用于口干缓解的口腔内电刺激器：一项长期、多中心、开放性、非对照、临床研究。
Intraoral electrostimulator for xerostomia relief: a long-term, multicenter, open-label, uncontrolled, clinical trial.
机构信息
Department of Oral Medicine, School of Dental Medicine, University of Zagreb, Zagreb, Croatia.
出版信息
Oral Surg Oral Med Oral Pathol Oral Radiol. 2012 Jun;113(6):773-81. doi: 10.1016/j.oooo.2012.01.012.
OBJECTIVE
A previous sham-controlled multinational study demonstrated the short-term efficacy and safety for xerostomia treatment of an intraoral device that delivers electrostimulation to the lingual nerve. The objective of this study was to test the hypothesis that those beneficial effects would be sustained over an 11-month period.
STUDY DESIGN
The device was tested on a mixed sample of 94 patients with xerostomia in an open-label, uncontrolled, prospective multicenter trial. Statutory outcome assessments were done at 5th, 8th, and 11th months and analyzed by multiple comparisons.
RESULTS
Improvements achieved at month 5 from baseline were sustained throughout the follow-up period for the primary outcome, xerostomia severity, and the secondary outcomes resting whole salivary flow rate, xerostomia frequency, oral discomfort, and difficulties in speech, swallowing, and sleeping. No significant side effects were detected.
CONCLUSIONS
The beneficial effects of a removable intraoral electrostimulating device were sustained for an 11-month period.
目的
先前的一项假手术对照多中心研究证明，一种向舌神经传递电刺激的口腔内装置治疗口干症具有短期疗效和安全性。本研究旨在验证以下假设，即这些有益效果将持续 11 个月。
研究设计
该装置在一项开放标签、非对照、前瞻性多中心试验中对 94 名口干症患者进行了测试。在第 5、8 和 11 个月进行法定结果评估，并通过多重比较进行分析。
结果
从基线到第 5 个月，主要结局——口干严重程度，以及次要结局——静止全唾液流率、口干频率、口腔不适以及言语、吞咽和睡眠困难，都得到了持续改善。未发现明显的副作用。
结论
可摘入口内电刺激装置的有益效果持续了 11 个月。
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