Naldemedine for opioid-induced constipation in patients receiving palliative care: A real-world registry study (Phase-R OIC Study).
Naldemedine for opioid-induced constipation in patients receiving palliative care: A real-world registry study (Phase-R OIC Study).
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纳尔德米定治疗接受姑息治疗的患者中阿片类药物引起的便秘：一项真实世界注册研究（R 期 OIC 研究）。
DOI：
10.1200/jco.2019.37.15_suppl.11582
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发表时间：
2019
影响因子：
45.3
通讯作者：
E. Satomi
中科院分区：
文献类型：
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作者：
Masaki Shimizu;Takaomi Kessoku;H. Ishiki;Tetsuya Matsuura;Yusuke Hiratsuka;Y. Matsuda;Takaaki Hasegawa;Kengo Imai;Isseki Maeda;S. Oyamada;E. Satomi
11582背景：尽管纳地美丁是一种新型外周作用μ阿片受体拮抗剂，已被批准用于阿片类药物诱导的便秘（OIC）的治疗，但其在真实的临床实践中的安全性和有效性尚不清楚。研究方法：我们于2018年4月至12月在日本的14家医院姑息治疗团队和住院姑息治疗单位进行了一项真实的世界登记研究。接受纳地美汀治疗OIC的连续性癌症患者参加了一项为期7天的观察性研究。所有治疗和评估程序均按照公认的临床实践进行。该研究的主要结果是在初始给药纳地美定后24小时内经历自发排便的患者比例。根据不良事件通用术语标准（CTCAE）版本4.0报告表明与纳地美定治疗可能或更强因果关系的不良事件。结果：共有204例患者入组研究。患者的平均年龄为63±14岁，103例（50.5%）为男性。最常见的原发部位是肺（23.5%），其次是胃肠道（13.7%）和泌尿系统（9.3%）。接受积极癌症治疗的患者比例为59.9%。羟考酮是最常使用的常规阿片类药物（n = 115，56.4%），阿片类药物的中位口服吗啡等效日剂量为30 mg（四分位数间距：20-60 mg）。氧化镁（64.2%）和番泻叶（17.2%）用作伴随泻药。所有患者均接受0.2 mg纳地美丁口服，每日一次。大多数患者（90.2%）完成了7天观察。146例患者在首次给药后24小时内观察到自发排便（71.6%，95%可信区间65.4-77.8%）。近三分之二的患者在服用纳地美定后的一周内出现自发排便频率增加。最常见的不良事件为腹泻（CTCAE 1-2级，35例; 3级，1例）和腹痛（CTCAE 1-2级，10例; 3级，1例）。未报告包括胃肠道穿孔在内的严重不良事件。结论：在真实的世界肿瘤学和姑息治疗环境中，纳地美定治疗阿片类药物诱导的便秘是安全有效的。临床试验信息：UMIN 000031381。
11582 Background: Although naldemedine, a new peripherally-acting mu-opioid receptor antagonist, was approved for the management of opioid-induced constipation (OIC), its safety and effectiveness in real world clinical practice is unknown. Methods: We conducted a real world registry study in 14 hospital palliative care teams and inpatient palliative care units in Japan between April and December 2018. Consecutive cancer patients who received naldemedine for OIC were enrolled in a 7-day observational study. All treatment and assessment procedures were performed according to the accepted clinical practice. The primary outcome of the study was the proportion of patients who experienced spontaneous bowel movement within 24 hours after the initial administration of naldemedine. Adverse events, which indicated a possible or stronger causal relationship with naldemedine treatment, were reported according to the Common Terminology Criteria for Adverse Events (CTCAE) ver 4.0. Results: Overall, 204 patients were enrolled in the study. The mean age of the patients was 63±14 years, and 103 (50.5%) were male. The most common primary cancer site was lung (23.5%), followed by gastrointestinal (13.7%), and urological organs (9.3%). The proportion of patients undergoing active cancer treatment was 59.9%. Oxycodone was the most frequently used regular opioid (n = 115, 56.4%), and the median oral morphine-equivalent daily dose of opioids was 30 mg (interquartile range: 20-60 mg). Magnesium oxide (64.2%) and Senna (17.2%) were used as concomitant laxatives. All patients received 0.2 mg of naldemedine orally once daily. Most patients (90.2%) completed the 7-day observation. In 146 patients, spontaneous bowel movement was observed within 24 hour after the first administration of naldemedine (71.6%, 95% confidence interval 65.4-77.8%). Nearly two-thirds of the patients experienced increased frequency of spontaneous bowel movement in the week after naldemedine administration. The most prevalent adverse events were diarrhea (CTCAE grade 1-2, 35 cases; grade 3, 1 case) and abdominal pain (CTCAE grade 1-2, 10 cases; grade 3, 1 case). No serious adverse events including gastrointestinal perforation were reported. Conclusions: Naldemedine for opioid-induced constipation is safe and effective in the real world oncology and palliative care settings. Clinical trial information: UMIN000031381.