Department of Internal Medicine, Hanyang University Guri Hospital, Hanyang University College of Medicine, Guri 11923, South Korea.
Department of Internal Medicine, Dong-A University Hospital, Dong-A University College of Medicine, Busan 49201, South Korea.
World J Gastroenterol. 2017 Aug 28;23(32):5977-5985. doi: 10.3748/wjg.v23.i32.5977.
To evaluate the efficacy and safety of HL tablet extracted from for treating patients with nonalcoholic fatty liver disease (NAFLD).
Seventy-four patients with NAFLD diagnosed by ultrasonography were randomly assigned to 3 groups given high dose (400 mg) HL tablet, low dose (133.4 mg) HL tablet and placebo, respectively, daily for 12 wk. The primary endpoint was post-treatment change of hepatic fat content (HFC) measured by magnetic resonance spectroscopy. Secondary endpoints included changes of serum aspartate aminotransferase, alanine aminotransferase (ALT), cholesterol, triglyceride, free fatty acid, homeostasis model assessment-estimated insulin resistance, and body mass index (BMI).
The mean HFC of the high dose HL group, but not of the low dose group, declined significantly after 12 wk of treatment (high dose placebo, = 0.033; low dose placebo, = 0.386). The mean changes of HFC from baseline at week 12 were -1.7% ± 3.1% in the high dose group ( = 0.018), -1.21% ± 4.97% in the low dose group ( = 0.254) and 0.61% ± 3.87% in the placebo group (relative changes compared to baseline, high dose were: -12.1% ± 23.5%, low dose: -3.2% ± 32.0%, and placebo: 7.6% ± 44.0%). Serum ALT levels also tended to decrease in the groups receiving HL tablet while other factors were unaffected. There were no moderate or severe treatment-related safety issues during the study.
HL tablet is effective in reducing HFC without any negative lipid profiles, BMI changes and adverse effects.
评估 HL 片剂（从虎杖中提取）治疗非酒精性脂肪性肝病（NAFLD）患者的疗效和安全性。
74 例经超声诊断为 NAFLD 的患者被随机分为 3 组，分别给予高剂量（400mg）HL 片剂、低剂量（133.4mg）HL 片剂和安慰剂，每日 1 次，共 12 周。主要终点是磁共振波谱测量的肝脂肪含量（HFC）治疗后的变化。次要终点包括血清天门冬氨酸氨基转移酶、丙氨酸氨基转移酶（ALT）、胆固醇、甘油三酯、游离脂肪酸、稳态模型评估-胰岛素抵抗和体重指数（BMI）的变化。
高剂量 HL 组的 HFC 平均值在治疗 12 周后显著下降，但低剂量组没有（高剂量与安慰剂， = 0.033；低剂量与安慰剂， = 0.386）。高剂量组在第 12 周时 HFC 从基线的平均变化为-1.7%±3.1%（ = 0.018），低剂量组为-1.21%±4.97%（ = 0.254），安慰剂组为 0.61%±3.87%（与基线相比的相对变化，高剂量组为：-12.1%±23.5%，低剂量组为：-3.2%±32.0%，安慰剂组为：7.6%±44.0%）。接受 HL 片剂治疗的组血清 ALT 水平也呈下降趋势，而其他因素不受影响。研究过程中无中度或重度与治疗相关的安全问题。
HL 片剂可有效降低 HFC，对血脂谱、BMI 变化和不良反应无影响。
