理气和中汤对接受基于顺铂方案治疗的子宫体癌或宫颈癌患者化疗引起的恶心和呕吐的疗效——安慰剂对照、双盲、随机验证性研究（JORTC-KMP03）
Efficacy of Rikkunshito on Chemotherapy-Induced Nausea and Vomiting in Patients With Uterine Corpus or Cervical Cancer Treated With Cisplatin-Based Regimen-Placebo-controlled, Double-Blind, Randomized Confirmatory Study (JORTC-KMP03).
作者信息
Konno Yosuke, Ohnishi Shunsuke, Minobe Shinichiro, Nomura Eiji, Nagasawa Takayuki, Fujimoto Etsuko, Ohara Tatsuru, Nishio Shin, Kato Hisamori, Yokoyama Yoshihito, Miyagi Etsuko, Tokunaga Hideki, Nishino Koji, Kikuchi Akira, Yoshida Yoshio, Iwata Takashi, Noguchi Daito, Kudaka Wataru, Oyamada Shunsuke, Ariyoshi Keisuke, Kihara Kota, Watari Hidemichi
机构信息
Hokkaido University Graduate School of Medicine, Sapporo, Japan.
Hokkaido University, Sapporo, Japan.
出版信息
Integr Cancer Ther. 2025 Jan-Dec;24:15347354251329346. doi: 10.1177/15347354251329346. Epub 2025 Mar 29.
BACKGROUND
The current standard treatment for chemotherapy-induced nausea and vomiting (CINV) with standard antiemetics is insufficient. Rikkunshito, a Japanese traditional herbal medicine, has been shown to improve cisplatin-induced anorexia and functional dyspepsia, and our exploratory study found that rikkunshito has an additive beneficial effect on CINV in patients with uterine corpus and cervical cancer receiving cisplatin containing chemotherapy (JORTC KMP-02).
METHODS
One hundred eighty patients with uterine corpus or cervical cancer who were scheduled to receive treatment with a cisplatin based regimen as initial chemotherapy were enrolled across 17 Japanese institutions. Patients were randomized with a 1:1 equal allocation ratio to the rikkunshito group or placebo groups and given oral administration on days 1 to 5 with standard antiemetics (granisetron, aprepitant, and dexamethasone). The primary endpoint was complete response (CR; no vomiting or rescue medication) during the delayed phase (24-120 hours after cisplatin treatment). The secondary endpoints were complete control (CC; CR without significant nausea) and total control (TC; CR without nausea) rates during the overall (0-120 hours), acute (0-24 hours), and delayed phases, as well as the CR rate during the overall and acute phases, time to treatment failure, degree of nausea and appetite during the overall phase, and adherence to the intervention.
RESULTS
The CR rate in the delayed phase was similar between the rikkunshito group and control groups (50.6% vs 58.9%, = .2631), as were the secondary endpoints: CR rates in the overall and acute phases, CC and TC rates in the overall, acute, and delayed phases, degrees of nausea and appetite, and time to treatment failure.
CONCLUSION
Rikkunshito had no additive effect on CINV prevention in patients with uterine corpus or cervical cancer who were treated with a cisplatin based regimen and standard antiemetics.
CLINICAL TRIAL REGISTRATION
https://jrct.mhlw.go.jp/re/reports/detail/66957, identifier jRCT1011190007.
背景
目前使用标准止吐药治疗化疗引起的恶心和呕吐（CINV）并不充分。日本传统草药理气剂已被证明可改善顺铂引起的厌食和功能性消化不良，我们的探索性研究发现，理气剂对接受含顺铂化疗的子宫体癌和宫颈癌患者的CINV有附加有益作用（JORTC KMP - 02）。
方法
180例计划接受以顺铂为基础方案进行初始化疗的子宫体癌或宫颈癌患者在17家日本机构入组。患者以1:1的等分配比例随机分为理气剂组或安慰剂组，并在第1至5天与标准止吐药（格拉司琼、阿瑞匹坦和地塞米松）一起口服给药。主要终点是延迟期（顺铂治疗后24 - 120小时）的完全缓解（CR；无呕吐或急救药物）。次要终点是总体（0 - 120小时）、急性期（0 - 24小时）和延迟期的完全控制（CC；无明显恶心的CR）和完全控制率（TC；无恶心的CR），以及总体和急性期的CR率、治疗失败时间、总体期的恶心程度和食欲，以及对干预的依从性。
结果
理气剂组和对照组在延迟期的CR率相似（50.6%对58.9%，P = 0.2631），次要终点也是如此：总体和急性期的CR率、总体、急性期和延迟期的CC和TC率、恶心和食欲程度以及治疗失败时间。
结论
理气剂对接受以顺铂为基础方案和标准止吐药治疗的子宫体癌或宫颈癌患者预防CINV没有附加作用。
临床试验注册
https://jrct.mhlw.go.jp/re/reports/detail/66957，标识符jRCT1011190007。
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