Is patient-reported outcome improved by nalfurafine hydrochloride in patients with primary biliary cholangitis and refractory pruritus? A post-marketing, single-arm, prospective study
Is patient-reported outcome improved by nalfurafine hydrochloride in patients with primary biliary cholangitis and refractory pruritus? A post-marketing, single-arm, prospective study
复制标题
盐酸纳芙拉芬治疗原发性胆汁性胆管炎和难治性瘙痒患者的患者报告结果是否有所改善？
DOI：
10.1007/s00535-018-1465-z
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发表时间：
2018
影响因子：
6.3
通讯作者：
H. Takikawa
中科院分区：
文献类型：
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作者：
M. Yagi;A. Tanaka;T. Namisaki;A. Takahashi;M. Abe;A. Honda;Y. Matsuzaki;H. Ohira;H. Yoshiji;H. Takikawa
原发性胆汁性胆管炎（PBC）患者常伴有瘙痒，严重影响其健康相关生活质量（HRQOL）。盐酸纳呋萘芬是一种选择性κ-阿片受体激动剂，最近在日本获批用于慢性肝病患者的难治性瘙痒，但仍不清楚该治疗是否能改善PBC患者的难治性瘙痒患者报告结局（PRO）。在此，我们进行了一项多中心，上市后，单臂前瞻性研究，以探讨纳呋拉芬的疗效在PRO方面，和任何临床特征的疗效的关联性。MethodsAfter筛选瘙痒症在496例PBC患者使用PBC-40和视觉模拟量表（VAS），我们确定了141例中度至重度瘙痒症;他们被邀请参加这项研究。参与者接受2.5 μg纳呋拉芬每日一次，持续12周，并在治疗的第12周评估瘙痒和HRQOL。通用HRQOL，短形式36，血液化学，血清autotaxin水平也测定在基线和12周。在研究期间，平均PBC-40瘙痒领域评分和VAS分别从基线时的8.56降至7.63（P = 0.041）和从42.9降至29.3（P = 0.001），表明纳呋萘芬具有显著作用。PBC-40的其他结构域和SF-36的所有结构域均未被该处理显著改变。我们未能发现VAS和PBC-40瘙痒评分的变化与任何临床变量之间存在任何相关性。血清autotaxin水平显着增加，在研究period.ConclusionsThis study demonstrated，纳呋拉芬改善瘙痒症患者PBC，独立于他们的临床特征，但有一个有限的影响PRO。
BackgroundPatients with primary biliary cholangitis (PBC) frequently suffer from pruritus, which can severely impair their health-related quality of life (HRQOL). Nalfurafine hydrochloride, a selective κ-opioid receptor agonist, was recently approved in Japan for refractory pruritus in patients with chronic liver diseases, but it still remains unclear whether this treatment improves the patient-reported outcome (PRO) in PBC patients with refractory pruritus. Herein, we conducted a multicenter, post-marketing, single-arm prospective study to investigate the efficacy of nalfurafine in terms of PRO, and the associations of the efficacy with any clinical characteristics.MethodsAfter screening for pruritus in 496 patients with PBC using PBC-40 and the visual analog scale (VAS), we identified 141 patients with moderate to severe pruritus; these were invited to participate in the study. The participants received 2.5 μg nalfurafine once daily for 12 weeks, and pruritus and HRQOL were assessed in week 12 of this treatment. Generic HRQOL, short form 36, blood chemistries, and serum autotaxin levels were also measured at baseline and at week 12.ResultsForty-four patients participated in this study. The mean PBC-40 itch domain scores and VAS declined during the study period, from 8.56 to 7.63 (P = 0.041) and from 42.9 to 29.3 (P = 0.001) at baseline and at week 12, respectively, indicating a significant effect of nalfurafine. The other domains of PBC-40 and all domains of SF-36 were not significantly altered by this treatment. We failed to find any association between the change in VAS and PBC-40 itch scores and any clinical variable. Serum autotaxin levels were significantly increased during the study period.ConclusionsThis study demonstrated that nalfurafine improved pruritus in patients with PBC, independent of their clinical characteristics, but had a limited effect on the PRO.
《关于动脉系统的若干发现（分布于肾锥体的动脉的解剖学研究，特别是螺旋动脉）》《Jikei医学杂志》。
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