Double-blind, placebo-controlled, randomized phase II study of TJ-14 (hangeshashinto) for gastric cancer chemotherapy-induced oral mucositis.
Double-blind, placebo-controlled, randomized phase II study of TJ-14 (hangeshashinto) for gastric cancer chemotherapy-induced oral mucositis.
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DOI：
10.1007/s00280-014-2440-x
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发表时间：
2014-05
影响因子：
3
通讯作者：
Tsuburaya, Akira
中科院分区：
文献类型：
--
作者：
Aoyama, Toru;Nishikawa, Kazuhiro;Takiguchi, Nobuhiro;Tanabe, Kazuaki;Imano, Motohiro;Fukushima, Ryoji;Sakamoto, Junichi;Oba, Mari S.;Morita, Satoshi;Kono, Toru;Tsuburaya, Akira
Hangeshashinto(TJ-14，一种Kampo药物)，降低前列腺素E2水平并影响环氧合酶活性，缓解化疗引起的口腔粘膜炎(COM)。我们进行了一项随机比较试验，以调查TJ-14是否预防和控制胃癌患者的COM。我们随机分配了在任何化疗周期中出现中到重度口腔粘膜炎(CTCAEV4.0级≧1)的胃癌患者接受TJ-14或安慰剂作为双盲试验。从下一个疗程开始，患者根据化疗方案接受安慰剂或TJ-14治疗2-6周。主要终点是方案治疗过程中≧2级口腔黏膜炎的发生率，次要终点是口腔黏膜炎消失的时间和不良事件的发生率。在盲法方案的关键开启之后，我们使用“按方案集”分析了91名符合条件的患者(TJ-14：45，安慰剂：46)。TJ-14组和安慰剂组≧2级COM的发生率分别为40.0%和41.3%(p=0.588)。TJ-14组和安慰剂组≧2级COM的中位持续时间分别为14天和16天(p=0.894)。同时，在筛查周期中出现1级症状的患者中，TJ-14组任何级别COM的中位持续时间为9天，安慰剂组为17天[风险比0.6；95%CI(0.23-1.59)，P=0.290]。虽然TJ-14治疗不能降低在胃癌化疗期间发生粘膜炎的患者的≥-2 COM的发生率，但在筛查周期中发生1级COM的患者中，TJ-14有降低COM风险的趋势。此外，需要进行更大样本量的第三阶段研究，以阐明TJ-14对COM的保护作用。
Hangeshashinto (TJ-14, a Kampo medicine), which reduces the level of prostaglandin E2 and affects the cyclooxygenase activity, alleviates chemotherapy-induced oral mucositis (COM). We conducted a randomized comparative trial to investigate whether TJ-14 prevents and controls COM in patients with gastric cancer. We randomly assigned patients with gastric cancer who developed moderate-to-severe oral mucositis (CTCAE v4.0 grade ≧1) during any cycle of chemotherapy to receive either TJ-14 or a placebo as a double-blind trial. The patients received a placebo or TJ-14 for 2–6 weeks according to the chemotherapy regimen from the beginning of the next course of chemotherapy. The primary end point was the incidence of grade ≧2 oral mucositis in the protocol treatment course, and the secondary end points were the time to disappearance of oral mucositis and the incidence of adverse events. Following the key opening of the blinding protocol, we analyzed 91 eligible patients (TJ-14: 45, placebo: 46) using a “per protocol set” analysis. The incidence of ≧grade 2 COM was 40.0 % in the TJ-14 group and 41.3 % in the placebo group (p = 0.588). The median duration of ≧grade 2 COM was 14 days in the TJ-14 group and 16 days in the placebo group (p = 0.894). Meanwhile, the median duration of any grade of COM was 9 days in the TJ-14 group and 17 days in the placebo group among the patients who developed grade 1 symptoms during the screening cycle [hazard ratio 0.60; 95 % CI (0.23–1.59), p = 0.290]. Although TJ-14 treatment did not reduce the incidence of ≥2 COM in the patients who developed mucositis during chemotherapy for gastric cancer, a trend was observed in which TJ-14 reduced the risk of COM in the patients who developed grade 1 COM during the screening cycle. Further, phase III studies with a larger sample size are needed to clarify the protective effects of TJ-14 for COM.
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影响因子：
2
作者：
Kase, Y;Saitoh, K;Komatsu, Y
通讯作者：
Komatsu, Y
影响因子：
3
作者：
Mori, K;Kondo, T;Tominaga, K
通讯作者：
Tominaga, K
影响因子：
4.8
作者：
Logan, Richard M.;Gibson, Rachel J.;Keefe, Dorothy M. K.
通讯作者：
Keefe, Dorothy M. K.
影响因子：
5.2
作者：
Kono, Toru;Satomi, Machiko;Furukawa, Hiroyuki
通讯作者：
Furukawa, Hiroyuki
影响因子：
7.9
作者：
Lantz, R. C.;Chen, G. J.;Timmermann, B. N.
通讯作者：
Timmermann, B. N.