双环醇联合血滞通胶囊对非酒精性脂肪性肝病的疗效研究

doi:10.12092/j.issn.1009-2501.2026.04.007

中国临床药理学与治疗学 ›› 2026, Vol. 31 ›› Issue (4): 486-492.doi: 10.12092/j.issn.1009-2501.2026.04.007

双环醇联合血滞通胶囊对非酒精性脂肪性肝病的疗效研究

金怡珊¹(), 江凤翔², 谭姣容¹, 朱明华³^,*()

1. 同济大学附属普陀人民医院内分泌科，上海 200060
2. 同济大学附属普陀人民医院消化内科，上海 200060
3. 上海市公共卫生临床中心检验医学科，上海 200083

收稿日期:2025-11-18 修回日期:2026-03-04 出版日期:2026-04-26 发布日期:2026-04-30
通讯作者: 朱明华 E-mail:jinyishan713@163.com;zhuminghua@shaphc.org
作者简介:金怡珊，女，硕士，住院医师，研究方向：非酒精性脂肪性肝病的诊断及治疗。E-mail：jinyishan713@163.com
基金资助:
上海市普陀区卫生健康系统科技创新重点项目（ptkwws202502）

Efficacy of bicyclol combined with Xuezhitong capsules in the treatment of non-alcoholic fatty liver disease

Yishan JIN¹(), Fengxiang JIANG², Jiaorong TAN¹, Minghua ZHU³^,*()

1. Department of Endocrinology, Putuo People's Hospital Affiliated to Tongji University, Shanghai 200060, China
2. Department of Gastroenterology, Putuo People's Hospital Affiliated to Tongji University, Shanghai 200060, China
3. Department of Laboratory Medicine, Shanghai Public Health Clinical Center, Shanghai 200083, China

Received:2025-11-18 Revised:2026-03-04 Online:2026-04-26 Published:2026-04-30
Contact: Minghua ZHU E-mail:jinyishan713@163.com;zhuminghua@shaphc.org

摘要/Abstract

摘要：

目的: 系统评价双环醇片与血滞通胶囊联用方案对非酒精性脂肪肝（NAFLD）患者的综合治疗效果及安全性特征。方法: 研究设计采用前瞻性随机对照试验，将160例NAFLD患者以1:1比例分配至两组：对照组80例接受双环醇片单一药物治疗，治疗组80例则采用双环醇片联合血滞通胶囊的复合治疗方案，全程治疗周期为12周。研究重点比较两组患者治疗前后肝功能关键指标，包括丙氨酸氨基转移酶（ALT）、天冬氨酸氨基转移酶（AST）、γ-谷氨酰转肽酶（GGT）、血脂谱参数[总胆固醇（TC）、甘油三酯（TG）、低密度脂蛋白胆固醇（LDL-C）、高密度脂蛋白胆固醇（HDL-C）]、肝纤维化进展指标、炎症介质水平变化以及不良反应事件发生率。结果: 经过12周系统治疗后，两组患者的肝功能指标及血脂参数均呈现显著改善趋势（P<0.05）。值得注意的是，治疗组在ALT水平下降41.8%（对照组为26.4%）、AST降低33.9%（对照组为21.8%）、TC减少14.4%（对照组为9.6%）、TG降幅达25.2%（对照组为14.3%）等关键指标的改善幅度上，显著优于对照组（P<0.05）。此外，治疗组的复合终点应答率为88.8%，明显优于对照组（66.2%）（P=0.001）。药物安全性分析显示，两组间不良反应发生率差异无统计学意义（6.9% vs. 10.6%，P=0.323）。结论: 双环醇片与血滞通胶囊的联合治疗方案在NAFLD治疗中展现出临床疗效优势，其治疗效果显著优于单药治疗。这一治疗策略为NAFLD的临床管理提供了良好的治疗选择。

关键词: 非酒精性脂肪肝, 双环醇片, 血滞通胶囊, 肝功能, 血脂

Abstract:

AIM: To systematically evaluate the comprehensive therapeutic efficacy and safety profile of the combination therapy of bicyclol tablets and Xuezhitong capsules in patients with non-alcoholic fatty liver disease (NAFLD). The research design employed a prospective randomized controlled trial, allocating 160 NAFLD patients in a 1:1 ratio to two groups: the control group (n=80) received bicyclol tablets monotherapy, while the experimental group (n=80) underwent a combination therapy of bicyclol tablets and Xuezhitong capsules, with a total treatment duration of 12 weeks. The study focused on comparing key liver function indicators, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), γ-glutamyl transpeptidase (GGT), lipid profile parameters, including total cholesterol (TC), triglycerides (TG), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), liver fibrosis progression markers, inflammatory mediator levels, and adverse event incidence rates between the two groups before and after treatment. RESULTS: After 12 weeks of systematic treatment, both groups demonstrated significant improvements in liver function indicators and lipid profile parameters (P<0.05). Notably, the experimental group showed superior improvements in key indicators compared to the control group: ALT levels decreased by 41.8% (vs. 26.4% in the control group), AST reduced by 33.9% (vs. 21.8%), TC decreased by 14.4% (vs. 9.6%), and TG showed a reduction of 25.2% (vs. 14.3%) (P<0.05). Furthermore, the composite endpoint response rate in the experimental group was 88.8%, significantly higher than the control group's 66.2% (P=0.001). Safety analysis revealed no statistically significant difference in adverse event incidence between the two groups (6.9% vs. 10.6%, P=0.323). CONCLUSION: The combination therapy of bicyclol tablets and Xuezhitong capsules demonstrates superior clinical efficacy in NAFLD treatment. This innovative therapeutic strategy provides an optimal treatment option for the clinical management of NAFLD.

Key words: non-alcoholic fatty liver disease, bicyclol, Xuezhitong capsule, liver function, lipids

中图分类号:

金怡珊, 江凤翔, 谭姣容, 朱明华. 双环醇联合血滞通胶囊对非酒精性脂肪性肝病的疗效研究[J]. 中国临床药理学与治疗学, 2026, 31(4): 486-492.

Yishan JIN, Fengxiang JIANG, Jiaorong TAN, Minghua ZHU. Efficacy of bicyclol combined with Xuezhitong capsules in the treatment of non-alcoholic fatty liver disease[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2026, 31(4): 486-492.

图/表 5

参考文献 16

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Variable	Control group (n=80)	Experimental group (n=80)	Statistic	P value
Age (years)	48.1±13.4	50.6±16.2	t=?1.085	0.280
Gender (male/female)	55/25	57/23	χ2=0.030	0.863
ALT (U/L)	60.8±72.1	54.2±40.5	t=0.713	0.477
AST (U/L)	37.9±21.0	40.6±25.2	t=?0.733	0.464
GGT (U/L)	63.3±68.9	73.4±88.4	t=?0.805	0.422
TC (mmol/L)	5.17±1.37	4.84±0.99	t=1.742	0.083
TG (mmol/L)	2.71±3.79	2.26±2.06	t=0.920	0.359
LDL-C (mmol/L)	3.80±1.48	3.49±1.21	t=1.447	0.150
HDL-C (mmol/L)	2.42±1.97	2.20±1.92	t=0.711	0.478

Variable	Control group (n=80)	Experimental group (n=80)	Statistic	P value
Age (years)	48.1±13.4	50.6±16.2	t=?1.085	0.280
Gender (male/female)	55/25	57/23	χ2=0.030	0.863
ALT (U/L)	60.8±72.1	54.2±40.5	t=0.713	0.477
AST (U/L)	37.9±21.0	40.6±25.2	t=?0.733	0.464
GGT (U/L)	63.3±68.9	73.4±88.4	t=?0.805	0.422
TC (mmol/L)	5.17±1.37	4.84±0.99	t=1.742	0.083
TG (mmol/L)	2.71±3.79	2.26±2.06	t=0.920	0.359
LDL-C (mmol/L)	3.80±1.48	3.49±1.21	t=1.447	0.150
HDL-C (mmol/L)	2.42±1.97	2.20±1.92	t=0.711	0.478

Indicator	Control group				Experimental group				P value (post- treatment)
Indicator	Pre- treatment	Post- treatment	Change rate (%)	P value	Pre- treatment	Post- treatment	Change rate (%)	P value	P value (post- treatment)
ALT (U/L)	60.8±72.1	44.7±50.7	?26.4	0.000	54.2±40.5	31.5±22.3	?41.8	0.000	0.035
AST (U/L)	37.9±21.0	29.6±18.3	?21.8	0.000	40.6±25.2	26.8±18.3	?33.9	0.000	0.335
GGT (U/L)	63.3±68.9	54.5±58.8	?14.0	0.000	73.4±88.4	48.0±59.1	?34.6	0.000	0.491

Indicator	Control group				Experimental group				P value (post- treatment)
Indicator	Pre- treatment	Post- treatment	Change rate (%)	P value	Pre- treatment	Post- treatment	Change rate (%)	P value	P value (post- treatment)
ALT (U/L)	60.8±72.1	44.7±50.7	?26.4	0.000	54.2±40.5	31.5±22.3	?41.8	0.000	0.035
AST (U/L)	37.9±21.0	29.6±18.3	?21.8	0.000	40.6±25.2	26.8±18.3	?33.9	0.000	0.335
GGT (U/L)	63.3±68.9	54.5±58.8	?14.0	0.000	73.4±88.4	48.0±59.1	?34.6	0.000	0.491

Indicator	Control group				Experimental group				P value (pre- vs. post-)
Indicator	Pre- treatment	Post- treatment	Change rate (%)	P value	Pre- treatment	Post- treatment	Change rate (%)	P value	P value (pre- vs. post-)
TC (mmol/L)	5.17±1.37	4.67±1.23	?9.6	0.000	4.84±0.99	4.14±0.93	?14.4	0.000	0.003
TG (mmol/L)	2.71±3.79	2.32±3.32	?14.3	0.000	2.26±2.06	1.69±1.48	?25.2	0.000	0.124
LDL-C (mmol/L)	3.80±1.48	3.60±1.54	?5.2	0.058	3.49±1.21	3.14±1.49	?9.8	0.007	0.061
HDL-C (mmol/L)	2.42±1.97	2.46±1.89	2.0	0.669	2.20±1.92	2.31±1.69	5.3	0.246	0.597

双环醇联合血滞通胶囊对非酒精性脂肪性肝病的疗效研究

Efficacy of bicyclol combined with Xuezhitong capsules in the treatment of non-alcoholic fatty liver disease

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参考文献 16

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Indicator	Control_Pre	Control_Post	Control_P value	Experimental_ pre	Experimental_ post	Ex p value	P value_post (control vs. experiment)
HA (ng/mL)	186.5±42.3	128.3±31.5	0.001	192.3±45.6	98.8±26.7	0	0.012
PCⅢ (ng/mL)	124.3±35.6	92.6±27.8	0.002	128.5±37.2	68.4±21.5	0	0.008
Ⅳ-C (ng/mL)	98.7±28.4	76.4±21.3	0.003	102.4±29.8	54.3±18.6	0	0.015
LN (ng/mL)	145.2±32.1	112.5±26.7	0.001	148.7±33.5	86.2±22.3	0	0.009
TNF-α (pg/mL)	12.5±4.3	8.5±3.2	0.002	13.2±4.5	5.5±2.1	0	0.003
IL-6 (pg/mL)	8.7±3.1	6.2±2.5	0.005	9.1±3.3	3.8±1.9	0	0.007
APRI score	1.43±0.52	1.01±0.43	0.001	1.48±0.55	0.89±0.38	0	0.042

Outcome	Control group (n=80)	Experimental group (n=80)	χ2 value	P value
Adverse event rate	10.0% (8/80)	6.25% (5/80)	0.978	0.323
Adverse event types	Dizziness (6), nausea (4), rash (4), abdominal distension (3)	Rash (4), dizziness (3), abdominal distension (2), nausea (2)	-	-

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