Oral Pentoxifylline vs. Placebo in Acute Pancreatitis: ... (short title)

描述（由申请人提供）：急性胰腺炎（AP）是胰腺的炎症，也是最常见的胃肠道排泄诊断（2009年约有280,000例入院）。它每年造成26亿美元的保健费用，主要是由于这种疾病的更严重形式。缺乏任何特殊的药物来治疗这种疾病，也没有预测因素来确定哪些患者会发展成更严重的疾病。这项研究的长期目标是找到一种治疗这种疾病的药物，改善患者的预后，并降低医疗保健费用。基于我们的动物实验经验和一项小规模的人体实验，我们的假设和具体目标是：在诊断后72小时内给予己酮可可碱，可改善临床结果，减少更严重形式AP的发生。己酮茶碱降低了血液中炎症标志物的水平，这与临床结果的改善有关。本研究是一项新颖的、探索性的临床研究，该药物在动物研究中已被证实在阻断AP的炎症反应中起作用。这也是一项高回报的研究，将导致AP治疗的突破，并挑战长期以来单独支持治疗的建议。因此，它与美国国立卫生研究院R21拨款的使命非常吻合。该研究将分为两组，每组64名患者，均患有AP，随机分配给药物或安慰剂，看起来像药物，为期7天，或者直到他们出院时，如果出院是在入院后7天内。炎症标志物（CRP, IL-6， IL-8和TNF-a）的水平将在基线和连续5天或直到出院时进行测量，以较早者为准。小组规模的确定基于先前的试点研究，以减少任何重要的不良结果，在研究期间提供10%的辍学率。2012年，该机构接收了263名AP患者，该机构拥有成功完成临床药物干预试验所需的基础设施。在NIH规定的2年时间内，可以招募所需数量的患者进行研究。

DESCRIPTION (provided by applicant): Acute pancreatitis (AP) is an inflammation of the pancreas gland and the most common gastrointestinal discharge diagnosis (approximately 280,000 admissions in 2009). It has resulted in $2.6 billion, annually, in health care costs, mainly due to the more serious forms of the disease. Lack of any specific drug to treat the condition and predictors to identify patients who will develop more serious forms of the disease contribute to this. Long-term objectives of the study are to find a drug to treat this disease, improve patient outcomes, and reduce the costs of health care. Based on our experience with animals and a small, human subjects pilot study, our hypothesis and specific aims are: 1. Pentoxifylline, administered within 72 hours of diagnosis, improves the clinical outcomes and decreases the occurrence of more serious forms of AP. 2. Pentoxifylline reduces the blood levels of inflammatory markers, which correlates with improvement in clinical outcomes. This study is a novel, exploratory clinical study of the effect of a drug that has a proven role in animal studies in blocking the inflammatory response in AP. It is also a high reward study that will lead to a breakthrough in the treatment of AP and challenge the age old recommendation of supportive treatment alone. Thus it aligns extremely well with the NIH mission of R21 grants. The study will have 2 groups of 64 patients each, all with AP, randomly assigned to either the drug or a placebo, which looks like the drug, for a period of 7 days or until the time they are discharged, if hospital discharge is within 7 days of admission. The levels of markers of inflammation (CRP, IL-6, IL-8 and TNF-a) will be measured at baseline and on 5 successive days or until the time of discharge, whichever occurs earlier. Determination of group size was based on the previous pilot study to decrease any of the important adverse outcomes, providing for a dropout rate of 10% during the study. During 2012, 263 patients with AP were admitted to this institution, which possesses the needed infrastructure for successful completion of clinical drug intervention trials. In the stipulated period of 2 years by the NIH, the required number of patients for the study could be recruited.