Department of Psycho-Oncology, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan; Behavioral Sciences and Survivorship Research Group, Division of Health Care Research, Center for Public Health Sciences, National Cancer Center Japan, Chuo-ku, Tokyo, Japan.
Department of Psycho-Oncology, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan; Behavioral Sciences and Survivorship Research Group, Division of Health Care Research, Center for Public Health Sciences, National Cancer Center Japan, Chuo-ku, Tokyo, Japan; Innovation Center for Supportive, Palliative and Psychosocial Care, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan.
J Pain Symptom Manage. 2021 Jan;61(1):71-80. doi: 10.1016/j.jpainsymman.2020.07.009. Epub 2020 Aug 12.
No standard preventive or therapeutic methods have been established for preoperative anxiety and postoperative delirium in patients with cancer.
To clarify the therapeutic effect of yokukansan for perioperative psychiatric symptoms in patients with cancer as well as to confirm its safety profile.
This is a randomized, double-blind, and placebo-controlled trial conducted at a single center in Tokyo, Japan. About 195 patients with cancer scheduled to undergo tumor resection took one packet of the study drug, which was administered orally. Coprimary outcomes were change in preoperative anxiety assessed with the Hospital Anxiety and Depression Scale-Anxiety and incidence of postoperative delirium assessed with the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. Interim analysis was performed with one-third (n = 74) of the target number of registered patients.
Because this trial was canceled based on the results of the interim analysis and the protocol treatment was discontinued in patients who were already registered, conclusions were based on the full analysis set of 160 participants. There were no significant differences between groups in the change of mean Hospital Anxiety and Depression Scale-Anxiety score (intervention group [SD] 0.4 [3.0] vs. placebo group 0.5 [3.0]; P = 0.796) or the incidence of postoperative delirium (32% vs. 30%; P = 0.798). There were no serious adverse events in either group.
In patients with cancer undergoing highly invasive surgeries, yokukansan demonstrated no significant efficacy for the treatment of preoperative anxiety or the prevention of postoperative delirium. Yokukansan is already used in daily practice in Japan, but we should be careful with its future use.
目前，对于癌症患者术前焦虑和术后谵妄，尚无标准的预防或治疗方法。
阐明和汉安神剂治疗癌症患者围手术期精神症状的疗效，并确认其安全性。
这是一项在日本东京的单中心、随机、双盲、安慰剂对照试验。约 195 例计划接受肿瘤切除术的癌症患者服用了 1 包研究药物，口服给药。主要结局是使用医院焦虑抑郁量表-焦虑（HADS-A）评估术前焦虑的变化和使用精神障碍诊断与统计手册第五版（DSM-5）评估术后谵妄的发生率。在登记患者的三分之一（n=74）完成时进行了中期分析。
由于该试验根据中期分析的结果被取消，并且已经登记的患者停止了方案治疗，因此结论基于 160 名参与者的全分析集。两组间 HADS-A 评分的平均变化（干预组[SD]0.4[3.0] vs. 安慰剂组 0.5[3.0]；P=0.796）或术后谵妄的发生率（32% vs. 30%；P=0.798）均无显著差异。两组均无严重不良事件。
在接受高侵袭性手术的癌症患者中，和汉安神剂治疗术前焦虑或预防术后谵妄的疗效不显著。和汉安神剂在日本已被用于日常实践，但我们应谨慎使用。
