Center of Innovation, Technology and Education (CITE) at São José dos Campos Technology Park, São Paulo, Brazil.
Institute of Biomedical Engineering, Anhembi Morumbi University, Laureate International Universities, São José dos Campos, Brazil.
Front Endocrinol (Lausanne). 2020 Apr 30;11:239. doi: 10.3389/fendo.2020.00239. eCollection 2020.
The purpose of this investigational study was to assess the effects of melatonin replacement therapy on cardiac autonomic modulation in pinealectomized patients. This was an open-label, single-arm, single-center, proof-of-concept study consisting of a screening period, a 3-month treatment period with melatonin (3 mg/day), and a 6-month washout period. The cardiac autonomic function was determined through heart rate variability (HRV) measures during polysomnography. Pinealectomized patients ( = 5) with confirmed absence of melatonin were included in this study. Melatonin treatment increased vagal-dominated HRV indices including root mean square of the successive R-R interval differences (RMSSD) (39.7 ms, 95% CI 2.0-77.4, = 0.04), percentage of successive R-R intervals that differ by more than 50 ms (pNN50) (17.1%, 95% CI 9.1-25.1, = 0.003), absolute power of the high-frequency band (HF power) (1,390 ms, 95% CI 511.9-2,267, = 0.01), and sympathetic HRV indices like standard deviation of normal R-R wave interval (SDNN) (57.6 ms, 95% CI 15.2-100.0, = 0.02), and absolute power of the low-frequency band (LF power) (4,592 ms, 95% CI 895.6-8,288, = 0.03). These HRV indices returned to pretreatment values when melatonin treatment was discontinued. The HRV entropy-based regularity parameters were not altered in this study, suggesting that there were no significant alterations of the REM-NREM ratios between the time stages of the study. These data show that 3 months of melatonin treatment may induce an improvement in cardiac autonomic modulation in melatonin-non-proficient patients. NCT03885258.
这项研究的目的是评估褪黑素替代疗法对松果体切除患者心脏自主神经调节的影响。这是一项开放标签、单臂、单中心的概念验证研究，包括筛查期、3 个月的褪黑素治疗期（每天 3 毫克）和 6 个月的洗脱期。通过多导睡眠图中的心率变异性（HRV）测量来确定心脏自主神经功能。本研究纳入了已确认缺乏褪黑素的 5 名松果体切除患者。褪黑素治疗增加了迷走神经主导的 HRV 指数，包括均方根差值（RMSSD）（39.7 毫秒，95%置信区间 2.0-77.4， = 0.04）、连续 R-R 间隔差异超过 50 毫秒的百分比（pNN50）（17.1%，95%置信区间 9.1-25.1， = 0.003）、高频带绝对功率（HF 功率）（1390 毫秒，95%置信区间 511.9-2267， = 0.01），以及交感神经 HRV 指数，如正常 R-R 波间隔标准差（SDNN）（57.6 毫秒，95%置信区间 15.2-100.0， = 0.02）和低频带绝对功率（LF 功率）（4592 毫秒，95%置信区间 895.6-8288， = 0.03）。当褪黑素治疗停止时，这些 HRV 指数恢复到治疗前的值。本研究中，基于 HRV 熵的规则性参数没有改变，这表明研究各个时间阶段之间 REM-NREM 比值没有明显变化。这些数据表明，3 个月的褪黑素治疗可能会改善褪黑素不敏感患者的心脏自主神经调节。NCT03885258。
