Gordon Adam, Hobbs Daryl A, Bowden D Scott, Bailey Michael J, Mitchell Joanne, Francis Andrew J P, Roberts Stuart K
Department of Gastroenterology, The Alfred Hospital, Victoria, Australia.
J Gastroenterol Hepatol. 2006 Jan;21(1 Pt 2):275-80. doi: 10.1111/j.1440-1746.2006.04138.x.
BACKGROUND/AIMS: Silybum marianum is a herbal preparation commonly used by subjects with chronic hepatitis C (CHC). The aims of this pilot study were to assess the efficacy and safety of S. marianum on serum hepatitis C virus (HCV) RNA, alanine aminotransferase levels and well-being in patients with CHC.
Twenty-four subjects with CHC were enrolled into a randomized, double-blind, placebo-controlled, crossover study. Subjects received 12 weeks of S. marianum (either 600 mg or 1200 mg/day) and placebo separated by a 4-week washout interval. Baseline biochemical, virological, psychological and quality-of-life tests were performed, with biochemical tests repeated monthly, and HCV RNA titer and quality-of-life and psychological assessments repeated at the end of both treatment periods.
Seventeen patients completed the trial. Mean changes in HCV RNA titers, serum ALT levels and Short Form-36 scores were not significantly different for subjects on S. marianum compared to those on placebo. There was no significant change in mean State-Trait Anxiety Inventory State-Anxiety scores on S. marianum from baseline. Adverse events were similar with S. marianum and placebo.
S. marianum is well tolerated in subjects with CHC, but does significantly affect serum HCV RNA, alanine aminotransferase levels, quality of life or psychological well-being in subjects with this condition.
背景/目的：水飞蓟是慢性丙型肝炎（CHC）患者常用的一种草药制剂。本初步研究的目的是评估水飞蓟对CHC患者血清丙型肝炎病毒（HCV）RNA、丙氨酸转氨酶水平及健康状况的疗效和安全性。
24例CHC患者被纳入一项随机、双盲、安慰剂对照、交叉研究。受试者接受12周的水飞蓟治疗（600毫克或1200毫克/天）和安慰剂治疗，中间间隔4周的洗脱期。进行了基线生化、病毒学、心理和生活质量测试，每月重复进行生化测试，在两个治疗期结束时重复进行HCV RNA滴度、生活质量和心理评估。
17例患者完成了试验。与服用安慰剂的受试者相比，服用水飞蓟的受试者HCV RNA滴度、血清ALT水平和简明健康状况调查量表（Short Form-36）评分的平均变化无显著差异。服用水飞蓟后，状态-特质焦虑量表的状态焦虑评分与基线相比无显著变化。水飞蓟和安慰剂的不良事件相似。
水飞蓟在CHC患者中耐受性良好，但对该疾病患者的血清HCV RNA、丙氨酸转氨酶水平、生活质量或心理健康没有显著影响。
