{"title":"一项随机对照临床试验：纳美芬有效缓解胸椎硬膜外阿片类药物引起的瘙痒而不影响镇痛。","authors":"Guiting Li, Huan Yan, Weishan Li, Ailun Li, Yiqi Zhu, Jiapeng Huang, Jing Cang, Fang Fang","doi":"10.21037/jtd-24-1455","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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).</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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% <i>vs.</i> 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.</p><p><strong>Conclusions: </strong>A single dose of intravenous nalmefene could relieve postoperative pruritus from epidural opioids without affecting analgesic effects.</p><p><strong>Trial registration: </strong>The study was retrospectively registered in the Chinese Clinical Trial Registry (ChiCTR2000039596) on November 2, 2020.</p>","PeriodicalId":17542,"journal":{"name":"Journal of thoracic disease","volume":"17 4","pages":"2028-2037"},"PeriodicalIF":2.1000,"publicationDate":"2025-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12090119/pdf/","citationCount":"0","resultStr":"{\"title\":\"Nalmefene effectively relieves thoracic epidural opioid-induced pruritus without affecting analgesia: a randomized controlled clinical trial.\",\"authors\":\"Guiting Li, Huan Yan, Weishan Li, Ailun Li, Yiqi Zhu, Jiapeng Huang, Jing Cang, Fang Fang\",\"doi\":\"10.21037/jtd-24-1455\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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).</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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% <i>vs.</i> 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.</p><p><strong>Conclusions: </strong>A single dose of intravenous nalmefene could relieve postoperative pruritus from epidural opioids without affecting analgesic effects.</p><p><strong>Trial registration: </strong>The study was retrospectively registered in the Chinese Clinical Trial Registry (ChiCTR2000039596) on November 2, 2020.</p>\",\"PeriodicalId\":17542,\"journal\":{\"name\":\"Journal of thoracic disease\",\"volume\":\"17 4\",\"pages\":\"2028-2037\"},\"PeriodicalIF\":2.1000,\"publicationDate\":\"2025-04-30\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12090119/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of thoracic disease\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.21037/jtd-24-1455\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/4/23 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q3\",\"JCRName\":\"RESPIRATORY SYSTEM\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of thoracic disease","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.21037/jtd-24-1455","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/4/23 0:00:00","PubModel":"Epub","JCR":"Q3","JCRName":"RESPIRATORY SYSTEM","Score":null,"Total":0}
引用次数: 0
摘要
背景：瘙痒是神经轴性阿片类药物的一个突出副作用。瘙痒症是一种令人不快的感觉，会导致抓挠和不适。本试验旨在研究纳美芬治疗阿片类药物所致硬膜外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。将患者随机分为纳美芬组和对照组，分别给予0.5µg/kg纳美芬或等量生理盐水，评价纳美芬治疗阿片类药物硬膜外瘙痒的疗效及其对术后PCEA的影响。主要观察指标是治疗后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pcea相关不良事件、瘙痒评分和瘙痒缓解时间。结果：共纳入160例患者。纳美芬组在治疗后24小时内瘙痒完全缓解率显著高于对照组(68 / 80；85% vs 51 / 80；63.7%, P = 0.002)。视觉模拟量表（VAS）疼痛评分中位数、其他pcea相关不良事件发生率和瘙痒评分无差异。Kaplan-Meier曲线显示，静脉注射纳美芬可将瘙痒缓解的中位数[四分位数范围（IQR）]时间从15.62（7.59 ~ 23.65）小时缩短至1.5（0.84 ~ 2.16）小时。结论：单次静脉注射纳美芬可缓解术后硬膜外阿片类药物引起的瘙痒，且不影响镇痛效果。试验注册：该研究于2020年11月2日在中国临床试验注册中心（ChiCTR2000039596）回顾性注册。
Nalmefene effectively relieves thoracic epidural opioid-induced pruritus without affecting analgesia: a randomized controlled clinical trial.
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% vs. 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.
期刊介绍：
The Journal of Thoracic Disease (JTD, J Thorac Dis, pISSN: 2072-1439; eISSN: 2077-6624) was founded in Dec 2009, and indexed in PubMed in Dec 2011 and Science Citation Index SCI in Feb 2013. It is published quarterly (Dec 2009- Dec 2011), bimonthly (Jan 2012 - Dec 2013), monthly (Jan. 2014-) and openly distributed worldwide. JTD received its impact factor of 2.365 for the year 2016. JTD publishes manuscripts that describe new findings and provide current, practical information on the diagnosis and treatment of conditions related to thoracic disease. All the submission and reviewing are conducted electronically so that rapid review is assured.
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