Volume 14, issue 4
Article
Risperidon (Rispolept®) w leczeniu schizofrenii – wyniki badania wieloośrodkowego w Polsce
Małgorzata Rzewuska1, Aleksander Araszkiewicz1, Adam Bilikiewicz1, Jacek Bomba1, Jan Horodnicki1, Jerzy Samochowiec1, Andrzej Kiejna1, Irena Krupka-Matuszczyk1, Jerzy Landowski1, Wiesław Leksowski1, Marek Masiak1, Irena Namysłowska1, Andrzej Piotrowski1, Andrzej Rajewski1, Janusz Rybakowski1, Stefan Smoczyński1, Waldemar Szelenberger1, Jacek Wciórka1, Jarosław Więckowski1, Elżbieta Żyto1
1. Samodzielna Pracownia Farmakoterapii i Kliniki Psychiatryczne Instytutu Psychiatrii i Neurologii w Warszawie; Kliniki Psychiatryczne Akademii Medycznych: w Bydgoszczy, Gdańsku, Katowicach, Lublinie, Poznaniu, Warszawie, Wrocławiu, Szczecinie i UJ
Farmakoterapia w Psychiatrii i Neurologii, 1998, 4, 13-32
Abstract
The results of a long term (7 months) clinical trial evaluating efficacy and safety of risperidone in treatment of schizophrenia are presented (DSM-3-R). The study was conducted in 14 clinical centers in Poland; 193 patients aged 15-65 years were enrolled. Efficacy parameters were estimated in PANSS (total and subscales) and CGI. Safety was assessed by analysis of vital signs, clinical laboratory tests, ECG, adverse events and extrapyramidal symptoms by means of the ESRS. The result s of the study confirmed high efficacy of risperidone in the treatment of positive and negative symptoms of schizophrenia. Low incidences of adverse events, particularly extrapyramidal symptoms, prove good safety and tolerability profile of risperidone.