An observational randomized study of the efficacy and safety of the drug Longidase®, vaginal and rectal suppositories 3000 iu in the treatment of patients with symptoms of the lower urinary tract on the background of benign prostatic hyperplasia


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Abstract

Introduction. Benign prostatic hyperplasia (BPH) is among the most significant urological diseases, and improving the effectiveness of treatment of patients with this disease is one of the main tasks in modern urology. The aim of the study is to evaluate the effectiveness of Longidase® in the treatment of men with benign prostatic hyperplasia. Materials and methods. The study included 120 patients with lower urinary tract symptoms caused by BPH, who were randomly assigned to 2 groups of 60 people. In the main group (MG), Longidaza® 3000 ME therapy was performed in combination with tamsulosin. In the comparison group (CG), tamsulosin monotherapy was performed. The patients were examined during 5 visits for 162±3 days. Results. During the treatment period, compliance was 100%, all patients followed the doctor’s prescriptions, there were no cases of refusal of therapy. In addition, there were no cases of adverse events associated with taking the drug Longidaza. The examination initially revealed symptoms of the lower urinary tract in both groups against the background of prostatic hyperplasia, erectile dysfunction and a decrease in the quality of life. The therapy performed in both groups was effective, as evidenced by a decrease in the average score on the I-PSS scale, an increase in maximum urine flow rate, a decrease in volume of residual urine, which led to an improvement in the quality of life according to the QoL scale. Nevertheless, in the group of patients receiving Longidaza, after 50 days of therapy, there was a more pronounced positive dynamics of both the average score on the I-PSS and QoL scales, and the average maximum urine flow rate value according to the results of uroflowmetry. The differences between the groups according to these indicators were statistically significant (p<0.05). After 50 days of follow-up in GS, the average prostate volume did not change significantly, whereas in MG it decreased, and the differences between the groups were statistically significant (p=0.001). During subsequent visits, there was a tendency to decrease the size of the prostate in the MG, while in the CG there was a moderate increase in the volume of prostate according to ultrasound. Conclusion. Thus, according to the results obtained in the course of this observational study, the drug Longidaza® 3000 ME can be effectively used in patients with BPH, prevent the progression of the disease, contribute to the persistent relief of LUTS and improve the quality of life of patients in this category.

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About the authors

A. V Kuzmenko

Voronezh State Medical University n.a. N.N. Burdenko

Email: kuzmenkoav09@yandex.ru
MD, professor, Head of Department of Urology Voronezh, Russiа

V. V Kuzmenko

Voronezh State Medical University n.a. N.N. Burdenko

Email: kuzmenkovv2003@mail.ru
MD, professor at the Department of Urology Voronezh, Russiа

T. A Gyaurgiev

Voronezh State Medical University n.a. N.N. Burdenko

Email: tima001100@mail.ru
Ph.D., associate professor at the Department Voronezh, Russiа

Yu. Yu Vinnik

GBOU VO “Krasnoyarsk State Medical University” named after professor V.F. Voyno-Yasenetsky of the Ministry of Health of Russia

Email: vinnik33@mail.ru
Ph.D., MD, professor at the Department of Urology, Andrology and Sexology IPO Krasnoyarsk, Russiа

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