中国中西医结合杂志2025，Vol.45Issue(9)：1070-1077,8.DOI:10.7661/j.cjim.20250320.093
清肝通乳方联合益生菌治疗哺乳期急性乳腺炎随机对照试验
Qinggan Tongru Formula Combined with Probiotics for Lactational Acute Mastitis:A Randomized Controlled Trial
摘要
Abstract
Objective To observe the clinical efficacy of Qinggan Tongru Formula(QTF)and probiotics(Clostridium butyricum Capsules)alone or in combination for lactational acute mastitis(AM),and to explore their effects on breast milk microbiota.Methods A total of 177 patients with AM during lactation(Gan-Wei stagnant heat syndrome)who visited the outpatient department of First Affiliated Hospital,Zhejiang Chinese Medical University from December 2021 to June 2023 were screened,and 138 cases met the inclusion criteria.According to the random number table method,they were assigned to QTF group(Qinggan Tongru Formula,46 cases),probiotics group(Clostridium butyricum Capsules,MY group,46 cases),and combination group(QTF+Clostridium butyricum Capsules,CB group,46 cases).One week after the treatment,clinical symptoms(body temperature,breast redness/swelling area,mass size,pain score),therapeutic effect evaluation and breast milk microbiota changes were compared before and after treatment among the three groups.Results Finally,41 cases in QTF group,40 cases in MY group,and 40 cases in CB group completed the trial and were included for analyses.After 7 days of treatment the clinically cured rate of CB group(80％,32/40 cases)was significantly higher than that of MY group(50％,20/40 cases;P＜0.05).Intra-group comparisons showed that breast redness/swelling area,mass size,and pain scores were all improved significantly in the three groups after treatment(P＜0.01).Inter-group comparisons revealed that CB group had smaller mass size and lower pain scores than MY group(P＜0.05),while no significant differences were observed in fever duration or breast redness/swelling area in QTF group and CB group(P＞0.05).16S rDNA sequencing indicated that Proteobacteria,Firmicutes,and Actinobacteria were the core microbiota in breast milk.Compared with the baseline,Firmicutes and Actinobacteria abundance decreased,while Proteobacteria abundance increased in MY and CB groups,but the opposite trend was observed in QTF group.At the genus level,Streptococcus abundance decreased in MY group,and both Staphylococcus and Streptococcus decreased in CB group,with no statistical significance(P＞0.05).The abundance of Ralstonia in CB group was down-regulated after treatment(P＜0.05).No adverse reactions were observed in any group.Conclusions QTF combined with probiotics effectively alleviated local symptoms of AM patients and might regulate breast milk microbiota structures.Therefore,probiotics supplementation could be considered as an adjunct to traditional Chinese medicine in treating lactational AM.关键词
哺乳期急性乳腺炎/清肝通乳方/益生菌/乳汁微生物群/乳汁菌群/随机对照试验/中西医结合Key words
lactational acute mastitis/Qinggan Tongru Formula/probiotics/breast milk microbiota/randomized controlled trial/integrative medicine引用本文复制引用
余青红,丁海宁,陈怡安,高秀飞..清肝通乳方联合益生菌治疗哺乳期急性乳腺炎随机对照试验[J].中国中西医结合杂志,2025,45(9):1070-1077,8.基金项目
国家中医药综合改革示范区科技共建项目(No.GZY-KJS-ZJ-2025-021) （No.GZY-KJS-ZJ-2025-021）
国家自然科学基金面上项目(No.82074438) （No.82074438）
