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

描述(由申请人提供)：急性胰腺炎(AP)是一种胰腺炎症，也是最常见的胃肠道排泄物诊断(2009年约有28万人入院)。这导致了每年26亿美元的医疗费用，主要是由于更严重的疾病形式。缺乏任何治疗这种疾病的特定药物和预测因素来确定哪些患者将发展为更严重的疾病形式，这是造成这种情况的原因之一。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，并降低医疗保健成本。根据我们在动物和一项小型人类受试者的初步研究中的经验，我们的假设和具体目标是：1.在确诊后72小时内给予己酮可可碱，可以改善临床结果，减少更严重形式的AP的发生。2.己酮可可碱可降低血液中炎症标志物的水平，这与临床结果的改善有关。这项研究是一项新的、探索性的临床研究，目的是研究一种在动物实验中被证明具有阻断AP炎症反应作用的药物的效果。这也是一项高回报的研究，将导致AP治疗的突破，并挑战古老的仅支持治疗的建议。因此，它与美国国立卫生研究院的R21拨款任务非常吻合。这项研究将有两组患者，都是AP患者，随机分配到药物或安慰剂(看起来像药物)，为期7天，或者直到他们出院，如果入院在7天内。炎症标志物(CRP、IL-6、IL-8和TNF-α)水平将在基线、连续5天或出院时(以较早发生者为准)进行检测。群体规模的确定是基于先前的先导性研究，以减少任何重要的不良后果，规定研究期间的辍学率为10%。2012年，该机构收治了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。在美国国立卫生研究院规定的两年内，可以招募到研究所需的患者数量。

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.