双歧三联杆菌活菌胶囊联合草酸艾司西酞普兰治疗成人首发抑郁症的临床研究

李薇薇; 王鹭; 潘友让; 陈晶

doi:10.16766/j.cnki.issn.1674-4152.004167

双歧三联杆菌活菌胶囊联合草酸艾司西酞普兰治疗成人首发抑郁症的临床研究

doi: 10.16766/j.cnki.issn.1674-4152.004167

绍兴市第七人民医院心身一病区(睡眠病区)，浙江绍兴 312000

基金项目:

浙江省医药卫生科技计划项目 2023KY1272

详细信息

通讯作者:
王鹭, E-mail：568350420@qq.com

中图分类号: R749.4
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出版历程
- 收稿日期: 2025-01-01
- 网络出版日期: 2025-11-17

Clinical study of Tricobacterium bifidum capsule combined with escitalopram oxalate in the treatment of adult first episode depression

Department One of Psychosomatic Medicine (Sleep Ward), Shaoxing Seventh People' s Hospital, Shaoxing, Zhejiang 312000, China

摘要

摘要: 目的 “微生物-肠-脑轴(MGB)”理论为抑郁症治疗提供新视角，本研究探讨双歧三联杆菌活菌胶囊和常用抗抑郁药物联合治疗成人首发抑郁症的效果。方法选择2023年4月—2024年10月绍兴市第七人民医院心身医学科收治的126例成人首发抑郁症患者，采用信封法随机分为对照组和研究组，各63例，分别给予草酸艾司西酞普兰、双歧三联杆菌活菌胶囊联合草酸艾司西酞普兰的治疗方案，均治疗12周。比较2组汉密尔顿抑郁-17项(HAMD-17)量表评分及减分率、新鲜粪便肠道菌群检测、相关生化指标[白细胞介素-6(IL-6)、5-羟色胺(5-HT)]、临床疗效和治疗安全性。结果对照组、研究组分别有58、60例完成研究。2组治疗4、8、12周HAMD-17评分均呈下降趋势(P＜0.05)，治疗8、12周研究组HAMD-17评分低于对照组(P＜0.05)。治疗12周后研究组HAMD-17减分率[(53.93±5.81)% vs.(36.69±5.17)%]高于对照组(t=17.042，P＜0.05)，疗效优于对照组(P＜0.05)。治疗12周后，研究组乳杆菌数量、双歧杆菌数量、B/E值(0.89±0.16 vs.0.74±0.13)和血清5-HT水平均高于对照组(P＜0.05)，肠球菌数量、肠杆菌数量和血清IL-6水平均低于对照组(P＜0.05)。2组不良反应发生率比较差异无统计学意义(P＞0.05)。结论双歧三联杆菌活菌胶囊联合草酸艾司西酞普兰能明显改善成人首发抑郁症患者的肠道菌群失衡状态和调节血清IL-6、5-HT，有效缓解抑郁症状和提高临床获益。
- 成人首发抑郁症 /
- 肠道益生菌 /
- 双歧三联杆菌活菌胶囊 /
- 草酸艾司西酞普兰 /
- 汉密尔顿抑郁-17项量表 /
- 5-羟色胺
Abstract: Objective The microbial-gut-brain axis (MGB) theory provides a new perspective for the treatment of depression. This study was to investigate the effect of living bacteria capsule of Tricobacterium bifidum combined with commonly used antidepressants in the treatment of adult first-episode depression. Methods A total of 126 adult patients with first-episode depression admitted to the Department of Psychosomatic Medicine of Shaoxing Seventh People ' s Hospital from April 2023 to October 2024 were randomly divided into a control group (escitalopram oxalate alone) and a study group (Tricobacterium bifidum live capsules combined with escitalopram oxalate) for 12 weeks (n=63 each). The score and reduction rate of Hamilton depression-17 (HAMD-17) scale, intestinal flora detection in fresh stool, relevant biochemical indicators [interleukin-6 (IL-6), 5-hydroxytryptamine (5-HT)], clinical efficacy, and treatment safety were compared. Results Fifty-eight cases in the control group and 60 cases in the study group completed the study. The HAMD-17 scores decreased significantly in both groups at 4, 8, and 12 weeks (P < 0.05). The HAMD-17 scores of the study group at 8 and 12 weeks were lower than those of the control group (P < 0.05). The reduction rate of HAMD-17 was higher in the study group [(53.93±5.81)% vs. (36.69±5.17)%, t=17.042, P < 0.05] after 12 weeks of treatment, with superior overall efficacy (P < 0.05). After 12 weeks of treatment, the Lactobacillus count, Bifidobacterium count, B/E value (0.89±0.16 vs. 0.74±0.13), and serum 5-HT level in the study group were higher than those in the control group (P < 0.05), while the Enterococcus count, Enterobacter count, and serum IL-6 in the study group were lower than those in the control group (P < 0.05). No significant difference was observed in the adverse reaction rates between the two groups (P>0.05). Conclusion In adult patients with first-episode depression, Bifidobacterium live capsule combined with escitalopram oxalate can significantly improve intestinal flora balance, regulate serum IL-6 and 5-HT levels, and improve clinical benefits without increasing adverse effects.
- Adult first-episode depression /
- Intestinal probiotics /
- Bifidobacterium live capsule /
- Escitalopram oxalate /
- Hamilton depression-17 item scale /
- 5-hydroxytryptamine

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表 1 2组抑郁症患者基线资料比较

Table 1. Comparison of baseline data between the two groups of patients with depression

组别	例数	性别 (男/女，例)	年龄 (x±s，岁)	病程 (x±s，月)	家族遗传史 [例(%)]	伴睡眠障碍 [例(%)]	HAMD-17评分 (x±s，分)
对照组	63	28/35	39.78±8.01	11.47±3.10	5(7.94)	17(26.98)	21.67±3.02
研究组	63	26/37	40.12±7.76	12.01±3.16	3(4.76)	19(30.16)	22.03±3.07
统计量		0.130^a	0.205^b	0.818^b	0.134^a	0.052^a	0.561^b
P值		0.719	0.838	0.415	0.715	0.819	0.576
注：^a为χ²值，^b为t值。

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表 2 2组抑郁症患者HAMD-17量表评分比较(x±s，分)

Table 2. Comparison of HAMD-17 scale scores between the two groups of depressed patients(x±s, points)

组别	例数	治疗前	治疗4周	治疗8周	治疗12周
对照组	58	21.67±3.02	18.90±2.86^a	15.84±2.58^ab	13.72±2.35^abc
研究组	60	22.03±3.07	17.02±2.71^a	13.14±2.36^ab	10.15±2.12^abc
F值		0.513	1.207	3.886	4.372
P值		0.487	0.268	0.005	＜0.001
注：与同组治疗前比较，^aP＜0.05；与同组治疗4周比较，^bP＜0.05；与同组治疗8周比较，^cP＜0.05。

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表 3 2组抑郁症患者疗效比较[例(%)]

Table 3. Comparison of curative effect between the two groups of depressed patients[cases(%)]

组别	例数	痊愈	显效	好转	无效
对照组	58	9(15.52)	13(22.41)	25(43.10)	11(18.97)
研究组	60	15(25.00)	22(36.67)	19(31.67)	4(6.67)

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表 4 2组抑郁症患者肠道菌群检测指标比较(x±s)

Table 4. Comparison of intestinal flora detection indicators between the two groups of patients with depression(x±s)

组别	例数	乳杆菌(log10 CFU/g)		双歧杆菌(log10 CFU/g)		肠球菌(log10 CFU/g)		肠杆菌(log10 CFU/g)		B/E值
组别	例数	治疗前	治疗12周	治疗前	治疗12周	治疗前	治疗12周	治疗前	治疗12周	治疗前	治疗12周
对照组	58	7.72±1.32	8.41±1.54^b	7.16±0.84	7.47±0.95	9.30±1.26	9.15±1.30	10.56±1.37	10.13±1.32	0.68±0.11	0.74±0.13
研究组	60	7.76±1.40	9.66±1.70^b	7.20±0.89	8.36±1.02^b	9.34±1.31	8.24±1.12^b	10.42±1.40	9.38±1.26^b	0.69±0.13	0.89±0.16^b
统计量		0.160^a	8.532^c	0.251^a	15.238^c	0.169^a	12.576^c	0.549^a	10.473^c	0.450^a	13.523^c
P值		0.874	＜0.001	0.802	＜0.001	0.866	＜0.001	0.584	＜0.001	0.653	＜0.001
注：^a为t值，^c为F值；与同组治疗前比较，^bP＜0.05。

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表 5 2组抑郁症患者血清IL-6、5-HT水平比较(x±s)

Table 5. Comparison of serum IL-6 and 5-HT levels between the two groups of depression patients (x±s)

组别	例数	IL-6(ng/L)		5-HT(ng/mL)
组别	例数	治疗前	治疗12周	治疗前	治疗12周
对照组	58	38.27±4.31	31.40±4.16^b	27.56±5.11	46.72±7.10^b
研究组	60	37.68±4.35	27.15±3.80^b	28.09±5.13	58.94±8.15^b
统计量		0.740^a	16.423^c	0.562^a	15.928^c
P值		0.461	＜0.001	0.575	＜0.001
注：^a为t值，^c为F值；与同组治疗前比较，^bP＜0.05。

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