Taira Kenkichiro, Fujiwara Kazunori, Fukuhara Takahiro, Koyama Satoshi, Takeuchi Hiromi
Division of Otolaryngology, Head and Neck Surgery, Department of Sensory and Motor Organs, School of Medicine, Faculty of Medicine, Tottori University, Yonago 683-8504, Japan.
Yonago Acta Med. 2020 Aug 20;63(3):183-187. doi: 10.33160/yam.2020.08.007. eCollection 2020 Aug.
Oral mucositis (OM) is a side effect of chemotherapy in head and neck cancer. Severe OM often has a large impact on quality of life. Therefore, the treatment of OM during chemotherapy is very important. It was recently reported that Hangeshashinto (TJ-14), a Japanese traditional medicine (Kampo), is effective for OM caused by fluorinated pyrimidine-based agents used in colon cancer. We investigated the efficacy of TJ-14 for OM.
We enrolled patients with head and neck cancer who were treated with induction chemotherapy between September 2014 and March 2016. In this double-blind trial, patients were randomly assigned to the TJ-14 group or placebo group. Patients were instructed to dissolve 2.5 g of TJ-14 or placebo in 100 ml of drinking water, rinse their mouths with the solution for 30 s and then spit it out. They were not allowed to eat anything for 30 minutes before or after using the mouthwash.
The incidence of ≥ grade 2 OM was 37.5% (three patients) in the TJ-14 group and 50.0% (four patients) in the placebo group, with no significant difference between the two groups. The mean day of onset was 9.7 in the TJ-14 group and 6.7 in the placebo group. The mean duration of ≥ grade 2 OM was 1.3 days in the TJ-14 group and 3.7 days in the placebo group. Thus TJ-14 significantly reduced the duration of ≥ grade 2 OM.
Treatment of OM with TJ-14 was associated with a statistically significant reduction in the duration of ≥ grade 2 OM compared to placebo. Gargling with TJ-14 is a safe and effective method of administering the drug to patients with head and neck cancer.
口腔黏膜炎（OM）是头颈癌化疗的一种副作用。严重的OM常常对生活质量有很大影响。因此，化疗期间OM的治疗非常重要。最近有报道称，日本传统医学（汉方）方剂“半夏泻心汤”（TJ - 14）对结肠癌中使用的氟嘧啶类药物所致的OM有效。我们研究了TJ - 14对OM的疗效。
我们纳入了2014年9月至2016年3月期间接受诱导化疗的头颈癌患者。在这项双盲试验中，患者被随机分配到TJ - 14组或安慰剂组。患者被指导将2.5克TJ - 14或安慰剂溶解于100毫升饮用水中，用该溶液漱口30秒后吐出。在使用漱口水前后30分钟内不允许进食任何东西。
TJ - 14组≥2级OM的发生率为37.5%（3例患者），安慰剂组为50.0%（4例患者），两组之间无显著差异。TJ - 14组≥2级OM的平均发病日为9.7天，安慰剂组为6.7天。TJ - 14组≥2级OM的平均持续时间为1.3天，安慰剂组为3.7天。因此，TJ - 14显著缩短了≥2级OM的持续时间。
与安慰剂相比，用TJ - 14治疗OM在统计学上显著缩短了≥2级OM的持续时间。用TJ - 14漱口是对头颈癌患者给药的一种安全有效的方法。
