Medical Oncology Department, Hospital Regional Universitario de Málaga, Málaga, Spain
IBIMA, Málaga, Spain.
BMJ Support Palliat Care. 2023 Dec 7;13(e2):e318-e326. doi: 10.1136/bmjspcare-2020-002816.
Naloxegol is a peripherally acting µ-opioid receptor antagonist (PAMORA) for treatment of opioid-induced constipation (OIC). The main objective was to analyse the long-term efficacy, quality of life (QOL) and safety of naloxegol in patients with cancer in a real-world study.
This one-year prospective study included patients older than 18 years, with active oncological disease who were under treatment with opioids for pain control and Karnofsky≥50 and OIC with inadequate response to treatment with laxative (s). All the patients received treatment with naloxegol according to clinical criteria. The main efficacy objectives were measured by the patient assessment of constipation QOL questionnaire (PAC-QOL), the PAC symptoms (PAC-SYM), the response rate at day 15, and months 1-3-6-12, and global QOL (EuroQoL-5D-5L).
A total of 126 patients (58.7% males) with a mean age of 61.5 years (95% CI 59.4 to 63.7) were included. PAC-SYM and PAC-QOL total score and all their dimensions improved from baseline (p<0.0001). At 12 months, 77.8% of the patients were responders to naloxegol treatment. Global QOL was conserved from baseline. A total of 28 adverse reactions, mainly gastrointestinal were observed in 15.1% of the patients (19/126), being 75% (21) mild, 17.9% (5) moderate and 7.1% (2) severe. Most adverse reactions (67.9%) appeared the first 15 days of treatment.
The results of this first long-term and real-world-data study in patients with cancer, showed the sustained efficacy and safety of naloxegol for the treatment of OIC in this group of patients.
纳洛酮是一种外周作用型μ阿片受体拮抗剂（PAMORA），用于治疗阿片类药物引起的便秘（OIC）。主要目的是在真实世界研究中分析纳洛酮治疗癌症患者的长期疗效、生活质量（QOL）和安全性。
这是一项为期一年的前瞻性研究，纳入了年龄大于 18 岁、患有活动性肿瘤疾病、正在接受阿片类药物治疗以控制疼痛且 Karnofsky 评分≥50 分和对泻药治疗反应不足的 OIC 患者。所有患者均根据临床标准接受纳洛酮治疗。主要疗效指标通过患者便秘生活质量问卷（PAC-QOL）、PAC 症状（PAC-SYM）、第 15 天和第 1、3、6、12 个月的应答率以及全球生活质量（EuroQoL-5D-5L）进行评估。
共纳入 126 例患者（58.7%为男性），平均年龄为 61.5 岁（95%CI 59.4 至 63.7）。PAC-SYM 和 PAC-QOL 总分及其所有维度均较基线改善（p<0.0001）。在 12 个月时，77.8%的患者对纳洛酮治疗有应答。全球生活质量从基线保持不变。共观察到 28 例不良反应，主要为胃肠道反应，占 15.1%（19/126），其中 75%（21）为轻度，17.9%（5）为中度，7.1%（2）为重度。大多数不良反应（67.9%）出现在治疗的前 15 天。
这项针对癌症患者的首次长期真实世界数据研究结果表明，纳洛酮治疗 OIC 的疗效持久且安全。
