带食管发音假体的无喉患者念珠菌预防治疗的评估

Evaluation of prophylaxis treatment of Candida in alaryngeal patients with tracheoesophageal voice prostheses.

作者信息

Messing Barbara P, Kim Melissa, Hirata Richard, Thompson Carol B, Gebhart Samantha, Sugar Elizabeth A, Saunders John M, Sciubba James, Califano Joseph A

机构信息

Milton J. Dance, Jr. Head and Neck Center, Baltimore, Maryland, U.S.A.

出版信息

Laryngoscope. 2015 May;125(5):1118-23. doi: 10.1002/lary.25034. Epub 2014 Nov 24.

DOI:10.1002/lary.25034

PMID:25418079

Abstract

OBJECTIVES/HYPOTHESIS: The objective of this study was to evaluate the effectiveness of nystatin and Biotène(®) mouthwash Oral Rinse for controlling Candida in total laryngectomy (TL) patients with a tracheosophageal voice prosthesis (TEP) because Biotène(®) mouthwash Oral Rinse is a less costly alternative to nystatin and requires less adherence time.

STUDY DESIGN

Randomized, unblinded, crossover trial.

METHODS

Twenty-one TL patients were randomized to receive nystatin followed by Biotène(®) mouthwash Oral Rinse, or the reverse order, after a basic oral-care phase (i.e., brushing teeth, cleaning dentures). A Provox(®) 2, 22.5 French TEP, which is an indwelling silicone voice prosthesis, was placed at the beginning of each phase. Patients were provided with oral care instructions at randomization and medication-specific instructions with each treatment's initiation. TEPs were processed and evaluated for Candida growth as colony-forming units (CFUs). Wilcoxon signed-rank tests were used for comparisons between treatments.

RESULTS

Fifteen patients were available for comparisons of Candida counts (6 received nystatin; 9 received Biotène(®) mouthwash first). Overall, the median log10 (CFUs) remained high regardless of treatment (no medication: 8.9; nystatin: 8.7; Biotène(®) mouthwash: 8.4). However, the median counts for both nystatin and Biotène(®) mouthwash Oral Rinse were lower than those for no medication (difference [Δ]:-0.9 and -0.3, respectively), although only nystatin was significantly lower (P = 0.02). There was no significant difference between the two treatments (P = 0.22). Overall, median medication-adherence was high (97%), and Biotène(®) mouthwash adherence was significantly higher than that of nystatin (Δ: 7.6%; P = 0.03).

CONCLUSION

Nystatin and Biotène(®) mouthwash Oral Rinse had similar CFU levels, with nystatin showing a significant improvement over usual oral care. Biotène(®) mouthwash is a less costly alternative to nystatin, with a less complex treatment protocol that might make it preferable to patients and clinicians.

LEVEL OF EVIDENCE

摘要

目的/假设：本研究的目的是评估制霉菌素和保丽净漱口水对全喉切除术（TL）且带有气管食管发音假体（TEP）的患者控制念珠菌的有效性，因为保丽净漱口水相较于制霉菌素成本更低且使用时间要求更少。

研究设计

随机、非盲、交叉试验。

方法

21例TL患者在经过基本口腔护理阶段（即刷牙、清洁假牙）后，随机分为先接受制霉菌素治疗随后接受保丽净漱口水治疗，或顺序相反。在每个阶段开始时放置一个Provox 2型、22.5法式TEP，这是一种植入式硅胶发音假体。患者在随机分组时会得到口腔护理指导，并在每次治疗开始时得到特定药物的使用说明。对TEP进行处理并评估念珠菌生长情况，以菌落形成单位（CFU）表示。采用Wilcoxon符号秩检验对不同治疗方法进行比较。

结果

15例患者可用于念珠菌计数比较（6例先接受制霉菌素治疗；9例先接受保丽净漱口水治疗）。总体而言，无论采用何种治疗方法，log10（CFU）中位数均保持在较高水平（未用药：8.9；制霉菌素：8.7；保丽净漱口水：8.4）。然而，制霉菌素和保丽净漱口水的计数中位数均低于未用药时（差异[Δ]：分别为 -0.9和 -0.3），尽管只有制霉菌素显著更低（P = 0.02）。两种治疗方法之间无显著差异（P = 0.22）。总体而言，药物依从性中位数较高（97%），保丽净漱口水的依从性显著高于制霉菌素（差异：7.6%；P = 0.03）。