About this trial
This study aims to investigate the efficacy and safety of high-dose Oryz-Aspergillus Enzyme And Pancreatin Tablet in treating postoperative pancreatic exocrine insufficiency (PEI), aiming to fill the gap in evidence-based medicine and promote standardized treatment.
Eligibility criteria
Qualifiers
Age between 18 and 75 years (inclusive of boundary values), regardless of gender;
For tumor patients, the primary tumor stage before or during surgery must be Stage I or II (AJCC 8th edition). Patients in the interval between anti-tumor treatments must have undergone a washout period exceeding 28 days to avoid interference from anti-tumor therapy on this study;
Diagnosis of pancreatic exocrine insufficiency (PEI) based on comprehensive assessment by the investigator considering medical history, symptoms, nutritional status, and pancreatic function;
Gastrointestinal Quality of Life Index (GIQLI) score ≤ 105 points;
Disqualifiers
Known allergy to any component of micafungin pancreatic enzyme tablets;
Patients with acute pancreatitis or acute exacerbation during active phase of chronic pancreatitis, or those with known contraindications listed in the product label;
Patients with rare inherited fructose intolerance, glucose-galactose malabsorption, or sucrose-isomaltase deficiency
Gastrointestinal obstruction;
Trial design
Treatments tested in this trial
- High-dose group: Oryz-Aspergillus Enzyme and Pancreatin Tablet
- Low-dose group: Oryz-Aspergillus Enzyme And Pancreatin Tablet