Objective: To evaluate the efficacy, safety, and adherence of the gastric mucosal protective agent teprenone in the treatment of glucocorticoid-induced drug-related gastrointestinal injury. Study Design: This study is a prospective, open-label, randomized controlled trial. The study population consists of patients with systemic lupus erythematosus requiring medium- to high-dose glucocorticoid therapy (30-60 mg/day). Eligible patients are enrolled according to inclusion and exclusion criteria and randomly assigned in a 1:1 ratio into two groups: a proton pump inhibitor (PPI) group and a mucosal protective agent group. The PPI group receives omeprazole capsules 20 mg once daily before meals, while the mucosal protective agent group receives teprenone 50 mg three times daily after meals. Both groups are treated for 12 weeks. Primary Endpoint: To assess the improvement in the 7-point overall symptom scale from baseline to week 12.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Omeprazole cap 20 mg, q.d.
Teprenone 50 mg, t.i.d.
Improvement in the 7-point Global Overall Symptom Scale (GOSS) at week 12
Time frame: From enrollment to the end of treatment at 12 weeks
Proportion of patients with a positive fecal occult blood test
Time frame: At weeks 4, 8, and 12
changes in levels of hemoglobin
Time frame: At weeks 4, 8, and 12.
Changes in levels of fecal calprotectin
Time frame: At weeks 4, 8, and 12
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