A Prospective Clinical Study on the Efficacy and Safety of Bacterial Lysate (OM-85) Combined with Antihistamines in the Treatment of Chronic Spontaneous Urticaria (CSU): A Single-Centre, Observational, Cohort Study
The participants were fully informed of the purpose, procedure and risks of the study and voluntarily signed the informed consent form.
Aged 18 to 65 (inclusive), no gender restrictions.
Meets the CSU diagnostic criteria, with a disease duration of ≥6 weeks.
Antihistamine resistance: Regular use of a standard dose (as recommended in the package leaflet) of a second-generation H1 antihistamine (e.g. desloratadine 5 mg, levocetirizine 5 mg, etc.) for at least 2 weeks prior to screening, but with symptoms still not effectively controlled. Defined as: a UAS7 score of ≥7 within 7 days prior to the screening visit (V1) and baseline visit (V2).
Special types of urticaria: These primarily include physical urticaria (such as artificial urticaria, cold contact urticaria and cholinergic urticaria), urticarial vasculitis, and angioedema caused by hereditary or acquired C1 esterase inhibitor deficiency;
Systemic use of glucocorticoids (oral or injectable) within the four weeks prior to screening;
Exclude patients who have used immunosuppressants (such as cyclosporine, methotrexate, or Tripterygium wilfordii) within the previous four weeks;
Exclude patients who have used biologics (such as omazulimab, dupilumab, etc.) within the previous three months;