理气剂预防肺癌患者化疗引起的恶心和呕吐:两项前瞻性随机2期试验的结果
Rikkunshito for Preventing Chemotherapy-Induced Nausea and Vomiting in Lung Cancer Patients: Results from 2 Prospective, Randomized Phase 2 Trials.
作者信息
Harada Toshiyuki, Amano Toraji, Ikari Tomoo, Takamura Kei, Ogi Takahiro, Fujikane Toshiaki, Fujita Yuka, Taima Kageaki, Tanaka Hisashi, Sasaki Takaaki, Okumura Shunsuke, Sugawara Shunichi, Yokouchi Hiroshi, Yamada Noriyuki, Morikawa Naoto, Dosaka-Akita Hirotoshi, Isobe Hiroshi, Nishimura Masaharu
机构信息
Center for Respiratory Diseases, JCHO Hokkaido Hospital, Sapporo, Japan.
Clinical Research and Medical Innovation Center, Hokkaido University Graduate School of Medicine, Sapporo, Japan.
出版信息
Front Pharmacol. 2018 Jan 16;8:972. doi: 10.3389/fphar.2017.00972. eCollection 2017.
The herbal medicine rikkunshito has the potential to improve chemotherapy-induced nausea and vomiting (CINV) by stimulating ghrelin secretion. We aimed to evaluate the efficacy and safety of rikkunshito in preventing CINV for patients with lung cancer. Two separate prospective, randomized, phase II parallel design studies were conducted in patients with lung cancer. Fifty-eight and sixty-two patients scheduled to receive highly emetogenic chemotherapy (HEC) and moderately emetogenic chemotherapy (MEC), respectively, were randomized 1:1 to receive either standard antiemetic therapy in accordance with international guidelines (S group) or standard antiemetic therapy plus oral rikkunshito (R group). The primary endpoint was overall complete response (CR)-that is, no emesis and rescue medication in the first 120 h post-chemotherapy. Secondary endpoints included CR in the acute (0-24 h) and delayed (>24-120 h) phases and safety. Fifty-seven patients (S group, 28; R group, 29) receiving HEC and sixty-two patients (S group, 30; R group, 32) receiving MEC with comparable characteristics were evaluated. The CR rates were similar across the S and R groups for the HEC study in the overall (67.9% vs. 62.1%), acute (96.4% vs. 89.6%), and delayed (67.9% vs. 62.1%) phases, respectively, and for the MEC study in the overall (83.3% vs. 84.4%), acute (100% vs. 100%), and delayed (83.3% vs. 84.4%) phases, respectively. No severe adverse events were observed. Although rikkunshito was well tolerated, it did not demonstrate an additional preventative effect against CINV in lung cancer patients receiving HEC or MEC. This study is registered with the University Hospital Medical Information Network (UMIN) Clinical Trial Registry, identification numbers UMIN 000014239 and UMIN 000014240.
中药六君子汤有可能通过刺激胃饥饿素分泌来改善化疗引起的恶心和呕吐(CINV)。我们旨在评估六君子汤对肺癌患者预防CINV的疗效和安全性。对肺癌患者进行了两项独立的前瞻性、随机、II期平行设计研究。计划分别接受高度致吐化疗(HEC)和中度致吐化疗(MEC)的58例和62例患者,按1:1随机分组,分别接受符合国际指南的标准止吐治疗(S组)或标准止吐治疗加口服六君子汤(R组)。主要终点是总体完全缓解(CR),即在化疗后120小时内无呕吐且未使用救援药物。次要终点包括急性(0-24小时)和延迟(>24-120小时)阶段的CR以及安全性。对57例接受HEC的患者(S组28例;R组29例)和62例接受MEC且特征相当的患者(S组30例;R组32例)进行了评估。在HEC研究中,S组和R组在总体(67.9%对62.1%)、急性(96.4%对89.6%)和延迟(67.9%对62.1%)阶段的CR率分别相似,在MEC研究中,总体(83.3%对84.4%)、急性(100%对100%)和延迟(83.3%对84.4%)阶段的CR率也分别相似。未观察到严重不良事件。尽管六君子汤耐受性良好,但在接受HEC或MEC的肺癌患者中,它并未显示出对CINV的额外预防作用。本研究已在大学医院医学信息网络(UMIN)临床试验注册中心注册,识别号为UMIN 000014239和UMIN 000014240。