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

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。慢性胰腺炎腹痛的治疗效果不理想。药物治疗包括戒除酒精、止痛剂和胰酶。非肠包被酶主要用于治疗疼痛，因为它们将丝氨酸蛋白酶传递到十二指肠，可以减少这些患者CCK的过度刺激。这些酶的随机试验表明，它们可以减轻一些患者的疼痛。药物治疗的失败并不罕见。有些患者需要内窥镜或手术治疗；这些只能应用于有实质性胰管异常的患者亚组。尽管有药物和其他治疗方法，许多患者仍然感到疼痛。需要更好的治疗方法。本试验的主要目的是评估Sandostatin LAR¿对疼痛性慢性胰腺炎患者疼痛的影响，并将其与生物等效剂量的Sandostatin¿进行比较。主要终点是通过视觉模拟评分（VAS）来确定疼痛的减轻程度。次要终点将是生活质量的改变、营养状况、止痛药减少的百分比以及对受试者报告的健康结果的影响。大约25名已经在服用桑多司他汀的受试者将被纳入研究，并作为自己的对照。符合条件的受试者将接受总共6个月的桑多司他汀LAR治疗。受试者将每天记录止痛药的使用情况，并在VAS上记录当天最严重的疼痛。将定期评估受试者的生活质量、营养状况和报告的健康结果。

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.