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益生菌含漱液能否降低成年扁桃体切除术后患者的发病率?一项先导、三盲、随机、对照试验及可行性研究。

Can probiotic gargles reduce post-tonsillectomy morbidity in adult patients? A pilot, triple-blind, randomised, controlled trial and feasibility study.

机构信息

Department of ENT Surgery, Frankston Hospital, Peninsula Health, Frankston, Australia.

Academic Unit, Central Clinical School, Monash University, Frankston, Melbourne, Australia.

出版信息

J Laryngol Otol. 2023 Mar;137(3):323-341. doi: 10.1017/S0022215122000743. Epub 2022 Mar 23.

Abstract

OBJECTIVE

This study aimed to determine the efficacy of probiotic gargles compared with placebo gargles on reducing post-tonsillectomy morbidity in adults.

METHOD

This was a triple-blind, randomised, controlled trial and feasibility study. Thirty adults underwent elective tonsillectomy and were randomly assigned to receive either probiotic or placebo gargles for 14 days after surgery. Daily pain scores and requirement of analgesia were measured for 14 days post-operatively. Secondary outcomes assessed probiotic safety and tolerability and the feasibility of the trial.

RESULTS

The probiotic group experienced less pain at rest on day 2. However, the amount of oxycodone (5 mg) tablets used was greater in the probiotic group compared with placebo. There were no statistically significant differences in the frequency of adverse effects between both groups. This trial was feasible.

CONCLUSION

This pilot study suggested that probiotic gargles do not reduce post-tonsillectomy pain or bleeding, highlighting the importance of pilot and feasibility studies in clinical research.

摘要

目的

本研究旨在确定与安慰剂含漱相比,益生菌含漱对减少成人扁桃体切除术后发病率的疗效。

方法

这是一项三盲、随机、对照的可行性研究。30 名成年人接受择期扁桃体切除术,并随机分为术后接受益生菌或安慰剂含漱 14 天。术后 14 天每天测量疼痛评分和镇痛需求。次要结局评估益生菌的安全性和耐受性以及试验的可行性。

结果

益生菌组在第 2 天休息时疼痛程度较低。然而,与安慰剂相比,益生菌组使用的羟考酮(5 毫克)片剂数量更多。两组不良反应的发生频率无统计学差异。该试验是可行的。

结论

本初步研究表明,益生菌含漱并不能减轻扁桃体切除术后的疼痛或出血,凸显了在临床研究中进行初步和可行性研究的重要性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e8d0/9975764/4f571cf4fbb9/S0022215122000743_fig1.jpg

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