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舞茸 D 组分对同期放化疗中晚期喉咽癌的疗效:一项随机临床试验。

Effect of Maitake D-fraction in advanced laryngeal and pharyngeal cancers during concurrent chemoradiotherapy: A randomized clinical trial.

机构信息

Department of Otolaryngology, Wuxi No.2 People's Hospital, No. 68 Zhongshan Road, Wuxi 214002, Jiangsu, China.

出版信息

Acta Biochim Pol. 2022 Sep 7;69(3):625-632. doi: 10.18388/abp.2020_5996.

DOI:10.18388/abp.2020_5996
PMID:36070433
Abstract

BACKGROUND

Concurrent chemo-radiotherapy (CCRT) is an ideal treatment for advanced head and neck squamous cell carcinoma (HNSCC). The performance of CCRT induces severe toxicities in HNSCC patients and decreases the quality of life (QOL). Maitake D-Fraction is proteoglycan which has anti-tumor function associated with its immunomodulatory capacity. The polysaccharides of Maitake also have anti-radiation effect in radiation therapy during cancer treatment. This research aimed to illustrate Maitake D-Fraction effects on CCRT-associated adverse events and QOL.

METHODS

During CCRT, Maitake capsules were taken orally 3 times a day, each time 4 capsules, one hour before meals. QOL were analyzed by EORTC QLQ-C30-Chinese version and EORTC QLQ-HandN-35-Chinese version. 141 patients were recruited and divided into an intervention group and a placebo group.

RESULTS

Frequencies of severe CCRT-associated adverse events in intervention group were less than in placebo group. Global QOL score in intervention group was higher than in placebo group 5 weeks post treatment. The proportion of patients returning to baseline global QOL score at 6-month was increased by Maitake D-Fraction administration.

CONCLUSION

In conclusion, this randomized clinical trial demonstrated that in advanced laryngeal and pharyngeal cancer patients, the oral administration of Maitake D-Fraction alleviated CCRT-related adverse events and deterioration in QOL.

摘要

背景

同期放化疗(CCRT)是治疗晚期头颈部鳞状细胞癌(HNSCC)的理想方法。CCRT 治疗会导致 HNSCC 患者出现严重毒性反应,并降低生活质量(QOL)。舞茸 D 片段是一种糖蛋白,具有抗肿瘤功能,与其免疫调节能力有关。舞茸多糖在癌症治疗的放射治疗中也具有抗辐射作用。本研究旨在阐明舞茸 D 片段对 CCRT 相关不良事件和 QOL 的影响。

方法

在 CCRT 期间,每天口服舞茸胶囊 3 次,每次 4 粒,饭前 1 小时服用。采用 EORTC QLQ-C30-中文版和 EORTC QLQ-HandN-35-中文版分析 QOL。共招募 141 例患者,分为干预组和安慰剂组。

结果

干预组严重 CCRT 相关不良事件的发生率低于安慰剂组。治疗后 5 周,干预组的全球 QOL 评分高于安慰剂组。舞茸 D 片段的使用增加了 6 个月时恢复基线全球 QOL 评分的患者比例。

结论

总之,这项随机临床试验表明,在晚期喉癌和咽癌患者中,口服舞茸 D 片段可减轻 CCRT 相关的不良反应和 QOL 恶化。

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