电刺激装置可缓解干燥综合症的口干
发表者：付 坤
日期：2015-03-08
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摘要：目的：评价由刺激电极、电子电路和电源组成的口内电刺激装置治疗口干的疗效和安全性。该设备发射电刺激，通过口腔黏膜到舌神经，以增强唾液腺反射。
方法：采用前瞻性、随机、多中心临床研究，测试该装置对干燥综合症和其他干燥症导致口干患者的疗效及安全性。研究分两阶段进行，第一阶段为双盲交叉研究，比较电刺激装置或假装置治疗1个月的疗效；第二阶段为3个月的开放研究，旨在评估电刺激装置的长期疗效。主要观察指标为与基线相比的口干严重程度改善情况。
结果：114名患者随机分组。在第一阶段，用刺激装置患者的口干症严重程度（P <0.002）、口干频率（P <0.05）、生活质量降低（P <0.01）和吞咽困难（P <0.02）的改善明显优于对照组。第二阶段结束时，患者口干症的严重程度（P <0.0001）、口干频率（P <0.0001）、口腔不适（P <0.001）、说话困难（P <0.02）、睡眠困难（P <0.001）和静息唾液流率均有显著改善。
结论：该研究结果表明，日常使用该装置能缓解口腔干燥症状及口干引起的其他并发症如语言和睡眠困难，并增加唾液流率。该装置从开始到试验结束的疗效为累加作用。
附原文：Abstract 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 Sjögren'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.
引自：Frank P. Strietzel1, Gloria I. Lafaurie2, Gloria R. Bautista Mendoza2, et al. Efficacy and safety of an intraoral electrostimulation device for xerostomia relief: A multicenter, randomized trial. Arthritis Rheum, 2011,63(1):180-190 （注：干燥综合症病人或亲属可加QQ群交流，群号： 118194945 ，本网站站长私人微信号： ssgzz88 ）
方法：采用前瞻性、随机、多中心临床研究，测试该装置对干燥综合症和其他干燥症导致口干患者的疗效及安全性。研究分两阶段进行，第一阶段为双盲交叉研究，比较电刺激装置或假装置治疗1个月的疗效；第二阶段为3个月的开放研究，旨在评估电刺激装置的长期疗效。主要观察指标为与基线相比的口干严重程度改善情况。
结果：114名患者随机分组。在第一阶段，用刺激装置患者的口干症严重程度（P <0.002）、口干频率（P <0.05）、生活质量降低（P <0.01）和吞咽困难（P <0.02）的改善明显优于对照组。第二阶段结束时，患者口干症的严重程度（P <0.0001）、口干频率（P <0.0001）、口腔不适（P <0.001）、说话困难（P <0.02）、睡眠困难（P <0.001）和静息唾液流率均有显著改善。
结论：该研究结果表明，日常使用该装置能缓解口腔干燥症状及口干引起的其他并发症如语言和睡眠困难，并增加唾液流率。该装置从开始到试验结束的疗效为累加作用。
附原文：Abstract 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 Sjögren'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.
引自：Frank P. Strietzel1, Gloria I. Lafaurie2, Gloria R. Bautista Mendoza2, et al. Efficacy and safety of an intraoral electrostimulation device for xerostomia relief: A multicenter, randomized trial. Arthritis Rheum, 2011,63(1):180-190 （注：干燥综合症病人或亲属可加QQ群交流，群号： 118194945 ，本网站站长私人微信号： ssgzz88 ）