Mouly Stéphane J, Orler Jean-Baptiste, Tillet Yves, Coudert Anne-Claude, Oberli Frantz, Preshaw Phillip, Bergmann Jean-François
Assistance Publique-Hôpitaux de Paris, Unit of Therapeutic Research, Department of Internal Medicine, Lariboisière Hospital, Paris.
J Clin Psychopharmacol. 2007 Oct;27(5):437-43. doi: 10.1097/jcp.0b013e31814db434.
Xerostomia is a subjective sensation of mouth dryness often occurring as an unwanted effect of psychotropic drugs.
The clinical efficacy and acceptability of a new oxygenated glycerol triester (OGT) oral spray (1 or 2 sprays up to 4 times daily) in the treatment of xerostomia was compared with those of a commercially available artificial saliva substitute (ASS [Saliveze]) in a 2-week, open-labeled, randomized, parallel-group study. Clinical assessment of xerostomia included evaluation of mouth dryness by means of a 10-cm-long visual analog scale, objective blinded assessment of the oral tissue condition by a dental hygienist by means of a 4-point ordinal scale, and subjective patient-based assessment of dry mouth symptoms by means of dichotomous responses to a questionnaire. [Day 14 - baseline] patient-based mouth dryness score was the primary end point.
Seventy-four patients (41 women and 33 men, 44 +/- 15 years) undergoing long-term psychotropic drug treatment were consecutively enrolled. At day 14, OGT resulted in better efficacy than ASS in mouth dryness score (mean difference, 1.2 +/- 0.4; P = 0.006), speech difficulties (mean difference, 1.2 +/- 0.4; P = 0.005), taste (mean difference, 1.1 +/- 0.4; P = 0.02), and overall mouth condition (mean difference, 1.4 +/- 0.9; P = 0.005). Taste of OGT was better than that of ASS (mean difference, 1.4 +/- 0.6; P = 0.04), as was OGT acceptability (mean difference, 1.4 +/- 0.9; P = 0.005).
Oxygenated glycerol triester lubricant oral spray was superior to a commercially available ASS in improving xerostomia and overall condition of the oral tissue.
口干症是一种口腔干燥的主观感觉，常作为精神药物的不良效应出现。
在一项为期2周的开放标签、随机、平行组研究中，将一种新型含氧甘油三酯（OGT）口腔喷雾剂（每日最多4次，每次1或2喷）治疗口干症的临床疗效和可接受性与一种市售人工唾液替代品（ASS [Saliveze]）进行比较。口干症的临床评估包括通过10厘米长的视觉模拟量表评估口腔干燥程度，由牙科保健员通过4分有序量表对口腔组织状况进行客观盲法评估，以及通过对问卷的二分法回答进行基于患者主观的口干症状评估。[第14天 - 基线]基于患者的口干评分是主要终点。
连续纳入74例接受长期精神药物治疗的患者（41名女性和33名男性，44±15岁）。在第14天，OGT在口干评分（平均差异，1.2±0.4；P = 0.006）、言语困难（平均差异，1.2±0.4；P = 0.005）、味觉（平均差异，1.1±0.4；P = 0.02）和口腔总体状况（平均差异，1.4±0.9；P = 0.005）方面的疗效优于ASS。OGT的味道优于ASS（平均差异，1.4±0.6；P = 0.04），OGT的可接受性也优于ASS（平均差异，1.4±0.9；P = 0.005）。
含氧甘油三酯润滑剂口腔喷雾剂在改善口干症和口腔组织总体状况方面优于市售的ASS。
