Reported Side Effects, Weight and Blood Pressure, After Repeated Sessions of Transcranial Photobiomodulation
Reported Side Effects, Weight and Blood Pressure, After Repeated Sessions of Transcranial Photobiomodulation
复制标题
DOI：
10.1089/photob.2019.4678
复制
发表时间：
2019-10-01
影响因子：
1.8
通讯作者：
Iosifescu, Dan V.
中科院分区：
文献类型：
--
作者：
Cassano, Paolo;Caldieraro, Marco Antonio;Iosifescu, Dan V.
背景：经颅光生物调节（t-PBM）包括将近红外光（NIR）输送到头皮，直接到达大脑皮层区域。近红外t-PBM最近成为抑郁症的潜在治疗方法，尽管反复治疗的安全性尚未得到充分探讨。目的：本研究评估了在使用发光二极管源的重复NIR t-PBM期间的副作用发生率，包括体重和血压变化。方法：我们对t-PBM治疗重度抑郁症的双盲临床试验进行了二次分析。18名患者接受NIR t-PBM治疗（n=9）或假治疗（n=9），每周两次，持续8周。使用治疗紧急效应特异性查询系统评估来评估副作用。在14个个体中(n(NIR)=6 vs n(sham)=8)，在基线和终点记录体重和全身血压。结果：与假手术组相比，NIR t-PBM组出现了更多的副作用，但仅观察到统计学意义的趋势(chi (2)=3.60；df = 1;p = 0.058)。被参与者描述为“严重”的副作用发生率在治疗组之间很低且相似(chi (2)=0.4；df = 1;P =0.53)，无严重不良事件发生。大多数副作用在研究期间消除，治疗中断是不需要的。各组间体重和收缩压的变化既不显著也不接近显著。在NIR t-PBM组，舒张压升高，达到统计学意义，但无临床意义（5.677.26 vs -6.13 +/- 6.88; z=-2.40, p=0.016）。结论：这项小样本的探索性研究表明，重复的NIR t-PBM治疗可能与治疗后出现的副作用有关。重复t-PBM的全身代谢和血流动力学表现为良性。为了更准确地确定NIR t-PBM的副作用和安全性，未来的研究需要更大的样本和更长的随访时间。
Background: Transcranial photobiomodulation (t-PBM) consists in the delivery of near-infrared light (NIR) to the scalp, directed to cortical areas of the brain. NIR t-PBM recently emerged as a potential therapy for depression, although safety of repeated treatments has not been adequately explored. Objective: This study assessed incidence of side effects, including weight and blood pressure changes, during repeated sessions of NIR t-PBM using a light-emitting diode source. Methods: We performed a secondary analysis of a double-blind clinical trial on t-PBM for major depressive disorder. Eighteen individuals received NIR t-PBM (n=9) or sham (n=9) twice weekly for 8 weeks. Side effects were assessed using the Systematic Assessment for Treatment-Emergent Effects-Specific Inquiry. In 14 individuals (n(NIR)=6 vs. n(sham)=8), body weight and systemic blood pressure were recorded at baseline and end-point. Results: More subjects in the NIR t-PBM group experienced side effects compared to sham, but only a trend for statistical significance was observed (chi (2)=3.60; df=1; p=0.058). The rate of side effects described by participants as "severe" in intensity was low and similar between the treatment groups (chi (2)=0.4; df=1; p=0.53), with no serious adverse events. Most side effects resolved during the study and treatment interruption were not required. Changes in weight and systolic blood pressure across groups were neither significant nor approached significance. In the NIR t-PBM group, diastolic blood pressure increased and reached statistical-however not clinical-significance (5.677.26 vs. -6.13 +/- 6.88; z=-2.40, p=0.016). Conclusions: This small-sample, exploratory study indicates repeated sessions of NIR t-PBM might be associated with treatment-emergent side effects. The systemic metabolic and hemodynamic profile of repeated t-PBM appeared benign. Future studies with larger samples and longer follow-up are needed to more accurately determine the side-effect profile and safety of NIR t-PBM.