Chronic sinusitis type 2 (with or without nasal polyps)
Conditions
Interventions
ESS side group:ESS Surgery combined with biological therapy
EEIES side group:EEIES Surgery combined with biological therapy
Sponsors
China-Japan Friendship Hospital of Jilin University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The diagnostic criteria for chronic sinusitis refer to the "Chinese Guidelines for the Diagnosis and Treatment of Chronic Sinusitis (2018)", namely: (1) Symptoms: nasal congestion, sticky or mucopurulent nasal discharge; Secondary symptoms: head and face swelling and pain, loss or loss of smell; (2) Nasal endoscopy: bilateral lesions, viscous or mucopurulent discharge from the middle nasal passage, olfactory cleft, nasal mucosal congestion, edema or polyps. The difference between the two sides of the nasal endoscopic score is less than or equal to 2 points; (3) Imaging examination: bilateral lesions, sinus CT scan can show sinus oronasal complex and/or sinus mucositic lesions. The difference between the two sides of the sinus CT score is less than or equal to 2 points; The diagnostic criteria for type 2.2 chronic sinusitis refer to the "2023 EPOS on the indications for the treatment of CRSwNP biologics", namely: (1) Evidence of type 2 inflammation: tissue EOS>=10/hpf, or blood EOS>=150, or total IgE>=100; (2) Need for systemic glucocorticoids or systemic glucocorticoid contraindications: >=2 courses of treatment per year, or long-term (>3 months) low-dose glucocorticoids; (3) Significantly impaired quality of life: SNOT-22>=40; (4) Obvious loss of smell: anosmia in the olfactory test; (5) Diagnosed with asthma: asthma requiring regular inhalation of glucocorticoids; 3. The history of sinusitis is more than 2 years, and the enrolled patients in China-Japan Friendship Hospital of Jilin University live in Northeast China to meet the postoperative follow-up requirements (including Hulunbuir City, Xing'an League, Tongliao City, Chifeng City, and Xilin Gol League in Heilongjiang Province, Jilin Province, Liaoning Province and Inner Mongolia Autonomous Region).
Exclusion criteria
Exclusion criteria: 1. Pregnant women; 2. Patients with diabetes, hypertension, coronary heart disease, tuberculosis, asthma, and malignant tumors who cannot tolerate general anesthesia surgery; 3. Other patients who cannot receive or are unwilling to undergo surgical treatment due to severe systemic diseases or mental illnesses; 4. Patients who cannot cooperate with postoperative follow-up; 5. Age75 years old; 6. Patients who have been treated with allergen-specific immunotherapy or biologics in the past 1 year; 7. Patients with a history of sinus surgery in the past; 8. Those with acute infectious diseases, upper respiratory tract infections, or systemic inflammatory symptoms such as fever and chills; 9. Those who cannot tolerate relevant examinations or severe systemic or local adverse reactions when collecting specimens. 10. Patients who cannot be enrolled in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| symptom score (VAS score); | — |
Secondary
| Measure | Time frame |
|---|---|
| nasal polyp score;Paranasal sinus CT score (Lund-Mackey score);quality of life score (SNOT-22 and SF-36);Nasal endoscopy score (Lund-Kennedy score); | — |
Countries
China
Contacts
Public ContactDongdong Zhu
China-Japan Friendship Hospital of Jilin University
Outcome results
None listed