Efficiency and safety of phenazopyridine for treatment of uncomplicated urinary tract infection: results of multi-center, randomized, placebo-controlled, clinical study


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Aim: to evaluate the efficiency and safety of phenazopyridine for the treatment of patients with uncomplicated lower urinary tract infection, accompanied by pain. Materials and methods. A multicenter double-blind, randomized, placebo-controlled study with parallel groups to evaluate the efficacy and safety of phenazopyridine in patients with acute uncomplicated cystitis was performed. A total of 60 women were divided into two groups of 30 patients. In the main group (average age 32.6±7.4 years) phenazopyridine was prescribed (2 tablets of 100 mg p.o., with a total dose of 200 mg, once). In the control group, patients (mean age 35.53±8.79 years) received a placebo according to the same scheme. To evaluate the efficiency of treatment, the severity of the main symptoms 6 hours after taking the drug was analyzed. After that, patients started antibiotic therapy. They were followed-up for the next three days. The tolerance of therapy was evaluated by the presence of adverse events. Results. All 30 patients taking phenazopyridine had an improvement after 6 hours, and the most frequent response was “significant improvement” (43.3%). The responses of patients in the main group significantly (p<0.05) differed from responses of patients in the control group. Six hours after taking phenazopyridine/placebo, the severity of all values according to VAS score, including the degree of general discomfort, pain during urination and increased frequency of urination improved significantly in the main group compared to the control group. The average assessment of general discomfort in the main group decreased by 53.4% in comparison with 28.8% in the control group, while the severity of pain during urination and urination frequency decreased by 57.4 vs. 35.9% and 39.6 vs. 27.6%, respectively. An analysis of the time before the complete absence of the general discomfort was performed. In the main group this period of time was significantly less than in the control group (p<0.05). There were no serious adverse events while taking phenazopyridine. Rate of adverse events was comparable between two groups. Conclusion. The results of the study showed that phenazopyridine is an effective and well-tolerated drug for symptomatic therapy in patients with acute uncomplicated cystitis and can be recommended in addition to etiological therapy.

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作者简介

S. Petrov

Pavlov First Saint Petersburg State Medical University of the Ministry of Health of Russia

Email: petrov-uro@yandex.ru
Dr.Med.Sci., professor, Head of the Scientific and Research Center of Urology. Scientific and Research Institute for Surgery and Emergency Medicine of Pavlov First Saint Petersburg State Medical University of the Ministry of Health of Russia Saint Petersburg, Russia

M. Slesarevskaya

Pavlov First Saint Petersburg State Medical University of the Ministry of Health of Russia

Email: mns-1971@yandex.ru
M.N. - Ph.D., senior researcher at Scientific and Research Center of Urology in Scientific and Research Institute for Surgery and Emergency Medicine of Pavlov First Saint Petersburg State Medical University of the Ministry of Health of Russia Saint Petersburg, Russia

K. Chibirov

FGBOU Saint Petersburg Scientific and Research Institute of Phthisiopulmonology of Ministry of Health of Russia (Department of phthisionephrology and urology)

Email: ckk_mma@mail.ru
urologist, Department of Phthisionephrology and urology, FGBOU Saint Petersburg Scientific and Research Institute of Phthisiopulmonology of Ministry of Health of Russia Saint Petersburg, Russia

M. Topuzov

North-Western State Medical University n.a. I.I. Mechnikov

Email: martop@mail.ru
Dr.Med.Sci, MD, professor at the Department of Urology, North-Western State Medical University n.a. I.I. Mechnikov Saint Petersburg, Russia

O. Kagan

Ltd MedEsteticCenter Laboratory

Email: ofkagan@mail.ru
Dr.Med.Sci, MD, Ltd MedEsteticCenter Laboratory Saint Petersburg, Russia

E. Voronova

Ltd Avrora Medi

Email: Nickolaevna@mail.ru
urologist at the Ltd Avrora Medi Saint Petersburg, Russia

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