Namvar Hamidreza, Espahbodi Fatemeh, Moosazadeh Mahmood, Rahimnia Seyyed Mobin, Hendouei Narjes
Department of Clinical Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.
Department of Internal Medicine, Diabetes Research Center, Mazandaran University of Medical Sciences, Sari, Iran.
J Res Pharm Pract. 2025 Apr 24;13(4):127-136. doi: 10.4103/jrpp.jrpp_16_25. eCollection 2024 Oct-Dec.
Uremic pruritus (UP) is a prevalent and debilitating condition experienced by patients undergoing hemodialysis, influenced by multiple underlying mechanisms. Despite the availability of various treatment options, many patients still endure significant pruritus. This double-blind, placebo-controlled clinical trial aims to assess and compare the safety and efficacy of mirtazapine and hydroxyzine in treating UP and improving sleep quality in hemodialysis patients.
Twenty-seven patients in the mirtazapine group received 15 mg/night (7.5 mg for the first two nights) with a hydroxyzine placebo, while 28 patients in the hydroxyzine group received 25 mg/night (12.5 mg for the first two nights) with a mirtazapine placebo for 2 weeks. UP was assessed using the 5D-itch scale, and sleep quality was measured with the Pittsburgh Sleep Quality Index (PSQI) at baseline, weeks 2, 3, and 4. Adverse effects were recorded using the Antidepressant Side Effect Checklist at each visit from baseline to week 2.
UP ratings based on the 5D-itch scale decreased for both groups, with a more significant reduction in the mirtazapine group ( = 0.04). The mirtazapine group also showed a significant improvement in the PSQI compared to hydroxyzine ( = 0.01). Dry mouth was the only notable adverse effect, occurring more frequently in the mirtazapine group ( = 0.02).
This study suggests that short-term treatment with mirtazapine is more effective than hydroxyzine in reducing the severity of UP and improving sleep quality for patients undergoing hemodialysis.
尿毒症瘙痒（UP）是血液透析患者中普遍存在且使人衰弱的病症，受多种潜在机制影响。尽管有多种治疗选择，但许多患者仍遭受严重瘙痒。这项双盲、安慰剂对照临床试验旨在评估和比较米氮平与羟嗪在治疗血液透析患者的UP及改善睡眠质量方面的安全性和疗效。
米氮平组的27名患者每晚服用15毫克（前两晚为7.5毫克）并搭配羟嗪安慰剂，而羟嗪组的28名患者每晚服用25毫克（前两晚为12.5毫克）并搭配米氮平安慰剂，为期2周。在基线、第2周、第3周和第4周时，使用5D瘙痒量表评估UP，并使用匹兹堡睡眠质量指数（PSQI）测量睡眠质量。从基线到第2周的每次就诊时，使用抗抑郁药副作用清单记录不良反应。
两组基于5D瘙痒量表的UP评分均下降，米氮平组下降更为显著（ = 0.04）。与羟嗪相比，米氮平组在PSQI方面也有显著改善（ = 0.01）。口干是唯一值得注意的不良反应，在米氮平组中出现频率更高（ = 0.02）。
本研究表明，对于血液透析患者，短期使用米氮平在减轻UP严重程度和改善睡眠质量方面比羟嗪更有效。
