Study of Teprenone in the Treatment of Glucocorticoid-Induced Drug-Related Gastrointestinal Injury

Study of Teprenone in the Treatment of Glucocorticoid-Induced Drug-Related Gastrointestinal Injury

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.

Inclusion Criteria:

1. Age 18 to 70 years;
2. Patients diagnosed with systemic lupus erythematosus (SLE) meeting the 2019 EULAR/ACR classification criteria for SLE;
3. Receiving moderate to high doses of glucocorticoids (prednisone or its equivalent 30-60 mg , once daily);
4. Voluntarily participate in this study and sign the informed consent form.

Exclusion Criteria:

1. Presence of other gastric mucosal lesions, such as active ulcers, active bleeding, gastric cancer, gastric polyps, etc.;
2. History of subtotal gastrectomy;
3. History of endoscopic treatments, such as Endoscopic Submucosal Dissection (ESD) or Endoscopic Mucosal Resection (EMR);
4. Significant psychiatric and behavioral abnormalities or mood disorders;
5. History of clinically significant diseases, including: Chronic congestive heart failure (NYHA Class IV); History of echocardiography-confirmed ejection fraction (EF) < 30%; Myocardial infarction, acute coronary syndrome, viral myocarditis, or pulmonary embolism within 6 months; Coronary revascularization within 6 months; Severe arrhythmia requiring treatment with Class Ia or III antiarrhythmic drugs;History of sick sinus syndrome, Mobitz II and Complete Heart Block without a permanent pacemaker implanted; QTc interval≥480 ms on screening ECG;
6. Laboratory abnormalities at screening as follows: Total bilirubin > 3 times ULN (Upper Limit of Normal); AST/ALT > 3 times ULN; Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m²;
7. Currently receiving treatment (e.g., chemotherapy, radiotherapy, immunotherapy) for other malignancies;
8. Pregnant or lactating women;
9. Allergy or hypersensitivity to the study drug(s).