EVALUATING SILYMARIN IN CHRONIC HEPATITIS C

评估水飞蓟素治疗慢性丙型肝炎的效果

• 批准号: 6165632
• 负责人: George Thomas Strickland
• 金额: $ 30.71万
• 依托单位: UNIVERSITY OF MARYLAND BALTIMORE
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-09-01 至 2004-01-01
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6165632
• 关键词: Egypt; alternative medicine; angiosperms; chronic disease /disorder; clinical research; cytoprotection; dietary supplements; hepatitis C; hepatitis C virus; human subject; human therapy evaluation; liver disorder; medicinal plants; plant extracts; quality of life

DESCRIPTION (Adapted from Applicant's Abstract): The objective of this exploratory project is to assess the feasibility of investigating the effect of silymarin, derived from the milk thistle plant, Silybum marianum, in preventing and reversing the complications of chronic infection with HCV and/or clearing HCV infections, thereby generating preliminary results to serve as the basis of more definitive study. Allopathic therapeutic interventions have not proved promising, particularly with the genotype most commonly encountered in Egypt, and they are prohibitively expensive in the developing world. Egypt has the highest prevalence of HCV infection in the world, averaging 15-25% in rural communities. There are limited rigorous assessments of the dietary supplement milk thistle, but there is promise of salutary effect. The specific aims are to evaluate whether silymarin, the extract of milk thistle: 1) improves hepatic morbidity in subjects with chronic HCV hepatitis and/or cirrhosis; 2) prevents progression of liver disease in participants who have chronic HCV infections but who have normal liver enzyme levels; 3) helps clear HCV infections; and 4) improves these participants' quality of life. Participants will be randomly assigned to receive silymarin or a vitamin supplement (below antioxidant levels). Participants will be recruited from a cohort of HCV-infected individuals currently enrolled in a large observational study in Egypt. Participants will receive the supplements daily for 18 months, with measures obtained every six months. Measures to be assessed will include: retention in the study, compliance with study assignment, self-described symptoms, alanine aminotransferase (ALT) levels, serum collagen markers, abdominal ultrasound, viral load and clearance, and quality of life (SF36 survey). It is hypothesized that silymarin will not lead to clearance of HCV infections but can prevent progression of liver disease in participants with chronic HCV hepatitis and, in some cases, reverse hepatic lesions that are already present, as well as improving the quality of life in individuals who use this dietary supplement. This exploratory project is anticipated to result in successful initiation of larger and more definitive studies of the effect of milk thistle on HCV infection.

描述（改编自申请人摘要）：本文的目的 探索性项目是为了评估调查效果的可行性， 水飞蓟素，来源于牛奶蓟植物，水飞蓟，在预防 以及逆转HCV慢性感染的并发症和/或清除 HCV感染，从而产生初步结果，作为 更权威的研究。对抗疗法的治疗干预尚未证明 很有希望，特别是在埃及最常见的基因型， 而且在发展中国家价格高得令人望而却步。埃及有 世界上HCV感染率最高，农村平均为15-25% 社区.对膳食补充剂的严格评估有限 牛奶蓟，但有希望的有益效果。 具体的目的是评估是否水飞蓟素，牛奶的提取物， 蓟：1）改善慢性HCV肝炎患者的肝脏发病率 和/或肝硬化; 2）预防以下参与者的肝病进展： 有慢性HCV感染，但谁有正常的肝酶水平; 3）帮助 明确的HCV感染;和4）改善这些参与者的生活质量。 参与者将被随机分配接受水飞蓟素或维生素 补充剂（低于抗氧化剂水平）。参与者将从一个 一组HCV感染者目前参加了一项大型观察性研究， 在埃及学习。参与者将在18个月内每天接受补充剂， 每六个月测量一次。有待评估的措施将包括： 在研究中的保留，对研究分配的依从性，自我描述 症状，丙氨酸氨基转移酶（ALT）水平，血清胶原蛋白标志物， 腹部超声、病毒载量和清除率以及生活质量（SF 36 调查）。 据推测，水飞蓟素不会导致清除HCV感染 但可以预防慢性HCV参与者的肝脏疾病进展 肝炎，在某些情况下，逆转已经存在的肝脏病变， 以及改善使用这种饮食的人的生活质量 补充.这一探索性项目预计将取得成功， 开始对奶蓟的影响进行更大和更明确的研究 关于HCV感染