Avtor/Urednik		Tršinar, Bojan
Naslov		Tolterodin - novo zdravilo za bolnike s čezmerno aktivnim sečnim mehurjem
Prevedeni naslov		Tolterodine - a new drug for patients with an overactive bladder
Tip		članek
Vir		Zdrav Vestn
Vol. in št.		Letnik 69, št. 12
Leto izdaje		2000
Obseg		str. 813-6
Jezik		slo
Abstrakt		Background. Tolterodine is a new antimuscarinic drug for the treatment of patients with clinical symptoms and signs of overactive bladder. The objective of this trial was to compare the clinical efficacy and safety of tolterodine with that of placebo. Patients and methods. This international prospective, randomized, enrolled 21 patients. The study group (n = 11) was given tolterodine 2 mg twice daily for 12 weeks and the control group (n = 10) received placebo for the same period of time. Three days before and 3 days after the trial, micturition charts were completed by all subjects to provide the following data: number of voidings per 24 hours, urine volume voided per micturition, and number of urge incontinence episodes per 24 hours. At two control control visits, the subject were asked to report side effects of the drug. After 12 weeks' treatment, the patients' subjective assessment of the clinical efficacy of the drug was recorded. Statistical analysis was done using the Student t-test. Results. Before the study, there were no significant differences between the two groups concerning sex, body weight, height and micturition problems. After 12 weeks' treatment with tolterodine, volume voided per micturition increased by 25% (p < 0.05), and the number of urge incontinence episodes/24 hours declined by 47% (p < 0.05). There was a nonsignificant decrease in the frequency of micturition per 24 hours (13%). The effect of placebo was statistically negligible. Six of the 11 subjects in the study group felt that tolterodine was a very effective drug, and only one of the 10 control subjects felt the same about placebo. The most frequent adverse effect was dry mouth, reported by 5 subjects on tolterodine and 4 subjects on placebo.
Izvleček		Izhodišča. Tolterodin je novo antimuskarisko zdravilo za zdravljenje bolnikov s kliničnimi simptomi in znaki čezmerno aktivnega sečnega mehurja. Namen raziskave je bil primerjati učinkovitost in varnost tolterodina s placebom. Bolniki in metode. V mednarodno, prospektivno, randomizirano, dvojno slepo, s placebom kontrolirano raziskavo je bilo v Sloveniji vključenih 21 bolnikov (11 v preiskovani, 10 v kontrolni skupini). Vsi so 12 tednov prejemali tolterodin ali placebo po 2-krat 2 mg dnevno. Tri dni pred začetkom in tri dni pred koncem zdravljenja so morali izpolniti zapis svoje mikcije: število mikcij v 24 urah, količino urina ob vsaki mikciji in število urgentnih inkontinenčnih epizod v 24 urah. Ob kontrolah so morali navesti morebitne stranske učinke zdravila, ob zadnji po 12 tednih pa svoje menje o tem, kakšen je bil subjektivni klinični učinek zdravila. Za statistično analizo rezultatov smo uporabili Studentov t-test. Rezultati. Bolniki v obeh skupinah se pred začetkom zdravljenja niso pomembno razlikovali v spolu, teži, višini in mikcijskih težavah. Tolterodin je po 12 tednih statistično pomembno povečal volumen urina enkratne mikcije za 25% (p < 0,05) in statistično pomembno zmanjšal število inkontinenčnih epizod v 24 urah za 47% (p < 0,05). Statistično nepomembno je zmanjšal pogostnost mikcije v 24 urah za 13%. Učinek placeba je bil statistično nepomemben. Tolterodin je bil subjektivno zelo učinkovit pri šestih od enajstih bolnikov, placebo pa le pri enem od desetih. Od stranskih učinkov so bolniki najpogosteje navajali suha usta: pet bolnikov v preiskovani in štirje v kontrolni skupini.
Deskriptorji		URINARY INCONTINENCE MUSCARINIC ANTAGONISTS PROSPECTIVE STUDIES BLADDER DOUBLE-BLIND METHOD URINATION TREATMENT OUTCOME