慢性肝病患者停用盐酸纳呋拉啡后瘙痒的复发率：初步前瞻性验证试验
Recurrence rates of pruritus after the stop of nalfurafine hydrochloride in chronic liver disease: Preliminary prospective confirmatory trial.
作者信息
Akuta Norio, Kumada Hiromitsu, Fujiyama Shunichiro, Kawamura Yusuke, Sezaki Hitomi, Hosaka Tetsuya, Kobayashi Masahiro, Kobayashi Mariko, Saitoh Satoshi, Suzuki Yoshiyuki, Suzuki Fumitaka, Arase Yasuji, Ikeda Kenji
机构信息
Department of Hepatology, Toranomon Hospital, Okinaka Memorial Institute for Medical Research, Tokyo, Japan.
Liver Research Laboratory, Toranomon Hospital, Tokyo, Japan.
出版信息
Hepatol Res. 2018 Sep;48(10):810-813. doi: 10.1111/hepr.13075. Epub 2018 Apr 24.
AIM
The recurrence rates of pruritus after stopping nalfurafine hydrochloride are unknown in chronic liver disease.
METHODS
A prospective confirmatory trial was carried out to determine the recurrence rates of pruritus after cessation of nalfurafine hydrochloride in chronic liver disease. After pretreatment with nalfurafine hydrochloride for 4 weeks or more, 15 consecutive Japanese patients, who confirmed the improvement of pruritus (decrease in the visual analogue scale (VAS) of ≥50 mm), were enrolled in the present study. Patients were classified to the continuous group (continuation of nalfurafine hydrochloride for 4 weeks) or the discontinuous group (cessation of nalfurafine hydrochloride) at the time of consent to study protocol, by self-determination.
RESULTS
The recurrence rates (increase in VAS of ≥25 mm after stopping nalfurafine hydrochloride) were 100% (5 of 5 patients) and 0% (0 of 10) in the discontinuous and continuous groups, respectively. In the discontinuous group, 3 patients selected retreatment with nalfurafine hydrochloride as salvage therapy, and they generally recovered to the levels of VAS at the discontinuation of treatment.
CONCLUSION
The present prospective trial showed the high recurrence rates of pruritus after the stop of nalfurafine hydrochloride in chronic liver disease.
目的
在慢性肝病中，停用盐酸纳呋拉啡后瘙痒的复发率尚不清楚。
方法
开展一项前瞻性验证性试验，以确定慢性肝病患者停用盐酸纳呋拉啡后瘙痒的复发率。在接受盐酸纳呋拉啡预处理4周或更长时间后，15名连续入选的日本患者确认瘙痒症状改善（视觉模拟量表（VAS）下降≥50 mm），纳入本研究。在患者同意研究方案时，根据其自主决定将患者分为持续组（盐酸纳呋拉啡持续使用4周）或间断组（停用盐酸纳呋拉啡）。
结果
间断组和持续组的复发率（停用盐酸纳呋拉啡后VAS增加≥25 mm）分别为100%（5例患者中的5例）和0%（10例中的0例）。在间断组中，3例患者选择再次使用盐酸纳呋拉啡作为挽救治疗，他们通常恢复到治疗中断时的VAS水平。
结论
本前瞻性试验表明，慢性肝病患者停用盐酸纳呋拉啡后瘙痒复发率很高。
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