METHODS: A randomized, single-blind clinical trial was carried out involving 89 patients divided into the following groups: group 1 (laser, The Helbo® Theralite Laser 3D Pocket Probe + clonazepam) (n = 20), group 2 (sham laser placebo) (n = 19), group 3 (laser) (n = 21) and group 4 (clonazepam) (n = 18). Symptom intensity was scored based on a visual analogue scale (VAS). Sialometry was performed before and after treatment, and the Xerostomia Inventory, Oral Health Impact Profile-14 (OHIP-14) and Mini-Nutritional Assessment (MNA) questionnaires were administered. The following markers were measured in saliva samples: interleukins (IL2, IL4, IL5, IL6, IL7, IL8, IL1β, IL10, IL12, IL13, IL17, IL21 and IL23), proteins (MIP-3α, MIP-1α and MIP-1β), GM-CSF, interferon gamma (IFNγ), interferon-inducible T-cell alpha chemoattractant (ITAC), fractalkine and tumor necrosis factor α (TNFα).
RESULTS: A significant decrease in the VAS scores was observed after treatment in group 1 (laser + clonazepam) (p = 0.029) and group 3 (laser) (p = 0.005). In turn, group 3 (laser) showed a decrease in the salivary concentration of fractalkine (p = 0.025); interleukins IL12 (p = 0.048), IL17 (p = 0.020), IL21 (p = 0.008), IL7 (p = 0.001) and IL8 (p = 0.007); proteins MIP1α (p = 0.048) and MIP1β (p = 0.047); and TNFα (p = 0.047) versus baseline. Following treatment, group 1 (laser + clonazepam) showed significant differences in IL21 (p = 0.045) and IL7 (p = 0.009) versus baseline, while group 4 (clonazepam) showed significant differences in IL13 (p = 0.036), IL2 (p = 0.020) and IL4 (p = 0.001). No significant differences were recorded in group 2 (sham laser placebo).
CONCLUSIONS: The low-level diode laser is a good treatment option in BMS, resulting in a decrease in patient symptoms and in salivary biomarkers. However, standardization of the intervention protocols and laser intensity parameters is needed in order to draw more firm conclusions.
方法:随机,进行了单盲临床试验,涉及89例患者,分为以下组:第1组(激光,Helbo®Theralite激光3D袖珍探头+氯硝西泮(n=20),第2组(假激光安慰剂)(n=19),第3组(激光)(n=21)和第4组(氯硝西泮)(n=18)。根据视觉模拟量表(VAS)对症状强度进行评分。在治疗前和治疗后进行唾液酸测定,和口干症清单,进行了口腔健康影响概况-14(OHIP-14)和迷你营养评估(MNA)问卷。在唾液样品中测量了以下标记:白介素(IL2,IL4,IL5,IL6,IL7,IL8,IL1β,IL10、IL12、IL13、IL17、IL21和IL23),蛋白质(MIP-3α,MIP-1α和MIP-1β),GM-CSF,干扰素γ(IFNγ),干扰素诱导的T细胞α化学引诱物(ITAC),Fractalkine和肿瘤坏死因子α(TNFα)。
结果:治疗后,第1组(激光氯硝西泮)(p=0.029)和第3组(激光)(p=0.005)的VAS评分显着降低。反过来,第3组(激光)显示fractalkine的唾液浓度降低(p=0.025);白细胞介素IL12(p=0.048),IL17(p=0.020),IL21(p=0.008),与基线相比,IL7(p=0.001)和IL8(p=0.007);蛋白质MIP1α(p=0.048)和MIP1β(p=0.047);和TNFα(p=0.047)。治疗后,第1组(激光+氯硝西泮)与基线相比,IL21(p=0.045)和IL7(p=0.009)有显著差异,而第4组(氯硝西泮)在IL13中显示出显着差异(p=0.036),IL2(p=0.020)和IL4(p=0.001)。在第2组(假激光安慰剂)中没有记录到显著差异。
结论:低能级二极管激光是BMS的良好治疗选择,导致患者症状和唾液生物标志物的减少。然而,需要对干预协议和激光强度参数进行标准化,以得出更可靠的结论。