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广东省中西医结合医院,广东 佛山 528200
Received:22 June 2020,
Published Online:30 November 2020,
Published:05 February 2021
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谢维宁,彭红兵,李烨等.柴胡疏肝散对肝郁脾虚型非酒精性脂肪肝患者的临床疗效及肠道菌群的影响[J].中国实验方剂学杂志,2021,27(03):129-137.
XIE Wei-ning,PENG Hong-bing,LI Ye,et al.Liver with Liver Stagnation and Spleen Deficiency Syndrome and Intestinal Microflora[J].Chinese Journal of Experimental Traditional Medical Formulae,2021,27(03):129-137.
谢维宁,彭红兵,李烨等.柴胡疏肝散对肝郁脾虚型非酒精性脂肪肝患者的临床疗效及肠道菌群的影响[J].中国实验方剂学杂志,2021,27(03):129-137. DOI: 10.13422/j.cnki.syfjx.20210212.
XIE Wei-ning,PENG Hong-bing,LI Ye,et al.Liver with Liver Stagnation and Spleen Deficiency Syndrome and Intestinal Microflora[J].Chinese Journal of Experimental Traditional Medical Formulae,2021,27(03):129-137. DOI: 10.13422/j.cnki.syfjx.20210212.
目的
2
研究柴胡疏肝散对肝郁脾虚型非酒精性脂肪肝患者的临床疗效及肠道菌群的影响。
方法
2
该研究纳入2019年1月至2020年1月在广东省中西医结合医院肝病门诊就诊的非酒精性脂肪肝(NAFLD)患者80例。随机分为治疗组(柴胡疏肝散组,
n
=40)和对照组(安慰剂组,
n
=40)。两组患者予生活方式干预作为基础方案。治疗组予口服柴胡疏肝散辨证加减;对照组口服安慰剂。每次1剂,分早晚服,疗程为12周。观察治疗前、后脂肪肝疗效;丙氨酸氨基转移酶(ALT),天冬氨酸氨基转氨酶(AST),谷氨酰转肽酶(
γ
-GT);血脂:高密度脂蛋白胆固醇(HDL-C),低密度脂蛋白胆固醇(LDL-C),总胆固醇(TC),甘油三酯(TG);炎症指标:白细胞介素(IL)-6,IL-1
β
,外周血单个核细胞Toll样受体-4(TLR-4)及肠道菌群变化。
结果
2
彩超评估显示,治疗组总有效率81.08%(30/37),对照组总有效率68.57%(24/35)(
Z
=2.67,
P
<
0.05)。两组治疗后与基线的差值比较,治疗组治疗后BMI,ALT,AST,TC,LDL-C,
γ
-GT与基线的差值低于对照组,而HDL-C差值高于对照组(
P
<
0.05),两组TG的差值差异无统计学意义。炎症因子、肝脏受控衰减系数(CAP)及肝脏硬度值(LSM)比较,两组治疗后与基线的差值比较,治疗组在IL-6,TNF-α,IL-1
β
,TLR-4,CAP及LSM与基线差值显著低于对照组(
P
<
0.01)。肠道菌群治疗后比较,治疗组双歧杆菌及乳杆菌丰度显著升高,而大肠埃希菌及肠球菌丰度则显著下降(
P
<
0.01)。
结论
2
生活方式干预基础上,柴胡疏肝散可以更好地改善NAFLD患者血脂代谢及肝功能,调节肠道菌群,抑制炎症因子水平。
Objective
2
To study the clinical efficacy of Chaihu Shugansan on non-alcoholic fatty liver(NAFLD) patients with liver stagnation and spleen deficiency syndrome and its effect on intestinal flora.
Method
2
The study was a single-center, randomized,single-blind, placebo-controlled clinical study involving 80 patients with NAFLD treated from January 2019 to January 2020 at our hospital. They were divided into two groups (Chaihu Shugansan group,
n
=40) and control group (placebo group,
n
=40). The two groups of patients were given lifestyle intervention as the basic protocol. The treatment group was orally given Chaihu Shugansan,and the control group was orally given placebo. The drugs were given twice in the morning and evening, 1 dose/time. Patients were followed up for 12 weeks. Before and after treatment,the efficady on liver steatosis was observed by abdominal ultrasound and transient elastography (Fibroscan), levels of alanine aminotransferase(ALT),aspartate aminotransferase(AST),glutamyl transpeptidase(
γ
-GT),high density lipoprotein cholesterol(HDL-C),low density lipoprotein cholesterol(LDL-C),total cholesterol(TC),triglyceride(TG),interleukin(IL)-6,IL-1
β
,Toll-like receptor-4(TLR-4) in peripheral blood mononuclear cells(PBMCs) and intestinal flora were also detected.
Result
2
There were 37 patients in the treatment group and 35 patients in the control group who finally completed the study protocol. The total effective rate of NAFLD in the treatment group(81.08%,30/37) was higher than that in the control group (68.57%,24/35)(
Z
=2.67,
P
<
0.05). The treatment group was superior to the control group in reducing the levels of BMI,ALT,AST,TC,LDL-C,TG,
γ
-GT and increasing the level of HDL-C(
P
<
0.05). The levels of pro-inflammatory cytokines(TNF-
α
,IL-1
β
and IL-6),the values of Controlled Attenuation Parameter(CAP),Liver Stiffness Measurement(LSM) and expression of TLR4 were down-regulated in the treatment group (
P
<
0.01). In addition,the treatment group showed increase in the abundance of beneficial bacteria (
Bifidobacterium
and
Lactobacillus
) and inhibited the abundance of pathogenic bacteria (
Enterobacter
and
Enterococcus
) in the gut(
P
<
0.01).
Conclusion
2
In addition to the lifestyle intervention,Chaihu Shugansan can improve lipid metabolism and liver function,regulate intestinal flora and inhibit the level of inflammatory factors in patients with NAFLD.
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