Efficacy and Safety of an Intraoral Electrostimulation Device for Xerostomia Relief A Multicenter, Randomized Trial

被引：55

作者：

Strietzel, Frank P. ^{[23
]}

Lafaurie, Gloria I. ^{[22
]}

Bautista Mendoza, Gloria R. ^{[22
]}

Alajbeg, Ivan ^{[21
]}

Pejda, Slavica ^{[21
]}

Vuletic, Lea ^{[21
]}

Mantilla, Ruben ^{[20
]}

Falcao, Denise P. ^{[19
]}

Leal, Soraya C. ^{[19
]}

Barreto Bezerra, Ana C. ^{[19
]}

Tran, Simon D. ^{[18
]}

Menard, Henri A. ^{[17
,18
]}

Kimoto, Suguru ^{[16
]}

Pan, Shaoxia ^{[14
,15
]}

Martin-Granizo, Rafael A. ^{[13
]}

Maniegas Lozano, M. Lourdes ^{[13
]}

Zunt, Susan L. ^{[12
]}

Krushinski, Cheryl A. ^{[12
]}

Melilli, Dario ^{[11
]}

Campisi, Giuseppina ^{[11
]}

Paderni, Carlo ^{[11
]}

Dolce, Sonia ^{[11
]}

Yepes, Juan F. ^{[10
]}

Lindh, Liselott ^{[9
]}

Koray, Meltem ^{[8
]}

Mumcu, Gonca ^{[7
]}

Elad, Sharon ^{[6
]}

Zeevi, Itai ^{[6
]}

Aldape Barrios, Beatriz C. ^{[5
]}

Lopez Sanchez, Rodrigo M. ^{[5
]}

Beiski, Ben Z. ^{[1
]}

Wolff, Andy ^{[1
]}

Konttinen, Yrjo T. ^{[2
,3
,4
]}

机构：

[1] Saliwell Ltd, IL-60917 Harutzim, Israel

[2] ORTON Orthopaed Hosp, Helsinki, Finland

[3] Univ Helsinki, Helsinki Univ Cent Hosp, Helsinki, Finland

[4] COXA Hosp Joint Replacement, Tampere, Finland

[5] Univ Nacl Autonoma Mexico, Mexico City 04510, DF, Mexico

[6] Hebrew Univ Jerusalem, Hadassah Sch Dent Med, Jerusalem, Israel

[7] Univ Marmara, Istanbul, Turkey

[8] Istanbul Univ, Istanbul, Turkey

[9] Malmo Univ, Malmo, Sweden

[10] Univ Kentucky, Lexington, KY 40506 USA

[11] Univ Palermo, Palermo, Italy

[12] Indiana Univ, Indianapolis, IN 46204 USA

[13] Hosp Clin San Carlos, Madrid, Spain

[14] Peking Univ, Beijing 100871, Peoples R China

[15] Hosp Stomatol, Beijing, Peoples R China

[16] Nihon Univ Sch Dent, Mastudo, Japan

[17] McGill Univ Hlth Ctr, Montreal, PQ, Canada

[18] McGill Univ, Montreal, PQ, Canada

[19] Univ Brasilia, Brasilia, DF, Brazil

[20] Clin Artritis & Rehabil, Bogota, Colombia

[21] Univ Zagreb, Zagreb 41000, Croatia

[22] Univ El Bosque, Bogota, Colombia

[23] Charite, D-13353 Berlin, Germany

来源：

ARTHRITIS AND RHEUMATISM | 2011年 / 63卷 / 01期

基金：

芬兰科学院; 加拿大健康研究院;

关键词：

SALIVARY-GLAND HYPOFUNCTION; SJOGRENS-SYNDROME PATIENTS; DRY MOUTH; LINGUAL NERVE; STIMULATION; FLOW; MASTICATION; MECHANISMS;

D O I：

10.1002/art.27766

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Objective. To evaluate the efficacy and safety of an intraoral electrostimulation device, consisting of stimulating electrodes, an electronic circuit, and a power source, in treating xerostomia. The device delivers electrostimulation through the oral mucosa to the lingual nerve in order to enhance the salivary reflex. Methods. The device was tested on a sample of patients with xerostomia due to Sjogren's syndrome and other sicca conditions in a 2-stage prospective, randomized, multicenter trial. Stage I was a double-blind, crossover stage designed to compare the effects of the electrically active device with the sham device, each used for 1 month, and stage II was a 3-month open-label stage designed to assess the long-term effects of the active device. Improvement in xerostomia severity from baseline was the primary outcome measure. Results. A total of 114 patients were randomized. In stage I, the active device performed better than the sham device for patient-reported xerostomia severity (P < 0.002), xerostomia frequency (P < 0.05), quality of life impairment (P < 0.01), and swallowing difficulty (P < 0.02). At the end of stage II, statistically significant improvements were verified for patient-reported xerostomia severity (P < 0.0001), xerostomia frequency (P < 0.0001), oral discomfort (P < 0.001), speech difficulty (P < 0.02), sleeping difficulty (P < 0.001), and resting salivary flow rate (P < 0.01). Conclusion. Our findings indicate that daily use of the device alleviated oral dryness, discomfort, and some complications of xerostomia, such as speech and sleeping difficulties, and increased salivary output. The results show a cumulative positive effect of the device over the period of the study, from baseline to the end of the trial.

引用

页码：180 / 190

页数：11

共 43 条

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