Efficacy of comprehensive treatment of patients with acute salpingo-oophoritis and exacerbation of chronic salpingo-oophoritis using a biological medicinal product based on the secretome of peripheral blood leukocytes

Recurrent inflammation of the uterine appendages is associated with an increased risk of chronic pelvic pain, tubal infertility, and fallopian tube damage. Therefore, there is a need for adjunctive therapies to standard antibacterial treatment that may help reduce persistent inflammatory activity. Objective. To evaluate the efficacy and safety of combination therapy including a biological medicinal product based on the peripheral blood leukocyte secretome (PBLS) in patients with acute salpingo-oophoritis and exacerbation of chronic salpingo-oophoritis. Material and methods. A total of 205 women aged 24—39 years with acute salpingo-oophoritis or exacerbation of chronic salpingo-oophoritis (ICD-10 codes: N70.0—N70.1) were enrolled. The main group received standard therapy in combination with PBLS, whereas the comparison group received standard therapy alone. Clinical and laboratory parameters were assessed on day 10, and recurrent exacerbations were recorded during 12 months of follow-up. Results. On day 10, complete pain resolution was achieved in 82.9% of patients in the main group and 71.0% in the comparison group (RR=1.167; 95% CI 1.002—1.359; p=0.044); mean VAS scores were 0.6±0.9 and 1.2±1.3, respectively (p<0.001). Persistent leukocytosis (35.2% vs 49.0%; p=0.046), neutrophilia (21.9% vs 38.0%; p=0.012), elevated band neutrophil counts (17.1% vs 29.0%; p=0.044), monocytosis (14.3% vs 28.0%; p=0.016), ESR >20 mm/h (37.1% vs 51.0%; p=0.046), and C-reactive protein >5 mg/L (27.6% vs 41.0%; p=0.044) were less frequent in the main group. At 12 months, recurrent exacerbations were recorded in 0.9% of patients in the main group and 14.0% in the comparison group (p<0.001). No adverse events considered potentially related to PBLS were recorded. Conclusion. The addition of PBLS to standard therapy was associated with a higher rate of pain resolution, a lower frequency of persistent laboratory signs of systemic inflammation, and fewer recurrent exacerbations. These findings require confirmation in larger studies.