Meniere's disease
Conditions
Interventions
Methotrexate combined with Dupriyou:Duprizumab (300mg) 2ml, once every 4 weeks, lasting for 16 weeks
Sponsors
Shandong Second Provincial General Hospital(Shandong Provincial ENT Hospital,Shandong ENT Institute)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Confirmed Meniere's disease, according to the 2015 Barany diagnostic criteria. i. Two or more spontaneous dizziness attacks, each lasting 20 minutes to 12 hours. Ii. At least one auditory recording of low to mid frequency sensorineural hearing loss (0.5, 1, 2k Hz) prior to, during, or after the onset of dizziness. Iii. Fluctuating auditory symptoms of the affected ear (hearing, tinnitus, or tinnitus). Iv. Other vestibular diagnoses cannot better explain. 2) Patients with poor control after 6 months of traditional treatment (Betamethasone 12 mg t.i.d po, Hydrochlorothiazide 25 mg b. i.d po; Acute systemic or tympanic injection of glucocorticoids) (with an average of = 1 episode per month in the first 3 months of enrollment) 3) Merge and clarify allergic diseases and/or laboratory indicators to support the existence of allergic factors. ? Laboratory indicators include: high IgE or specific IgE elevation, positive skin prick test, or elevated IL-4, any of the above indicators are sufficient; ? Allergic diseases include but are not limited to allergic rhinitis, atopic dermatitis (such as contact dermatitis, atopic dermatitis), allergic asthma, food allergies, drug allergies, urticaria, and allergic conjunctivitis. 4) >=18 years old.
Exclusion criteria
Exclusion criteria: 1) Cerebellopontine angle tumors or other intracranial space occupying lesions; 2) Age beyond the range of 18-70 years old; 3) There are drug contraindications and a history of adverse/allergic reactions to such drugs. 4) Complicated middle ear diseases that may interfere with treatment and evaluation (such as active middle ear diseases); 5) Pregnant women; 6) Oral corticosteroids, monoclonal antibodies, and immunosuppressive therapy within 6 weeks prior to screening; 7) Subjects who have used any of the following treatment methods within 4 weeks prior to baseline visit or within a period equivalent to 5 times the half-life of the medication, whichever is longer: ? Immunosuppressive/immunomodulatory drugs (such as systemic corticosteroids, cyclosporine, mycophenolate mofetil, IFN - ?, Janus kinase inhibitors, azathioprine, etc.), systemic anti-inflammatory drugs ? Other biological agents: within 5 half-lives (if known) or 16 weeks, whichever is longer. 8) Positive for syphilis, HIV, and hepatitis viruses. 9) Severe comorbidities such as cancer, liver disease, or kidney disease 9) Merge autoimmune diseases, including but not limited to rheumatoid arthritis, lupus, thyroid autoimmune diseases, psoriasis, ankylosing spondylitis, polymyositis, and multiple sclerosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Security;Number of vertigo episodes in 3 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| Effective control rate of vertigo;Pure tone average;Vestibular function;Scale evaluation; | — |
Countries
China
Contacts
Public ContactHaibo Wang
Shandong Second Provincial General Hospital(Shandong Provincial ENT Hospital,Shandong ENT Institute)
Outcome results
None listed