chronic rhinosinusitis with nasal polyps
Conditions
Interventions
experimental group:Stapokibart, nasal glucocorticoid combined with sinus surgery
control group:Nasal corticosteroids combined with sinus surgery
Sponsors
Jiangsu Provincial People's Hospital, The First Affiliated Hospital with NanJing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18 - 65 years old, gender not restricted, with or without bronchial asthma or allergic rhinitis 2. Meet the diagnostic criteria for chronic sinusitis with nasal polyps, with a disease duration of >= 12 weeks 3. Nasal endoscopy confirms bilateral nasal polyps, and the nasal polyp score (NPS) is >= 4 points 4. Sinus CT shows inflammatory changes in both sinuses, and the Lund-Mackay score is >= 12 points 5. Serum total IgE >= 100 IU/mL 6. Previous standard conservative treatment (including nasal glucocorticoids for >= 8 weeks) was ineffective, and surgical indications were met 7. Signed informed consent form and was able to cooperate to complete the entire follow-up
Exclusion criteria
Exclusion criteria: 1. Pregnant or breastfeeding women; 2. Severe cardiac, liver and renal insufficiency; 3. Patients with malignant tumors or life expectancy <1 year; 4. Active infection or immunodeficiency diseases; 5. Treatment with biological agents within the past 3 months; 6. Treatment with systemic glucocorticoids within the past 1 month; 7. Allergic to spicubicumab or its excipients; 8. Past history of sinus surgery; 9. Nasal sinus malignancy; 10. Genetic diseases such as cystic fibrosis and primary ciliary dysmotic disorders; 11. Other situations that the researchers believe are not suitable for participating in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of nasal epithelialization;Olfactory Function Assessment; | — |
Countries
China
Contacts
Public ContactMeiping Lu
Jiangsu Provincial People's Hospital, The First Affiliated Hospital with NanJing Medical University
Outcome results
None listed