NCT02161653已完成4 期
Impact of Metadoxine in the Oxidative Stress and Early Mortality in Patients With Severe Alcoholic Hepatitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- 30 day-survival
研究概览
简要总结
The purpose of this study is to determine whether metadoxine is effective for improve survival and reduced oxidative stress in patients with severe alcoholic hepatitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with clinical and biochemical criteria for severe alcoholic hepatitis: Total bilirubin greater than 5 mg/dl in absence of biliary tract obstruction evidenced by ultrasound, history of chronic alcohol intake, leukocytosis, neutrophilia, elevation of transaminases with an aspartate aminotransferase / alanine aminotransferase ratio equal or greater than 2, discriminant function greater than 32.
排除标准
- •Diabetes, chronic kidney disease, hepatitis C, hepatitis B and or human immunodeficiency virus infection, asthma or history of atopy or allergic reactions, therapy in the previous two years with steroids, pentoxifylline, metadoxine, S-adenosyl L- methionine, antioxidants or multivitamins.
研究组 & 干预措施
Prednisone plus metadoxine
Experimental
Prednisone 40 mg daily by mouth plus Metadoxine 500 mg thrice in day by mouth during 30 days.
干预措施: Prednisone plus Metadoxine (Drug)
Pentoxifylline plus metadoxine
Experimental
Pentoxifylline 400 mg thrice in day by mouth plus Metadoxine 500 mg thrice in day by mouth during 30 days.
干预措施: Pentoxifylline plus Metadoxine (Drug)
结局指标
主要结局
30 day-survival
时间窗: 30 days
Malondialdehyde serum levels
时间窗: 14 and 30 days
次要结局
- 3 month-survival(3 months)
- 6 month-survival(6 months)
研究者
MARIA DE FATIMA HIGUERA DE LA TIJERA
MD, MSc.
Hospital General de Mexico
研究点 (1)
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