Pioglitazone versus vitamin E versus placebo for the treatment of non-diabetic patients with non-alcoholic steatohepatitis: PIVENS trial design.
Pioglitazone versus vitamin E versus placebo for the treatment of non-diabetic patients with non-alcoholic steatohepatitis: PIVENS trial design.
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DOI：
10.1016/j.cct.2008.09.003
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发表时间：
2009-01
影响因子：
2.2
通讯作者：
NASH CRN Research Group
中科院分区：
文献类型：
--
作者：
Chalasani NP;Sanyal AJ;Kowdley KV;Robuck PR;Hoofnagle J;Kleiner DE;Unalp A;Tonascia J;NASH CRN Research Group
非酒精性脂肪性肝炎(NASH)是一种常见的与肥胖和糖尿病相关的肝脏疾病。NASH是一种进行性疾病，可导致肝硬变和肝功能衰竭。胰岛素抵抗和氧化应激被认为在其发病机制中起重要作用。目前还没有针对纳什的特效药。Pivens的研究是为了验证这样的假设，即吡格列酮(一种噻唑烷二酮胰岛素增敏剂)或维生素E(一种自然可获得的抗氧化剂)治疗将导致活检证实为NASH的非糖尿病成年人的肝脏组织学改善。Pivens是一项随机、多中心、双掩蔽、安慰剂对照试验，旨在评估与安慰剂治疗相比，吡格列酮或维生素E治疗96周是否改善了患有NASH的非糖尿病成年人的肝脏组织学。治疗前后的肝活检以掩蔽方式集中读取，以评估脂肪性肝炎和NAFLD活动评分(NAS)，包括脂肪变性、小叶炎和肝细胞气球。主要结果衡量标准是至少两个NAS特征中NAS改善2个或更多，或治疗后NAS改善3个或更少，肝细胞膨胀改善1个或更多，且肝纤维化没有恶化。Pivens的登记从2005年1月开始，到2007年1月结束，247名患者随机接受吡格列酮(30 mg q.d)、维生素E(800IU q.d)或安慰剂治疗96周。在停止治疗后，参与者将再接受24周的跟踪。研究方案结合了几份有效问卷的使用和样本库。该方案得到了所有参与的中心机构审查委员会(IRBs)和一个独立的数据和安全监测委员会(DSMB)的批准，该委员会成立的目的是在试验进展过程中监测累积的临时数据，以确保患者安全，审查疗效以及数据收集和整体研究管理的质量。
Nonalcoholic steatohepatitis (NASH) is a common liver disease associated with obesity and diabetes. NASH is a progressive disorder that can lead to cirrhosis and liver failure. Insulin resistance and oxidative stress are thought to play important roles in its pathogenesis. There is no definitive treatment for NASH. PIVENS is conducted to test the hypotheses that treatment with pioglitazone, a thiazolidinedione insulin sensitizer, or vitamin E, a naturally available antioxidant, will lead to improvement in hepatic histology in nondiabetic adults with biopsy proven NASH. PIVENS is a randomized, multicenter, double-masked, placebo-controlled trial to evaluate whether 96 weeks of treatment with pioglitazone or vitamin E improves hepatic histology in nondiabetic adults with NASH compared to treatment with placebo. Before and post-treatment liver biopsies are read centrally in a masked fashion for an assessment of steatohepatitis and a NAFLD Activity Score (NAS) consisting of steatosis, lobular inflammation, and hepatocyte ballooning. The primary outcome measure is defined as either an improvement in NAS by 2 or more in at least two NAS features, or a post-treatment NAS of 3 or less, and improvement in hepatocyte ballooning by 1 or more, and no worsening of fibrosis. PIVENS enrollment started in January 2005 and ended in January 2007 with 247 patients randomized to receive either pioglitazone (30 mg q.d.), vitamin E (800 IU q.d.), or placebo for 96 weeks. Participants will be followed for an additional 24 weeks after stopping the treatment. The study protocol incorporates the use of several validated questionnaires and specimen banking. This protocol was approved by all participating center Institutional Review Boards (IRBs) and an independent Data and Safety Monitoring Board (DSMB) which was established for monitoring the accumulated interim data as the trial progresses to ensure patient safety and to review efficacy as well as the quality of data collection and overall study management.
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影响因子：
29.4
作者：
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通讯作者：
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