Efficacy of Saliva Orthana in the Management of Xerostomia in Hospice Patients

Pharmaceutical sciences, Health care management, Medicine

Sweeney, Margaret Petrina

University:University of Glasgow

关键词: Pharmaceutical sciences, Health care management, Medicine;   

Others  :  http://theses.gla.ac.uk/76116/1/13818927.pdf

来源: University of Glasgow

【 摘 要 】

Oral disease has been reported as a common feature in patients with advanced malignancy, although this area has been poorly researched. The development of appropriate mouth care regimes, particularly for use by nursing staff, is therefore a priority. Dryness of the mouth, often secondary to the use of xerogenic medication or previous radiotherapy, affects up to 70% of terminally ill cancer patients, but there have been no formal studies of its treatment in this group. This thesis describes a placebo-controlled, double-blind clinical trial of a mucin-based salivary substitute spray, among 70 hospice patients (25 male and 45 female; age range 42 - 88 [mean 66] years) complaining of xerostomia. At baseline, demographic data and details of symptomatology were recorded, and the mouth fully examined for clinical abnormalities. Imprint cultures were collected from the tongue and, in denture wearers, from the palate and denture fitting surface. These were cultured for yeasts, coliforms and staphylococci. A swab was collected for culture of herpes simplex virus. Sixty eight patients (97%) complained of oral dryness during the day, 21 (30%) indicating that it was a severe problem and 35 (50%) that it was a moderately severe problem. Fifty nine patients (84%) also complained of oral dryness at night. Soreness of the mouth was reported by 22 patients (31%). Forty six patients (66%) had difficulty talking and 36 (51%) reported difficulty eating. Of the 56 denture wearers, 23 (41%) complained of denture problems. On examination, 63 (90%) of the patients had clinical evidence of xerostomia. Oral mucosal abnormalities were detected in 45 patients (65%), most commonly erythema (20%), coated tongue (20%), atrophic glossitis (17%), angular cheilitis (11%) and pseudomembranous candidosis (9%). Forty seven (67%) of the patients carried yeasts in the mouth, 18 (26%) were carriers of Staphylococcus aureus and 13 (19%) carried coliforms. Herpes simplex virus was isolated from five patients, of whom two had herpetic stomatitis. These significant oral complications and abnormalities of the oral microflora confirmed previous reports on oral health in cancer patients. The clinical trial examined effectiveness of the mucin-containing mouth spray. Saliva Orthana (Nycomed [UK]), against a mucin-free version of the same preparation in this group of 70 patients. Each preparation was used for 14 days and the participants were interviewed, examined and specimens collected as described above, at days 7 and 14. The trial was complicated by reports from some of the earlier-enrolled patients of a burning sensation of the oral mucosa. On investigation, all of those affected were using active spray, and the trial was halted at Patient 35. Although chemical analysis revealed no abnormalities in the first spray batch, when the trial re-commenced three months later a new batch of active and placebo sprays was used for the remaining 35 patients. For the first 35 patients, 8/16 on Saliva Orthana and 6/13 on placebo felt by Day 7 that the respective sprays had been beneficial in relation to dryness during the day. For dryness at night the corresponding figures were 6/16 for Saliva Orthana and 5/13 for placebo. None of these differences between preparations were statistically significantly different. Similarly, with the exception of'oral soreness', there were no significant differences between the active and placebo sprays for any of the other symptoms recorded. This pattern of results was repeated at Day 14. Significantly more patients on Saliva Orthana complained of soreness of the oral mucosa between days 1 and 7 (p=0.04). For the second 35 patients, relief of oral dryness during the day was reported by 9/15 on Saliva Orthana and 10/16 patients on placebo by Day 7, with a similar degree of improvement maintained to Day 14. The corresponding figures by Day 7 for relief of dryness at night were 8/15 for Saliva Orthana and 8/16 for placebo. There were no statistically significant differences between those on active and those on placebo spray for any of the oral symptoms recorded. Neither spray had any major impact on the oral micro flora. However, the majority of patients in both treatment groups wished to continue using a mouth spray at the end of their involvement in the trial. Whilst the data from this study provide no evidence for increased benefit of a mucin-containing spray over a mucin-free placebo among xerostomic hospice patients, it was clear that both sprays provided worthwhile symptomatic relief of oral dryness for many of the participants. Further studies are required to determine the optimum saliva substitute for use by patients with advanced cancer.