Abstract
To investigate clinical and immunological features of fixed drug eruption (FDE) in patients with different relapse rates and to compare the obtained immune parameters with those of a control group.
A single-center open clinical and laboratory observational study was conducted. The study included 62 patients with clinically confirmed FDE observed from 2018 to 2025. There were 38 men (61.3%) and 24 women (38.7%); the age of patients ranged from 20 to 60 years. The control group consisted of 20 apparently healthy volunteers of comparable age without a history of drug-induced dermatoses or chronic inflammatory skin diseases. All participants underwent clinical examination, assessment of drug history, routine laboratory testing, biochemical blood tests, and immunological assessment including CD3+, CD4+, CD8+, CD4/CD8 ratio, IFN-γ, TNF-α, IL-6, IL-10, IgG, and IgM. Patients were stratified according to the number of relapses: 1–3 episodes, 4–7 episodes, and 8–10 episodes.
FDE was most frequently associated with ampicillin, co-trimoxazole, ceftriaxone, paracetamol, citramon, diclofenac, fluconazole, and metronidazole. Compared with the control group, FDE patients demonstrated decreased CD4+ cells, increased CD8+ cells, reduced CD4/CD8 ratio, increased IFN-γ, TNF-α, and IL-6 levels, and decreased IL-10 levels. The most pronounced immune alterations were observed in patients with 8–10 relapses. After treatment, improvement of immune parameters was more evident in patients receiving combination therapy; however, due to the observational design, absence of randomization and potential confounding factors, these findings should be interpreted cautiously.
FDE is associated with alterations in cellular and cytokine immunity. The severity of these changes is related to relapse frequency and may contribute to a recurrent clinical course.
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