Huang Tianjian1, Chen Jiaying1, Yu Jiangting1, Zhou Yiming1, Xu Leilai2, Gu Xidong21Zhejiang Chinese Medical University, Hangzhou 310053, China; 2The First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou 310006, China

Corresponding author: GUXIDONG, guxidong@163.com

DOI: 10.12201/bmr.202601.00023

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  Abstract: Objective: To observe the clinical efficacy of Lactobacillus fermentum CECT5716 combined with Yanghe Decoction in the treatment of Yin syndrome non-lactating mastitis (NLM). Methods: A total of 42 patients with Yin syndrome non-lactating mastitis admitted to The First Affiliated Hospital of Zhejiang Chinese Medical University from April 2023 to December 2024 were selected as the research objects. They were divided into two groups: the combined group (22 cases) treated with Lactobacillus fermentum CECT5716 combined with Yanghe Decoction, and the TCM group (20 cases) treated with Yanghe Decoction alone. A 12-week period was set as one course of treatment. The SF-36 Quality of Life Scale scores, TCM syndrome scores, Granulomatous Lobular Mastitis Disease Activity Index (GDMAI), and treatment effective rate were compared between the two groups. Results: After treatment, the SF-36 Quality of Life Scale scores, TCM syndrome scores, and GDMAI of patients in both groups were significantly improved compared with those before treatment. Moreover, the Role Limitations due to Physical Health (RP) scores, Social Functioning (SF) scores, percentage reduction of TCM syndrome scores, and improvement of lump texture in the combined group were more significant than those in the TCM group (P<0.05). After treatment, the treatment effective rate of the combined group (73.0%) was significantly higher than that of the TCM group (60.0%), and the difference was statistically significant (P<0.05). Conclusion: Lactobacillus fermentum CECT5716 combined with Yanghe Decoction can significantly improve the quality of life, alleviate clinical symptoms, and increase the treatment effective rate of patients with Yin syndrome non-lactating mastitis. Its effect is better than that of TCM treatment alone, and it is worthy of clinical promotion and application.

  Key words: Non-lactating Mastitis; Lactobacillus fermentum CECT5716; Yanghe Decoction; Yin Syndrome; Clinical Observation

  Submit time: 9 January 2026

  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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