• 国家药监局综合司 国家卫生健康委办公厅
  • 国家药监局综合司 国家卫生健康委办公厅

Clinical study of recombinant human granulocyte-macrophage colony-stimulating factor combined with bifidobacterium in treatment of oral mucositis after chemotherapy
Lan? Qinghua 1, Zeng Qingfang 1, Xiao Wei 2, Zhan Tao 1,Zhong Jianming 1, Qiu Liujin 1

DOI: 10.12201/bmr.202505.00045
Statement: This article is a preprint and has not been peer-reviewed. It reports new research that has yet to be evaluated and so should not be used to guide clinical practice.
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    Abstract: Objective: To investigate the clinical efficacy of recombinant human granulocyte-macrophage colony-stimulating factor (rhGM-CSF) combined with bifidobacterium in the treatment of oral mucositis after chemotherapy. Methods: 60 patients with oral mucositis after chemotherapy treated in Ganzhou Cancer Hospital from 2022.08 to 2024.12 were selected and divided into group observation and group control, n=30. The group control was gargled with rhGM-CSF, and the observation group was orally supplemented with bifidobacterium triplex viable tablets. After 2 weeks of treatment, the clinical efficacy, symptom score, inflammatory factor level, oral microecological index and treatment safety were evaluated. Results: The group observation total effective rate was higher than group control (P<0.05). Group observation symptom scores including edema, congestion, ulcer and visual analogue scale (VAS) were lower than group control (P<0.05). The group observation inflammatory factors toll-like receptor 4(TLR4), Galectin-3 (Galectin-3) and interleukin-8 (IL-8) were lower than group control (P<0.05). the oral microflora including Lactobacillus and bifidobacterium in observation group were higher than those in control group, while porphyromonas gingivalis and Forsetanella were lower than group control (P<0.05). There difference was no incidence of adverse reactions between the two groups (P>0.05). Conclusion: Recombinant human granulocyte-macrophage colony-stimulating factor combined with bifidobacterium has significant clinical efficacy in the treatment of oral mucositis after chemotherapy, which can reduce the symptoms of patients, inhibit the expression of inflammatory factors, improve the oral microecological, and the treatment is safe.

    Key words: chemotherapy; Oral mucositis; Bifidobacterium; Recombinant human granulocyte-macrophage colony-stimulating factor; Clinical effect; Oral microecology

    Submit time: 29 May 2025

    Copyright: The copyright holder for this preprint is the author/funder, who has granted biomedRxiv a license to display the preprint in perpetuity.
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[authors missed]. Clinical study of recombinant human granulocyte-macrophage colony-stimulating factor combined with bifidobacterium in treatment of oral mucositis after chemotherapy
Lan? Qinghua 1, Zeng Qingfang 1, Xiao Wei 2, Zhan Tao 1,Zhong Jianming 1, Qiu Liujin 1. 2025. biomedRxiv.202505.00045

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