Efficiency of local cytokine therapy used in the combination treatment of female patients with chronic cystitis


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Abstract

26-36 million cases of urinary tract infections are registered annually in Russia. An exacerbation of cystitis within 6 months after the start of the primary episode occurs in about one-third of patients and it turns into a chronic relapsing form in 10%. It is the recurring nature of chronic cystitis, which substantially worsens quality of life in female patients and increases the number of cases of temporary disability, determining the socioeconomic significance of this disease. Objective: To evaluate the efficiency of combination treatment in patients with chronic recurrent cystitis using local cytokine therapy (Superlymph) in combination with antibacterial therapy. Subjects and methods. The prospective randomized study enrolled 60 women whose mean age was 34.7±15.7 years. After the screening period, the patients were randomized into two groups in a 1:1 ratio: 1) 30 women who received combination therapy (antibacterial therapy + Superlymph) and 2) 30 women who used monotherapy (antibacterial therapy). A control group consisted of 10 healthy women (mean age 29.8±9.3 years). A control group consisted of10healthy women (mean age 29.8±9.3years). Group 1 patients used one rectal 25-USuperlymph suppository once daily for 10 days at Visit 1 and Visit 3. The total duration of therapy was 20 days. As an antibacterial drug, fosfomycin trometamol was used at a single 3-g dose overnight in both groups. The investigation involved 4 planned visits and the following steps: screening, therapy, and follow-up. Bladder diaries and an acute cystitis symptom scale (ACSS) were used to evaluate the severity of the disease. Results. Dysuric disorders (painful, frequent urination, burning, etc.) were noted in all the patients included in the study. Analyzing the bladder diaries revealed that the average number of times to urinate per day was 12.8±5.3; daytime and nighttime urinations were 9.6±4.5 and 3.5±0.9, respectively. At the same time, the urge to micturate was recorded in 57 (95.0%) patients and urge urinary incontinence was noted in 3 (5.0%). Mild, moderate, and severe symptoms were diagnosed in 7 (11.7%), 48 (80.0%), and (8.3%) patients, respectively. Group 1 patients receiving combination treatment (antibacterial therapy + Superlymph) showed a significant reduction in clinical symptoms (by 24.6±3.7 ACSS scores) and also a decrease in leukocyturia, as evidenced by the general urinalysis, and normalization of the urinary flora compared with the monotherapy group (Group 2) (by 13.1±4.9 scores) (p <0.001). The investigation conducted after treatment demonstrated that in Group 1, the proportion of pathogenic and opportunistic microflora significantly decreased compared to the baseline data. Conclusion. The findings show that the incorporation of Superlymph into combination treatment for chronic recurrent cystitis may enhance therapeutic efficiency by 2.6 times, prolongs remission between exacerbations by an average of 30.3±5.9 days, and improves quality of life in patients.

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About the authors

Inna A. Apolikhina

V.I. Kulakov National Medical Research Center of Obstetrics, Gynecology, and Perinatology, Ministry of Health of Russia; I.M. Sechenov First Moscow State Medical University (Sechenov University), Ministry of Health of Russia

Email: apolikhina@inbox.ru

Aina S. Saidova

V.I. Kulakov National Medical Research Center of Obstetrics, Gynecology, and Perinatology, Ministry of Health of Russia

Email: asekova14@yandex.ru

Tatyana A. Teterina

V.I. Kulakov National Medical Research Center of Obstetrics, Gynecology, and Perinatology, Ministry of Health of Russia

Email: palpebra@inbox.ru

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