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半夏泻心汤延缓下咽或喉癌患者二级放疗所致黏膜炎发展的有效性：一项随机临床试验的初步结果

Effectiveness of Hangeshashinto in delaying grade 2 radiotherapy-induced mucositis development in patients with hypopharyngeal or laryngeal cancer: Preliminary finding of a randomized clinical trial.

作者信息

Kawashita Yumiko, Umeda Masahiro, Murata Maho, Yoshimatsu Masako, Shiraishi Chiaki, Omori Aya, Yamazaki Takuya, Nishi Hideaki, Soutome Sakiko, Ukai Takashi, Toya Ryo, Kumai Yoshihiko

机构信息

Department of Oral Health, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.

Division of Research and Treatment for Oral and Maxillofacial Congenital Anomalies, School of Dentistry, Aichi Gakuin University, Aichi, Japan.

出版信息

Medicine (Baltimore). 2025 Jun 13;104(24):e42870. doi: 10.1097/MD.0000000000042870.

DOI:10.1097/MD.0000000000042870
PMID:40527845
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12173290/
Abstract

BACKGROUND

The efficacy of Hangeshashinto (TJ-14) during radiotherapy administration in patients with head and neck cancer remains unknown. We investigated the effectiveness of TJ-14 in delaying grade 2 radiotherapy-induced mucositis development in patients with hypopharyngeal or laryngeal cancer.

METHODS

The trial involved 28 participants, allocated in a 1:1 ratio, to either the control or intervention group using a stratified randomization method adjusted for primary cancer location and treatment type.

RESULTS

Kaplan-Meier curves showed that the 50% incidence rate of grade 2 pharyngeal mucositis between the intervention and control group (46 Gy vs 34 Gy, P = .49). Six participants in the intervention group stopped taking TJ-14 during the development of grade 1 pharyngeal mucositis (mean oral medication period: 2.7 days).

CONCLUSION

The findings of this single-center randomized clinical trial showed that taking TJ-14 from the onset of grade 1 mucositis tended to delay the development of grade 2 mucositis. However, patient compliance was poor in the intervention group. Therefore, multicenter randomized controlled trials should be planned with considering the low compliance of this population to understand the effectiveness of TJ-14.

摘要

背景

在头颈部癌患者的放射治疗期间，半夏泻心汤（TJ - 14）的疗效尚不清楚。我们研究了TJ - 14在延迟下咽或喉癌患者2级放射性粘膜炎发生方面的有效性。

方法

该试验纳入28名参与者，采用根据原发癌位置和治疗类型调整的分层随机化方法，以1:1的比例分配到对照组或干预组。

结果

Kaplan - Meier曲线显示，干预组和对照组之间2级咽部粘膜炎的发生率为50%（46 Gy对34 Gy，P = 0.49）。干预组中有6名参与者在1级咽部粘膜炎发生期间停止服用TJ - 14（平均口服药物时间：2.7天）。

结论

这项单中心随机临床试验的结果表明，从1级粘膜炎发作开始服用TJ - 14倾向于延迟2级粘膜炎的发生。然而，干预组的患者依从性较差。因此，应考虑到该人群的低依从性，计划开展多中心随机对照试验，以了解TJ - 14的有效性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ef05/12173290/64656447a25b/medi-104-e42870-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ef05/12173290/2cdaffee2b81/medi-104-e42870-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ef05/12173290/64656447a25b/medi-104-e42870-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ef05/12173290/2cdaffee2b81/medi-104-e42870-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ef05/12173290/64656447a25b/medi-104-e42870-g002.jpg

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本文引用的文献

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Hangeshashinto for prevention of oral mucositis in patients undergoing hematopoietic stem cell transplantation: a randomized phase II study.汉方制剂化肌饮防治造血干细胞移植患者口腔黏膜炎的随机Ⅱ期临床研究。
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Efficacy of Cryotherapy and Hangeshashinto for Radiation-induced Oral Stomatitis: Preliminary Study.冷冻疗法和汉方药治疗放射性口腔炎的疗效：初步研究。
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MASCC/ISOO 临床实践指南：癌症治疗相关黏膜炎的管理。
Cancer. 2020 Oct 1;126(19):4423-4431. doi: 10.1002/cncr.33100. Epub 2020 Jul 28.
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Oral management strategies for radiotherapy of head and neck cancer.头颈部癌放疗的口腔管理策略
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Effectiveness of a comprehensive oral management protocol for the prevention of severe oral mucositis in patients receiving radiotherapy with or without chemotherapy for oral cancer: a multicentre, phase II, randomized controlled trial.接受放化疗或单纯放疗治疗口腔癌患者中，综合性口腔管理方案预防重度口腔黏膜炎的有效性：一项多中心、二期、随机对照试验。
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Kampo (Traditional Japanese Herbal) Formulae for Treatment of Stomatitis and Oral Mucositis.用于治疗口腔炎和口腔黏膜炎的汉方（传统日本草药）配方。
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