Efficacy of herbal medicine TJ-14 for acute radiation-induced enteritis: a multi-institutional prospective Phase II trial
Efficacy of herbal medicine TJ-14 for acute radiation-induced enteritis: a multi-institutional prospective Phase II trial
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DOI：
10.1093/jrr/rrz025
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发表时间：
2020-01-01
影响因子：
2
通讯作者：
Shibamoto, Yuta
中科院分区：
文献类型：
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作者：
Murai, Taro;Matsuo, Masayuki;Shibamoto, Yuta
这项多机构II期试验研究的目的是前瞻性地研究草药TJ-14对急性放射性肠炎(ARE)的疗效。口服TJ-14作为ARE的一线治疗。主要终点是1周时的疗效。次要终点是：(I)TJ-14在用药后2周和3周的疗效，(Ii)用药后1、2和3周的生活质量评分(FACT-G)，以及(Iii)不良事件。如果在8名或更少的患者中观察到TJ-14的疗效，则其疗效被拒绝。结果：共纳入40例接受盆腔放疗的患者。其中，22架是TJ-14研制和接收的。其中19人患有宫颈癌，9人接受放化疗。22例患者中有19例(86%)表现出TJ-14有效。1周时每日排便次数明显减少(平均+/-SD：4.9+/-2.1vs 3.7+/-1.9，P=0.02)。2周(2.2+/-1.4，P=0.004.0 5)和3周(2.1+/-0.9，P=0.0 5)继续起作用。22例患者中有13例(59%)持续TJ-14直到放射治疗结束。服用TJ-14后，未观察到FACT-G评分恶化。观察到4名患者出现1级低钾血症，3名患者出现1级便秘。我们得出结论，TJ-14足够有希望在III期试验中进行检查。目前正在计划一项随机对照试验。
The purpose of this multi-institutional Phase II trial study was to prospectively investigate the efficacy of the herbal medicine TJ-14 for acute radiation-induced enteritis (ARE). TJ-14 was administered orally as a first-line treatment for ARE. The primary end point was efficacy at 1 week. The secondary end points were: (i) the efficacy of TJ-14 at 2 and 3 weeks after its administration, (ii) the quality of life score (FACT-G) at 1, 2 and 3 weeks after its administration, and (iii) adverse events. If the efficacy of TJ-14 was observed in eight patients or fewer, its efficacy was rejected. Results: Forty patients receiving pelvic radiotherapy were enrolled. Of these, 22 developed ARE and received TJ-14. Among these, 19 had cervical cancer and 9 received chemoradiotherapy. TJ-14 efficacy was shown in 19 out of the 22 patients (86%). Stool frequency per day at 1 week significantly decreased (mean +/- SD: 4.9 +/- 2.1 vs 3.7 +/- 1.9, P = 0.02). This effect continued at 2 (2.2 +/- 1.4, P = 0.004) and 3 weeks (2.1 +/- 0.9, P = 0.05). Thirteen out of the 22 patients (59%) continued TJ-14 until the end of radiotherapy. FACT-G score deterioration was not observed after the administration of TJ-14. Grade 1 hypokalemia was observed in 4 patients, and Grade 1 constipation in 3. We concluded that TJ-14 is sufficiently promising to be examined in a Phase III trial. A randomized controlled trial is currently being planned.