Abstract:
OBJECTIVES:Currently available pancreatic enzyme products are crude porcine products with few data available regarding their efficacy, safety, and manufacture. We conducted a phase 1 study of a novel pancreatic enzyme product, TheraCLEC-Total (TCT), a proprietary formulation of microbial-derived lipase, protease, and amylase, to determine its safety and preliminary efficacy in cystic fibrosis. METHODS:We conducted an open-label, dose-ranging study in 23 subjects diagnosed with pancreatic insufficiency with cystic fibrosis. The subjects received TCT containing lipase dose of 100, 500, 1000, 2500, or 5000 USP U/kg per meal with each meal or snack for 3 days. The clinical and laboratory parameters and adverse events (AEs) were monitored. RESULTS:There were no serious AEs. Most AEs were mild, although gastrointestinal complaints were common. TCT increased the coefficient of fat and nitrogen absorption in all groups except in the low-dose group. At the other dosing levels, the mean coefficient of fat and nitrogen absorption increases were 19.1% +/- 24.9% and 17.8% +/- 13.6%, respectively, whereas the mean stool weight decreased by 517 +/- 362 g. CONCLUSIONS:TCT was well tolerated in this short-term exposure study. The preliminary efficacy data demonstrate lipase and protease activity with little difference seen with lipase doses greater than 500 USP U/kg per meal. These data support a larger randomized phase 2 trial.
journal_name
Pancreasjournal_title
Pancreasauthors
Borowitz D,Goss CH,Stevens C,Hayes D,Newman L,O'Rourke A,Konstan MW,Wagener J,Moss R,Hendeles L,Orenstein D,Ahrens R,Oermann CM,Aitken ML,Mahl TC,Young KR Jr,Dunitz J,Murray FTdoi
10.1097/01.mpa.0000202952.10612.21subject
Has Abstractpub_date
2006-04-01 00:00:00pages
258-63issue
3eissn
0885-3177issn
1536-4828pii
00006676-200604000-00004journal_volume
32pub_type
杂志文章,多中心研究相关文献
PANCREAS文献大全abstract:OBJECTIVES:An impaired host immunity might concur in determining the dismal prognosis of patients with pancreatic cancer (PC). Our aim was to ascertain whether the immunophenotype pattern of blood lymphocytes in PC correlates with tumor stage, grade, or survival. METHODS:We studied 115 patients with PC, 44 with chroni...
journal_title:Pancreas
pub_type: 杂志文章
doi:10.1097/01.mpa.0000188305.90290.50
更新日期:2006-01-01 00:00:00
abstract:AIM:To assess the feasibility and usefulness of secretin-enhanced magnetic resonance cholangiopancreatography (S-MRCP) for evaluation of pancreatic exocrine function. METHODOLOGY:S-MRCP was performed in 20 patients with mild (n = 8) or severe (n = 12) chronic pancreatitis (according to the grade of exocrine pancreatic...
journal_title:Pancreas
pub_type: 杂志文章
doi:10.1097/00006676-200110000-00015
更新日期:2001-10-01 00:00:00
abstract:OBJECTIVE:Secreted apoptosis-related protein (SARP) families are considered to counteract the oncogenic Wnt signaling pathway, and inactivation of this gene may aid cancer development and progression. Recently, the aberrant methylation of SARP2 was detected frequently in pancreatic carcinoma (PCa) tissue, but not in no...
journal_title:Pancreas
pub_type: 杂志文章
doi:10.1097/01.mpa.0000221617.89376.38
更新日期:2006-05-01 00:00:00
abstract::We examined whether pancreas grafts preserved by the two-layer method maintained adenine nucleotides pool as substrates for ATP synthesis before reperfusion and had the ability to recover pancreatic tissue perfusion and synthesize ATP promptly after reperfusion. After preservation by the two-layer cold storage method ...
journal_title:Pancreas
pub_type: 杂志文章
doi:10.1097/00006676-199704000-00011
更新日期:1997-04-01 00:00:00
abstract::Conscious rats were infused with optimal doses of secretin (16 clinical units [CU]/kg/h), cerulein (0.25 microgram/kg/h), and both for varying periods of time over 24 h. The presence of zymogen granules in acinar cells and the tissue content of enzymes showed progressive decreases over 3 and 12 h for cerulein and secr...
journal_title:Pancreas
pub_type: 杂志文章
doi:10.1097/00006676-198611000-00010
更新日期:1986-01-01 00:00:00
abstract::The mechanism of tissue alteration in chronic pancreatitis (CP) is still unclear. Different hypotheses have been discussed, including increasing oxidant stress in the acinar cells, often as a result of exposure to xenobiotics. To evaluate the role of oxidative stress in CP, the authors investigated the expression of t...
journal_title:Pancreas
pub_type: 杂志文章
doi:10.1097/00006676-200105000-00009
更新日期:2001-05-01 00:00:00
abstract::We evaluated the diagnostic significance of the K-ras point mutations at codon 12 in duodenal lavage fluid (DLF) compared with pure pancreatic juice (PPJ). The DLF was easily and safely collected by injecting distilled water into the duodenum and then aspirating through the working channel of the endoscope during endo...
journal_title:Pancreas
pub_type: 杂志文章
doi:10.1097/00006676-199903000-00004
更新日期:1999-03-01 00:00:00
abstract::We collected pure pancreatic juice during an entire day and examined pancreatic secretory changes induced by ordinary meals in a male patient having an external drainage of the main pancreatic duct. The ingestion of breakfast, lunch, and dinner each caused a marked increase in pancreatic secretion above basal levels. ...
journal_title:Pancreas
pub_type: 杂志文章
doi:10.1097/00006676-198709000-00020
更新日期:1987-01-01 00:00:00
abstract::Peptide YY (PYY) is a recently isolated gut peptide that is found primarily in the mucosal endocrine cells of the terminal ileum, colon, and rectum of several mammalian species, including humans. The purpose of this study was to characterize the effect of PYY on pancreatic exocrine secretion in six conscious dogs prep...
journal_title:Pancreas
pub_type: 杂志文章
doi:10.1097/00006676-198707000-00013
更新日期:1987-01-01 00:00:00
abstract:OBJECTIVES:The aim of this study was to determine the accuracy of cytology, carcinoembryonic antigen (CEA), and amylase levels in the preoperative diagnosis of intraductal papillary mucinous neoplasms (IPMNs). METHODS:An international registry was started in 2005 and included patients with clinically suspected IPMNs. ...
journal_title:Pancreas
pub_type: 杂志文章,多中心研究
doi:10.1097/MPA.0000000000000559
更新日期:2016-07-01 00:00:00
abstract::Dogs with chronic pancreatic fistulae were given 0.5 ml of nonimmune rabbit serum or antibody S5, an antibody raised against the C-terminal pancreatic polypeptide (PP) hexapeptide. A 3-h infusion of secretin (125 ng/kg/h) and CCK8 (50 ng/kg/h) was started 30 min after injecting serum. Exogenous BPP (400 pmol/kg/h) was...
journal_title:Pancreas
pub_type: 杂志文章
doi:10.1097/00006676-198705000-00011
更新日期:1987-01-01 00:00:00
abstract:OBJECTIVE:Pancreatic stellate cells (PSCs) are important players in pancreatic fibrosis and are major contributors to the extracellular matrix proteins observed with the stromal response characteristic of pancreatic ductal adenocarcinoma (PDAC). Pancreatic stellate cells are also believed to secrete soluble factors tha...
journal_title:Pancreas
pub_type: 杂志文章
doi:10.1097/MPA.0b013e318214efaf
更新日期:2011-05-01 00:00:00
abstract:OBJECTIVES:We evaluated carcinoid syndrome (CS) symptoms and the real-world effectiveness of telotristat ethyl (TE) among patients with ≤3 bowel movements (BM) per day. METHODS:Patients with CS initiating TE between March and November 2017 could participate in a nurse support program collecting demographic and CS symp...
journal_title:Pancreas
pub_type: 杂志文章
doi:10.1097/MPA.0000000000001496
更新日期:2020-03-01 00:00:00
abstract::This study compared diet, type of alcoholism, and smoking in three groups of alcoholic men, with chronic pancreatitis (n = 56), with histological cirrhosis (n = 50), and without pancreatitis or cirrhosis (controls; n = 50) by a multidimensional analysis. Only patients in whom the first symptom of pancreatitis or cirrh...
journal_title:Pancreas
pub_type: 杂志文章
doi:10.1097/00006676-199504000-00003
更新日期:1995-04-01 00:00:00
abstract::Amylase inhibition has gastrointestinal and metabolic effects that may aid in the treatment of diabetes and obesity. We tested whether 4 g of a commercially available wheat amylase inhibitor (WAI) affected postprandial carbohydrate (CHO) absorption and plasma glucose or hormones. Twelve persons (four lean and four obe...
journal_title:Pancreas
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1097/00006676-199808000-00011
更新日期:1998-08-01 00:00:00
abstract::Stimulation of the exocrine pancreas with cholecystokinin analogues leads to a variety of intraacinar processes, many coupled to energy consumption. It was hypothesized that extensive ATP depletion could play a role in the pathophysiology of acute pancreatitis, especially in the hyperstimulation (cerulein) model. Mice...
journal_title:Pancreas
pub_type: 杂志文章
doi:10.1097/00006676-199508000-00005
更新日期:1995-08-01 00:00:00
abstract::A 50-year-old female was referred to our hospital because of postprandial epigastric pain and pancreatic head mass. On admission, an elastic hard mass with tenderness was palpable in the epigastric region. Laboratory findings showed no abnormalities, except for a slightly elevated C-reactive protein value and iron def...
journal_title:Pancreas
pub_type: 杂志文章
doi:10.1097/01.mpa.0000236730.08747.69
更新日期:2006-11-01 00:00:00
abstract::In dispersed acini from rat pancreas, verapamil (a phenylalkylamine calcium channel blocker) potentiated amylase secretion stimulated by vasoactive intestinal peptide (VIP), secretin, peptide histidine isoleucine, helodermin, forskolin, and 8-bromocyclic AMP. The action of verapamil on VIP-stimulated amylase secretion...
journal_title:Pancreas
pub_type: 杂志文章
doi:10.1097/00006676-199303000-00012
更新日期:1993-03-01 00:00:00
abstract::High-quality and well-annotated biorepositories are needed to better understand the pathophysiology and biologic mechanisms of chronic pancreatitis (CP) and its consequences. We report a methodology for the development of a robust standard operating procedure (SOP) for a biorepository based on the experience of the cl...
journal_title:Pancreas
pub_type: 杂志文章
doi:10.1097/MPA.0000000000001171
更新日期:2018-11-01 00:00:00
abstract::The present investigation provides follow-up data (up to 36 months) of exocrine and endocrine pancreatic function, inflammatory activity, pain, and body weight in 23 chronic pancreatitis patients submitted to Whipple's procedure plus intraoperative Ethibloc occlusion of the remaining pancreatic duct system between Jan...
journal_title:Pancreas
pub_type: 杂志文章
doi:10.1097/00006676-198711000-00016
更新日期:1987-01-01 00:00:00
abstract:OBJECTIVE:Bax-interacting factor 1 (Bif-1) protein plays a critical role in apoptosis, mitochondrial morphogenesis, and autophagy, and its loss promotes tumorigenesis. The role of Bif-1 in pancreatic cancer has not been studied. METHODS:We determined Bif-1 expression in 82 human pancreatic ductal adenocarcinomas (PDCs...
journal_title:Pancreas
pub_type: 杂志文章
doi:10.1097/MPA.0b013e318205eb03
更新日期:2011-04-01 00:00:00
abstract::A case of papillary cystic tumor (PCT) of the pancreas in a 55-year-old woman is described. She presented with a gradually enlarging and painless abdominal mass for > 26 years. The tumor was encapsulated and measured 16 x 12 x 10 cm. The gross features and conventional light microscopic appearance of this tumor were c...
journal_title:Pancreas
pub_type: 杂志文章
doi:10.1097/00006676-199301000-00023
更新日期:1993-01-01 00:00:00
abstract:OBJECTIVES:To study the association of binge drinking and the outcomes of severe acute pancreatitis (SAP). METHODS:This retrospective study included 347 patients with first-attack SAP from January 2001 to February 2004. On the basis of the history of binge drinking or not, the patients were divided into the alcohol (n...
journal_title:Pancreas
pub_type: 杂志文章
doi:10.1097/MPA.0b013e3181baeae6
更新日期:2010-03-01 00:00:00
abstract:OBJECTIVES:Endoscopic ultrasound (EUS) may offer a diagnostic tool through the combination of imaging and guided fine-needle aspiration of pancreatic cysts. The purpose of this investigation was to determine the most accurate test for differentiating mucinous from nonmucinous cysts. METHODS:The results of EUS imaging,...
journal_title:Pancreas
pub_type: 杂志文章
doi:10.1097/MPA.0b013e31821bd62f
更新日期:2011-10-01 00:00:00
abstract:OBJECTIVES:Nuclear factor κB (NF-κB) plays an intrinsic role in promoting growth, angiogenesis, and metastasis in pancreatic cancer (PC) and serves as a mechanism underlying therapeutic resistance. Accordingly, we investigated the efficacy of bioactive phytochemicals in inhibiting radiotherapy (RT)-induced NF-κB activi...
journal_title:Pancreas
pub_type: 杂志文章
doi:10.1097/MPA.0b013e31821f677d
更新日期:2011-10-01 00:00:00
abstract:OBJECTIVES:Porcine islets are the most suitable for xeno-islet transplantation. However, it is necessary to establish an effective preservation method against its fragility. Recently, we developed a new cooling and preservation (Keep and Fresh [KFC]; FUJIYA Co, Tokushima, Japan) system, which can maintain viability of ...
journal_title:Pancreas
pub_type: 杂志文章
doi:10.1097/MPA.0b013e3181dab19a
更新日期:2010-10-01 00:00:00
abstract::Computed tomography (CT), magnetic resonance imaging (MRI), and positron emission tomography (PET) are sophisticated modalities typically used in the second-line diagnosis following routine clinical practice. Among them, CT is regarded as the standard imaging in diagnosing pancreatic cancer at present in Japan due to ...
journal_title:Pancreas
pub_type: 杂志文章
doi:10.1097/00006676-200404000-00011
更新日期:2004-04-01 00:00:00
abstract::Glucocorticoids are effective in the treatment of certain leukemias and lymphomas, but their effects on the growth of several solid tumors have not been determined. We report here that cortivazol (CVZ), a potent synthetic glucocorticoid, inhibits the growth of a hamster pancreatic adenocarcinoma, H2T, in vivo. CVZ reg...
journal_title:Pancreas
pub_type: 杂志文章
doi:10.1097/00006676-199301000-00004
更新日期:1993-01-01 00:00:00
abstract:OBJECTIVES:Angiogenesis plays a major role in tumor progression and metastasis; however, its role in pancreatic cancer (PC) remains unclear. The aim of the study was to explore the cumulative evidence concerning the impact of microvessel density (MVD), an estimator of angiogenesis, on resected PC patients. METHODS:A s...
journal_title:Pancreas
pub_type: 杂志文章,meta分析
doi:10.1097/MPA.0000000000001237
更新日期:2019-02-01 00:00:00
abstract:OBJECTIVES:Patients undergoing therapeutic endoscopic retrograde cholangiopancreatography (ERCP) are at a higher risk of developing post-ERCP pancreatitis than patients undergoing diagnostic ERCP. The aim of this study was to evaluate the effectiveness of somatostatin in preventing post-therapeutic ERCP pancreatitis. ...
journal_title:Pancreas
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1097/MPA.0b013e3181733721
更新日期:2008-11-01 00:00:00