Author/Editor		Šuškovič, Stanislav; Košnik, Mitja
Title		Zdravljenje bolnikov z od glukokortikoidov odvisno astmo z majhnimi odmerki ciklosporina
Translated title		Treatment of steroid dependent asthmatics with low doses of cyclosporine
Type		članek
Source		Zdrav Vestn
Vol. and No.		Letnik 73, št. 1
Publication year		2004
Volume		str. 1-4
Language		slo
Abstract		Background. Asthmatics with glucocorticoid dependent asthma should be treated with systemic steroids. Cyclosporine is in many ways a potent anti-inflammatory drug. Cyclosporine is sometimes very effective in treating asthmatics and could allow us to lower the dose of oral steroid. In some randomized, double blind studies steroid dependent asthmatics were treated 12-36 weeks with cyclosporine in dose 5 mg/kg/day. We tried cyclosporine in steroid dependent asthmatics in shorter course and in lower dose. Methods. 13 steroid dependent asthmatics were in the first four weeks of the study treated by their own drugs (phase 1). Then they were for the next four weeks (phase 2) randomly and in double blind fashion treated with either cyclosporine (mean 1.7 mg/kg/day, SD 0.5, 6 patients - group 1) or by identical placebo (7patients - group 2). To the patients in the group 2 serum concentration of cyclosporine was measured on the eight day of the study. Results. Morning peak expiratory flow (PEF) raised significantly in group 1 (200 L/sec to 247 L/sec or for 23%). Patients in group 1 had significantly less episodes of nocturnal asthma (2.2 episodes/night to 1.5 episodes/night or for 32%). In group 2 were not found any changes between first phase and second phase of the study. Steroid consumption did not change in any group. Mean serum concentration of cyclosporine in patients of groupl was 35.7 microg/L. We did not find any adverse effects of cyclosporine or placebo. Conclusions. Cyclosporine could have dangerous side effects, which are dependent on its serum concentration. So it should be administered in the lowest possible dose and for the most possible short period. (Abstract truncated at 2000 characters).
Summary		Izhodišča. Bolnike z od glukokortikoidov odvisno astmo moramo trajno zdraviti z oralnimi glukokortikoidi. Ciklosporin je učinkovito protivnetno zdravilo. Z dodatkom ciklosporina oralnim glukokortikoidom je možno izboljšati astmo. V randomiziranih kliničnih preizkusih so zdravili bolnike z od glukokortikoidov odvisno astmo vsaj 12-36 tednov s 5 mg ciklosporina/kg telesne mase. Namen naše raziskave je bil razkriti klinične učinke ciklosporina, danega kratek čas v majhnem dnevnem odmerku. Metode. Izvedli smo dvojno slepi, randomizirani in s placebom kontrolirani preizkus ciklosporina pri 13 bolnikih z od glukokortikoidov odvisno astmo. Bolniki so prvih 28 dni preizkusa merili jutranji in večerni največji ekspiratorni pretok (PEF) ter izpolnjevali vprašalnik o simptomih astme. Prejemali so svoja ustaljena zdravila. Vsi so prejemali oralni metilprednizolon. 29. dan raziskave smo bolnike randomizirali v skupinol (6 bolnikov), ki smo jih nadaljnjih 28 dni zdravili z 1,7 mg (SD 0, 5 mg) ciklosporina/kg telesne mase dnevno. Skupino 2 (7 bolnikov) smo zdravili s placebom ciklosporina. Bolnikom iz skupine 1 smo 8. dan zdravljenja izmerili serumsko koncentracijo ciklosporina. Rezultati. V skupini 1 smo ugotovili statistično pomembno povečanje jutranjih PEE (od 200 L/min na 247 L/min ali za 23%) ter statistično pomembno zmanjšanje nočne astme (.s 2,2 epizode/noč na 2,5 epizode/noč ali za 32%). V skupini 2 nismo ugotovili pomembnih sprememb pri niti enem od spremjanih parametrov. Poraba metilprednizolona je ostala v obeh skupinah nespremenjena. Povprečna serumska koncentracija ciklosporina je bila 35,7 Ng/L seruma. Pri bolnikih, ki so prejemali ciklosporin, nismo ugotovili pomembnih biokemičnih motenj ali subjektivnih težav. Krvni tlak so imeli normalen. (Abstract truncated at 2000 characters).
Descriptors		ASTHMA GLUCOCORTICOIDS, SYNTHETIC CYCLOSPORINE PEAK EXPIRATORY FLOW RATE DYSPNEA TREATMENT OUTCOME RANDOMIZED CONTROLLED TRIALS