Topical Application of Hangeshashinto (TJ-14) in the Treatment of Chemotherapy-Induced Oral Mucositis.
Topical Application of Hangeshashinto (TJ-14) in the Treatment of Chemotherapy-Induced Oral Mucositis.
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DOI：
10.4021/wjon263w
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发表时间：
2010-12-01
影响因子：
5.2
通讯作者：
Furukawa, Hiroyuki
中科院分区：
文献类型：
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作者：
Kono, Toru;Satomi, Machiko;Furukawa, Hiroyuki
背景：化疗引起的口腔粘膜炎的最佳治疗方法尚未确定。最近的一项研究表明，hangeshashinto（TJ-14）可能是通过下调人类环氧合酶途径中的促炎素来治疗牙周病。我们的研究旨在确定TJ-14是否有效的化疗引起的口腔粘膜炎的管理方法：14例患者化疗引起的口腔粘膜炎mFOLFOX 6或FOLFIRI治疗晚期结直肠癌转移期间被随机分配到局部TJ-14治疗7天，每天三次。患者将2.5 g TJ-14溶于自来水中，制备50 ml溶液，冲洗口腔粘膜5秒以上，然后将其吐出。TJ-14也用棉球局部涂敷在粘膜病变处。在TJ-14治疗一周前后，使用不良事件通用术语标准第4版评估口腔粘膜炎的严重程度。结果：在TJ-14局部治疗一周后，14名患者中的13名（92.8%）显示口腔粘膜炎改善，平均CTCAE等级显著降低（P = 0.0012）。与基线相比，没有患者的CTCAE等级恶化。TJ-14治疗的依从性好，副作用从TJ-14没有observed.CONCLUSIONS：TJ-14的局部应用可能有治疗作用，化疗引起的口腔粘膜炎患者通过下调促炎性前列腺素。一个前瞻性的，随机的，对照的，双盲的研究是必要的，以确认这项开放标签，试点研究的结果。
BACKGROUND: The optimal treatment of chemotherapy-induced oral mucositis is not well established. A recent study showed that hangeshashinto (TJ-14) might be useful for periodontal disease via downregulating pro-inflammatory prostaglandins in the cyclooxygenase pathway in human. Our study aimed to determine whether TJ-14 is effective in the management of chemotherapy-induced oral mucositis.METHODS: Fourteen patients afflicted with chemotherapy-induced oral mucositis during mFOLFOX6 or FOLFIRI treatment for metastasis of advanced colorectal cancer were randomly assigned to topical TJ-14 treatment thrice daily for 7 days. Patients prepared a 50 ml solution with 2.5 g of TJ-14 dissolved in tap water and rinsed their oral mucosa for more than 5 seconds and then expectorated it. TJ-14 was also topically applied with a cotton pellet on the mucosal lesions. The severity of oral mucositis was evaluated using the Common Terminology Criteria for Adverse Events version 4 before and after one-week TJ-14 treatment.RESULTS: After the one-week topical treatment with TJ-14, thirteen of the fourteen patients (92.8 %) showed improvements in oral mucositis, with significantly decreased mean CTCAE grades (P = 0.0012). Compared to baseline, none of the patients' CTCAE grades worsened. The compliance of TJ-14-treatment was good and side effects from TJ-14 were not observed.CONCLUSIONS: Topical application of TJ-14 may have therapeutic effects in patients with chemotherapy-induced oral mucositis via downregulation of pro-inflammatory prostaglandins. A prospective, randomized, controlled, double-blind studies are necessary to confirm the findings of this open-label, pilot study.