Sigurnost i djelotvornost azitromicina u liječenju infekcija donjih dišnih putova: međunarodna multicentrična ne-usporedna studija

Abstract

The aim of this study was to describe clinical effectiveness of azithromycin in the management of lower respiratory tract infections in daily clinical practice, to examine duration of symptoms after therapy initiation, and to record any possible adverse effects of azithromycin treatment. A total of 153 patients were included in the analysis of the effectiveness of azithromycin: 94 patients with community acquired pneumonia (CAP) and 59 with acute exacerbation of chronic bronchitis (AECB). Clinical effectiveness was assessed as improvement, cure or failure after three-day treatment with azithromycin. The assessment was based on a calculation of clinical score for each diagnosis before treatment and on days 4, 10 and 28 after treatment initiation. Clinical effectiveness of azithromycin was 93.6% in CAP group and 94.9% in AECB group. Azithromycin led to relief of symptoms within three days in 88.6% of CAP patients and 77.2% of AECB patients. Overall, 15 adverse events were reported in 14 (9.1%) patients. The most common adverse events were abdominal pain, diarrhea and vomiting, each reported in four (2.6%) patients. Accordingly, azithromycin was found to have high clinical effectiveness and a small number of adverse events in the treatment of lower respiratory tract infections. ISRCTN38391551.Ciljevi ove studije bili su opisati kliničku djelotvornost azitromicina u liječenju infekcija donjih dišnih putova u kliničkoj praksi, ispitati trajanje simptoma nakon početka terapije te prikupiti podatke o neželjenim događajima. Uispitivanje su bila uključena 153 bolesnika: 94 bolesnika s pneumonijom iz opće populacije te 59 bolesnika s akutnom egzacerbacijom kroničnog bronhitisa. Klinička djelotvornost je ocijenjena kao poboljšanje, izlječenje ili neuspjeh liječenja trodnevnom terapijom azitromicinom. Procjena se osnivala na izračunu kliničkog indeksa za svaku dijagnozu prije početka terapije te nakon 4, 10 i 28 dana. Uovom ispitivanju klinička djelotvornost azitromicina bila je 93,6% u skupini bolesnika s pneumonijom iz opće populacije te 94,9% u bolesnika s akutnom egzacerbacijom kroničnog bronhitisa. Azitromicin je doveo do olakšanja simptoma unutar 3 dana kod 88,6% bolesnika s pneumonijom i 77,2% bolesnika s akutnom egzacerbacijom kroničnog bronhitisa. Zabilježeno je 15 neželjenih događaja kod 14 (9,1%) bolesnika. Najčešći neželjeni događaji su bili dijareja i povraćanje, od kojih je svaki zabilježen u 4 (2,6%) bolesnika. Rezultati ispitivanja pokazuju da azitromicin ima visoku djelotvornost u liječenju infekcija donjih dišnih putova i izaziva mali broj nuspojava. ISRCTN38391551