背景:尽管传统上使用水飞蓟素进行肝脏保护,目前,关于水飞蓟素在治疗代谢功能障碍相关的脂肪变性肝病(MASLD)中的有效性的随机对照试验(RCT)研究有限且尚无定论,特别是当它单独使用时。水飞蓟素的低生物利用度突出了肠道菌群对水飞蓟素有效性的可能影响;然而,没有人类研究调查这方面。
目的:确定水飞蓟素在改善MASLD指标方面的潜在功效,并研究与肠道菌群相关的潜在机制。
方法:在这项为期24周的随机研究中,双盲,安慰剂对照试验,83例MASLD患者随机接受安慰剂(n=41)或水飞蓟素(103.2mg/d,n=42)。在0、12和24周,使用FibroScan评估肝脏硬度和肝脏脂肪变性,收集血液样本进行生化检测,而在第0周和第24周收集粪便样品进行16SrRNA测序。
结果:水飞蓟素补充剂显着降低了肝脏硬度(LSM,-0.21±0.17vs.0.41±0.17,P=0.015)和血清γ-谷氨酰转肽酶(GGT,-8.21±3.01vs.1.23±3.16,P=0.042)和ApoB(-0.02±0.03vs.0.07±0.03,P=0.023),但对受控衰减参数(CAP)没有显着影响,其他生化指标(转氨酶,总胆红素,葡萄糖和脂质参数,hsCRP,SOD,和UA),物理测量(DBP,SBP,BMI,WHR,BF%,和BMR),或APRI和FIB-4指数。肠道菌群分析显示,水飞蓟素组的物种多样性和蛇尾科的富集增加。
结论:这些发现表明水飞蓟素补充剂可以改善MASLD患者的肝脏硬度,可能是通过调节肠道微生物群。
背景:该试验已在中国临床试验注册中心(ChiCTR2200059043)注册。
BACKGROUND: Despite centuries of traditional use of silymarin for hepatoprotection, current randomized controlled trial (RCT) studies on the effectiveness of silymarin in managing metabolic dysfunction-associated steatotic liver disease (MASLD) are limited and inconclusive, particularly when it is administered alone. The low bioavailability of silymarin highlights the possible influence of gut microbiota on the effectiveness of silymarin; however, no human studies have investigated this aspect.
OBJECTIVE: To determine the potential efficacy of silymarin in improving MASLD indicators and to investigate the underlying mechanisms related to gut microbiota.
METHODS: In this 24-week randomized, double-blind, placebo-controlled trial, 83 patients with MASLD were randomized to either placebo (n = 41) or silymarin (103.2 mg/d, n = 42). At 0, 12, and 24 weeks, liver stiffness and hepatic steatosis were assessed using FibroScan, and blood samples were gathered for biochemical detection, while faecal samples were collected at 0 and 24 weeks for 16S rRNA sequencing.
RESULTS: Silymarin supplementation significantly reduced liver stiffness (LSM, -0.21 ± 0.17 vs. 0.41 ± 0.17, P = 0.015) and serum levels of γ-glutamyl transpeptidase (GGT, -8.21 ± 3.01 vs. 1.23 ± 3.16, P = 0.042) and ApoB (-0.02 ± 0.03 vs. 0.07 ± 0.03, P = 0.023) but had no significant effect on the controlled attenuation parameter (CAP), other biochemical indicators (aminotransferases, total bilirubin, glucose and lipid parameters, hsCRP, SOD, and UA), physical measurements (DBP, SBP, BMI, WHR, BF%, and BMR), or APRI and FIB-4 indices. Gut microbiota analysis revealed increased species diversity and enrichment of Oscillospiraceae in the silymarin group.
CONCLUSIONS: These findings suggest that silymarin supplementation could improve liver stiffness in MASLD patients, possibly by modulating the gut microbiota.
BACKGROUND: The trial was registered at the Chinese Clinical Trial Registry (ChiCTR2200059043).