A randomized controlled trial to assess the safety and efficacy of silymarin on symptoms, signs and biomarkers of acute hepatitis.
A randomized controlled trial to assess the safety and efficacy of silymarin on symptoms, signs and biomarkers of acute hepatitis.
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DOI：
10.1016/j.phymed.2009.02.002
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发表时间：
2009-05
期刊：
影响因子：
7.9
通讯作者：
Strickland, G. Thomas
中科院分区：
文献类型：
--
作者：
El-Kamary, Samer S.;Shardell, Michelle D.;Abdel-Hamid, Mohamed;Ismail, Soheir;El-Ateek, Mohamed;Metwally, Mohamed;Mikhail, Nabiel;Hashem, Mohamed;Mousa, Amr;Aboul-Fotouh, Amr;El-Kassas, Mohamed;Esmat, Gamal;Strickland, G. Thomas
水飞蓟或其纯化提取物水飞蓟素（Silybum marianum）被广泛用于治疗急性或慢性肝炎。虽然水飞蓟素在动物实验和一些人类肝毒性暴露中具有保肝作用，但其改善急性临床肝炎症状的疗效仍无定论。在这项研究中，我们的目的是确定水飞蓟素是否改善急性临床肝炎患者的症状，体征和实验室检查结果，无论病因如何。这是一项随机、安慰剂对照试验，其中参与者、治疗医生和数据管理人员对治疗组设盲。该研究在埃及Tanta和Banha的两家发热医院进行，其中招募了症状与急性临床肝炎相符且血清丙氨酸氨基转移酶（ALT）水平>正常上限的2.5倍的患者。干预包括每日三次摄入标准推荐剂量140 mg的水飞蓟素（Legalon®，MADAUS GmbH，科隆，德国）或维生素安慰剂，持续四周，并进行额外的四周随访。主要结果是急性肝炎的症状和体征以及第2、4和7天以及第2、4和8周的肝功能检查结果。通过自我报告确定副作用和不良事件。从2003年7月至2005年10月，105名合格患者在提供知情同意书后入组。没有发现不良事件，水飞蓟素和安慰剂都耐受良好。随机分配到水飞蓟素组的患者与胆汁潴留相关的症状更快消退：尿色深（p=0.013）、黄疸（p=0.02）和巩膜黄疸（p=0.043）。接受水飞蓟素治疗的患者间接胆红素降低（p=0.012），但其他变量（包括直接胆红素、ALT和天冬氨酸氨基转移酶（AST））并未显着降低。接受水飞蓟素治疗的患者在胆汁排泄的主观和临床指标方面有较早的改善。尽管样本量适中，急性临床肝炎的病因多种多样，我们的研究结果表明，标准推荐剂量的水飞蓟素是安全的，并可能有效地改善急性临床肝炎的症状，尽管缺乏可检测的影响，对生物标志物的基础肝细胞炎症过程。
Milk thistle or its purified extract, silymarin (Silybum marianum), is widely used in treating acute or chronic hepatitis. Although silymarin is hepatoprotective in animal experiments and some human hepatotoxic exposures, its efficacy in ameliorating the symptoms of acute clinical hepatitis remains inconclusive. In this study, our purpose was to determine whether silymarin improves symptoms, signs and laboratory test results in patients with acute clinical hepatitis, regardless of etiology. This is a randomized, placebo-controlled trial in which participants, treating physicians and data management staff were blinded to treatment group. The study was conducted at two fever hospitals in Tanta and Banha, Egypt where patients with symptoms compatible with acute clinical hepatitis and serum alanine aminotransferase (ALT) levels > 2.5 times the upper limit of normal were enrolled. The intervention consisted of three times daily ingestion of either a standard recommended dose of 140 mg of silymarin (Legalon®, MADAUS GmbH, Cologne, Germany), or a vitamin placebo for four weeks with an additional four-week follow-up. The primary outcomes were symptoms and signs of acute hepatitis and results of liver function tests on days 2, 4 and 7 and weeks 2, 4, and 8. Side-effects and adverse events were ascertained by self-report. From July 2003 through October 2005, 105 eligible patients were enrolled after providing informed consent. No adverse events were noted and both silymarin and placebo were well tolerated. Patients randomized to the silymarin group had quicker resolution of symptoms related to biliary retention: dark urine (p=0.013), jaundice (p=0.02) and scleral icterus (p=0.043). There was a reduction in indirect bilirubin among those assigned to silymarin (p=0.012), but other variables including direct bilirubin, ALT and aspartate aminotransferase (AST) were not significantly reduced. Patients receiving silymarin had earlier improvement in subjective and clinical markers of biliary excretion. Despite a modest sample size and multiple etiologies for acute clinical hepatitis, our results suggest that standard recommended doses of silymarin are safe and may be potentially effective in improving symptoms of acute clinical hepatitis despite lack of a detectable effect on biomarkers of the underlying hepatocellular inflammatory process.
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影响因子：
29.4
作者：
Ferenci, Peter;Scherzer, Thomas-Matthias;Steindl-Munda, Petra
通讯作者：
Steindl-Munda, Petra
影响因子：
3.3
作者：
MURIEL, P;MOURELLE, M
通讯作者：
MOURELLE, M
影响因子：
5.1
作者：
Lee, DYW;Liu, YZ
通讯作者：
Liu, YZ
影响因子：
13.5
作者：
Strickland, GT
通讯作者：
Strickland, GT
DOI：
10.1016/s0035-9203(96)90418-6
发表时间：
1996-11-01
影响因子：
2.2
作者：
Corwin, AL;Dai, TC;Hyams, KC
通讯作者：
Hyams, KC