STuDIJA ML20474 PRIMJENE ERITROPOETINA BETA (NEORECORMON) u LIJEčENJu ANEMIJE PREDIJALIZNIH BOLESNIKA – HRVATSKO ISKuSTVO

Autor: INGRID PRKAčIN, DRAGAN KLARIć, VESNA LOVčIć, KREšIMIR GALEšIć, MARIO ILIć, SANJIN RAčKI
Jazyk: chorvatština
Rok vydání: 2016
Předmět:
Zdroj: Acta medica Croatica : Časopis Akademije medicinskih znanosti Hrvatske
Volume 70
Issue Suplement 2
ISSN: 1848-8897
1330-0164
Popis: Prikazano je prospektivno, neintervencijsko, opservacijsko praćenje učinkovitosti i podnošljivosti eritropoetina beta (NeoRecormon®) u liječenju anemije u bolesnika s kroničnom bubrežnom bolesti (KBB) koji još nisu podvrgnuti nadomjestnom bubrežnom liječenju u Hrvatskoj. U studiji ML20474 uključeno je ukupno 368 bolesnika u 3 do 5. stadiju KBB s anemijom u kojih je bilo indicirana primjena lijekova koji stimuliraju eritropoezu (LSE). Svi su bolesnici primili eritropoetin beta (Neorecormon) supkutano u dozi od 4000 do 6000 IU jednom tjedno u razdoblju do korekcije anemije ili porasta Hb za 10 g/L a potom jednom tjedno u reduciranoj dozi od 50% u odnosu na početnu. Bolesnici su praćeni u razdoblju od 3 do maksimalno 52 mjeseca, prosječno 13.6 (Std.dev.10,36) mjeseci. Većina bolesnika bili su muškarci (55,3%), dob preko 51 godina (81,3%). Medijan vrijednosti razine hemoglobina iznosio je 93.5 g/L na početku studije a nakon 12 mjeseci 104,23 g/L. Nije bilo statistički značajne razlike u razini Hb ovisno o uzroku osnovne bubrežne bolesti i dobi bolesnika. Na kraju praćenja većina je bolesnika navela bolje podnošenje napora, bolje spavanje i manju razdražljivost. Nuspojave primjene terapije eritropoetinom beta nismo uočili. Rezultati pokazuju da je primjena učinkovita i sigurna u liječenju anemije u bolesnika s KBB koji nisu započeli liječenje nadomještanjem bubrežne funkcije.
We performed observational multicenter study on CKD patients in stage 3-5, with renal anemia. Key inclusion criteria were: haemoglobin level > 6.0 g/dL, age >18 years and written inform consent. Exclusion criteria were dialysis and transplanted patients and haemoglobin level > 12.0 g/dL. Study was performed from 2006.-2012. and 368 patients were included. All patients received Erythropoietin beta (Neorecormon®; Roche, Basel, Switzerland) subcutaneously in dose of 4000-6000 IU every week during the correction phase of anemia treatment or once weekly 2000-4000IU during the maintenance treatment. Iron supplementation was administrated orally in >80% patients in order to achieve serum ferritin 200-500 μg/L. From 368 patients on beginning, 246 were followed and statistically analyzed (M:F=136/110). Mean duration study period was 13.6 (Std.dev.10.36) months (max 52 months). Patients were mainly men (55.3%), age >51 years (81.3%). The median of Hb level at baseline was 9.35 g/dL and after 12 months 10.4 g/dL respectively. After 12 months, most of patients had Hb range 10.0 g/dL to 11.0 g/dL. There were no statistically significant differences between Hb in groups of patients stratified according to the primary kidney disease and age, and between sex: mean level of Hb in M at the end of study was 10.27 g/dl and in F 10.58 g/dl (p=0.051). Baseline eGFR (Cocroft Gault) values were 16.31 (range form 4.1-62.6) vs. 16.71 (range from 4.9-43.8) mL/min after 12 months. The majority of patients had reported better exercise tolerance and sleep. 47.7% of patients have started after predialysis education with dialysis and in 2 patients preemptive transplantation was performed. The results of this multicenter observational study in Croatia suggest that the use of erythropoietin beta is effective and safe in correction of anemia in pre-dialysis CKD patients.
Databáze: OpenAIRE
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