Center for Prevention and Cure of Breast Diseases, Maternal and Child Health Hospital, Haidian District, Beijing, 100080, China.
Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Radiology, Peking University Cancer Hospital and Institute, Beijing, China.
Sci Rep. 2022 Oct 6;12(1):16692. doi: 10.1038/s41598-022-20756-w.
Although oral probiotics can improve breast microecology and alleviate the inflammatory response, there are no data regarding cases with existing abscesses. We aimed to investigate the effect of Lactobacillus fermentum CECT5716 during needle aspiration in patients with lactational breast abscesses. Patients (aged 20-41 years) with lactational single-cavity breast abscesses (diameter 3-6 cm) from 12 hospitals were randomly assigned to the experimental (n = 51) and control groups (n = 50). Outcome measures included the abscess cure rate on treatment day-5, delactation rate, relieving pain rate, and number of needle aspirations until day-28. The experimental group's 5-day cure rate (43.1%) was significantly higher (p < 0.05). Breastfeeding continuation on day-5 did not differ significantly (experimental group: 88.2%, control group: 96.0%, p = 0.269). In the experimental and control groups, 19.6% and 14.0% of patients experienced moderate to severe pain on day-5, respectively, with no statistically significant differences (p = 0.451). Four patients in each group developed diarrhea, with adverse reaction rates of 7.84% and 8.0%, respectively. No adverse reactions were reported in the infants. L. fermentum can shorten the healing time in patients with lactational breast abscesses.Trial registration This study was registered in the Chinese Clinical Trial Registry ( http://www.chictr.org.cn ), registration number: ChiCTR2000032682, registration date: 6/May/ 2020; first entry date: 11/May/2020.
虽然口服益生菌可以改善乳房微生态，缓解炎症反应，但对于已有脓肿的病例尚无数据。我们旨在研究在哺乳期乳腺脓肿患者中行针吸时使用发酵乳杆菌 CECT5716 的效果。来自 12 家医院的年龄在 20-41 岁之间的哺乳期单房乳腺脓肿（直径 3-6cm）患者被随机分为实验组（n=51）和对照组（n=50）。观察指标包括治疗第 5 天的脓肿治愈率、退乳率、缓解疼痛率和第 28 天前的针吸次数。实验组第 5 天的治愈率（43.1%）明显更高（p<0.05）。第 5 天继续母乳喂养的比例无显著差异（实验组：88.2%，对照组：96.0%，p=0.269）。实验组和对照组分别有 19.6%和 14.0%的患者在第 5 天出现中度至重度疼痛，差异无统计学意义（p=0.451）。两组各有 4 例患者出现腹泻，不良反应发生率分别为 7.84%和 8.0%。婴儿未出现不良反应。发酵乳杆菌可缩短哺乳期乳腺脓肿患者的愈合时间。
试验注册 本研究在中国临床试验注册中心（http://www.chictr.org.cn）注册，注册号：ChiCTR2000032682，注册日期：2020 年 5 月 6 日；首次入组日期：2020 年 5 月 11 日。
