纳美芬可有效缓解胸段硬膜外阿片类药物引起的瘙痒且不影响镇痛效果：一项随机对照临床试验。

Nalmefene effectively relieves thoracic epidural opioid-induced pruritus without affecting analgesia: a randomized controlled clinical trial.

作者信息

Li Guiting, Yan Huan, Li Weishan, Li Ailun, Zhu Yiqi, Huang Jiapeng, Cang Jing, Fang Fang

机构信息

Department of Anesthesiology, Xiamen Branch, Zhongshan Hospital, Fudan University, Xiamen, China.

Department of Anesthesiology, Zhongshan Hospital, Fudan University, Shanghai, China.

出版信息

J Thorac Dis. 2025 Apr 30;17(4):2028-2037. doi: 10.21037/jtd-24-1455. Epub 2025 Apr 23.

DOI:10.21037/jtd-24-1455

PMID:40400984

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12090119/

Abstract

BACKGROUND

Pruritus is a prominent side effect of neuraxial opioids. Pruritus is an unpleasant sensation that leads to scratching and discomfort. This trial was aimed to study nalmefene's efficacy for treating epidural opioid-induced pruritus and its effect on postoperative patient-controlled epidural analgesia (PCEA).

METHODS

We recruited 166 patients who developed postoperative pruritus due to epidural opioid analgesia. Patients were randomized to the nalmefene group or control group and received either 0.5 µg/kg nalmefene or the equivalent volume of saline to evaluate nalmefene's efficacy for treating epidural opioid-induced pruritus and its effect on postoperative PCEA. The primary outcome was the complete relief rate of pruritus within 24 hours after the treatment. Secondary outcomes included postoperative pain scores, other PCEA-related adverse events, itch scores, and the time of itching relief.

RESULTS

A total of 160 patients were included in the final analysis. The complete pruritus relief rate in the nalmefene group was significantly higher than that in the control group within 24 hours after the treatment (68 of 80; 85% 51 of 80; 63.7%, P=0.002). The median Visual Analog Scale (VAS) pain score, the incidence of other PCEA-related adverse events, and itch scores showed no difference. The Kaplan-Meier curves showed that intravenous nalmefene reduced the median [interquartile range (IQR)] time of itching relief from 15.62 (7.59-23.65) to 1.5 (0.84-2.16) hours (P<0.001). The multivariable analysis indicated that female patients without allergic history were associated with more complete relief of itching.

CONCLUSIONS

A single dose of intravenous nalmefene could relieve postoperative pruritus from epidural opioids without affecting analgesic effects.

TRIAL REGISTRATION

The study was retrospectively registered in the Chinese Clinical Trial Registry (ChiCTR2000039596) on November 2, 2020.

摘要

背景

瘙痒是椎管内使用阿片类药物的一种突出副作用。瘙痒是一种令人不适的感觉，会导致搔抓和不适。本试验旨在研究纳美芬治疗硬膜外阿片类药物引起的瘙痒的疗效及其对术后患者自控硬膜外镇痛（PCEA）的影响。

方法

我们招募了166例因硬膜外阿片类镇痛而出现术后瘙痒的患者。患者被随机分为纳美芬组或对照组，分别接受0.5µg/kg纳美芬或等量生理盐水，以评估纳美芬治疗硬膜外阿片类药物引起的瘙痒的疗效及其对术后PCEA的影响。主要结局是治疗后24小时内瘙痒的完全缓解率。次要结局包括术后疼痛评分、其他与PCEA相关的不良事件、瘙痒评分以及瘙痒缓解时间。

结果

共有160例患者纳入最终分析。治疗后24小时内，纳美芬组的瘙痒完全缓解率显著高于对照组（80例中的68例；85% 对80例中的51例；63.7%，P=0.002）。视觉模拟量表（VAS）疼痛评分中位数、其他与PCEA相关的不良事件发生率和瘙痒评分无差异。Kaplan-Meier曲线显示，静脉注射纳美芬使瘙痒缓解的中位[四分位间距（IQR）]时间从15.62（7.59-23.65）小时缩短至1.5（0.84-2.16）小时（P<0.001）。多变量分析表明，无过敏史的女性患者瘙痒完全缓解的情况更多。