Nishiba Hiromi, Imai Hisao, Fujita Yukiyoshi, Hiruta Eriko, Masuno Takashi, Yamazaki Shigeki, Tanaka Hajime, Kamiya Teruhiko, Ito Masako, Takei Satoshi, Matsuura Masato, Mogi Junnosuke, Minato Koichi, Obayashi Kyoko
Division of Pharmacy, Japan Community Health Care Organization (JCHO) Gunma Chuo Hospital, 1-7-13, Kouun, Maebashi 371-0025, Gunma, Japan.
Graduate School of Pharmaceutical Sciences, Takasaki University of Health and Welfare, 37-1, Nakaorui, Takasaki 370-0033, Gunma, Japan.
J Clin Med. 2022 May 9;11(9):2672. doi: 10.3390/jcm11092672.
The efficacy and safety of naldemedine for opioid-induced constipation in patients with cancer has not been investigated in clinical practice. We conducted a multicenter, retrospective study to assess the effects of naldemedine among 10 Japanese institutions between June 2017 and August 2019. We evaluated the number of defecations 7 days before and after naldemedine administration. A total of 149 patients (89 male) with a median age of 72 years (range, 38−96) were included. The performance status was 0−1, 2, and ≥3 in 40, 38, and 71 patients, respectively. The median opioid dose in oral morphine equivalents was 30 mg/day (range: 7.5−800 mg). We observed 98 responders and 51 non-responders. The median number of defecations increased significantly in the 7 days following naldemedine administration from three to six (p < 0.0001). Multivariate analysis revealed that an opioid dose <30 mg/day [odds ratio, 2.08; 95% confidence interval, 1.01−4.32; p = 0.042] was significantly correlated with the effect of naldemedine. Diarrhea was the most common adverse event (38.2%) among all grades. The efficacy and safety of naldemedine in clinical practice are comparable to those of prospective studies, suggesting that it is effective in most patients.
纳地美定治疗癌症患者阿片类药物所致便秘的疗效和安全性尚未在临床实践中得到研究。我们进行了一项多中心回顾性研究，以评估2017年6月至2019年8月期间日本10家机构中纳地美定的效果。我们评估了纳地美定给药前后7天的排便次数。共纳入149例患者（89例男性），中位年龄72岁（范围38 - 96岁）。体能状态为0 - 1、2和≥3级的患者分别有40例、38例和71例。口服吗啡当量的中位阿片类药物剂量为30 mg/天（范围：7.5 - 800 mg）。我们观察到98例有反应者和51例无反应者。纳地美定给药后7天内，排便次数中位数从3次显著增加至6次（p < 0.0001）。多变量分析显示，阿片类药物剂量<30 mg/天[比值比，2.08；95%置信区间，1.01 - 4.32；p = 0.042]与纳地美定的效果显著相关。腹泻是所有级别中最常见的不良事件（38.2%）。纳地美定在临床实践中的疗效和安全性与前瞻性研究相当，表明它对大多数患者有效。
