文章：

纳洛昔醇用于治疗癌痛患者阿片类药物所致便秘：真实世界数据的汇总分析

Naloxegol for the Treatment of Opioid-Induced Constipation in Patients with Cancer Pain: A Pooled Analysis of Real-World Data

原文发布日期：3 March 2025

DOI: 10.3390/cancers17050865

类型: Article

开放获取: 是

英文摘要：

Objective: The aim of the NALOPOOL project was to assess the efficacy and safety of naloxegol in patients with cancer pain who exhibited opioid-induced constipation (OIC) and were treated under real-world conditions. Methods: We pooled individual patient data from three multicenter observational studies conducted with naloxegol in patients with cancer who exhibited OIC and were prescribed naloxegol under real-world conditions. Efficacy outcomes were evaluated after 4 weeks of treatment. All analyses were performed via a visit-wise approach. Heterogeneity was assessed via Cochran’s Q-test or Levene’s test. Results: Spontaneous bowel movements (SBM) response (≥3 SBM per week and an increase of ≥1 from baseline; three studies) was reported in 223 of 314 evaluable patients (71%, 95% CI 66–76); clinically relevant improvement in the Patient Assessment of Constipation Quality-of-Life Questionnaire (>0.5 points; three studies) occurred in 179 of 299 evaluable patients (60%, 95% CI 56–74) and in the Patient Assessment of Constipation Symptoms (>0.5 points; two studies) was reported in 131 of 190 evaluable patients (69%, 95% CI 62–76); and clinically relevant improvement in the Bowel Function Index (score ≥ 12 points at the endpoint; two studies;) was reported in 133 of 195 evaluable patients (68%, 95% CI 62–75). No significant heterogeneity was found for any efficacy outcome. The pooled proportion of patients who discontinued the drug owing to adverse reactions was 6.1% (95% CI 3.8% to 8.4%). Conclusions: Our results support the use of naloxegol for the management of OIC in patients with cancer pain who do not respond to laxative treatment.

摘要翻译： 

目的：NALOPOOL项目旨在评估纳洛西醇在现实条件下治疗癌痛患者阿片类药物所致便秘（OIC）的有效性和安全性。方法：我们汇总了三项多中心观察性研究中接受纳洛西醇治疗的癌痛伴OIC患者的个体数据，这些研究均在现实条件下开展。疗效结果在治疗4周后进行评估，所有分析均采用按访视点分析的方法。通过Cochran's Q检验或Levene's检验评估异质性。结果：在314例可评估患者中，223例（71%，95% CI 66-76）报告达到自主排便（SBM）应答标准（每周≥3次SBM且较基线增加≥1次；三项研究）；299例可评估患者中179例（60%，95% CI 56-74）报告便秘患者生活质量问卷出现临床相关改善（>0.5分；三项研究）；190例可评估患者中131例（69%，95% CI 62-76）报告便秘症状评估量表出现临床相关改善（>0.5分；两项研究）；195例可评估患者中133例（68%，95% CI 62-75）报告肠道功能指数出现临床相关改善（终点评分≥12分；两项研究）。所有疗效结果均未发现显著异质性。因不良反应停药患者的合并比例为6.1%（95% CI 3.8%至8.4%）。结论：本研究结果支持使用纳洛西醇治疗对泻药无应答的癌痛患者OIC。

原文链接：

Naloxegol for the Treatment of Opioid-Induced Constipation in Patients with Cancer Pain: A Pooled Analysis of Real-World Data