Wolfhagen F H, Sternieri E, Hop W C, Vitale G, Bertolotti M, Van Buuren H R
Department of Hepatogastroenterology, University Hospital Rotterdam-Dijkzigt, The Netherlands.
Gastroenterology. 1997 Oct;113(4):1264-9. doi: 10.1053/gast.1997.v113.pm9322521.
BACKGROUND & AIMS: The efficacy of currently available therapeutic agents for cholestatic pruritus is often disappointing. The aim of this study was to assess the antipruritic effect of naltrexone, an oral opiate receptor antagonist.
Sixteen patients with pruritus of chronic cholestasis were randomized to receive naltrexone (4-week course of 50 mg naltrexone daily) or placebo. Pruritus, quality of sleep, fatigue (using visual analogue scales), side effects, and liver function were assessed every 2 weeks. Serum naltrexone and 6 beta-naltrexol concentrations in all patients and 5 healthy controls were measured during the first day of naltrexone treatment.
Mean changes with respect to baseline were significantly different, in favor of the naltrexone group, for daytime itching (-54% vs. 8%; P < 0.001) and nighttime itching (-44% vs. 7%, P = 0.003). In 4 naltrexone-treated patients, side effects (transient in 3 cases) consistent with an opiate withdrawal syndrome were noted. No deterioration of the underlying disease was observed. Naltrexone and 6 beta-naltrexol levels did not differ between patients and controls, and there was no significant association with treatment response.
For patients with cholestatic liver disease and itching, refractory to regular antipruritic therapy, oral naltrexone may be an effective and well-tolerated alternative.
目前可用的治疗胆汁淤积性瘙痒的药物疗效往往不尽人意。本研究旨在评估口服阿片受体拮抗剂纳曲酮的止痒效果。
16例慢性胆汁淤积性瘙痒患者被随机分为两组，分别接受纳曲酮（每日50mg，疗程4周）或安慰剂治疗。每2周评估瘙痒程度、睡眠质量、疲劳程度（使用视觉模拟量表）、副作用及肝功能。在纳曲酮治疗的第一天，测量所有患者及5名健康对照者的血清纳曲酮和6β-纳曲醇浓度。
与基线相比，纳曲酮组白天瘙痒（-54% vs. 8%；P < 0.001）和夜间瘙痒（-44% vs. 7%，P = 0.003）的平均变化有显著差异，有利于纳曲酮组。在4例接受纳曲酮治疗的患者中，观察到与阿片戒断综合征一致的副作用（3例为短暂性）。未观察到基础疾病恶化。患者与对照组的纳曲酮和6β-纳曲醇水平无差异，且与治疗反应无显著相关性。
对于胆汁淤积性肝病伴瘙痒且常规止痒治疗无效的患者，口服纳曲酮可能是一种有效且耐受性良好的替代治疗方法。
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