Abstract

A comparative evaluation of the efficacy and safety of Canephron N and Cystone as monotherapy in women with acute uncomplicated cystitis and antibiotic allergy or intolerance was performed. A prospective, randomized, controlled study of drug Canephron N as monotherapy for acute uncomplicated cystitis in 51 women with a history of antibiotic allergy or intolerance was carried out in 3 urological centers in Perm from 2016 to 2019. In the main group, patients received Canephron N for 30 days, while in comparison group, Cystone was prescribed. The Acute Cystitis Symptom Score (ACSS), microscopic study of urine sediment, urine culture and other methods were used. Results were evaluated 3, 6, 30 days and 1 year after the start of treatment. In the main group, monotherapy with Canephron N for 30 days resulted in a decrease in the total ACSS score from the baseline 12.9 to 0.3 points, while in Cyston group, changes of ACSS score were less pronounced, from baseline 12.8 to 1.4 points (p<0.01). Clinical cure rate in the main and comparison group was 88.5% and 68%, respectively. In another 3.8% and 1% of patients in the main and comparison group, an improvement was seen. The number of patients with leukocyturia in the Canephron N group decreased to 11.5% compared to 28% in Cyston group (p>0.05). Bacteriuria rate in the main group was 7.7%, which was less than in the comparison group (20%, p>0.05). Number of sick days in the main group was 4.9+/-0.4, compared to 7.4+/-0.6 days in Cyston group. In the Canephron N group, 1-year recurrence rate was only 7.7%, while in the Cyston group the recurrence was seen in 16% of patients. According to the results, Canephron N is an effective and safe drug as monotherapy for acute uncomplicated cystitis, and can be considered as drug of choice for the treatment of women with antibiotic allergy or intolerance.

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