Author/Editor     Tršinar, Bojan
Title     Kombinirano zdravljenje bolnikov z benigno hiperplazijo prostate
Translated title     Combination therapy in patients with benign prostatic hyperplasia
Type     članek
Source     Zdrav Vestn
Vol. and No.     Letnik 75, št. 11
Publication year     2006
Volume     str. 697-701
Language     slo
Abstract     Background The purpose of observational program of patients with lower urinary tract symptoms (LUTS) because of benign prostatic hyperplasia (BPH) (LUTS/BPH) was to acquire additional pharmaco-epidemiological data on the safety and efficacy of combination therapy with finasteride and tamsulosin. Methods Observational program of men with BPH was conducted in urological outpatient clinics in Slovenia from April 2004 until November 2005. In open-label, non-interventional program 1173 patients were observed, who had been treated because of LUTS/BPH with com bination therapy with finasteride and tamsulosin, in the framework of common treat meat. At baseline and after six months of treatment for each patient the International Prostatic Symptom Score (IPSS) questionnaire and assessment of quality of life (QL) were filled in. In addition, urinary flow rate and prostate volume were determined. Adverse effects of drugs were reported spontaneously. For statistical analysis the Student's t-test was performed. Results Combination therapy with finasteride and tamsulosin was well tolerated. 89 (7.6%) patients discontinued with medication because of lack of efficacy or because of adverse effects of drugs. Symptom score, assessment of quality of patients' lives and volume of prostates were significantly lower (p < 0.0001), while urinary flow rate was significantly higher (p < 0.0001) after six months of treatment with finasteride and tamsulosin.
Summary     Izhodišča Namen programa opazovanja bolnikov s težavami z mokrenjem (LUTS - Lower Urinary Tract Symptoms) zaradi benigne hiperplazije prostate (BHP) (LUTS/BHP) je bil pridobiti dodatne farmakoepidemiološke podatke o varnosti in učinkovitosti kombiniranega zdravljenja s finasteridom in tamsulozirnom. Metode Program opazovanja moških z diagnosticirano BHP je potekal v uroloških ambulantah po Sloveniji od aprila 2004 do novembra 2005. V odprtem programu so zdravniki v okviru rednega zdravljenja v ambulantah opazovali 1173 bolnikov, pri katerih so se odločili za zdravljenje LUTS/BHP s kombiniranim zdravljenjem s finasteridom 5 mg/dan in tamsulozinom 0,4 mg/dan. Za vsakega opazovanega bolnika so morali izpolniti Mednarodni vprašalnik za točkovno vrednotenje simptomov BHP (IPSS - International Prostatic Symptom Score) in Vprašalnik o oceni kakovosti življenja (QL) ter izmeriti pretok seča in volumen prostate ob izhodišču in po šestih mesecih zdravljenja. Zabeležiti so morali tudi morebitne neželene učinke zdravljenja. Za statistično analizo podatkov smo uporabili enosmerni Studentov t-test. Rezultati Kombinirano zdravljenje s finasteridom in tamsulozinom so bolniki dobro prenašali. 89 (7,6%) bolnikov je prenehalo jemati zdravila zaradi nezadovoljivega učinka ali pa zaradi neželenih učinkov zdravil. Po šestih mesecih zdravljenja s finasteridom in tamsulozinom so bili seštevek točk v vprašalniku IPSS, v vprašalniku QL in volumen prostate značilno nižji (p < 0,0001), pretok seča pa značilno višji (p < 0,0001) v primerjavi z izhodiščnimi vrednostmi. Zaključki Kombinirano zdravljenje bolnikov z LUTS/BHP s finasteridom in tamsulozinom je učinkovito in varno.
Descriptors     PROSTATIC HYPERPLASIA
FINASTERIDE
ADRENERGIC ALPHA-ANTAGONISTS
DRUG THERAPY, COMBINATION
TREATMENT OUTCOME