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Related Experiment Videos

Efficacy of pancrease: crossover comparative study versus eurobiol in cystic fibrosis.

J P Chazalette1, M P Dain, J P Castaigne

  • 1Clinique de Mucoviscidose, Hôpital R. Sabran, Giens, France.

Journal of Pediatric Gastroenterology and Nutrition
|January 1, 1988
PubMed
Summary
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Pancrease, a pH-sensitive microsphere formulation, significantly improved lipid absorption and reduced steatorrhea in cystic fibrosis patients compared to lyophilized pancreas (Eurobiol). Patients also found Pancrease more acceptable, with no adverse effects reported for either treatment.

Area of Science:

  • Gastroenterology
  • Pediatric Medicine
  • Pharmacology

Background:

  • Cystic Fibrosis (CF) is a genetic disorder affecting multiple organs, including the pancreas, leading to exocrine pancreatic insufficiency.
  • Pancreatic enzyme replacement therapy (PERT) is crucial for managing maldigestion and malabsorption in CF patients.
  • Different PERT formulations exist, varying in composition and delivery mechanisms, necessitating comparative efficacy studies.

Purpose of the Study:

  • To compare the efficacy and patient acceptability of Pancrease (pH-sensitive enteric-coated microspheres) versus Eurobiol (lyophilized total pancreas) in pediatric CF patients.
  • To assess the impact of each treatment on steatorrhea and lipid absorption.
  • To evaluate the safety and tolerability of both pancreatic enzyme preparations.

Main Methods:

Related Experiment Videos

  • An open crossover study design was employed involving 11 pediatric patients (age 6-17 years) with documented CF.
  • Patients received either Pancrease or Eurobiol for two consecutive 1-week periods, with a switch to the alternate treatment in the second week.
  • Diet and concomitant CF therapies were standardized; stool samples were collected for analysis of steatorrhea and lipid absorption over the final 3 days of each treatment week.

Main Results:

  • Pancrease demonstrated a significantly higher coefficient of lipid absorption (74.1% ± 13.3%) compared to Eurobiol (58.6% ± 22.5%) (p < 0.02).
  • Pancrease resulted in a 33.9% decrease in steatorrhea and a 26.5% increase in lipid absorption relative to Eurobiol.
  • All patients reported superior acceptability of Pancrease over Eurobiol, with no adverse effects noted for either treatment.

Conclusions:

  • Pancrease is a more effective pancreatic enzyme replacement therapy for pediatric cystic fibrosis patients, evidenced by improved lipid absorption and reduced steatorrhea.
  • The pH-sensitive microsphere formulation of Pancrease offers enhanced efficacy and patient acceptability compared to lyophilized total pancreas preparations.
  • Both Pancrease and Eurobiol appear safe and well-tolerated in this patient population, but Pancrease provides superior clinical outcomes.