Clinical study on the treatment of non-alcoholic fatty liver disease with Danggui Shaoyao San combined with Bacillus subtilis dual active bacteria enteric coated capsules

doi:10.11958/20252632

Abstract

Abstract:

Objective To investigate the effects of Danggui Shaoyao San combined with Bacillus subtilis dual live bacteria enteric coated capsules on the body shape, biochemical and imaging indicators of patients with non-alcoholic fatty liver disease (NAFLD). Methods A total of 118 NAFLD patients were selected as the research subjects and randomly divided into the control group and the observation group using a random number table method, with 59 cases in each group. The control group was treated with Bacillus subtilis dual active bacteria enteric coated capsules, while the observation group was treated with Danggui Shaoyao San on this basis. The body morphology indicators such as body fat percentage and body mass index (BMI), and serum levels of total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were measured between the two groups before treatment, after 2 months of treatment and at 6-month of follow-up. Enzyme-linked immunosorbent assay (ELISA) was used to determine serum concentrations of tumor necrosis factor-α (TNF-α), adiponectin (APN) and interleukin-6 (IL-6). Hepatic steatosis was graded using color Doppler ultrasound. Adverse events during treatment were recorded. Results Compared with baseline, both groups showed significant reduction in body fat percentage, BMI, TG, TC, LDL-C, IL-6, TNF-α, AST and ALT levels, along with increase in HDL-C and APN levels and improvements in fatty liver classification at 2 months of treatment and 6 months of follow up (all P<0.05). At both time points, the improvements were significantly greater in the observation group than those in the control group (P<0.05). There was no significant difference in the overall incidence of adverse reactions between the two groups. Conclusion Danggui Shaoyao San combined with Bacillus subtilis dual active bacteria enteric coated capsules can effectively improve body shape, blood lipid levels and fatty liver grading of NAFLD patients, regulate liver function, and have high safety.

Key words: non-alcoholic fatty liver disease, bacillus subtilisnon, enterococcus faecium, Danggui Shaoyao San, liver function, lipid metabolism

CLC Number:

R575.5

Figures/Tables 7

References 20

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组别	性别（男/女）	年龄/岁	BMI/（kg/m²）
对照组	30/29	51.51±8.57	24.62±5.31
观察组	31/28	51.86±8.38	24.19±5.66
χ²或t	0.034	0.224	0.426

组别	性别（男/女）	年龄/岁	BMI/（kg/m²）
对照组	30/29	51.51±8.57	24.62±5.31
观察组	31/28	51.86±8.38	24.19±5.66
χ²或t	0.034	0.224	0.426

组别	体脂率/%			BMI/（kg/m²）
组别	治疗前	治疗2个月	随访6个月	治疗前	治疗2个月	随访6个月
对照组	33.64±5.63	31.07±3.85^a	29.75±3.92^a	24.62±5.31	22.91±3.06^a	21.87±2.23^a
观察组	33.65±5.56	29.02±2.74^a	28.16±2.53^a	24.19±5.66	21.73±2.71^a	21.05±2.09^a
t	0.010	3.332^＊	2.618^＊	0.426	2.217^＊	2.061^＊
F_组间/F_组内/F_交互	8.548^＊＊/37.275^＊＊/1.788			4.648^＊/22.742^＊＊/0.333

组别	体脂率/%			BMI/（kg/m²）
组别	治疗前	治疗2个月	随访6个月	治疗前	治疗2个月	随访6个月
对照组	33.64±5.63	31.07±3.85^a	29.75±3.92^a	24.62±5.31	22.91±3.06^a	21.87±2.23^a
观察组	33.65±5.56	29.02±2.74^a	28.16±2.53^a	24.19±5.66	21.73±2.71^a	21.05±2.09^a
t	0.010	3.332^＊	2.618^＊	0.426	2.217^＊	2.061^＊
F_组间/F_组内/F_交互	8.548^＊＊/37.275^＊＊/1.788			4.648^＊/22.742^＊＊/0.333

组别		TG						TC
组别		治疗前		治疗2个月		随访6个月		治疗前		治疗2个月		随访6个月
对照组		1.78±0.25		1.41±0.22^a		1.39±0.26^a		4.95±0.63		4.16±0.45^a		4.08±0.42^a
观察组		1.79±0.26		1.05±0.14^a		1.02±0.13^a		4.93±0.61		3.72±0.40^a		3.60±0.39^a
t		0.213		10.604^＊＊		9.777^＊＊		0.175		5.613^＊＊		6.433^＊＊
F_组间/F_组内/F_交互		99.577^＊＊/290.329^＊＊/32.585^＊＊						38.573^＊＊/172.363^＊＊/7.293^＊
组别	LDL-C						HDL-C
组别	治疗前		治疗2个月		随访6个月		治疗前		治疗2个月		随访6个月
对照组	4.02±0.26		2.56±0.32^a		2.40±0.30^a		1.21±0.34		1.32±0.25^a		1.36±0.27^a
观察组	4.03±0.25		2.10±0.21^a		1.95±0.20^a		1.21±0.35		1.53±0.38^a		1.59±0.39^a
t	0.213		9.231^＊＊		9.587^＊＊		0.000		3.546^＊＊		3.725^＊＊
F_组间/F_组内/F_交互	131.554^＊＊/1 727.825^＊＊/30.683^＊＊						20.042^＊＊/19.351^＊＊/3.678^＊