Oral L-ornithine-L-aspartate therapy of chronic hepatic encephalopathy: results of a placebo-controlled double-blind study
| Autor: | Peter Malfertheiner, K Beckh, Rüdiger Hendricks, Dirk Mayer, Christian Karoff, Hans Ditschuneit, Sabine Stauch, Wolfgang Rösch, Guideo Adler, Albert Heuser, Jakob Steffens, Roman Görtelmeyer, Gerald Kircheis |
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| Rok vydání: | 1998 |
| Předmět: |
Adult
Male medicine.medical_specialty Cirrhosis Encephalopathy Administration Oral Neuropsychological Tests Placebo Gastroenterology Placebos Double-Blind Method Ammonia Internal medicine medicine Humans Hepatic encephalopathy Subclinical infection Hepatology business.industry Therapeutic effect Hyperammonemia Dipeptides Middle Aged Postprandial Period medicine.disease Surgery Postprandial Hepatic Encephalopathy Female Dietary Proteins Mental Status Schedule business |
| Zdroj: | Journal of Hepatology. 28:856-864 |
| ISSN: | 0168-8278 |
| DOI: | 10.1016/s0168-8278(98)80237-7 |
| Popis: | In the current state of knowledge of the pathophysiology of hepatic encephalopathy, a reduction in hyperammonemia is the most important evidence of effective treatment. Therefore, the therapeutic efficacy of oral L-ornithine-L-aspartate, which improves impaired ammonia detoxification, was investigated in patients with cirrhosis, hyperammonemia and stable, overt, chronic hepatic encephalopathy, and in subclinical hepatic encephalopathy in a randomized, double-blind, placebo-controlled clinical trial.Oral L-ornithine-L-aspartate was administered three times daily at fixed times for 14 consecutive days in a total dose of 18 g per day. The design was chosen to prevent an increase in ammonia induced by a protein meal of 0.25 g/kg body weight, given at the start of the daily treatment period. Efficacy variables were: fasting and postprandial ammonia concentration, Number-Connection-Test time, mental state grades, and a Portosystemic Encephalopathy Index. Analyses were based on the total study sample of 32 placebo- and 34 L-ornithine-L-aspartate-treated patients as well as on the subgroup samples in the overt (20 placebo- and 23 L-ornithine-L-aspartate-treated) and subclinical hepatic encephalopathy (12 placebo- and 11 L-ornithine-L-aspartate-treated) patients.Number Connection Test performance times (p0.01) as well as fasting (p0.01) and postprandial (p0.05) venous blood ammonia concentrations in the L-ornithine-L-aspartate-treated group showed improvement in comparison to placebo. Also, the mental state grade (p0.05) and the Portosystemic Encephalopathy Index (p0.01), improved to a much greater degree in the L-ornithine-L-aspartate group than in the placebo group. Adverse events were observed in neither the placebo nor the L-ornithine-L-aspartate-treated patients.Oral L-ornithine-L-aspartate is a safe, well-tolerated treatment with a good compliance rate and a beneficial therapeutic effect in patients with cirrhosis and stable, overt, chronic hepatic encephalopathy. |
| Databáze: | OpenAIRE |
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