Messing Barbara P, Kim Melissa, Hirata Richard, Thompson Carol B, Gebhart Samantha, Sugar Elizabeth A, Saunders John M, Sciubba James, Califano Joseph A
Milton J. Dance, Jr. Head and Neck Center, Baltimore, Maryland, U.S.A.
Laryngoscope. 2015 May;125(5):1118-23. doi: 10.1002/lary.25034. Epub 2014 Nov 24.
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.
Randomized, unblinded, crossover trial.
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.
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).
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.
1b
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。
随机、非盲、交叉试验。
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。
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）。
制霉菌素和保丽净漱口水的CFU水平相似，制霉菌素相较于常规口腔护理有显著改善。保丽净漱口水是制霉菌素成本更低的替代方案，其治疗方案更简单，可能对患者和临床医生更具吸引力。
1b
