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

doi:10.12092/j.issn.1009-2501.2026.04.007

Abstract

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

CLC Number:

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.

Figures/Tables 5

References 16

1	范建高, 杨荣. 全球非酒精性脂肪性肝病的流行趋势与疾病负担[J]. 中华消化杂志, 2023, 43 (4): 248- 252. doi: 10.3760/cma.j.cn311367-20230202-00038
2	中国医药生物技术协会慢病管理分会, 中国研究型医院学会肝病(中西医结合)专业委员会, 中华医学会全科医学分会, 等. 代谢相关脂肪性肝病基层诊疗与管理指南(2025年)[J]. 中华全科医师杂志, 2025, 24 (5): 513- 525. doi: 10.3760/cma.j.cn501113-20250305-00073
3	Eslam M, Sarin SK, Wong VWS, et al. The Asian Pacific Association for the Study of the Liver clinical practice guidelines for the diagnosis and management of metabolic associated fatty liver disease[J]. Hepatology International, 2020, 14 (6): 889- 919. doi: 10.1007/s12072-020-10094-2
4	Friedman SL, Neuschwander-Tetri BA, Rinella M, et al. Mechanisms of NAFLD development and therapeutic strategies[J]. Nat Med, 2018, 24 (7): 908- 922. doi: 10.1038/s41591-018-0104-9
5	李小珍, 冯丹丹, 赵华山. 强肝胶囊联合双环醇片治疗非酒精性脂肪性肝炎的疗效[J]. 西北药学杂志, 2025, 40 (3): 214- 220. doi: 10.3969/j.issn.1004-2407.2025.03.030
6	邵俊侠, 王静. 血滞通胶囊联合阿托伐他汀对老年非酒精性脂肪肝病人肝纤维化的影响以及疗效分析[J]. 实用老年医学, 2020, 34 (9): 930- 933. doi: 10.3969/j.issn.1003-9198.2020.09.018
7	范建高, 徐小元, 南月敏, 等. 代谢相关(非酒精性)脂肪性肝病防治指南(2024年版)[J]. 实用肝脏病杂志, 2024, 27 (4): 494- 510. doi: 10.12449/JCH240908
8	中国血脂管理指南修订联合专家委员会. 中国血脂管理指南(基层版2024年)[J]. 中华心血管病杂志, 2024, 52 (4): 330- 337. doi: 10.3760/cma.j.cn112148-20240102-00002
9	European Association for the Study of the Liver. EASL Clinical Practice Guidelines on non-invasive tests for evaluation of liver disease severity and prognosis - 2021 updat e[J]. J Hepatol, 2021, 75 (3): 659- 689. doi: 10.1016/j.jhep.2021.05.025
10	陈智恒, 高博文, 桂蓓, 等. 代谢相关脂肪性肝病发生脂肪性肝炎的无创诊断模型构建及分析[J]. 临床肝胆病杂志, 2023, 39 (8): 1857- 1866. doi: 10.3969/j.issn.1001-5256.2023.08.014
11	李钊, 黄赞松, 李繁. 非诺贝特联合双环醇治疗非酒精性脂肪性肝病患者肝组织PPARγ2 mRNA水平变化[J]. 实用肝脏病杂志, 2021, 24 (1): 59- 62. doi: 10.3969/j.issn.1672-5069.2021.01.016
12	Wu T, Roger H, Xie L, et al. Bicyclol for chronic hepatitis B[J]. Cochrane Database Syst Rev, 2006, 2006 (4): CD004480. doi: 10.1002/14651858.cd004480
13	Liu TT, Sun HF, Tang MZ, et al. Bicyclol attenuates pulmonary fibrosis with silicosis via both canonical and non-canonical TGF-β1 signaling pathways[J]. J Transl Med, 2024, 22 (1): 682. doi: 10.1186/s12967-024-05399-x
14	Hou Y, Jiao Y, Zhang X, et al. Allicin ameliorates liver damage in Streptozotocin-induced type 2 diabetic rats by modulating intestinal microbiota and metabolic processes[J]. Food Biosci, 2025, 64, 105861. doi: 10.1016/j.fbio.2025.105861
15	Luo X, Zhang H, Wei X, et al. Aloin suppresses lipopolysaccharide-induced inflammatory response and apoptosis by inhibiting the activation of NF-κB[J]. Molecules, 2018, 23 (3): 517. doi: 10.3390/molecules23030517
16	Zhang C, He X, Sheng Y, et al. Allicin regulates energy homeostasis through brown adipose tissue[J]. iScience, 2020, 23 (5): 101113. doi: 10.1016/j.isci.2020.101113

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