Objective  To evaluate the efficacy and safety of modified Yupingfeng granules (MYG) combined with probiotics in the treatment of patients with chronic spontaneous urticaria (CSU).

Methods  Patients with CSU who attended Guang'anmen Hospital, China Academy of Chinese Medical Sciences from June 2021 to June 2023 were enrolled. According to the random number table method, CUS patients were divided into MYG group (loratadine combined with MYG) and MYGP group [loratadine combined with MYG and probiotics (live combined bacillus subtilis and enterococcus enteric-coated capsules)]. The urticaria activity score (UAS7), dermatological life quality index (DLQI) and TCM pattern score were used to evaluate the efficacy. The differential levels of inflammatory factors [serum interleukin-6 (IL-6) and tumor necrosis factor-α (TNF-α)] and immune factors (peripheral blood CD3+, CD4+, CD8+, CD4+/CD8+ levels), IgE were detected and compared before and after treatment. The treatment efficacy betwenen tow groups and occurrence of adverse reactions during treatment was observed and compared. Three months after the completion of treatment, the recurrence of the two groups was compared.

Results  A total of 240 patients with CSU were included in the study, including 120 patients in the MYG group and 120 in the MYGP group. After treatment, USA7, DLQI, TCM pattern score, IL-6, TNF-α, CD8+ and IgE in the MYGP group were significantly lower than those in the MYG group, while CD3+, CD4+ and CD4+/CD8+ were significantly higher than those in the MYG group (P<0.05). The total effective rate of CSU patients in the MYGP group was significantly higher than that in the MYG group (P<0.05), while the incidence of adverse reactions and recurrence were significantly lower than those in the MYG group (P<0.05).

Conclusion  The efficacy of probiotics combined with MYG adjuvant therapy for CSU is significantly better than that of MYG monotherapy adjuvant therapy, which can significantly improve the treatment effect, reduce inflammatory factors, regulate immune function, improve quality of life, reduce the recurrence rate and adverse reaction rate of CSU, and have high safety.

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