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一种新型口干缓解口腔凝胶的疗效——一项随机双盲试验。

Efficacy of a newly developed mouth gel for xerostomia relief-A randomized double-blind trial.

机构信息

Centre of Dental Medicine, Department of Operative Dentistry and Periodontology, University of Cologne, Köln, Germany.

Faculty of Medicine, Institute of Medical Statistics and Computational Biology, University Hospital Cologne, University of Cologne, Köln, Germany.

出版信息

Oral Dis. 2019 Sep;25(6):1519-1529. doi: 10.1111/odi.13105. Epub 2019 May 3.

DOI:10.1111/odi.13105
PMID:30972871
Abstract

OBJECTIVES

To determine the efficacy of a new symptom-relieving mouth gel vs. a widely used control gel on xerostomic burden.

MATERIALS AND METHODS

This randomized, double-blind, crossover trial investigated the efficacy of the test gel (Dr. Wolff Gel) vs. control (Biotene) in participants with xerostomia (n = 32; mean age 60 years). Oral examinations were taken at baseline, and xerostomic visual analogue scales (xVAS), after-use questionnaires and willingness to pay were investigated before and after use.

RESULTS

Neither gel reduced xerostomic burden (xVAS) after 7-day application. There was some preference for the test gel regarding taste and healthy gum feeling. After 1-time application, there were differences favouring the test gel for symptom-relieving effects between test gel and water (p < 0.001), mucosal adhesion (p < 0.001) and taste persistence (p < 0.001). Overall symptomatic relief with the test gel lasted around 2 hr.

CONCLUSIONS

No mouth gel alleviated the overall xerostomic burden. Nevertheless, the test gel led to short-term perceived symptomatic relief and improved patient-centred outcomes as taste and perceived gum health. The gel will probably mainly be effective at moments that patients mostly suffer from xerostomia. Selection of a product will be based on perceived subjective differences and their value in the context of the overall xerostomic burden.

摘要

目的

比较一种新型缓解症状口腔凝胶与一种广泛使用的对照凝胶在治疗口干症方面的疗效。

材料和方法

本随机、双盲、交叉试验研究了试验凝胶(Dr. Wolff Gel)与对照凝胶(Biotene)在口干症患者(n=32;平均年龄 60 岁)中的疗效。在基线和使用前后进行口腔检查,并进行口干视觉模拟量表(xVAS)、使用后问卷调查和支付意愿调查。

结果

两种凝胶在 7 天应用后均未减轻口干症负担(xVAS)。试验凝胶在口感和健康牙龈感觉方面有一些偏好。单次应用后,试验凝胶在缓解症状方面的效果优于试验凝胶和水之间的差异(p<0.001)、黏膜黏附(p<0.001)和味觉持久度(p<0.001)。试验凝胶的整体症状缓解持续时间约为 2 小时。

结论

没有口腔凝胶能减轻整体口干症负担。然而,试验凝胶在短时间内可缓解口干症状,并改善以味觉和牙龈健康感知为中心的患者结局。该凝胶可能主要在患者最易出现口干症的时刻有效。产品的选择将基于感知的主观差异及其在整体口干症负担背景下的价值。

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