Objective: To evaluate the effects of oxycodone naloxone prolonged-release tablets on bowel function, analgesic control, quality of life, and safety in patients with severe cancer pain and opioid-induced constipation (OIC). Methods: This study is an interim analysis of a prospective, multicenter, single-arm trial. Patients with severe cancer pain and OIC from nine medical institutions in China between April 2025 and January 2026 were enrolled and treated with oxycodone naloxone prolonged-release tablets for 4 weeks. The primary endpoint was bowel function improvement assessed by the Bowel Function Index (BFI). Secondary endpoints included analgesic effect (Brief Pain Inventory-Short Form, BPI-SF), defecation status (Complete Spontaneous Bowel Movement, CSBM), quality of life (Patient Assessment of Constipation Quality of Life, PAC-QOL), and safety (adverse events). One-way repeated measures analysis of variance was used to compare the above measures between different post-treatment time points and baseline. The Lan-DeMets α-spending function (with O'Brien-Fleming adjustment) was applied to adjust the α level for the interim analysis, yielding an interim analysis boundary value of 0.000 6 (two-sided) and a final analysis boundary value of 0.049 8. Results: Planned enrollment was 203 patients; by January 2026, 78 patients were actually enrolled. The modified full analysis set (mFAS) comprised 64 patients, and the safety analysis set (SAS) comprised 77 patients. In the mFAS group, BFI scores decreased significantly after treatment (F=36.39, P<0.001). The change from baseline in BFI score at week 4 was -26.7 (-39.2, -10.0) points (P<0.001). BPI-SF scores at all post-treatment time points were lower than baseline, and CSBM at all time points increased compared with baseline, and the PAC-QOL score at all time points decreased compared with baseline (all P<0.001). In the SAS group, the daily opioid dose was [M(Q1, Q3)] 40.0 (20.0, 65.5) mg. The overall incidence of adverse events was 54.5% (42/77), with the most common being nausea (15.6%, 12/77) and vomiting (14.3%, 11/77). The incidence of serious adverse events was 6.5% (5/77). Conclusion: Oxycodone naloxone prolonged-release tablets improve bowel function and defecation in Chinese patients with severe cancer pain and OIC, do not compromise analgesic effect, enhance constipation-related quality of life, and demonstrate acceptable safety. 目的： 评价羟考酮纳洛酮缓释片用于重度癌痛合并阿片相关便秘（OIC）患者的肠功能改善、镇痛效果、生活质量提升作用及安全性。 方法： 该研究为一项前瞻性、多中心、单臂研究的期中分析，纳入2025年4月至2026年1月国内9家医疗机构的重度癌痛合并OIC患者，予羟考酮纳洛酮缓释片治疗4周。以肠道功能指数（BFI）评估肠功能改善为主要结局指标；以简明疼痛量表（BPI-SF）、完全自发性排便（CSBM）次数、便秘患者生活质量自评量表（PAC-QOL）分别评估镇痛效果、排便情况及生活质量，同时记录不良事件评价安全性，上述指标为次要结局指标。使用单因素重复测量方差分析比较上述指标在治疗后不同时间点与基线的差异。采用Lan-DeMets α消耗函数（O′Brien-Fleming校正）对期中分析α进行调整，得到期中分析边界值为0.000 6（双侧），最终分析边界值为0.049 8。 结果： 计划入组203例，截至2026年1月实际入组78例，校正的全分析集（mFAS）64例、安全性分析集（SAS）77例。mFAS 集患者治疗后BFI评分降低（F=36.39，P<0.001），第4周BFI评分较基线的变化值为-26.7（-39.2，-10.0）分（P<0.001）；治疗后BPI-SF评分各时间点较基线均下降，CSBM各时间点较基线均增加，PAC-QOL评分各时间点较基线均下降（均P<0.001）。SAS集患者药物单日剂量为［M（Q1，Q3）］40.0（20.0，65.5）mg；不良事件发生率54.5%（42/77），常见为恶心（15.6%，12/77）、呕吐（14.3%，11/77）；严重不良事件发生率6.5%（5/77）。 结论： 羟考酮纳洛酮缓释片可改善重度癌痛合并OIC患者的肠道功能与排便情况，未影响镇痛效果，提升便秘相关生活质量，安全性可接受。.
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