Evidence construction of Silibinin capsules against alcoholic liver disease based on a meta-analysis and systematic review.

IF 4.8 2区医学 Q1 PHARMACOLOGY & PHARMACY Frontiers in Pharmacology Pub Date : 2025-02-04 eCollection Date: 2025-01-01 DOI:10.3389/fphar.2025.1516204

Yan Wang, Wenmin Yang, Yuan Yang, Xingning Liu, Lanfen Peng, Qi Huang, Kongli Fan, Rui Hu, Jinyu Yi, Xin Zhong, Jing Li, Jialing Sun, Xiaozhou Zhou

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Abstract

Background: In recent years, the incidence of alcoholic liver disease (ALD) has rapidly increased worldwide, becoming a significant health issue. Silibinin capsules have shown potential in treating ALD, but clinical evidence is still insufficient. This meta-analysis aimed to evaluate the efficacy and safety of Silibinin capsules in the treatment of ALD.

Methods: The study was registered with PROSPERO (CRD42024509676). Randomized controlled trials (RCTs) were included from six databases, covering the period from database inception to 30 December 2023. Primary outcomes included liver function indicators such as alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT), total bilirubin (TBIL), lipid indicators including triglycerides (TG) and total cholesterol (TC), coagulation indicators including prothrombin time (PT), liver fibrosis indicator (PC-III), and Effective Rate. Analysis was performed using Review Manager 5.4.1 and STATA 14.0.

Results: In 15 RCTs involving 1,221 patients, compared to the non-Silibinin group, Silibinin capsules showed significant efficacy in terms of liver function, lipid levels, and effective rate in patients with ALD. Detailed parameters were as follows: ALT [SMD = -1.16, 95% CI (-1.84, -0.47)], AST [SMD = -1.56, 95% CI (-2.18, -0.95)], GGT [SMD = -1.48, 95% CI (-2.09, -0.87)], TBIL [SMD = -1.14, 95% CI (-2.16, -0.13)], TG [SMD = -1.29, 95% CI (-1.93, -0.66)], TC [SMD = -1.11, 95% CI (-1.61, -0.61)], PT [SMD = -0.01, 95% CI (-0.29, 0.26)], PC-III [SMD = -1.94, 95% CI (-3.04, -0.84)], and Effective Rate [OR = 3.60, 95% CI (2.28, 5.70)]. Importantly, Silibinin capsules exhibited a favorable safety profile, with only mild gastrointestinal reactions and reports of insomnia as adverse events.

Conclusion: This review reveals the clinical efficacy and safety of Silibinin capsules in the treatment of ALD, and confirms that the drug is an effective adjuvant therapy to alleviate ALD. At present, the mechanism of action of this drug for ALD is still unclear, and we expect more experimental studies to prove the clinical value of Silibinin capsules.

Systematic review registration: https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=509676.

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水飞蓟宾胶囊抗酒精性肝病的meta分析和系统评价证据构建

背景：近年来，酒精性肝病（ALD）的发病率在全球范围内迅速增加，成为一个重要的健康问题。水飞蓟宾胶囊已显示出治疗ALD的潜力，但临床证据仍然不足。本荟萃分析旨在评价水飞蓟宾胶囊治疗ALD的有效性和安全性。方法：该研究在PROSPERO注册（CRD42024509676）。随机对照试验（rct）从6个数据库中纳入，涵盖从数据库建立到2023年12月30日的时间。主要结局包括肝功能指标如丙氨酸转氨酶（ALT）、天冬氨酸转氨酶（AST）、γ -谷氨酰转移酶（GGT）、总胆红素（TBIL）、脂质指标如甘油三酯（TG）、总胆固醇（TC）、凝血指标如凝血酶原时间（PT）、肝纤维化指标（PC-III）、有效率。使用Review Manager 5.4.1和STATA 14.0进行分析。结果：15项随机对照试验共1221例患者，与非水飞蓟宾组相比，水飞蓟宾胶囊对ALD患者的肝功能、血脂水平和有效率均有显著疗效。详细参数如下:ALT (SMD = -1.16, 95% CI (-1.84, -0.47)], AST (SMD = -1.56, 95% CI (-2.18, -0.95)], GGT (SMD = -1.48, 95% CI(-2.09, -0.87),治疗组(SMD = -1.14, 95% CI (-2.16, -0.13)], TG (SMD = -1.29, 95% CI (-1.93, -0.66)], TC (SMD = -1.11, 95% CI (-1.61, -0.61)], PT (SMD = -0.01, 95% CI (-0.29, 0.26)], PC-III (SMD = -1.94, 95% CI(-3.04, -0.84)],和有效的利率(OR = 3.60, 95% CI(2.28, 5.70)]。重要的是，水飞蓟宾胶囊显示出良好的安全性，只有轻微的胃肠道反应和失眠作为不良事件的报道。结论：本综述揭示水飞蓟宾胶囊治疗ALD的临床疗效和安全性，确认水飞蓟宾胶囊是缓解ALD的有效辅助治疗药物。目前，该药物对ALD的作用机制尚不清楚，我们期待更多的实验研究来证明水飞蓟宾胶囊的临床价值。系统评审注册：https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=509676。

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来源期刊

Frontiers in Pharmacology PHARMACOLOGY & PHARMACY-

CiteScore

7.80

自引率

8.90%

发文量

5163

审稿时长

14 weeks

期刊介绍： Frontiers in Pharmacology is a leading journal in its field, publishing rigorously peer-reviewed research across disciplines, including basic and clinical pharmacology, medicinal chemistry, pharmacy and toxicology. Field Chief Editor Heike Wulff at UC Davis is supported by an outstanding Editorial Board of international researchers. This multidisciplinary open-access journal is at the forefront of disseminating and communicating scientific knowledge and impactful discoveries to researchers, academics, clinicians and the public worldwide.