Efficacy of Interleukin-2 Gargle in the Treatment of Oral Mucosa Lesion in Pemphigus Vulgaris
Pemphigus Vulgaris
About this trial
This is an interventional treatment trial for Pemphigus Vulgaris focused on measuring pemphigus vulgaris, oral mucosal lesion, interleukin-2
Eligibility Criteria
Inclusion Criteria:
- Age: between 18 years and 70 years;
- Patients definitely diagnosed with pemphigus vulgaris according to 'Diagnostic Criteria for Pemphigus Vulgaris (Autoimmune Disease Sub-Professional Committee of Dermatologist Branch of Chinese Medical Doctor Association)'; or pemphigus vulgaris has been diagnosed in the past.
- Visible oral mucosa lesion due to pemphigus;
- Mucosal-dominant PV or moderate mucocutaneous PV (PDAI score: 15-45);
- Written informed consent was obtained, volunteer to participate in the project and complete as required.
Exclusion Criteria:
- Patients with severe diseases of heart, brain, lungs, liver, kidney or blood system; patients experienced organ transplantation;
- Patients with any acute severe infection such as pyemia and cellulitis, active tuberculosis, or an infection history of human immunodeficiency virus (HIV);
- Patients with allergic skin diseases with obvious pruritus such as eczema or urticaria, blood routine examination show elevated eosinophils or have a clear history of allergy to rhIL-2;
- Patients with persistent ventricular tachycardia, uncontrolled arrhythmias, chest pain with ECG changes, angina or myocardial infarction, cardiac tamponade;
- Patients with nausea, vomiting, peptic ulcer or intestinal ischemia;
- Patients with drug abuse, alcohol abuse, or mental disorders that are unable to cooperate or adhere to treatment;
- Pregnant women, lactating women or women who are ready to conceive within 3 months;
- Patients receiving treatment of immunosuppressants in the last 3 months;
- Patients receiving continuous treatment of glucocorticoids with a dose of more than 0.75 mg/kg/d in the last 2 weeks;
- Patients with oral fungal infection but don't receive antifungal therapy;
- Participated in other clinical trials within 3 months before the screening.
Sites / Locations
- The Second Xiangya Hospital of Central South UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
experimental group
control group
Patients will receive rhIL-2 solution oral gargle twice per day (2 million units of rhIL-2 dissolved in 5ml normal saline for each dose, garble for 3 minutes) and continue for 3 weeks. A standard dose of glucocorticoids (mucosal-dominant PV: prednisone 0.5 mg/kg/d, moderate mucocutaneous PV: prednisone 0.75 mg/kg/d) will be applied at the same time.
Patients will receive placebo solution oral gargle twice per day (5ml for each dose, garble for 3 minutes) and continue for 3 weeks. A standard dose of glucocorticoids (mucosal-dominant PV: prednisone 0.5 mg/kg/d, moderate mucocutaneous PV: prednisone 0.75 mg/kg/d) will be applied at the same time.