Author/Editor		Stračunski, L.S.
Title		Multicentrična primerjalna klinična raziskava macropena pri otrocih v Rusiji
Translated title		A multicenter comparative clinical trial on macropen in Children in Russia
Type		članek
Source		Krka Med Farm Supl
Vol. and No.		Letnik 16, št. 28
Publication year		1995
Volume		str. 34-40
Language		slo
Abstract		Macropen (midecamycin, midecamycin acetate) is one of the newer macrolide antibiotics. The first multicenter clinical trial conducted in Russia was a comparative trial investigating the clinical efficacy, tolerance and safety of Macropen and the traditional representative of the group of macrolide antibiotics erythromycin in the treatment of respiratory infections, infections of ears, nose and throat, and skin infections in children. out of 358 patients involved 355 concluded the trial. Both Macropen and erythromycin were shown very effective in the treatment of the above infections, producing a comparable clinical efficacy. Of the 179 Macropen-treated patients, cure or improvement were achieved in 173 (96,6%). Of the 176 erythromycin-treated patients, cure or improvement were achieved in 172 (97,7%). Tolerance was good. No frequently occurring or severe side effects were reported. The most commonly occurring side effects were gastrointestinal symptoms and abnormalities in biocheical parameters which, compared to Macropen, occurred with an approximately two times greater frequency in the group receiving erythromycin. Considering the state of the patient and the results of the evaluation of the clinical efficacy, safety, and tolerance of both agents, the final assessment demonstrated a statistically significant difference in favour of Macropen in patients with infections of ears, nose and throat (p=0,018) and in the overall final evaluation (p=0,013).
Descriptors		BACTERIAL INFECTIONS ANTIBIOTICS, MACROLIDE ERYTHROMYCIN CHILD MULTICENTER STUDIES RESPIRATORY TRACT INFECTIONS PYODERMA TREATMENT OUTCOME