Stomatology Department, Faculty of Medicine, University of Tirana, Fakulteti i Mjekesise, Rr. Dibres 371 Tirana, Albania.
Rheumatol Int. 2012 Sep;32(9):2877-81. doi: 10.1007/s00296-011-2085-6. Epub 2011 Sep 7.
The objective of the present study was to evaluate the efficacy of Oral Balance saliva substitute in alleviating dry mouth symptoms in a sample of patients with secondary Sjögren's syndrome. Twenty-one consecutive secondary Sjögren's syndrome patients with dry mouth complaints and hyposalivation were included in this study. Patients used a lactoperoxidase-system-containing gel (Biotène Oral Balance) for 4 weeks. The effects on subjective oral symptoms were recorded by means of a 7-items questionnaire which contained questions regarding dry mouth sensation and its effect on chewing, swallowing, taste, speech, burning sensation and denture retention. The severity of symptoms was assessed using a visual analogical scale. Oral symptom scores and unstimulated whole salivary flow were recorded at baseline and after 4 weeks' use of the product. Two patients withdrew from the study, because of nausea and unpleasant taste caused by the product. Nineteen patients (all women, mean age 52.7 years) participated throughout the entire study. Wilcoxon signed-ranked tests indicated significant improvements in visual analogical scale scores posttreatment for 5 of the 7 items on the oral dryness questionnaire, although no increase in salivary flow was found. However, the improvement in certain variables did not take a positive course in all cases. Patients with lower salivary flow at baseline tended to have greater improvement in oral symptoms. The study suggests that the use of Oral Balance gel is effective in alleviating the dry mouth symptoms in secondary Sjögren's syndrome patients, but a randomized controlled trial is needed to assess the placebo effect.
本研究的目的在于评估 Oral Balance 唾液替代物对缓解继发干燥综合征患者口干症状的疗效。本研究纳入了 21 例继发干燥综合征伴口干和唾液流率降低的患者。患者使用含乳过氧化物酶系统的凝胶（Biotène Oral Balance）治疗 4 周。采用包含口干感觉及其对咀嚼、吞咽、味觉、言语、烧灼感和义齿固位影响的 7 项问卷评估主观口腔症状的改善情况。使用视觉模拟评分法评估症状严重程度。在基线时和使用产品 4 周后记录口腔症状评分和非刺激性全唾液流率。由于产品引起的恶心和味觉异常，有 2 例患者退出研究。19 例患者（均为女性，平均年龄 52.7 岁）完成了整个研究。Wilcoxon 符号秩检验显示，7 项口干问卷中的 5 项在治疗后视觉模拟评分显著改善，尽管唾液流率没有增加。然而，并非所有变量的改善都呈积极趋势。基线唾液流率较低的患者的口腔症状改善更大。本研究表明，Oral Balance 凝胶的使用可有效缓解继发干燥综合征患者的口干症状，但需要进行随机对照试验以评估安慰剂效应。
