COMPARISON OF SANDOSTATIN TO SANDOSTATIN LAR DEPOT IN THE TRMT OF PANC PAIN

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 慢性胰腺炎腹痛的治疗效果并不理想。内科治疗包括戒酒、止痛药和胰酶。非肠道包被酶主要用于止痛，因为它们将丝氨酸蛋白酶传递到十二指肠，并可以减少CCK对这些患者的过度刺激。对这些酶的随机试验表明，它们可以减轻一些患者的疼痛。药物治疗失败的情况并不少见。一些患者是内窥镜或外科治疗的候选对象；这些治疗只能应用于有实质性胰管异常的一小部分患者。尽管接受了药物和其他治疗，许多患者仍继续感受到疼痛。需要更好的治疗方法。 这项先导试验的主要目的是评估善得定对慢性胰腺炎患者疼痛的疗效，并将其与生物等量的善得定进行比较。主要终点是确定VAS(视觉模拟评分)所确定的疼痛减轻程度。次要终点将是生活质量、营养状况、止痛药减少百分比以及对受试者报告的健康结果的影响。 大约25名已经服用善宁的受试者将被登记并作为他们自己的对照。符合条件的受试者将接受Sandostatin LAR？治疗，总共为期6个月。受试者将每天记录止痛药的使用情况，并在VAS上记录他们当天最严重的疼痛。将定期评估生活质量、营养状况和受试者报告的健康结果。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The treatment of abdominal pain in chronic pancreatitis is unsatisfactory. Medical therapy includes abstinence from alcohol, analgesics, and pancreatic enzymes. Nonenteric-coated enzymes are primarily used for pain since they deliver serine proteases to the duodenum and can reduce excess stimulation by CCK in these patients. Randomized trials of these enzymes demonstrate they reduce pain in some patients. Failure of medical therapy is not uncommon. Some patients are candidates for endoscopic or surgical therapy; these can only be applied in a subgroup of patients with substantial abnormalities of the pancreatic duct. Many patients continue to experience pain despite medical and other therapies. Better therapies are needed. The primary objective of this pilot trial is to evaluate the effect of Sandostatin LAR¿ on pain in subjects with painful chronic pancreatitis and to compare it to a bioequivalent dose of Sandostatin¿. The primary endpoint is to determine the reduction in pain as determined by VAS (visual analog scale). Secondary endpoints will be changes in quality of life, nutritional status, percent reduction in pain medication, and effect on subject reported health outcomes. Approximately 25 subjects already taking Sandostatin¿ will be enrolled and serve as their own control. Eligible subjects will be treated with Sandostatin LAR¿ for a total of 6 months. Subjects will keep a daily diary of pain medication usage and will record their worst pain for the day on a VAS. Quality of life, nutritional status and subject reported health outcomes will be assessed on a routine basis.