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;
The inclusion and exclusion criteria for the study participants are as set out above
Cohort
Prospective
Not listed
UAS7 score at week 12 of treatment (90 days)
Assessed using the 7-day Urticaria Activity Score (UAS7)，score is calculated between 0 (best score possible) and 42 (worstscore possible), compared with baseline
Proportion of subjects with UAS7 ≤ 6 at week 12 of treatment (disease well controlled)
Assessed using the 7-day Urticaria Activity Score (UAS7)，score is calculated between 0 (best score possible) and 42 (worstscore possible)
Changes in the CU-Q2oL score
Assessed using the Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL)，score is calculated between 0 (best score possible) and 92 (worst score possible)
Proportion of subjects with UCT ≥ 12 at week 12 of treatment
Assessment using the Urticaria Control Test (UCT), score is calculated between 0 (worst score possible) and 16 (best score possible). A UCT score of 12 or higher indicates that chronic urticaria is well controlled
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