Department of Psycho-Oncology, National Cancer Center Hospital, National Cancer Center Japan, Tokyo, Japan.
Department of Psychiatry, Juntendo University Nerima Hospital, Tokyo, Japan.
Jpn J Clin Oncol. 2023 Aug 30;53(9):851-857. doi: 10.1093/jjco/hyad061.
Postoperative delirium is an important issue in cancer patients, affecting surgical outcomes and the quality of life. Ramelteon is a melatonin receptor agonist with high affinity for MT1 and MT2 receptors. Clinical trials and observational studies in Japan, including in surgical cancer patients, have shown efficacy of ramelteon in delirium prevention, with no serious safety concerns. However, clinical trials from the USA have reported conflicting results. A Japanese phase II study investigated the efficacy and safety of ramelteon for delirium prevention following gastrectomy in patients aged ≥75 years, with findings suggesting the feasibility of a phase III trial. The aim of this multi-centre, double-blind, randomized placebo-controlled phase III trial is to evaluate the effectiveness and safety of oral ramelteon for postoperative delirium prevention in cancer patients aged ≥65 years as advanced medical care. The trial protocol is described here.
术后谵妄是癌症患者的一个重要问题，影响手术结果和生活质量。雷美替胺是一种褪黑素受体激动剂，对 MT1 和 MT2 受体具有高亲和力。日本的临床试验和观察性研究，包括在外科癌症患者中，已经显示了雷美替胺在预防谵妄方面的疗效，且没有严重的安全性问题。然而，来自美国的临床试验报告了相互矛盾的结果。一项日本的 II 期研究调查了雷美替胺在预防≥75 岁接受胃切除术的患者术后谵妄方面的疗效和安全性，研究结果表明进行 III 期试验是可行的。这项多中心、双盲、随机安慰剂对照 III 期试验的目的是评估口服雷美替胺预防≥65 岁癌症患者术后谵妄的有效性和安全性，作为高级医疗护理。本试验方案在此描述。
Zotero 插件