Naldemedine对癌痛患者阿片类药物相关性便秘的疗效  

Efficacy of Naldemedine in opioid-induced constipation in cancer patients

作　　者：王琳[1] 王海霞[1] 盛莉[1] 陈邓林[1] 李向璐 周美凤 杨生辉[1] 孙达统[1] 邱纯[1] 李赛[1] 吴健勇 Wang Lin;Wang Haixia;Sheng Li;Chen Denglin;Li Xianglu;Zhou Meifeng;Yang Shenghui;Sun Datong;Qiu Chun;Li Sai;Wu Jianyong(Department of Medical Oncology,Hainan General Hospital(Hainan Affiliated Hospital of Hainan Medical University),Haikou 570300,China)

机构地区：[1]海南省人民医院(海南医科大学附属海南医院)肿瘤内科,海口570300

出　　处：《中华医学杂志》2025年第15期1191-1194,共4页National Medical Journal of China

基　　金：海南省重点研发计划(ZDYF2019189)。

摘　　要：本研究旨在评估口服外周阿片受体μ拮抗剂(PAMORAs)Naldemedine对癌痛患者阿片类药物相关性便秘(OIC)的疗效及安全性。研究采用单中心、单臂、前瞻性试验设计,纳入12例18岁以上、稳定接受阿片类药物镇痛治疗至少7 d且符合OIC诊断的患者,给予0.2 mg/d Naldemedine口服至少12周,最长48周。主要研究终点为治疗最初2周内的自发排便(SBM)响应者比例;次要终点包括完全自发排便(CSBM)响应者比例等疗效终点,以及安全性评估和生活质量。结果显示,治疗前2周SBM和CSBM响应比例分别为66.7%(8/12)和33.3%(4/12);治疗第2周SBM/CSBM次数较基线增加(3.8±2.7)(/1.3±1.9)次;Naldemedine首次给药24 h内至少出现1次SBM/CSBM的比例分别为66.7%(8/12)和33.3%(4/12);给药后首次出现SBM/CSBM的中位时间分别4.0和16.6 h。16.7%(2/12)的患者报告轻度治疗相关不良事件。Naldemedin治疗后癌痛OIC患者生活质量评分均较基线改善。本研究提示Naldemedin在癌痛OIC患者中具有良好的疗效和安全性。This study evaluated the efficacy and safety of Naldemedine,an oral peripheralμ-opioid receptor antagonists(PAMORAs),in cancer patients with opioid-induced constipation(OIC).A single-center,single-arm,prospective real-world trial was conducted,enrolling 12 patients aged 18 years and above who had been on stable opioid analgesic therapy for at least 7 days and met the criteria for OIC.Participants were administered 0.2 mg/d Naldemedine orally for a minimum of 12 weeks(up to 48 weeks).The primary endpoint was the proportion of spontaneous bowel movement(SBM)responders within the first two weeks of treatment.Secondary endpoints included complete SBM(CSBM)responder rates and other efficacy endpoints,as well as safety assessments and quality of life.The results demonstrated SBM and CSBM responder rates of 66.7%(8/12)and 33.3%(4/12),respectively,within the initial two weeks.The mean frequency of SBM/CSBM increased for(3.8±2.7)/(1.3±1.9)times when compared with baseline after 2-week of treatment.Notably,66.7%(8/12)and 33.3%(4/12)of patients experienced≥1 SBM or CSBM within 24 hours after the first dose,with median times to first SBM and CSBM being 4.0 and 16.6 hours post-administration.Mild treatment-related adverse events were reported in 16.7%(2/12)of patients.Naldemedine improved QoL.Naldemedine shows promising efficacy and manageable safety in cancer pain patients with OIC.

关 键 词：便秘 阿片类药物相关性便秘 癌症 Naldemedine 前瞻性研究 

分 类 号：R730.5[医药卫生—肿瘤]