chronic rhinosinusitis with nasal polyps
Conditions
Interventions
Control group:Preoperative oral corticosteroids + Functional Endoscopic Sinus Surgery (FESS)
Experimental group:Stapokibart Injection + Functional Endoscopic Sinus Surgery (FESS)
Sponsors
Shenzhen Nanshan People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18–60 years, male or female. 2. Bilateral nasal polyps with an endoscopic polyp score >= 4 (scored 0–4 per side). 3. Meeting the indications for functional endoscopic sinus surgery. 4. Definite diagnosis of allergic disease (e.g., positive skin prick test or serum specific IgE). 5. Patients with chronic rhinosinusitis with nasal polyps inadequately controlled by corticosteroid therapy and/or surgical treatment. 6. Signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Prior treatment with biologic agents. 2. Presence of other structural abnormalities of the nasal cavity that may affect surgery. 3. Presence of major systemic diseases, active infections, malignancies, or immunodeficiencies. 4. Pregnant or breastfeeding women. 5. Allergy to Stapokibart Injection or its excipients. 6. Subjects considered by the investigator to be unsuitable for participation in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Nasal Polyp Score, NPS;Intraoperative blood loss;Lund-Kennedy Endoscopic Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| peripheral blood eosinophil count and serum total IgE;Surgery Time;VAS score for nasal symptoms;Surgical Field Clarity Score;Symptom severity and health?related quality of life ; | — |
Countries
China
Contacts
Public ContactLi Shuo
Shenzhen Nanshan People's Hospital
Outcome results
None listed