Oxycodone/naloxone PR versus oxycodone PR in advanced cancer: A multi-centre randomised trial (ENhANCE trial).

IF 3.9 2区医学 Q1 HEALTH CARE SCIENCES & SERVICES

Palliative Medicine Pub Date : 2025-10-01 Epub Date: 2025-08-27 DOI:10.1177/02692163251362563

Aaron K Wong, Anneke Grobler, Ruwani Mendis, Jennifer Philip, Brian Le

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引用次数: 0

Abstract

Background: Opioid-induced constipation is a common side effect of Oxycodone. Oxycodone/Naloxone Prolonged Release (OXN PR) mitigates opioid-induced constipation in non-cancer pain, however its evidence is limited in people with pain from advanced cancer.

Aims: To demonstrate analgesic non-inferiority, and superiority in reducing constipation for Oxycodone/Naloxone Prolonged Release (OXN PR) compared to Oxycodone Prolonged Release (Oxy PR).

Design: Multi-centre open-label randomised controlled trial comparing OXN PR to Oxy PR over 5 weeks. The primary aim was to demonstrate analgesic non-inferiority of OXN PR compared to Oxy PR. The secondary aim was to demonstrate superiority of constipation reduction in the OXN PR arm.

Setting/participants: Participants with moderate-severe pain (⩾4/10) from advanced cancer were eligible.

Results: Thirty seven of planned 96 patients were recruited with the study stopping early due to enrolment challenges during the COVID-19 pandemic. Average pain was -1.5 points (95% CI -3.3; 0.4) favouring the OXN PR arm compared to Oxy PR at 5 weeks, meeting analgesic non-inferiority, defined as falling within a one point non-inferiority margin. The OXN PR arm demonstrated less constipation with a significantly lower Bowel Function Index score (-24.87 (95% CI 47.54; 2.21), p = 0.03) compared to Oxy PR. Adverse effect safety profile favoured OXN PR.

Conclusions: OXN PR is non-inferior to Oxy PR in analgesic effectiveness and superior in reducing constipation. These results indicate OXN PR as the choice of opioid preparation in advanced cancer. Future studies may explore adding naloxone to other slow and immediate release opioid preparations.

Trial registry: Australian New Zealand Clinical Trials RegistryTrial registration number:ACTRN12619001282178URL of trial registry record:https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377673&isReview=true.

查看原文本刊更多论文

羟考酮/纳洛酮PR对晚期癌症的羟考酮PR：一项多中心随机试验（ENhANCE试验）。

背景：阿片类药物引起的便秘是羟考酮的常见副作用。羟考酮/纳洛酮缓释（OXN PR）可减轻阿片类药物引起的非癌症疼痛便秘，但其在晚期癌症疼痛患者中的应用证据有限。目的：研究羟考酮/纳洛酮缓释片（OXN PR）与羟考酮缓释片（Oxy PR）相比在镇痛作用上的非劣效性和减少便秘的优越性。设计：多中心开放标签随机对照试验，比较OXN PR和Oxy PR超过5周。主要目的是证明OXN PR与Oxy PR相比在镇痛方面的非劣效性。次要目的是证明OXN PR组在减少便秘方面的优势。环境/参与者：患有晚期癌症的中重度疼痛（大于或等于4/10）的参与者符合条件。结果：计划招募的96名患者中有37名被招募，由于COVID-19大流行期间的招募挑战，研究提前停止。在5周时，与Oxy PR组相比，OXN PR组的平均疼痛为-1.5分（95% CI -3.3; 0.4），符合镇痛的非劣效性，定义为落在1分的非劣效性范围内。与Oxy PR相比，OXN PR组便秘较少，肠功能指数评分显著降低（-24.87 (95% CI 47.54; 2.21), p = 0.03）。不良反应安全性分析有利于OXN PR。结论：OXN PR在镇痛效果上不逊于Oxy PR，在减少便秘方面优于Oxy PR。这些结果表明OXN PR是晚期癌症阿片类药物制剂的选择。未来的研究可能会探索将纳洛酮添加到其他缓释阿片类药物制剂中。试验注册中心：澳大利亚新西兰临床试验注册中心试验注册编号：actrn12619001282178试验注册记录url:https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377673&isReview=true。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Palliative Medicine 医学-公共卫生、环境卫生与职业卫生

CiteScore

7.60

自引率

9.10%

发文量

125

审稿时长

6-12 weeks

期刊介绍： Palliative Medicine is a highly ranked, peer reviewed scholarly journal dedicated to improving knowledge and clinical practice in the palliative care of patients with far advanced disease. This outstanding journal features editorials, original papers, review articles, case reports, correspondence and book reviews. Essential reading for all members of the palliative care team. This journal is a member of the Committee on Publication Ethics (COPE).