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CD2用于预防头颈部肿瘤患者口腔黏膜炎的多中心随机研究。

CD2 for Prevention of Oral Mucositis in Patients With Head and Neck Tumors: A Multicentric Randomized Study.

作者信息

DE Sanctis Vitaliana, Belgioia Liliana, Cante Domenico, LA Porta Maria R, Caspiani Orietta, Guarnaccia Roberta, Argenone Angela, Muto Paolo, Musio Daniela, DE Felice Francesca, Maurizi Francesca, Bunkhelia Feisal, Ruo Redda Maria Grazia, Reali Alessia, Valeriani Maurizio, Osti Mattia F, Alterio Daniela, Bacigalupo Almalina, Russi Elvio G

机构信息

Department of Medicine and Surgery and Translational Medicine, Radiation Oncology, S. Andrea Hospital, Sapienza University of Rome, Rome, Italy

Radiation Oncology, Policlinico San Martino and University, Genoa, Italy.

出版信息

Anticancer Res. 2019 Apr;39(4):1935-1942. doi: 10.21873/anticanres.13303.

Abstract

BACKGROUND

Oropharyngeal mucositis occurs in virtually all patients with head and neck cancer receiving radiochemotherapy. The manipulation of the oral cavity microbiota represents an intriguing and challenging target.

PATIENTS AND METHODS

A total of 75 patients were enrolled to receive Lactobacillus brevis CD2 lozenges or oral care regimen with sodium bicarbonate mouthwashes. The primary endpoint was the incidence of grade 3 or 4 oropharyngeal mucositis during radiotherapy treatment.

RESULTS

There was no statistical difference in the incidence of grade 3-4 oropharyngeal mucositis between the intervention and control groups (40.6% vs. 41.6% respectively, p=0.974). The incidence of pain, dysphagia, body weight loss and quality of life were not different between the experimental and standard arm.

CONCLUSION

Our study was not able to demonstrate the efficacy of L. brevis CD2 lozenges in preventing radiation-induced mucositis in patients with head and neck cancer. Although modulating homeostasis of the salivary microbiota in the oral cavity seems attractive, it clearly needs further study.

摘要

背景

几乎所有接受放化疗的头颈癌患者都会发生口咽黏膜炎。口腔微生物群的调控是一个有趣且具有挑战性的目标。

患者与方法

共纳入75例患者,给予短双歧杆菌CD2含片或用碳酸氢钠漱口水进行口腔护理方案。主要终点是放疗期间3级或4级口咽黏膜炎的发生率。

结果

干预组和对照组3 - 4级口咽黏膜炎的发生率无统计学差异(分别为40.6%和41.6%,p = 0.974)。实验组和标准组在疼痛、吞咽困难、体重减轻和生活质量的发生率方面无差异。

结论

我们的研究未能证明短双歧杆菌CD2含片在预防头颈癌患者放射性黏膜炎方面的疗效。尽管调节口腔唾液微生物群的稳态似乎很有吸引力,但显然还需要进一步研究。

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