Utjecaj ekstraezofagealnog refluksa na učestalost komplikacija i kvalitetu glasa bolesnika s govornom protezom Influence of extraesophageal reflux on the occurrence of voice prosthesis complications and voice quality after total laryngectomy and voice prosthesis implantation

摘要

Introduction and aimudTracheoesophageal speech with voice prosthesis (VP) is the gold standard in speech rehabilitation of laryngectomized patients. However, the voice quality and quality of life may be notably impaired by VP complications that may be related to certain surgical procedures during laryngectomy and the formation of tracheoesophageal fistula (TEF) or related to the TEF and the VP itself. There are several risk factors that contribute to the development of VP complications. In the last five years a small number of studies have examined the impact of extraesophageal reflux (EER) on several VP complications: tracheoesophageal wall atrophy, increasing diameter of TEF, and tracheal granulation and on the voice quality in laryngectomized patients. Until recently, multichannel 24-hour pH - metry was the gold standard in the diagnosis of EER. However, several studies identified pepsin as a sensitive and specific marker of EER, and showed that measurement of concentration of pepsin in saliva was a reliable, cheap, simple and non-invasive method to diagnoze EER. ----- Patients and methodsudThe study included 60 laryngectomees with VP and 30 healthy control subjects in whom concentrations of pepsin in saliva samples were analyzed with ELISA method. Clinical examination in the studied group evaluated the presence of VP complications and speech rehabilitation performance score with Harrison-Robillard-Schultz scale (HRS). Patients with VP complications were randomized in two groups: therapy with pantoprazole at a dose of 40 mg in the morning for 6 months or no medication. Statistical analysis was performed using Mann - Whitney test, Student's t-test, Spearmann's correlation test, chi square test and linear regression analysis. Significance level P was set to 0.05. ----- ResultsudThis study is the first to show the effect of EER on VP complications and voice quality by measuring the concentration of pepsin in saliva. Saliva samples of all subjects, laryngectomees and healthy controls, demonstrated the presence of pepsin. Using the results of normally distributed pepsin concentration values of control healthy subjects, normal range of pepsin concentrations in saliva were determined as: mean pepsin concentration in healthy controls ± 3 standard deviations, which covered 95% of all healthy controls. Values above 0.884 pg/ml, (within 95th percentile) were considered increased or abnormal. Finally, in all patients with pepsin values above 0.884 pg/ml EER was diagnozed. Using this method, in 25% of laryngectomized patients with VP EER was diagnozed.udMedian pepsin concentrations did not differ significantly between laryngectomized patients and controls. Also, median concentrations of pepsin and frequency of EER did not differ significantly between patients with and without VP complications, nor among patients with different types of VP complications. However, patients with biofilm formed on the GP or GP candidiasis had higher values of pepsin, but this difference was not statistically significant. Impact of EER on tracheoesophageal wall atrophy and TEF diameter increase could not be investigated in this study because there was only one patient with this kind of VP complication.udThis study demonstrated a high performance of speech rehabilitation but did not find any significant correlation between the concentration of pepsin in saliva and voice quality in patients with VP. Incidence of VP complications, analysis of voice quality and concentration of pepsin in saliva did not differ significantly among patients regarding radiotherapy. Although the incidence of VP complications after 3 and 6 months of treatment with pantoprazole was lower, this difference was not statistically significant. In addittion, pantoprazole therapy did not significantly reduce pepsin in saliva, or show any significant improvement of voice quality. ----- ConclusionudThis study demonstrated that EER, diagnozed non-invasively by concentration of pepsin in saliva, did not significantly affect the incidence of VP complications. Therefore, there are no data to support prophylactic protein pump inhibitor therapy in all patients with VP complications. Given that this study involved only one patient with tracheoesophageal wall atrophy and increasing TEF diameter, future research should include a larger number of patients with these kinds of VP complications in order to obtain results comparable with majority of previously published studies.