EASL2020[GS06] 随机，多中心，双盲，安慰剂对照， 员发起L2

StephenW

GS06
A randomized, multi-center, double-blinded, placebo controlled,
investigator-initiated trial to assess the impact of L-carnitine
administration on the quality of life in the liver cirrhosis with
covert hepatic encephalopathy
Eileen Yoon1, Dae Won Jun2, Sang Bong Ahn3, Yong Kyun Cho4,
Do Seon Song5, Jaeyoon Jeong6, Hee Yeon Kim7, Young Kul Jung8,
Myeong Jun Song9, Hyoung Su Kim10, Sung Eun Kim11,
Soung Won Jeong12, Sang Gyune Kim13, Tae Hee Lee14,
Hokyoung Ryu15. 1Sanggye Paik Hospital, Inje University College of
Medicine, Internal Medicine, Seoul, Korea, Rep. of South; 2Hanyang
University Hospital, Internal Medicine, Seoul, Korea, Rep. of South;
3Nowon Eulji Medical Center, Eulji University College of Medicine,
Internal Medicine, Seoul, Korea, Rep. of South; 4Kangbuk Samsung
Hospital, Sungkyunkwan University School of Medicine, Internal
Medicine, Seoul, Korea, Rep. of South; 5St. Vincent’s Hospital, College of
Medicine, The Catholic University of Korea, Internal Medicine, Suwon-si,Korea, Rep. of South; 6National Medical Center, Internal Medicine, Seoul,
Korea, Rep. of South; 7Uijeongbu St. Mary’s Hospital, The Catholic
University, Internal Medicine, Euijeongbu, Korea, Rep. of South; 8Korea
University Ansan Hospital, Korea University College of Medicine, Internal
Medicine, Ansan-si, Korea, Rep. of South; 9Daejeon St. Mary’s Hospital,
College of Medicine, The Catholic University of Korea, Internal Medicine,
Daejeon; 10Kangdong Sacred Heart Hospital, Hallym University College
of Medicine, Internal Medicine, Seoul; 11Hallym University Sacred Heart
Hospital, Hallym University College of Medicine, Internal Medicine,
Anyang-si, Korea, Rep. of South; 12Soonchunhyang University College of
Medicine, Soonchunhyang University Seoul Hospital, Internal Medicine,
Seoul, Korea, Rep. of South; 13Soonchunhyang University College of
Medicine, Soonchunhyang University Bucheon Hospital, Bucheon-si,
Korea, Rep. of South; 14Konyang University College of Medicine, Internal
Medicine, Daejeon; 15Hanyang University, Arts & Technology, Seoul,
Korea, Rep. of South
Email: [email protected]
Background and Aims: Covert hepatic encephalopathy (CHE) leads
to poor quality of life (QOL) in liver cirrhosis (LC) patients.We aimed
to evaluate the impact of L-carnitine on the QOL evaluated by the 36-
Item Short Form Survey (SF-36) in CHE patients following 24weeks of
treatment. Secondary endpointswere the effects of L-carnitine on the
improvement of cognitive dysfunction.
Method: We performed a prospective, randomized, double-blinded,
placebo-controlled study administering L-carnitine for 24 weeks to
LC patients with CHE. Thirteen centers fromKoreawere engaged. CHE
was defined as either West-Haven grade 1 or grade 0 with the
Psychometric hepatic encephalopathy score (PHES) below −4.
Patients who had previously experienced overt HE were excluded.
Results: A total of 230 LC patients were screened. 150 CHE patients
underwent randomization. The mean agewas 53 years and 65% were
male. Mostly they were chronic hepatitis B and 82% were Child-Pugh
A. Seventy two and 70 patients were randomly assigned to the
placebo group and the L-carnitine group. Baseline characteristics
including results of PHES scores were similar between the groups.
Although SF-36 levels were not different between the groups, the
differences of SF-36 between the baseline and at 24 weeks of
treatment were 2.42 ± 12.86 in the placebo vs. 4.60 ± 11.73 in the Lcarnitine
groups (P = 0.001). Trend analysis for PHES showed
significant improvement in the L-carnitine group (P = 0.023). The
rate correct score of inhibition test among the Korean Stroop Test at
24 weeks of treatment was significantly higher in the L-carnitine
group (P = 0.038). Additionally, the gap of total carnitine level
between the baseline and week 24 were positively correlated with
the improvement of rate correct scores of all four components in the
Korean Stroop Test (r = 0.3 for Color Test; r = 0.4 forWord Test; r = 0.5
for Inhibition Test; r = 0.3 for Inhibition/Switching Test; all P values
<0.05) in the L-carnitine group.
Conclusion: Administration of L-carnitine for 24 weeks in the LC
patients with CHE were related to improvement of QOL as well as
cognitive function.

StephenW

GS06
随机，多中心，双盲，安慰剂对照，
由研究人员发起的评估左旋肉碱影响的试验
肝硬化患者的生活质量管理
隐性肝性脑病
Eileen Yoon1，Dae Won Jun2，Sang Bong Ahn3，Yong Kyun Cho4，
杜善颂5，Jaeyoon Jeong6，Hee Yeon Kim7，Young Kul Jung8，
Myeong Jun Song9，Hyoung Su Kim10，Sung Eun Kim11，
宋元正12，桑久y Kim13，李泰熙14，
Hokyoung Ryu 15。 1仁济大学学院Sanggye Paik医院
医学，内科，韩国首尔，南方共和国； 2汉阳
韩国首尔大学附属医院，内科；
3乙支大学医学院现在的乙支乙支医学中心
内科，韩国首尔，南方共和国； 4江北三星
成均馆大学医学院附属医院内科
医药，韩国首尔，南方共和国； 5街文森特医院
韩国天主教大学，内科，韩国水原市医学。 6首尔国立内科医学中心
韩国南方共和国； 7天主教天主教会亭市圣玛丽医院
大学，内科学，韩国义亭市，韩国共和国； 8韩国
高丽大学医学院安山大学医院内部
医药，韩国安山市，南方共和国； 9大田圣玛丽医院
韩国天主教大学医学院，内科，
大田10哈林大学学院康东圣心医院
首尔内科医学院11哈利姆大学圣心
哈林大学医学院内科医院
韩国安养市，南方共和国； 12Soonchunhyang大学学院
淳淳大学首尔医院内科
韩国首尔，南方共和国； 13淳淳大学
淳春市大学富川医院医学
韩国南方共和国； 14光阳大学医学院内部
大田医学15汉阳大学艺术与技术学院，首尔
韩国，南韩
电子邮件：[email protected]
背景与目的：隐性肝性脑病（CHE）线索
旨在改善肝硬化（LC）患者的生活质量（QOL）。
评估左旋肉碱对36-
CHE患者24周后的项目简表调查（SF-36）
治疗。次要终点是左旋肉碱对
改善认知功能障碍。
方法：我们进行了前瞻性，随机，双盲，
安慰剂对照研究，服用左旋肉碱24周至
LC的CHE患者。雇用了来自韩国的13个中心。 CHE
被定义为West-Haven 1级或0级，
心理测量的肝性脑病评分（PHES）低于-4。
先前曾经历过明显的HE的患者被排除在外。
结果：共筛选了230名LC患者。 150 CHE患者
进行随机化。平均年龄为53岁，其中65％为
男。他们大多是慢性乙型肝炎，而82％是Child-Pugh
答：72例和70例患者被随机分配到
安慰剂组和左旋肉碱组。基线特征
两组之间的PHES评分结果相似。
尽管各组之间的SF-36水平没有差异，但是
基线和24周时SF-36的差异
安慰剂组的治疗为2.42±12.86，左卡尼汀为4.60±11.73
组（P = 0.001）。 PHES的趋势分析显示
左旋肉碱组有显着改善（P = 0.023）。的
在韩国的Stroop测试中对抑制测试的正确率进行评分
左旋肉碱治疗24周显着更高
组（P = 0.038）。此外，总肉碱水平的差距
基线和第24周之间的相关性与
改善所有四个组成部分的正确率评分
韩文Stroop测试（颜色测试r = 0.3；单词测试r = 0.4； r = 0.5
进行抑制试验；抑制/转换测试的r = 0.3；所有P值
<0.05）在左旋肉碱组中。
结论：左旋肉碱在LC中给药24周
CHE患者与QOL改善以及
认知功能。