Abstract:
BACKGROUND:Pancreatic exocrine insufficiency (PEI) results in maldigestion, leading to abdominal pain, steatorrhoea, malnutrition and weight loss. AIM:To assess the efficacy and safety of pancreatin (Creon 40000 MMS) in treating PEI due to chronic pancreatitis (CP). METHODS:This was a 1-week, double-blind, randomised, placebo-controlled, parallel-group, multicentre study in India. Men and women ≥18 years of age with proven CP and PEI [defined as a coefficient of fat absorption (CFA) ≤80% during run-in phase] were randomised 1:1 to pancreatin or placebo (two capsules orally per main meal, one with snacks). The primary outcome measure was change in CFA from baseline to end of double-blind treatment (analysis of covariance). RESULTS:Of 62 patients randomised (34 pancreatin, 28 placebo), 61 completed treatment; one patient in the placebo arm withdrew consent before completion. Patient characteristics were similar in both groups except for the proportion of men (pancreatin 82% vs. placebo 68%). Patients receiving pancreatin had a statistically significant greater improvement in fat absorption from baseline to the end of double-blind treatment compared with those receiving placebo, with a least squares mean change (95% CI) in CFA of 18.5% (15.8-21.2) vs. 4.1% (1.0-7.2), respectively. This resulted in a treatment difference of 14.4% (10.3-18.5); P = 0.001. Patients receiving pancreatin also had a statistically significant greater improvement in nitrogen absorption and greater reductions in mean stool fat, stool frequency and stool weight compared with those receiving placebo. Treatment-emergent adverse events occurred in 12 patients on pancreatin and in seven on placebo; none led to study discontinuation. CONCLUSIONS:The results provide evidence for the efficacy of pancreatin (Creon 40000 MMS) in patients with pancreatic exocrine insufficiency due to chronic pancreatitis, and confirm that this formulation is well tolerated, with a good safety profile, at the dose administered.
journal_name
Aliment Pharmacol Therjournal_title
Alimentary pharmacology & therapeuticsauthors
Thorat V,Reddy N,Bhatia S,Bapaye A,Rajkumar JS,Kini DD,Kalla MM,Ramesh Hdoi
10.1111/j.1365-2036.2012.05202.xsubject
Has Abstractpub_date
2012-09-01 00:00:00pages
426-36issue
5eissn
0269-2813issn
1365-2036journal_volume
36pub_type
杂志文章,多中心研究,随机对照试验abstract:BACKGROUND:There are few published data concerning the economic impact of antibiotic prophylaxis prior to endoscopic retrograde cholangiopancreatography in the setting of biliary obstruction. AIM:To perform decision analysis to determine the costs of prophylaxis in patients undergoing endoscopic retrograde cholangiopa...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章
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journal_title:Alimentary pharmacology & therapeutics
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doi:10.1111/j.1365-2036.2006.02971.x
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abstract:BACKGROUND:Fistulae will develop in approximately one-third of patients with Crohn's disease. With an expected spontaneous healing rate of only 10%, fistulizing Crohn's disease requires a comprehensive strategy with a medical and possible surgical approach. AIM:To summarize the current literature evaluating various me...
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doi:10.1111/j.1365-2036.2006.03126.x
更新日期:2006-11-01 00:00:00
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journal_title:Alimentary pharmacology & therapeutics
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doi:10.1111/j.1365-2036.2008.03911.x
更新日期:2009-03-01 00:00:00
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journal_title:Alimentary pharmacology & therapeutics
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journal_title:Alimentary pharmacology & therapeutics
pub_type: 临床试验,杂志文章,随机对照试验
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journal_title:Alimentary pharmacology & therapeutics
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journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1111/apt.12318
更新日期:2013-06-01 00:00:00
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journal_title:Alimentary pharmacology & therapeutics
pub_type: 临床试验,杂志文章,随机对照试验
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更新日期:1998-04-01 00:00:00
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pub_type: 杂志文章
doi:10.1111/apt.12771
更新日期:2014-06-01 00:00:00
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doi:10.1111/apt.14194
更新日期:2017-08-01 00:00:00
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journal_title:Alimentary pharmacology & therapeutics
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doi:10.1111/j.1365-2036.2011.04723.x
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journal_title:Alimentary pharmacology & therapeutics
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更新日期:2017-01-01 00:00:00
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journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章
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更新日期:1992-02-01 00:00:00
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journal_title:Alimentary pharmacology & therapeutics
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更新日期:1997-06-01 00:00:00
abstract:INTRODUCTION:Oral nonsteroidal anti-inflammatory drugs (NSAIDs) cause acute gastric mucosal injury but the relative importance of systemic and topical effect of NSAIDs to overall gastric damage remains uncertain. METHODS:Twenty-four healthy volunteers were allocated either oral or rectal naproxen 500 mg b.d. and gastr...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章
doi:10.1046/j.1365-2036.1996.726118000.x
更新日期:1996-04-01 00:00:00