一种基于糖聚合物的漱口水对口腔黏膜溃疡性和糜烂性病变相关疼痛的疗效：一项自身对照的初步研究。

Efficacy of a glycopolymer-based oral rinse upon pain associated with ulcerative and erosive lesions of the oral mucosa: A within-subject pilot study.

作者信息

Epstein Joel B, Villines Dana C, Baker Shenda

机构信息

Cedars-Sinai Health System, Los Angeles, CA, USA.

Advocate Health Care, Department of Research, Chicago, IL, USA.

出版信息

Oral Surg Oral Med Oral Pathol Oral Radiol. 2018 Sep;126(3):240-245. doi: 10.1016/j.oooo.2018.05.009. Epub 2018 May 29.

DOI:10.1016/j.oooo.2018.05.009

PMID:29935927

Abstract

OBJECTIVES

The purpose of this pilot study was to assess the magnitude of effect for a new topical rinse that may impact oral soreness and function in ulcerative oral mucosal lesions.

STUDY DESIGN

Twenty-five consecutive patients with ulcerative/erosion lesion and moderate pain visual analogue pain score (≥4) rated their mouth and throat soreness and oral symptoms at baseline and at 24, 48, and 72 hours after open-label use of a chitosan-based, nonanesthetic oral rinse (Synvaza) at least twice a day. No changes in prior therapy, including analgesics, were allowed during the trial.

RESULTS

All measures of oral soreness decreased in severity from baseline to 72 hours, and overall oral soreness decreased by 28% (P < .01). Oral soreness associated with talking decreased by 67% (P < .01), drinking by 62% (P < .01), swallowing by 56% (P = .04), sleeping by 51% (P = .02) and eating by 50% (P < .01). The product was rated favorably for texture, flavor, soothing relief, mouth feel, and burning/stinging with use.

CONCLUSIONS

Oral rinsing with the study product reduced mucosal pain without anesthetic effect and improved oral function.

摘要

目的

本初步研究的目的是评估一种新型局部含漱液对溃疡性口腔黏膜病变的口腔疼痛和功能的影响程度。

研究设计

25例连续性溃疡性/糜烂性病变且视觉模拟疼痛评分中度疼痛（≥4）的患者，在开放标签使用一种基于壳聚糖的非麻醉性口腔含漱液（Synvaza），每天至少两次，在基线以及用药后24、48和72小时对其口腔和咽喉疼痛以及口腔症状进行评分。试验期间不允许改变包括镇痛药在内的先前治疗方案。

结果

从基线到72小时，所有口腔疼痛指标的严重程度均降低，总体口腔疼痛降低了28%（P <.01）。与说话相关的口腔疼痛降低了67%（P <.01），与饮水相关的降低了6²%（P <.01），与吞咽相关的降低了56%（P =.04），与睡眠相关的降低了51%（P =.02），与进食相关的降低了50%（P <.01）。该产品在质地、味道、舒缓效果、口感以及使用时的灼烧/刺痛感方面得到了好评。