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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
High-dose group: Oryz-Aspergillus Enzyme And Pancreatin Tablet, 5 tablets each time, three times daily, taken with each main meal or after meals, continuous administration for 4 weeks (28 days);
Low-dose group: Oral study drug:Oryz-Aspergillus Enzyme And Pancreatin Tablet, 1 tablet each time, three times daily, taken with each main meal or after meals, continuous administration for 4 weeks (28 days).
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Change in Gastrointestinal Symptom Rating Scale (GSRS) from baseline in the two groups of patients before treatment, after 5 days of treatment, and after 4 weeks of treatment
Scale Full Name: Gastrointestinal Symptom Rating Scale (GSRS) The total score ranges from 15 (lowest, no symptoms) to 105 (highest, all symptoms extremely severe). Higher scores mean a worse outcome.
Time frame: 5 days,4 weeks
Change in nutritional status scores (NRS 2002 scale) of the two groups of patients after 4 weeks of treatment compared to baseline
Full name of the scale: Nutritional Risk Screening 2002 (NRS-2002) The NRS-2002 uses a weighted scoring system with a total score ranging from from 0 points (lowest) to 7 points (highest), consisting of four independent modules: disease severity score, nutritional status impairment score, age adjustment, and final integrated assessment criteria. A patient is considered to have a nutritional risk only if the total score is ≥3, warranting further nutritional assessment and medical nutrition intervention. higher scores mean a worse outcome
Time frame: 4 weeks
Laboratory values after 4 weeks of treatment in the two groups: changes in total protein levels
Time frame: 4 weeks
Laboratory values after 4 weeks of treatment in the two groups: changes in albumin levels
Time frame: 4 weeks
Laboratory values after 4 weeks of treatment in the two groups: changes in globulin levels
Time frame: 4 weeks
Laboratory values after 4 weeks of treatment in the two groups: changes in prealbumin levels
Time frame: 4 weeks
Laboratory values after 4 weeks of treatment in the two groups: changes in transferrin levels
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Time frame: 4 weeks
Weight changes from baseline after 4 weeks of treatment in two groups of patients
weight in kilograms
Time frame: 4 weeks
BMI changes from baseline after 4 weeks of treatment in two groups of patients
weight and height will be combined to report BMI in kg/m\^2
Time frame: 4 weeks