EVALUATING SILYMARIN IN CHRONIC HEPATITIS C

描述(改编自申请者摘要)：本报告的目的 探索性项目是评估调查影响的可行性 水飞蓟素，从水飞蓟植物水飞蓟中提取，用于预防 逆转慢性丙型肝炎病毒感染的并发症和/或清除 丙型肝炎病毒感染，从而产生初步结果作为基础 更明确的研究。对症治疗干预尚未得到证实 前景看好，尤其是在埃及最常见的基因， 而且在发展中国家，它们的价格高得令人望而却步。埃及拥有世界上 世界上丙型肝炎病毒感染率最高，农村平均为15%-25% 社区。对膳食补充剂的严格评估是有限的。 牛奶蓟，但有希望的有益效果。 具体目的是评估牛奶中提取的水飞蓟素 蓟：1)改善慢性丙型肝炎患者的肝脏发病率 和/或肝硬变；2)防止以下参与者的肝病进展 有慢性丙型肝炎病毒感染，但肝酶水平正常；3)有帮助 清除丙型肝炎病毒感染；以及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(低于抗氧化剂水平)。参与者将从 目前参加一项大型观察性研究的丙型肝炎病毒感染者队列 去埃及留学。参与者将在18个月内每天接受补充剂， 每六个月获得一次措施。待评估的措施将包括： 在研究中保留，遵守研究任务，自我描述 症状，丙氨酸氨基转移酶(ALT)水平，血清胶原标记物， 腹部超声、病毒载量和清除以及生活质量(SF36 调查)。 假设水飞蓟素不会清除丙型肝炎病毒感染。 但可以防止慢性丙型肝炎患者肝病的进展 肝炎，在某些情况下，逆转已经存在的肝脏损害， 以及改善使用这种饮食的个人的生活质量 副刊。这一探索性项目有望取得成功。 开始对水飞蓟的影响进行更大规模和更明确的研究 关于丙型肝炎病毒感染。

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.