Baharvand Paria, Abbasi Mohammad Reza, Ziaee Ardestani Shadi, Esmaeili Ayda, Namazi Soha
Department of Clinical Pharmacy, School of Pharmacy and Research Center for Rational Use of Drugs, Tehran University of Medical Sciences, Tehran, Iran.
Iran J Kidney Dis. 2021 Jan;15(1):38-47.
Uremic pruritus (UP) is one of the major complaints in hemodialysis patients without specific treatment. Considering the antipruritic effect of melatonin in atopic dermatitis (AD) and similarities in mechanism between pruritus in AD and UP, this randomized clinical trial designed to evaluate the antipruritic effect of melatonin on hemodialysis patients with UP.
This multicenter double-blind randomized clinical trial was conducted among the hemodialysis patients with UP. Adult patients were randomly assigned to receive two capsules of melatonin 5 mg /d for a 2 weeks period, undergoing a 1 week washout period, and then two capsules of placebo for another 2 weeks period, or the reverse sequence. Visual Analogue Scale (VAS), % affected Body Surface Area (%BSA) and 12-Pruritus Severity Scale questionnaire (12-PSS) were measured before and after each of the three periods. A crossover analysis of variance adjusted by treatment, period and carryover effect was performed by STATA 14.
Thirty-nine patients under hemodialysis (mean age of 55.08 ± 12.34 years) completed the study. Mean changes in VAS, 12-PSS, and %BSA after the interventions (melatonin vs. placebo, mean ± SD) were as follows, respectively: -3.21 ± 3.33 vs. -1.38 ± 2.23, -4.59 ± 5.22 vs. -2.08 ± 4.35, and -19.10 ± 30.31 vs. 4.64 ± 29.11 (P < .05). However, the statistical significance of the treatment effect from melatonin was observed, carryover and period effects were not significant (P > .05) for any of the main variables.
Based on to the preliminary results of this study, melatonin can be introduced as an effective drug for management of pruritus in uremic patients.
尿毒症瘙痒（UP）是血液透析患者的主要主诉之一，目前尚无特效治疗方法。鉴于褪黑素对特应性皮炎（AD）有止痒作用，且AD瘙痒与UP在发病机制上存在相似性，本随机临床试验旨在评估褪黑素对血液透析合并UP患者的止痒效果。
本多中心双盲随机临床试验在患有UP的血液透析患者中进行。成年患者被随机分配，连续2周每天服用2粒5mg褪黑素胶囊，经过1周的洗脱期后，再连续2周每天服用2粒安慰剂胶囊，或采用相反顺序。在三个阶段的每个阶段前后，分别测量视觉模拟量表（VAS）、体表面积受累百分比（%BSA）和12瘙痒严重程度量表问卷（12-PSS）。使用STATA 14对治疗、阶段和残留效应进行方差调整后的交叉分析。
39例血液透析患者（平均年龄55.08±12.34岁）完成了研究。干预后（褪黑素与安慰剂相比，均值±标准差）VAS、12-PSS和%BSA的平均变化分别如下：-3.21±3.33 对 -1.38±2.23，-4.59±5.22 对 -2.08±4.35，以及 -19.10±30.31 对 4.64±29.11（P<.05）。然而，尽管观察到褪黑素治疗效果具有统计学意义，但对于任何主要变量，残留效应和阶段效应均无统计学意义（P>.05）。
基于本研究的初步结果，褪黑素可作为治疗尿毒症患者瘙痒的有效药物。
