Department of Internal Medicine, Inje University Sanggye Paik Hospital, Seoul, Korea.
Department of Internal Medicine, Hanyang University Seoul Hospital, Hanyang University College of Medicine, Seoul, Korea.
Korean J Intern Med. 2022 Jul;37(4):757-767. doi: 10.3904/kjim.2021.338. Epub 2022 May 6.
BACKGROUND/AIMS: L-carnitine is potentially beneficial in patients with hepatic encephalopathy (HE). We aimed to evaluate the impact of L-carnitine on the quality of life and liver function in patients with liver cirrhosis and covert HE.
We conducted an investigator-initiated, prospective, multi-center, double- blind, randomized phase III trial in patients with covert HE. A total of 150 patients were randomized 1:1 to L-carnitine (2 g/day) or placebo for 24 weeks. Changes in quality of life and liver function were assessed at 6 months. The model for end-stage liver disease (MELD), the 36-Item Short Form Survey (SF-36), the psychometric hepatic encephalopathy score (PHES), and the Stroop Test were evaluated in all patients.
The total SF-36 score significantly improved in the L-carnitine group after 24 weeks (difference: median, 2; interquartile range, 0 to 11; p < 0.001); however, these values were comparable between the two groups. Furthermore, there was a significant ordinal improvement in PHES scores among patients with minimal HE who were in the L-carnitine group (p = 0.007). Changes in the total carnitine level also positively correlated with improvements in the Stroop test in the L-carnitine group (color test, r = 0.3; word test, r = 0.4; inhibition test, r = 0.5; inhibition/switching test, r = 0.3; all p < 0.05). Nevertheless, the MELD scores at week 24 did not differ between the groups.
Twenty-four weeks of L-carnitine supplementation was safe but ineffective in improving quality of life and liver function.
背景/目的：左旋肉碱对肝性脑病（HE）患者可能有益。我们旨在评估左旋肉碱对隐源性 HE 患者生活质量和肝功能的影响。
我们在隐源性 HE 患者中开展了一项由研究者发起的、前瞻性、多中心、双盲、随机 III 期临床试验。共有 150 名患者按照 1:1 的比例随机分为左旋肉碱（2 g/天）组或安慰剂组，治疗 24 周。在 6 个月时评估生活质量和肝功能的变化。所有患者均评估终末期肝病模型（MELD）评分、36 项简明健康调查问卷（SF-36）评分、心理测量性肝性脑病评分（PHES）和斯特鲁普测验。
24 周后，左旋肉碱组的总 SF-36 评分显著改善（差值：中位数 2；四分位距 0 至 11；p < 0.001）；然而，两组间这些评分值无差异。此外，左旋肉碱组中存在轻微 HE 的患者 PHES 评分显著呈有序改善（p = 0.007）。左旋肉碱组患者肉碱总水平的变化也与斯特鲁普测验的改善呈正相关（颜色测验，r = 0.3；文字测验，r = 0.4；抑制测验，r = 0.5；抑制/转换测验，r = 0.3；均 p < 0.05）。然而，两组间第 24 周的 MELD 评分无差异。
左旋肉碱补充 24 周安全，但不能改善生活质量和肝功能。
