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次氯酸与盐水鼻腔冲洗治疗变应性鼻炎的多中心、随机、双盲、安慰剂对照研究。

Hypochlorous Acid Versus Saline Nasal Irrigation in Allergic Rhinitis: A Multicenter, Randomized, Double-Blind, Placebo-controlled Study.

机构信息

Nowon Eulj Medical Center, 65407Eulji University School of Medicine, Seoul, Republic of Korea.

65387Chuncheon Sacred Heart Hospital, 96664Hallym University College of Medicine, Chuncheon, Republic of Korea.

出版信息

Am J Rhinol Allergy. 2022 Jan;36(1):129-134. doi: 10.1177/19458924211029428. Epub 2021 Jul 8.

Abstract

BACKGROUND

Low concentrations of hypochlorous acid (HOCl) have proven antipruritic, anti-inflammatory, and antimicrobial effects without toxicity, although the mechanism has not been fully elucidated.

OBJECTIVE

The aim of this study was to evaluate the effectiveness of HOCl nasal irrigation to reduce allergic rhinitis (AR) symptoms compared with saline nasal irrigation.

METHODS

This was multicenter, randomized, double-blind, placebo-controlled study. Initially, 139 patients with perennial AR were enrolled; however, 25 did not successfully complete the study. Patients were randomly assigned to the nasal irrigation with low-concentration HOCl (n = 55) or normal saline (n = 59) treatment groups for the 4-week study period. Participants completed the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) at every visit (baseline, Weeks 2 and 4), and Total Nasal Symptom Score (TNSS) was determined before and after nasal irrigation every morning and evening.

RESULTS

We found that RQLQ scores significantly decreased after 4 weeks in the HOCl and placebo groups, but the decrement of the RQLQ score was similar between the 2 groups. Additionally, TNSS improved in both groups between baseline and Week 4, whereas there were no significant differences in the change of TNSS between the 2 groups. The HOCl group did not show any clinical side effects related to nasal irrigation.

CONCLUSION

Allergic symptoms significantly decreased with low-concentration HOCl nasal irrigation, without significant adverse events. However, HOCl showed no additional improvement in symptoms compared with saline nasal irrigation for patients with perennial AR.

摘要

背景

低浓度次氯酸(HOCl)已被证明具有止痒、抗炎和抗菌作用,且无毒性,尽管其机制尚未完全阐明。

目的

本研究旨在评估 HOCl 鼻腔冲洗相对于生理盐水鼻腔冲洗,降低变应性鼻炎(AR)症状的有效性。

方法

这是一项多中心、随机、双盲、安慰剂对照研究。最初纳入了 139 例常年性 AR 患者,但有 25 例未能完成研究。患者被随机分配至低浓度 HOCl(n=55)或生理盐水(n=59)鼻腔冲洗治疗组,进行为期 4 周的研究。参与者在每次就诊时(基线、第 2 周和第 4 周)完成鼻结膜炎生活质量问卷(RQLQ),并在每天早晚鼻腔冲洗前后分别测定总鼻症状评分(TNSS)。

结果

我们发现,HOCl 和安慰剂组在 4 周后 RQLQ 评分均显著降低,但两组间 RQLQ 评分的降低幅度相似。此外,两组的 TNSS 均在基线至第 4 周之间得到改善,而两组间 TNSS 的变化无显著差异。HOCl 组未显示与鼻腔冲洗相关的任何临床不良反应。

结论

低浓度 HOCl 鼻腔冲洗可显著减轻变应性鼻炎症状,且无明显不良事件。然而,与生理盐水鼻腔冲洗相比,HOCl 对常年性 AR 患者的症状改善无额外作用。

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