INTRODUCTION: Chronic recurrent cystitis is a common and difficult problem of modern urology. Traditional use of antimicrobial drugs often cannot lead to the long-term remission.
AIM: To evaluate the efficacy and safety of using different dosages and routes of the drug Superlymph in rectal and vaginal suppositories 10 U and 25 U in patients with chronic recurrent cystitis.
MATERIALS AND METHODS: A randomized comparative clinical study in parallel groups included 60 patients aged from 18 to 80 years with a diagnosis of chronic recurrent bacterial uncomplicated cystitis. All study participants were randomized into three groups. In Group 1 (n=25), Superlymph suppositories 25 U were prescribed rectally once a day for 20 days. In group 2 (n=25), Superlymph suppositories 10 U were administered vaginally 2 times a day, for 20 days. In accordance with the prescription information, Superlymph 10 U/25 U can be used vaginally or rectally depending on the gender. In addition, it is possible to change the route of administration, for example, Superlymph 25 U one suppository once a day or Superlymph 10 U, one suppository 2 times a day in the morning and in the evening. The duration of the course is from 10 to 20 days. The main aim of the study was to compare an influence of various route of administration of Superlymph in women with frequent relapses of cystitis on the urothelium according to biopsy results, as well as on the symptoms of recurrent cystitis. The reparative effect of Superlymph was evaluated as well. In the control group (n=10), standard therapy was administered (fosfomycin trometamol 3.0 g once, and then, on the next day from the start of therapy, nitrofurantoin 100 mg three times a day for 5 days). The study consisted of screening, therapy and follow-up stages. The duration of therapy was 20 days. All groups did not differ significantly in the main baseline characteristics.
RESULTS: The drug Superlymph demonstrated efficacy as monotherapy of uncomplicated lower urinary tract infection in women compared with standard treatment. Rectal administration of the drug was more effective than vaginal. This was primarily manifested by a decrease in the level of urothelial metaplasia by the end of the study by 41% in the group of rectal suppositories and by 9% for the vaginal suppositories. In the control group, no changes in the level of metaplasia were found. A symptom scale showed an improvement of 36% in the group of rectal suppositories, 25% in the group of vaginal suppositories, and 19% in the control group. Improvements in the quality-of-life score were 50.8%, 33.9%, and 31.1%, respectively. The mean pelvic pain symptom scale score improved by 30%, 23%, and 13%, while a decrease in the mean leukocytes level in urine was most significant in the group of vaginal suppositories, by 39%. The respective indicators in the group of rectal suppositories and the control group were 27% and 21%, respectively. Innate immune factors were also assessed. The evaluation of gene expression levels in the bladder mucosa after using Superlymph was also performed. A significant decrease in TLR4 gene expression by 3 times, TNF gene expression by 4.2 times, and HBD1 expression by 2.7 times was found, which indicates a significant decrease in the level of inflammation in the bladder mucosa.
CONCLUSION: The immunomodulator Superlymph, representing a complex of natural antimicrobial peptides and cytokines, has demonstrated efficacy as monotherapy of chronic recurrent cystitis in women compared to standard treatment. Rectal route of administration was more effective than vaginal. This was primarily manifested by a decrease in the level of urothelial metaplasia by the end of the study. Therefore, the rectal suppositories should be used in older patients with a long history of the cystitis as intermittent therapy.