用于接受高侵袭性手术的癌症患者围手术期精神症状的 yokukansan。J-SUPPORT 1605（ProD 研究）：一项随机对照试验的研究方案。

Yokukansan for perioperative psychiatric symptoms in cancer patients undergoing high invasive surgery. J-SUPPORT 1605 (ProD Study): study protocol for a randomized controlled trial.

作者信息

Wada Saho, Sadahiro Ryoichi, Matsuoka Yutaka J, Uchitomi Yosuke, Yamaguchi Takuhiro, Shimizu Ken

机构信息

Department of Psycho-Oncology, National Cancer Center Hospital, 5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan.

Division of Health Care Research, Behavioral Sciences and Survivorship Research Group, Center for Public Health Sciences, National Cancer Center Japan, 5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan.

出版信息

Trials. 2019 Feb 8;20(1):110. doi: 10.1186/s13063-019-3202-1.

DOI:10.1186/s13063-019-3202-1

PMID:30736826

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6368807/

Abstract

BACKGROUND

Preoperative anxiety and postoperative delirium affect both short- and long-term prognoses in patients with cancer; therefore, these conditions require early prevention and treatment. However, no standard preventive or therapeutic methods have been established for them. Yokukansan, a Japanese herbal medicine for the treatment of insomnia and anxiety, causes relatively few adverse drug reactions and effectively improves the behavioral and psychological symptoms of dementia. Thus, it is expected to be useful for treating and/or preventing perioperative psychiatric symptoms in patients with cancer. The objective of this study is to clarify the therapeutic effect of Yokukansan for preoperative anxiety and its preventive effect on postoperative delirium in cancer patients, as well as to confirm its safety profile.

METHODS

This study is a randomized, double-blind, placebo-controlled study in cancer patients scheduled to undergo tumor resection. Patients who provide consent are randomly allocated to receive oral administration of Yokukansan or placebo, and study drug administration is continued for 4 days or longer prior to surgery. We defined two primary endpoints, change in preoperative anxiety and incidence of postoperative delirium. Secondary endpoints are severity score of postoperative delirium, duration of postoperative delirium, amount of benzodiazepines used prior to surgery, amount of antipsychotic agents used after surgery, and number of postoperative hospitalization days. We plan to complete the analysis on March 31, 2021. The target number of registered patients is 110 per group, or 220 in total.

DISCUSSION

This study is the first randomized, double-blind, placebo-controlled study intended to clarify the effects of a Japanese herbal medicine, Yokukansan, in the prevention and treatment of perioperative psychiatric symptoms in patients with cancer. The trial was initiated on August 14, 2017, with 195 subjects randomized by October 5, 2018.

TRIAL REGISTRATION

UMIN Clinical Trials Registry (UMIN-CTR), UMIN000027561 . Registered on 31 May 2017.

摘要

背景

术前焦虑和术后谵妄会影响癌症患者的短期和长期预后；因此，这些情况需要早期预防和治疗。然而，尚未建立针对它们的标准预防或治疗方法。 yokukansan是一种用于治疗失眠和焦虑的日本草药，药物不良反应相对较少，可有效改善痴呆症的行为和心理症状。因此，有望用于治疗和/或预防癌症患者围手术期的精神症状。本研究的目的是阐明yokukansan对癌症患者术前焦虑的治疗效果及其对术后谵妄的预防作用，并确认其安全性。

方法

本研究是一项针对计划接受肿瘤切除术的癌症患者的随机、双盲、安慰剂对照研究。提供同意的患者被随机分配接受yokukansan或安慰剂口服给药，并且在手术前持续4天或更长时间进行研究药物给药。我们定义了两个主要终点，即术前焦虑的变化和术后谵妄的发生率。次要终点包括术后谵妄的严重程度评分、术后谵妄的持续时间、手术前使用的苯二氮卓类药物的量、手术后使用的抗精神病药物的量以及术后住院天数。我们计划于2021年3月31日完成分析。每组登记患者的目标数量为110名，总共220名。