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麦卢卡蜂蜜与生理盐水鼻腔冲洗治疗囊性纤维化相关性慢性鼻-鼻窦炎:一项随机试验。

Manuka honey versus saline sinus irrigation in the treatment of cystic fibrosis-associated chronic rhinosinusitis: A randomised pilot trial.

机构信息

Department of Otolaryngology - Head and Neck Surgery, University of Washington, Seattle, WA, USA.

Department of Otolaryngology - Head and Neck Surgery, University of Illinois at Chicago, Chicago, IL, USA.

出版信息

Clin Otolaryngol. 2021 Jan;46(1):168-174. doi: 10.1111/coa.13637. Epub 2020 Oct 2.

Abstract

OBJECTIVES

Manuka honey attacks biofilms, which contribute to bacterial persistence in cystic fibrosis sinusitis. The primary objective was to determine feasibility of investigating manuka honey as an irrigation treatment for cystic fibrosis sinusitis and secondarily to assess the treatment's preliminary effectiveness.

DESIGN

Prospective, single-blinded (clinician only), randomised, parallel two-arm pilot trial.

SETTING

Tertiary rhinology clinic.

PARTICIPANTS

Subjects had recalcitrant cystic fibrosis sinusitis and previous sinus surgery. They received manuka honey or saline sinus irrigations twice daily for 30 days.

MAIN OUTCOME MEASURES

Main outcomes were recruitment/retention rates and tolerability. Preliminary effectiveness was assessed based on quality-of-life Sinonasal Outcome Test-22 and Lund-Kennedy endoscopic change scores and post-treatment culture negativity.

RESULTS

Over 10 months, 13 subjects were enrolled, and 77% (10/13) were included in the analysis. Manuka honey irrigations were well-tolerated. The quality-of-life change score was clinically significant for manuka honey (-9 [-14,-6]) but not saline (-5 [-9,-1]), although the difference was not statistically significant (P = .29). Lund-Kennedy endoscopic change score was significantly better for manuka honey (-3 [-5,-3]) versus saline (0 [0,0]) (P = .006). There was no difference in post-treatment culture negativity between manuka honey (1/5, 20%) and saline (0/5, 0%) (P = 1.00).

CONCLUSIONS

Manuka honey irrigations were well tolerated, and retention rates were high. Preliminary data showed that manuka honey achieved a clinically important difference in quality-of-life score and a significantly better endoscopic outcome. Microbiological control was difficult to achieve. A future definitive trial would require multi-institutional recruitment.

摘要

目的

麦卢卡蜂蜜可以攻击生物膜,这有助于细菌在囊性纤维化鼻窦炎中持续存在。主要目的是确定将麦卢卡蜂蜜作为囊性纤维化鼻窦炎冲洗治疗的可行性,其次是评估该治疗的初步效果。

设计

前瞻性、单盲(仅临床医生)、随机、平行双臂试验。

地点

三级鼻科诊所。

参与者

受试者患有难治性囊性纤维化鼻窦炎和既往鼻窦手术。他们接受麦卢卡蜂蜜或生理盐水鼻窦冲洗,每天两次,持续 30 天。

主要观察指标

主要结果是招募/保留率和耐受性。初步疗效基于生活质量鼻-鼻窦炎结局测试-22 及 Lund-Kennedy 内镜变化评分和治疗后培养阴性来评估。

结果

在 10 个月内,共纳入 13 例患者,其中 77%(10/13)纳入分析。麦卢卡蜂蜜冲洗耐受良好。麦卢卡蜂蜜组的生活质量变化评分具有临床意义(-9 [-14,-6]),但生理盐水组无变化(-5 [-9,-1]),但差异无统计学意义(P=.29)。Lund-Kennedy 内镜评分显示,麦卢卡蜂蜜组(-3 [-5,-3])显著优于生理盐水组(0 [0,0])(P=.006)。麦卢卡蜂蜜组(1/5,20%)和生理盐水组(0/5,0%)的治疗后培养阴性率无差异(P=1.00)。

结论

麦卢卡蜂蜜冲洗耐受良好,保留率高。初步数据显示,麦卢卡蜂蜜在生活质量评分和内镜结局方面具有显著差异,且具有良好的临床意义。微生物控制较难实现。未来的确定性试验需要多机构招募。

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