基于Meta分析和系统评价的水飞蓟宾胶囊治疗酒精性肝病的证据构建
Evidence construction of Silibinin capsules against alcoholic liver disease based on a meta-analysis and systematic review.
作者信息
Wang Yan, Yang Wenmin, Yang Yuan, Liu Xingning, Peng Lanfen, Huang Qi, Fan Kongli, Hu Rui, Yi Jinyu, Zhong Xin, Li Jing, Sun Jialing, Zhou Xiaozhou
机构信息
Department of Liver Disease, The Fourth Clinical Medical College of Guangzhou University of Chinese Medicine, Shenzhen, China.
Department of Liver Disease, Shenzhen Traditional Chinese Medicine Hospital, Shenzhen, China.
出版信息
Front Pharmacol. 2025 Feb 4;16:1516204. doi: 10.3389/fphar.2025.1516204. eCollection 2025.
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.
背景
近年来，酒精性肝病（ALD）在全球范围内的发病率迅速上升，成为一个重大的健康问题。水飞蓟宾胶囊已显示出治疗ALD的潜力，但临床证据仍不充分。本荟萃分析旨在评估水飞蓟宾胶囊治疗ALD的疗效和安全性。
方法
该研究已在国际前瞻性系统评价注册库（PROSPERO，注册号：CRD42024509676）登记。从六个数据库中纳入随机对照试验（RCT），涵盖从数据库建立至2023年12月30日的时间段。主要结局包括肝功能指标，如丙氨酸氨基转移酶（ALT）、天冬氨酸氨基转移酶（AST）、γ-谷氨酰转移酶（GGT）、总胆红素（TBIL）；血脂指标，包括甘油三酯（TG）和总胆固醇（TC）；凝血指标，包括凝血酶原时间（PT）、肝纤维化指标（PC-III）以及有效率。使用RevMan 5.4.1和STATA 14.0进行分析。
结果
在15项涉及1221例患者的RCT中，与非水飞蓟宾组相比，水飞蓟宾胶囊在ALD患者的肝功能、血脂水平和有效率方面显示出显著疗效。具体参数如下：ALT [标准化均数差（SMD）=-1.16，95%置信区间（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）]，有效率 [比值比（OR）=3.60，95% CI（2.28，5.70）]。重要的是，水飞蓟宾胶囊表现出良好的安全性，仅出现轻度胃肠道反应，且有失眠作为不良事件的报告。
结论
本综述揭示了水飞蓟宾胶囊治疗ALD的临床疗效和安全性，并证实该药物是缓解ALD的有效辅助治疗药物。目前，该药物治疗ALD的作用机制仍不清楚，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。
系统评价注册
https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=509676 。
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