Research PROSPECT IV (PROStamol: PErspectives of Combination Therapy) in Patients with Benign Prostatic Hyperplasia
Keywords:benign prostatic hyperplasia, acute urinary retention, Flosin, tamsulosin, Prostamol Uno
The objective: was to determine the efficacy and safety of nine-year therapy in patients with benign prostatic hyperplasia (ВРН) using the combination «Flosin – Prostamol Uno» by the method of assessing the quality of life and the possibility of improving objective data of urological status. The ultimate goal of nine-year follow-up of patients was to reduce the risk of developing acute urinary retention as a complication of this disease.
Materials and methods. A study of patients with BPH who were included in PROSPECT IV found that 37 people from the entire cohort at the age of 59–78 years (68.2±4.7) remained under observation for 2020 (of n=94 in PROSPECT III – 39.3 % of patients were followed up for 9 years). In a similar way, the subjects were randomized according to the conditions of previous therapy into two groups: the І group (clinical) included 33 patients who received the combination «Flosin – Prostamol Uno» for 9 years; ІІ group (control) consisted of 4 subjects who received a combination «doxazosin – finasteride» also for 9 years.
Results. The obtained results testify to the high therapeutic efficacy of the combination «Flosin – Prostamol Uno», comparable to the combination of drugs «doxazosin and finasteride». Combination therapy with Flosin and Prostamol Uno was well tolerated in patients with a low incidence of adverse events (5.75 %; p <0.05) compared with patients receiving the combination of doxazosin and finasteride (27 %, p <0, 05). 7 (18.9 %) patients were operated on during the last 5 years (TUR – 6; laser vaporization – 1); the level of acute urinary retention – in 7 people in the form of 1–2 episodes, which required operative assistance.Conclusion. The above facts made it possible to assert that: the adherence of patients to the combined conservative therapy of BPH according to the «Flosin – Prostamol Uno» scheme was high (43.2 %); adherence of patients operated on for acute urinary retention to this type of combination therapy was evident (all patients received Extr. Serenoa repens and tamsulosin in the postoperative period); the level of acute urinary retention in persons of group I with BPH who received treatment for 9 years was 19 % (p> 0.05).
Аляев Ю.Г., Винаров А.З., Демидко Ю.Л., Спивак Л.Г. (2013) Результаты 10-ти летнего исследования эффективности и безопасности применения экстракта Serenoa repens у пациентов с риском прогрессирования аденомы предстательной железы // Урология. – № 4. – С. 31–35.
Горпинченко И.И., Гурженко Ю.Н. (2011) Исследование ПРОСПЕКТ (ПРОСтамол: ПЕрспективы Комбинированной Терапии) ДГПЖ // Здоровье мужчины. – № 4. – С. 18–20.
Горпинченко И.И., Гурженко Ю.Н., Клименко П.М., Шуляк А.В., Спиридоненко В.В. (2012) Исследование ПРОСПЕКТ II (ПРОСтамол: ПЕрспективы Комбинированной Терапии) при ДГПЖ // Здоровье мужчины. – № 1. – С. 156–160.
Горпинченко И.И., Гурженко Ю.Н., Спиридоненко В.В. (2014) Исследование ПРОСПЕКТ III (ПРОСтамол: ПЕрспективы Комбинированной Терапии) при доброкачественной гиперплазии предстательной железы // Здоровье мужчины. – № 3 (50). – С. 12–17.
Lepor H. (2003) Landmark Studies Impacting the Medical Management of Benign Prostatic Hyperplasia. Rev Urol.; 5(Suppl 4): S34–S41.
Rhodes T., Girman C.J., Jacobsen D.J. et al. (2000) Longitudinal prostate volume in a community-based sample: 7 year follow up in the Olmsted County Study of urinary symptoms and health status among men. J Urol.; 163 (Suppl. 4): 249.
Roehrborn C.G., Boyle P., Bergner D. et al. (1999) Serum prostatespecific antigen and prostate volume predict long-term changes in symptoms and flow rate: results of a four-year, randomized trial comparing finasteride versus placebo. PLESS Study Group. Urology;54:662–669.
Vinarov A.Z., Spivak L.G., Platonova D.V., Rapoport L.M., Korolev D.O. (2018) 15 years` survey of safety and efficacy of Serenoa repens extract in benign prostatic hyperplasia patients with risk of progression // Urologia. – С. 1–6.
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