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

doi:10.11958/20252263

Abstract

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

CLC Number:

R714.256，R749.42

Figures/Tables 6

References 24

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组别	n	年龄/ 岁	入组孕周/周	抑郁严重程度（轻度/中度）	胰岛素治疗
对照组	81	27.45±5.42	26.18±1.26	46/35	12（14.81）
观察组	87	28.02±5.87	26.09±1.33	46/41	7（8.05）
χ²或t		0.653	0.449	0.260	1.916

组别	n	年龄/ 岁	入组孕周/周	抑郁严重程度（轻度/中度）	胰岛素治疗
对照组	81	27.45±5.42	26.18±1.26	46/35	12（14.81）
观察组	87	28.02±5.87	26.09±1.33	46/41	7（8.05）
χ²或t		0.653	0.449	0.260	1.916

基因名称	引物序列（5'→3'）	产物大小/bp
大肠埃希菌	上游：GTAATACCTTTGCTCATTGA	340
大肠埃希菌	下游：ACCAGGGTATCTAATCCTGTT	340
乳酸杆菌	上游：GAGGCAGCAGTAGGGAATCTTC	126
乳酸杆菌	下游：GGCCAGTTACTACCTCTATCCTTCTTC	126
双歧杆菌	上游：CTCCTGGAAACGGGTGG	550
双歧杆菌	下游：GGTGTTCTTCCCGATATCTACA	550
脆弱拟杆菌	上游：GAGAGGAAGGTCCCCCAC	106
脆弱拟杆菌	下游：CGCTACTTGGCTGGTTCAG	106
16S rDNA V3	上游：AGAGTTTGATCATGGCTCAG	540
16S rDNA V3	下游：ACCGCGACTGCTGGCAC	540

基因名称	引物序列（5'→3'）	产物大小/bp
大肠埃希菌	上游：GTAATACCTTTGCTCATTGA	340
大肠埃希菌	下游：ACCAGGGTATCTAATCCTGTT	340
乳酸杆菌	上游：GAGGCAGCAGTAGGGAATCTTC	126
乳酸杆菌	下游：GGCCAGTTACTACCTCTATCCTTCTTC	126
双歧杆菌	上游：CTCCTGGAAACGGGTGG	550
双歧杆菌	下游：GGTGTTCTTCCCGATATCTACA	550
脆弱拟杆菌	上游：GAGAGGAAGGTCCCCCAC	106
脆弱拟杆菌	下游：CGCTACTTGGCTGGTTCAG	106
16S rDNA V3	上游：AGAGTTTGATCATGGCTCAG	540
16S rDNA V3	下游：ACCGCGACTGCTGGCAC	540

组别	n	显效	有效	无效	总有效
对照组	81	44（54.32）	27（33.33）	10（12.35）	71（87.65）
观察组	87	58（66.67）	26（29.88）	3（3.45）	84（96.55）
χ²					4.651^＊