Abstract：
BACKGROUND: Tracheoesophageal speech is one of the most effective method used for voice rehabilitation after laryngectomy. The main limitation is the need for periodic voice prothesis (VP) replacements. The process of developing VP usage complications is still unexplored. The aim of this study was to assess the level of cytokines (IL-1β, IL-6, IL-8, IL-10, TNFα) and pepsin in saliva as potential factors reducing VP longevity.
METHODS: Prospective double-blind randomized clinical trial was conducted (NCT04268459). Patients were randomly divided into two groups depending on VP replacement regimen (regular-every 3 months, or irregular-when complications occur). Levels of IL-1β, IL-6, IL-8, IL-10, TNFα, and pepsin in saliva samples (fasting and after eating) of laryngectomized patients were measured using ELISA tests.
RESULTS: Fifty-two patients (26 in both groups) with control group (7 patients) participated in the study. The level of IL-1β, IL-6, IL-8, IL-10, TNFα, and pepsin did not differ according to regularity of VP replacements (p = 0.301-0.801). IL-6 levels were significantly higher when VP complications occurs (p = 0.012).
CONCLUSIONS: The saliva components were not significantly different depending on the frequency of VP replacements. IL-6 plays an important role in the development of VP use complications.
METHODS: Prospective double-blind randomized clinical trial was conducted (NCT04268459). Patients were randomly divided into two groups depending on VP replacement regimen (regular-every 3 months, or irregular-when complications occur). Levels of IL-1β, IL-6, IL-8, IL-10, TNFα, and pepsin in saliva samples (fasting and after eating) of laryngectomized patients were measured using ELISA tests.
RESULTS: Fifty-two patients (26 in both groups) with control group (7 patients) participated in the study. The level of IL-1β, IL-6, IL-8, IL-10, TNFα, and pepsin did not differ according to regularity of VP replacements (p = 0.301-0.801). IL-6 levels were significantly higher when VP complications occurs (p = 0.012).
CONCLUSIONS: The saliva components were not significantly different depending on the frequency of VP replacements. IL-6 plays an important role in the development of VP use complications.
摘要：
背景：气管食管语音是喉切除术后最有效的语音康复方法之一。主要的限制是需要周期性的语音假肢(VP)替换。发展VP使用并发症的过程仍未探索。本研究的目的是评估细胞因子(IL-1β，唾液中的IL-6，IL-8，IL-10，TNFα）和胃蛋白酶是降低VP寿命的潜在因素。
方法：进行前瞻性双盲随机临床试验（NCT04268459）。根据VP替代方案将患者随机分为两组(定期-每3个月，或不规则-发生并发症时)。IL-1β水平,IL-6，IL-8，IL-10，TNFα，使用ELISA测试测量喉切除患者的唾液样品（禁食和进食后）中的胃蛋白酶。
结果：52名患者（两组均为26名）和对照组（7名患者）参加了该研究。IL-1β水平,IL-6，IL-8，IL-10，TNFα，根据VP替换的规律性，胃蛋白酶没有差异（p=0.301-0.801）。当发生VP并发症时，IL-6水平显着升高（p=0.012）。
结论：根据VP替换的频率，唾液成分没有显着差异。IL-6在VP使用并发症的发展中起着重要作用。
方法：进行前瞻性双盲随机临床试验（NCT04268459）。根据VP替代方案将患者随机分为两组(定期-每3个月，或不规则-发生并发症时)。IL-1β水平,IL-6，IL-8，IL-10，TNFα，使用ELISA测试测量喉切除患者的唾液样品（禁食和进食后）中的胃蛋白酶。
结果：52名患者（两组均为26名）和对照组（7名患者）参加了该研究。IL-1β水平,IL-6，IL-8，IL-10，TNFα，根据VP替换的规律性，胃蛋白酶没有差异（p=0.301-0.801）。当发生VP并发症时，IL-6水平显着升高（p=0.012）。
结论：根据VP替换的频率，唾液成分没有显着差异。IL-6在VP使用并发症的发展中起着重要作用。
