Division of Gastroenterology and Hepatology, Department of Internal Medicine, Nippon Medical School, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan.
Core Research Facilities, The Jikei University School of Medicine, Tokyo, Japan.
Sci Rep. 2022 May 4;12(1):7311. doi: 10.1038/s41598-022-11431-1.
Nalfurafine hydrochloride, a selective κ-opioid receptor agonist has been approved for pruritus in patients with chronic liver disease. However, not all patients respond to nalfurafine hydrochloride. The aim of this study was to clarify the efficacy of nalfurafine hydrochloride. The subjects were patients with chronic liver disease complicated by pruritus who were treated with nalfurafine hydrochloride between May, 2015, and May, 2021. The degree of pruritus was evaluated based on the Visual Analog Scale (VAS) score and the Kawashima's pruritus score. Nalfurafine hydrochloride 2.5 μg was orally administered once a day for 12 weeks. A decrease in the VAS score of ≥ 25 mm or the Kawashima's pruritus score of ≥ 1 scores was designated as relevant response. The former of ≥ 50 mm or the latter of ≥ 2 scores as remarkable response. The 326 patients who were evaluated the efficacy at 12 weeks. The median time suffering from pruritus to administration of nalfurafine hydrochloride was 4 months. The median VAS score improved from 70.0 mm before administration to 40.0 and 30.0 mm at 4 and 12 weeks of treatment, respectively. On multivariate analysis, shorter itching period and lower FIB-4 index value were extracted as the independent factors related to remarkable responder. On multivariate analysis, shorter itching period was extracted as the only independent factor related to relevant responder. In conclusion, this study suggested nalfurafine hydrochloride treatment markedly improves pruritus in patients with chronic liver disease. A short pruritus period and less-advanced fibrosis were associated with response to nalfurafine hydrochloride.
盐酸那呋拉啡，一种选择性 κ 阿片受体激动剂，已被批准用于治疗慢性肝病患者的瘙痒症。然而，并非所有患者对盐酸那呋拉啡都有反应。本研究旨在阐明盐酸那呋拉啡的疗效。研究对象为 2015 年 5 月至 2021 年 5 月期间接受盐酸那呋拉啡治疗的慢性肝病合并瘙痒症患者。瘙痒程度根据视觉模拟评分（VAS）和川崎瘙痒评分进行评估。盐酸那呋拉啡 2.5μg，每日口服一次，疗程 12 周。VAS 评分下降≥25mm 或川崎瘙痒评分提高≥1 分为有效反应，VAS 评分下降≥50mm 或川崎瘙痒评分提高≥2 分为显著反应。对 12 周时进行疗效评估的 326 例患者进行分析。从开始使用盐酸那呋拉啡到出现瘙痒的中位时间为 4 个月。VAS 评分从治疗前的 70.0mm 下降至治疗 4 周和 12 周时的 40.0mm 和 30.0mm。多变量分析中，瘙痒持续时间较短和 FIB-4 指数值较低被提取为与显著反应相关的独立因素。多变量分析中，瘙痒持续时间较短被提取为与有效反应相关的唯一独立因素。综上所述，本研究表明，盐酸那呋拉啡治疗可显著改善慢性肝病患者的瘙痒症状。瘙痒持续时间较短和纤维化程度较轻与对盐酸那呋拉啡的反应相关。
