摘要:為評估低強度激光治療(LLLT)原發性幹燥綜合征患者口幹的療效,進行一項隨機臨床研究。該研究納入66名某大學醫院診斷原發性幹燥綜合征合並口幹症狀的患者,隨機分為兩組,一組接受LLLT(激光組,n=33),另一組接受安慰劑治療(安慰劑組,n=33)。激光組接受LLLT一周兩次共6周,共12次治療。用鋁镓砷化物激光二極管進行激光照射,波長為808納米,輸出功率為100毫瓦,每次照射點的能量密度為4焦耳/厘米。安慰劑治療采用與放療病人相同的方案,使用相同的激光裝置模擬真實輻射,但沒有主動激光發射,激光探針覆蓋鋁箔。評估口幹症量表評分、唾液流率、唾液β2-微球蛋白水平、唾液鈉和氯的濃度。結果顯示,口幹症狀在兩組均無改善。同樣,口幹症量表評分(p=0.301)、唾液流率(p=0.643)在兩組均無改善。唾液β2-微球蛋白、鈉濃度、氯濃度在治療前後及兩組之間均無顯著差異。LLLT治療不能改善原發性幹燥綜合征患者口幹或唾液流率。
附原文:Abstract To evaluate the effectiveness of low-level laser therapy (LLLT) in the treatment of xerostomia in primary Sjögren's syndrome (SS), a randomized clinical trial of patients with dry mouth symptoms associated with primary SS receiving care at a university hospital was conducted. Sixty-six patients were randomly assigned with a 1:1 allocation ratio to receive LLLT (laser group, n = 33) or placebo treatment (placebo group, n = 33). Patients in the laser group received LLLT twice a week for 6 weeks, for a total of 12 treatment sessions. Laser irradiation was performed with an aluminum-gallium-arsenide laser diode at a wavelength of 808 nm, 100-mW output power, and energy density of 4.0 J/cm2 per irradiation point per session. Placebo treatment was performed following the same protocol used for irradiated patients and using the same laser device to mimic a real irradiation, but with no active laser emission and the tip of the laser probe covered with aluminum foil. The outcomes of interest were xerostomia inventory scores, salivary flow rate, salivary beta-2 microglobulin levels, and salivary sodium and chlorine concentrations. Patients in both groups showed no improvement in xerostomia. Likewise, there was no significant improvement in xerostomia inventory scores (p = 0.301) or salivary flow rate (p = 0.643) in either group. There was no difference in salivary beta-2 microglobulin levels, sodium concentration, and chlorine concentration before and after intervention or between the two groups. The LLLT protocol used in this study effected no improvement in xerostomia or salivary flow rate in patients with primary SS. ClinicalTrials.gov Identifier: NCT02066896.
引自:Fidelix T, Czapkowski A, Azjen S, et al. Low-level laser therapy for xerostomia in primary Sjögren's syndrome: a randomized trial. Clin Rheumatol. 2018 Mar;37(3):729-736. doi: 10.1007/s10067-017-3898-9. Epub 2017 Nov 9.