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一种含有 1%苹果酸的局部唾液分泌促进剂喷雾在抗抑郁药引起的口干患者中的疗效:一项双盲、随机临床试验。

The efficacy of a topical sialogogue spray containing 1% malic acid in patients with antidepressant-induced dry mouth: a double-blind, randomized clinical trial.

机构信息

Department of Pharmacological Research in Dentistry, Faculty of Dentistry, University of Granada, Granada, Spain.

出版信息

Depress Anxiety. 2013 Feb;30(2):137-42. doi: 10.1002/da.22017. Epub 2012 Nov 1.

Abstract

BACKGROUND

One of the most important antidepressants side effects is dry mouth. The aim of this study was to evaluate the clinical efficacy of a topical sialogogue spray containing 1% malic acid on patients affected by dry mouth caused by antidepressants drug.

MATERIALS AND METHODS

This research took the form of a double-blind, randomized clinical trial at Faculty of Dentistry of University of Granada (Spain). Seventy participants with antidepressant-induced dry mouth were divided into two groups: for the first "intervention group" (35 subjects) a topical sialogogue spray (1% malic acid) was applied, while for the second "control group" (35 subjects), a placebo spray was applied; for both groups, the sprays were applied on demand during 2 weeks. The dry mouth questionnaire (DMQ) was used to evaluate dry mouth symptoms before and after product/placebo application. Unstimulated and stimulated salivary flows rates, before and after application, were measured.

RESULTS

Dry mouth symptoms improved after 1% malic acid topical spray application (p < .05). After 2 weeks of 1% malic acid application, unstimulated and stimulated salivary flows rates increased significantly (p < .05).

CONCLUSIONS

A sialogogue spray containing 1% malic acid improved dry mouth feeling of the patients suffering antidepressant-induced dry mouth and increased unstimulated and stimulated salivary flows rates.

摘要

背景

抗抑郁药最主要的副作用之一是口干。本研究旨在评估含有 1%苹果酸的局部唾液刺激剂喷雾对因抗抑郁药引起的口干的患者的临床疗效。

材料和方法

这是一项在西班牙格拉纳达大学牙科学院进行的双盲、随机临床试验。70 名因抗抑郁药引起口干的参与者被分为两组:第一组“干预组”(35 名患者)使用局部唾液刺激剂喷雾(1%苹果酸),第二组“对照组”(35 名患者)使用安慰剂喷雾;两组均按需在 2 周内使用喷雾。使用口干问卷(DMQ)在使用产品/安慰剂前后评估口干症状。在使用前后测量未刺激和刺激的唾液流速。

结果

使用 1%苹果酸局部喷雾后,口干症状得到改善(p<0.05)。使用 1%苹果酸 2 周后,未刺激和刺激的唾液流速显著增加(p<0.05)。

结论

含有 1%苹果酸的唾液刺激剂喷雾改善了因抗抑郁药引起口干的患者的口干感觉,并增加了未刺激和刺激的唾液流速。

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