date of approval 2024-09-04).

摘要

拔管后呼吸症状(PERS)是气管插管常见的后遗症,会阻碍术后恢复。尽管预防性使用皮质类固醇和对症治疗广泛应用,但这些方法在缓解PERS方面存在局限性。在本研究中,我们旨在评估韩国传统医学干预措施——鼻腔草药蒸汽疗法(NHST)对甲状腺癌气管插管患者PERS的疗效和安全性。在这项实用的平行组随机对照试验中,66例接受气管插管的甲状腺癌甲状腺切除术后患者将按1:1的比例随机分配至NHST组或标准护理组。干预组将连续5天接受个性化NHST,而对照组将遵循常规术后护理方案。主要终点是从基线到第5天威斯康星上呼吸道症状调查评分的变化。次要终点包括患者报告的症状缓解、安全性评估和依从率。通过研究NHST的治疗潜力,本研究将确立其作为一种非侵入性辅助干预措施在改善插管相关并发症方面的作用,可能有助于拓宽综合治疗策略并优化PERS患者的恢复结果。本研究将按照《赫尔辛基宣言》进行,并获得CHA Ilsan医疗中心机构审查委员会的批准(ICHA 2024 - 011 - 006,批准日期2024 - 09 - 04)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cfd2/12441290/e23e253e6100/10.1177_15347354251375469-fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cfd2/12441290/e23e253e6100/10.1177_15347354251375469-fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cfd2/12441290/e23e253e6100/10.1177_15347354251375469-fig1.jpg

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本文引用的文献

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Problems Related to Endotracheal Intubation as an Input for the Design of a New Endotracheal Tube.与气管插管相关的问题作为新型气管导管设计的依据
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Thyroidectomy for the Management of Differentiated Thyroid Carcinoma and their Outcome on Early Postoperative Complications: A 6-year Single-Centre Retrospective Study.
甲状腺切除术治疗分化型甲状腺癌及其术后早期并发症的结果:一项 6 年单中心回顾性研究。
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Eur Arch Otorhinolaryngol. 2021 May;278(5):1499-1504. doi: 10.1007/s00405-020-06595-3. Epub 2021 Jan 13.
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Steroid Side Effects.类固醇副作用。
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Types of nasal delivery drugs and medications in Iranian traditional medicine to treatment of headache.伊朗传统医学中用于治疗头痛的鼻腔给药药物类型
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