Author/Editor		Skerbinjek-Kavalar, Maja; Brunčko, Aleksander; Primožič, Stanislav; Kos, Mitja; Lampe-Ivanovska, Dalila; Strbad, Ervin
Title		Spremljanje varnosti in učinkovitosti flutikazon propionata pri otrocih in mladostnikih z astmo
Translated title		Follow-up of safety and effectiveness of fluticasone propionate in children and adolescents with asthma
Type		članek
Source		Zdrav Vestn
Vol. and No.		Letnik 70, št. 12
Publication year		2001
Volume		str. 727-31
Language		slo
Abstract		Background. For pediatric patients who suffer from persistent asthma, inhalation corticosteroid therapy is of an increasing importance. It has been known that inhalation therapy lowers drug related risks in this population. The present study was aimed to show that protective therapy using inhalation cortico seroid fluticasone propionate (ICS-FP) improves the health status of children with asthma and that low doses of ICS-FP have no clinically significant side effects, even in a long term use. Methods. Sixty-five children with predominantly moderate asthma treated with protective anti-inflammatory drug ICS-FP for more than six months were monitored in an ambulatory setting. The study included children and adolescents aged 5-18 years. The efficacy of the protective treatment with ICS-FP was investigated by measurements of eosinophilic cationic protein (ECP) in serum and spirometric parameters at the beginning and after six months of the treatment. The safety of protective treatment was assessed with measurements of body mass and height of the children and morning serum cortisol levels. Results. During the protective treatment the number of asthma exacerbation diminished. The triggers of nonallergic exacerbations were physical activity, changes of weather and viral inflammations and the triggers of allergic asthma exacerbations were allergens (hous-dust mite, pollens and animal dander) and infections. ECP values similarly showed a statistically significant decrease from 43.1 +- 27.8 nmol/L at the beginning to 20.3 +- 13.0 nmol/L after six months. Values of spirometric parameters, expressed as percentage of normal values for the population under study, exhibited 7-14% improvement in the six months observation period. (Abstract truncated at 2000 characters).
Summary		Izhodišča. Pri otrocih s perzistentno astmo imajo pri zdravljenju inhalacijski kortikosteroidi (IKS) vse večji pomen. Znano je, da inhalacijsko dajanje zmanjšuje tveganje pri uporabi teh zdravil. Z raziskavo smo želeli dokazati, da zaščitno zdravljenje z inhalacijskim kortikosteroidom flutikazon propionatom (IKS-EP) izboljša zdravje otrok in da nizki odmerki IKS-FP, tudi če so jih bolniki prejemali dlje časa, nimajo klinično značilnih sistemskih neželenih škodljivih učinkov. Metode. Ambulantno smo spremljali 65 otrok s pretežno zmerno obliko astme, ki so prejemali zaščitno protivnetno zdravilo IKS-FP. Odmerek je bil odvisen od starosti bolnika in teže njegove bolezni. Zaščito so prejemali več kot šest mesecev. Študija je obravnavala otroke in mladostnike, stare od 5 -18 let. Učinkovitost zaščitnega zdravljenja smo preverjali z meritvami serumskega ECP in spirometričnih parametrov na začetku in po šestih mesecih zaščite z IKS-FP ter z beleženjem pogostnosti in teže astmatičnih poslabšanj, varnost zaščitnega zdravljenja pa z meritvami jutranjih vrednosti kortizola v serumu ter meritvami telesne višine in teže otrok. Rezultati. Med zaščitnim zdravljenjem je bilo poslabšanj manj. Najpogostejši sprožilci poslabšanj nealergijske astme so bili telesni napor, spremembe vremena ter virusne okužbe, sprožilci poslabšanj alergijske astme pa alergeni (pršica, cvetni prah trav, živalska dlaka) ter okužbe. Vrednosti ECP so pokazale statistično značilen padec s 43,1 +- 27,8 nmol/L na začetku študije na 20,3 +- 13,0 nmol/L po 6 mesecih. Vrednosti spirometričnih preiskav, izražene v deležu normalnih vrednosti za dano populacijo, so pokazale izboljšanje za 7-14% v času opazovanja. Vse meritve so kazale statistično značilen porast, npr FEV1 od 82,8 +- 12,4% na 96,3 +- 16,0%. (Izvleček prekinjen pri 2000 znakih).
Descriptors		ASTHMA HYDROCORTISONE CHILD ADOLESCENCE TREATMENT OUTCOME SPIROMETRY