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左旋肉碱在降低肝硬化患者血氨和改善神经心理测试表现中的疗效:一项随机试验的结果。

Efficacy of L-carnitine in reducing hyperammonaemia and improving neuropsychological test performance in patients with hepatic cirrhosis : results of a randomised trial.

机构信息

Department of Clinical and Experimental Medicine 'F.Magrassi', II University of Naples, Naples, Italy.

出版信息

Clin Drug Investig. 2002 Nov;22(Suppl 1):7-14. doi: 10.2165/00044011-200222001-00002.

Abstract

OBJECTIVES

To determine the efficacy of L-carnitine in reducing hyperammonaemia and improving neuropsychological performance in patients with hepatic cirrhosis and subclinical hepatic encephalopathy (SHE).

DESIGN

Randomised, parallel group, controlled trial.

PATIENTS AND METHODS

The study enrolled 31 patients with hepatic cirrhosis resulting from hepatitis C and/or hepatitis B, alcohol abuse and other causes. Patients randomised to active treatment, received oral L-carnitine 6 g/day in two divided doses for 4 weeks. Diagnosis of SHE was based on psychometric tests (subtests of the Wechsler Adult Intelligence Scale-Revised and the Halstead-Reitan Neuropsychological Test Battery) carried out at beginning and end of study. Serum ammonia levels were measured before treatment and weekly thereafter.

RESULTS

A total of 27 patients completed the study. Sixteen patients received L-carnitine and 11 served as controls (no treatment). L-carnitine caused rapid and significant reductions in ammonia levels, sustained over the 4-week treatment period (mean reductions 60.1 and 1.4 (μmol/L in the treated and control groups, respectively). Normal ammonia levels were attained in 14 of 16 patients receiving L-carnitine. Based on psychometric test results, seven patients (43.7%) in the L-carnitine group and five (45.5%) in the control group had SHE at baseline. L-carnitine treatment for 4 weeks caused a net overall improvement in psychometric test results compared with controls. No clinically significant adverse events were reported and all patients receiving L-carnitine reported subjective improvements in their condition.

CONCLUSIONS

RESULTS of this preliminary study indicate that L-carnitine reduces hyperammonaemia and improves the clinical symptoms of SHE in patients with hepatic cirrhosis.

摘要

目的

确定左旋肉碱在降低肝硬化和亚临床肝性脑病(SHE)患者的高血氨和改善神经心理表现方面的疗效。

设计

随机、平行组、对照试验。

患者和方法

本研究纳入了 31 名因丙型肝炎和/或乙型肝炎、酒精滥用和其他原因导致肝硬化的患者。随机分配到活性治疗组的患者每天口服左旋肉碱 6 克,分两次服用,共 4 周。SHE 的诊断基于研究开始和结束时进行的心理计量测试(威斯康星卡片分类测试和 Halstead-Reitan 神经心理测试成套测验的子测验)。治疗前和每周后测量血清氨水平。

结果

共有 27 名患者完成了研究。16 名患者接受了左旋肉碱治疗,11 名作为对照组(未治疗)。左旋肉碱可迅速且显著降低氨水平,在 4 周治疗期间持续降低(治疗组和对照组的平均降低分别为 60.1 和 1.4μmol/L)。16 名接受左旋肉碱治疗的患者中有 14 名达到正常氨水平。根据心理计量测试结果,在接受左旋肉碱治疗的 16 名患者中有 7 名(43.7%)和对照组中有 5 名(45.5%)患者在基线时有 SHE。与对照组相比,左旋肉碱治疗 4 周后,心理计量测试结果总体上有明显改善。未报告任何临床显著的不良事件,所有接受左旋肉碱治疗的患者均报告其病情有所改善。

结论

这项初步研究的结果表明,左旋肉碱可降低肝硬化患者的高血氨并改善 SHE 的临床症状。

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