Monti J M, Debellis J, Alterwain P, Pellejero T, Monti D
Int J Clin Pharmacol Res. 1987;7(2):105-10.
The effects of delta sleep-inducing peptide (DSIP), on the sleep cycle of insomniac patients were assessed by means of polysomnographic recordings. DSIP in a dose of 25 nmol/kg or a placebo was administered i.v. during four nights using a double-blind crossover design. The number of nocturnal awakenings, non-rapid-eye-movement (NREM) sleep latency, total waking time and waking time after sleep onset were decreased under DSIP treatment, but no significant differences were found in comparison to baseline or to double-blind placebo nights. Total sleep time and NREM sleep time were increased by the peptide. Their increase was related to increases in stage 2, while stage 1, slow wave sleep (stages 3 and 4) and rapid-eye-movement sleep were not modified. For NREM sleep time and stage 2 sleep differences between DSIP and a placebo were significant, but the same differences existed already for the baseline values. It can be concluded that sleep improvement under DSIP treatment is of little clinical significance.
通过多导睡眠图记录评估了δ睡眠诱导肽（DSIP）对失眠患者睡眠周期的影响。采用双盲交叉设计，在四个晚上静脉注射25 nmol/kg剂量的DSIP或安慰剂。DSIP治疗期间，夜间觉醒次数、非快速眼动（NREM）睡眠潜伏期、总清醒时间和睡眠开始后的清醒时间均减少，但与基线或双盲安慰剂夜间相比，未发现显著差异。该肽增加了总睡眠时间和NREM睡眠时间。它们的增加与第2阶段的增加有关，而第1阶段、慢波睡眠（第3和第4阶段）和快速眼动睡眠未发生改变。对于NREM睡眠时间和第2阶段睡眠，DSIP与安慰剂之间存在显著差异，但基线值之间也存在相同差异。可以得出结论，DSIP治疗下的睡眠改善临床意义不大。
