天津医药 ›› 2025, Vol. 53 ›› Issue (12): 1304-1308.doi: 10.11958/20252263

• 药物临床观察 • 上一篇    下一篇

双歧杆菌三联活菌肠溶胶囊辅助治疗妊娠期糖尿病合并抑郁患者的临床研究

李惠珠1(), 柏智2, 杨茗1, 黄金智1,()   

  1. 1 广东医科大学第一临床医学院(邮编510006)
    2 广东医科大学附属东莞第一医院产科
  • 收稿日期:2025-06-13 修回日期:2025-08-18 出版日期:2025-12-15 发布日期:2025-12-08
  • 通讯作者: E-mail:huangjzgd@163.com
  • 作者简介:李惠珠(1986),女,主治医师,主要从事妊娠期糖尿病方面研究。E-mail:lihuiz5580@163.com
  • 基金资助:
    广东省基础与应用基础研究基金(2022A1515140133)

Clinical study on Bifidobacterium triple live bacteria enteric-coated capsules in adjuvant treatment of gestational diabetes mellitus

LI Huizhu1(), BAI Zhi2, YANG Ming1, HUANG Jinzhi1,()   

  1. 1 The First School of Clinical Medicine of Guangdong Medical University, Zhanjiang 510006, China
    2 Department of Obstetrics, the First Dongguan Affiliated Hospital of Guangdong Medical University
  • Received:2025-06-13 Revised:2025-08-18 Published:2025-12-15 Online:2025-12-08
  • Contact: E-mail:huangjzgd@163.com

摘要:

目的 探讨双歧杆菌三联活菌肠溶胶囊辅助治疗妊娠期糖尿病(GDM)合并抑郁患者的疗效及其对肠道菌群、炎症指标的影响。方法 选取168例GDM合并抑郁患者并采用随机数字表法分为对照组(81例,心理疏导+饮食控制+适当运动)和观察组(87例,在对照组的基础上联用双歧杆菌三联活菌肠溶胶囊,每日2次,每次2粒),2组连续治疗1个月后进行疗效评价。治疗前和治疗1个月后采用抑郁自评量表(SDS)评价患者的抑郁程度,对患者的空腹血糖(FBG)、餐后2 h血糖(2 hPG)进行检测,荧光定量PCR法检测肠道菌群,分别采用酶联免疫吸附试验和免疫比浊法检测炎症指标血清肿瘤坏死因子-ɑ(TNF-ɑ)和血清C反应蛋白(CRP)水平,全自动血液分析仪检测外周静脉血中性粒细胞和淋巴细胞计数,计算中性粒细胞与淋巴细胞比值(NLR),记录药物不良反应。结果 观察组患者的总有效率为96.55%,高于对照组的87.65%(P<0.05)。治疗1个月后,观察组和对照组SDS评分、FBG、2 hPG及血清TNF-ɑ、CRP和NLR均较治疗前有所下降,且观察组低于对照组(P<0.05)。治疗1个月后,对照组的肠道菌群数量与治疗前比较差异无统计学意义;观察组乳酸杆菌和双歧杆菌的菌群数量相较于治疗前增加,且观察组高于对照组;观察组大肠埃希菌、脆弱拟杆菌的菌群数量较治疗前降低,且观察组低于对照组(P<0.01)。观察组的不良反应发生率为3.45%,与对照组的1.23%比较差异无统计学意义。结论 双歧杆菌三联活菌肠溶胶囊辅助治疗GDM合并抑郁患者具有较好的临床疗效,有助于血糖的控制以及肠道菌群正向调节,并可降低炎症反应,安全性好。

关键词: 糖尿病, 妊娠, 抑郁, 胃肠道微生物组, 炎症, 双歧杆菌三联活菌肠溶胶囊

Abstract:

Objective To investigate the efficacy of Bifidobacterium triple live bacteria enteric-coated capsules in the adjuvant treatment of patientys with gestational diabetes mellitus (GDM) complicated with depression, and its effect on intestinal flora and inflammatory indicators. Methods A total of 168 patients with GDM complicated with depression were selected and randomly divided into the control group (81 cases, treated with psychological counseling, dietary control and appropriate exercise) and the observation group (87 cases, treated with Bifidobacterium trilactis enteric-coated capsules on the basis of the control group, 2 capsules each time, twice a day). Both groups were treated for 1 month continuously. The therapeutic effects were evaluated after treatment. The depression degree of patients was evaluated by Self-Rating Depression Scale (SDS) before treatment and one month after treatment. The fasting blood glucose (FBG) and 2-hour postprandial blood glucose (2 hPG) of patients were detected. The intestinal flora was detected by fluorescence quantitative PCR. The inflammatory indicators serum tumor necrosis factor-α (TNF-α) and serum C-reactive protein (CRP) were detected by enzyme-linked immunosorbent assay and immunoturbidimetry. The neutrophil and lymphocyte counts in peripheral venous blood were detected by automatic blood analyzer, and the neutrophil-to-lymphocyte ratio (NLR) was calculated. The adverse drug reactions were recorded. Results The total effective rate was 96.55% in the observation group, which was higher than that of the control group (87.65%, P<0.05). After 1 month of treatment, the SDS score, FBG, 2 hPG, serum TNF-α, CRP and NLR were decreased in both groups, and those of the observation group were lower than the control group (P<0.05). One month after treatment, there was no significant difference in the number of intestinal flora compared with that before treatment in the control group. The number of Lactobacillus and Bifidobacterium in the observation group was increased compared with that before treatment, while the number of Escherichia coli and Bacteroides fragilis decreased. After 1 month of treatment, the number of Lactobacillus and Bifidobacterium in the observation group was higher than that in the control group, while the number of Escherichia coli and Bacteroides fragilis was lower than that in the control group (P<0.01). The adverse reaction rate of the observation group was 3.45%, and there was no significant difference compared with 1.23% of the control group. Conclusion Bifidobacterium triple live bacteria enteric-coated capsules has a good clinical effect in the adjuvant treatment of GDM with depression, which can effectively control blood glucose level, improve intestinal flora, reduce inflammatory reaction and has good safety.

Key words: diabetes, gestational, depression, gastrointestinal microbiome, inflammation, bifid triple viable capsules dissolving at intestines

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