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.
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。