Efficacy and safety of afalaza in men with symptomatic benign prostatic hyperplasia at risk of progression: A multicenter, double-blind,...
Pushkar D., Vinarov A. Z., Spivak L. G., Kolontarev K., Putilovskiy M., Andrianova E., Epstein O.
Central European Journal of Urology
Vol.71, Issue4, P. 427-435
Опубликовано: 2018
Тип ресурса: Статья
DOI:10.5173/ceju.2018.1803
Аннотация:
Introduction In order to investigate the efficacy and safety of Afalaza in men with benign prostatic hyperplasia (BPH) at risk of progression, this multicenter, double-blind, placebo-controlled, randomized clinical trial was performed. Derived by technological treatment of antibodies to prostate-specific antigen (PSA) and endothelial nitric oxide synthase (eNOs), Afalaza was previously proved to modulate its molecular targets. The mechanism of action of the drug is associated with the modulating effect of the antibiodies (RA-Abs) on the molecular targets (PSA and eNOS) by way of conformational changes. Material and methods A total of 249 patients aged 45–60 years with BPH and moderate lower urinary tract symptoms (LUTS), total prostate volume (TPV) ≥30 cm3, Qmax 10–15 ml/s, and serum PSA<4 ng/ml were randomly assigned to receive either Afalaza (n = 125) or placebo (n = 124) for 12 months. Changes in BPH/LUTS symptoms (according to the International Prostate Symptom Score), Qmax, TPV
Ключевые слова:
Afalaza; Benign prostatic hyperplasia; BPH progression symptoms; Released-activity
afalaza; antibody; endothelial nitric oxide synthase; placebo; prostate specific antigen; unclassified drug; abdominal pain; adult; Article; asthenia; bladder obstruction; bronchitis; connective tissue disease; contact dermatitis; controlled study; coughing; diarrhea; disease exacerbation; disease severity; double blind procedure; drug efficacy; drug interaction; drug safety; gastroenteritis; gastrointestinal disease; headache; heartburn; hemorrhoid; herpes labialis; human; hypertensive crisis; inguinal hernia; intention to treat analysis; International Prostate Symptom Score; lower urinary tract symptom; major clinical study; male; middle aged; multicenter study; nausea; pharyngitis; postvoid residual urine volume; prostate hypertrophy; prostate volume; randomized controlled trial; rhinitis; risk factor; throat irritation; tongue swelling; transrectal ultrasonography; upper abdominal pain; upper respiratory tract infection; urinalysis; urinary tract infection; urine flow rate; urine r
Язык текста: Английский
ISSN: 2080-4873
Pushkar D.
Vinarov A. Z. Andrej Zinovyevich 1956-
Spivak L. G. Leonid Grigoryevich 1974-
Kolontarev K.
Putilovskiy M.
Andrianova E.
Epstein O.
Пушкар Д.
Винаров А. З. Андрей Зиновьевич 1956-
Спивак Л. Г. Леонид Григорьевич 1974-
Колонтарев К.
Путиловскиy М.
Андрианова Е.
Епстеин О.
Efficacy and safety of afalaza in men with symptomatic benign prostatic hyperplasia at risk of progression: A multicenter, double-blind, placebo-controlled, randomized clinical trial
Efficacy and safety of afalaza in men with symptomatic benign prostatic hyperplasia at risk of progression: A multicenter, double-blind,...
Текст визуальный непосредственный
Central European Journal of Urology
Vol.71, Issue4 P. 427-435
2018
Статья
Afalaza Benign prostatic hyperplasia BPH progression symptoms Released-activity
afalaza antibody endothelial nitric oxide synthase placebo prostate specific antigen unclassified drug abdominal pain adult Article asthenia bladder obstruction bronchitis connective tissue disease contact dermatitis controlled study coughing diarrhea disease exacerbation disease severity double blind procedure drug efficacy drug interaction drug safety gastroenteritis gastrointestinal disease headache heartburn hemorrhoid herpes labialis human hypertensive crisis inguinal hernia intention to treat analysis International Prostate Symptom Score lower urinary tract symptom major clinical study male middle aged multicenter study nausea pharyngitis postvoid residual urine volume prostate hypertrophy prostate volume randomized controlled trial rhinitis risk factor throat irritation tongue swelling transrectal ultrasonography upper abdominal pain upper respiratory tract infection urinalysis urinary tract infection urine flow rate urine r
Introduction In order to investigate the efficacy and safety of Afalaza in men with benign prostatic hyperplasia (BPH) at risk of progression, this multicenter, double-blind, placebo-controlled, randomized clinical trial was performed. Derived by technological treatment of antibodies to prostate-specific antigen (PSA) and endothelial nitric oxide synthase (eNOs), Afalaza was previously proved to modulate its molecular targets. The mechanism of action of the drug is associated with the modulating effect of the antibiodies (RA-Abs) on the molecular targets (PSA and eNOS) by way of conformational changes. Material and methods A total of 249 patients aged 45–60 years with BPH and moderate lower urinary tract symptoms (LUTS), total prostate volume (TPV) ≥30 cm3, Qmax 10–15 ml/s, and serum PSA<4 ng/ml were randomly assigned to receive either Afalaza (n = 125) or placebo (n = 124) for 12 months. Changes in BPH/LUTS symptoms (according to the International Prostate Symptom Score), Qmax, TPV