Salom Michel, Hachulla Eric, Bertolus Chloé, Deschaumes Christophe, Simoneau Guy, Mouly Stéphane
Hôpital Privé Léopold Bellan, Magnaville, France.
Department of Internal Medicine, hôpital Claude Huriez, University Nord-de-France, Lille, France.
Oral Surg Oral Med Oral Pathol Oral Radiol. 2015 Mar;119(3):301-9. doi: 10.1016/j.oooo.2014.12.005. Epub 2014 Dec 12.
The clinical efficacy, safety, and acceptability of a new oral saliva equivalent (Novasial) administered four times daily in the treatment of xerostomia in various medical conditions was compared with that of oxygenated glycerol triester oral spray (Aequasyal) and a moisturizing spray (Biotene) in a 2-week, multicenter, randomized, crossover study. Assessment included patient-based evaluation of mouth dryness score (primary endpoint) with a visual analog scale (VAS), blinded assessment of the oral tissue condition by a four-point ordinal scale, and patient-based assessment of tolerability and acceptability.
At day 14, Novasial decreased oral mouth dryness by 19.5%, (12.5 ± 22.6 mm, P < .0001 versus baseline), versus 10% (6.6 ± 17.9 mm with Aequasyal, P < .0001 versus Baseline; and P < .0156 versus Novasial) and 13% (8.6 ± 18.9 mm) with Biotene (P < .0001 versus baseline). The 50% decrease in the primary endpoint was not achieved, and the overall efficacy of Novasial and Aequasyal were similar with respect to xerostomia. Novasial was preferred to Aequasyal and Biotene in alleviating taste alteration and chewing difficulty. Treatment compliance was higher with Novasial (P = .0014 versus Aequasyal). The treatments improved the oral condition with equal efficacy and were safe and well tolerated (VAS 72-77 mm).
Novasial was a safe, well-tolerated, and acceptable treatment in patients with xerostomia induced by various treatments or pathologic conditions.
在一项为期2周的多中心随机交叉研究中，将一种每日服用4次的新型口服唾液替代品（Novasial）用于治疗多种医疗状况下的口干症的临床疗效、安全性及可接受性，与含氧甘油三酯口腔喷雾剂（Aequasyal）和保湿喷雾剂（Biotene）进行比较。评估包括基于患者的视觉模拟量表（VAS）对口腔干燥评分（主要终点）的评估、通过四点有序量表对口腔组织状况进行的盲法评估，以及基于患者的耐受性和可接受性评估。
在第14天，Novasial使口腔干燥程度降低了19.5%（12.5±22.6mm，与基线相比P<.0001），而Aequasyal降低了10%（6.6±17.9mm，与基线相比P<.0001；与Novasial相比P<.0156），Biotene降低了13%（8.6±18.9mm，与基线相比P<.0001）。主要终点降低50%的目标未达成，Novasial和Aequasyal在口干症方面的总体疗效相似。在缓解味觉改变和咀嚼困难方面，Novasial比Aequasyal和Biotene更受青睐。Novasial的治疗依从性更高（与Aequasyal相比P=.0014）。这些治疗在改善口腔状况方面疗效相当，且安全、耐受性良好（VAS为72 - 77mm）。
Novasial对于由各种治疗或病理状况引起的口干症患者而言，是一种安全、耐受性良好且可接受的治疗方法。
