P. Leophonte et al., CEFOTIAM HEXETIL VERSUS AMOXICILLIN-CLAVU LANIC ACID FOR TREATMENT OFACUTE EXACERBATION OF CHRONIC-BRONCHITIS, Medecine et maladies infectieuses, 27(2), 1997, pp. 111-116
The aim of this multicenter, prospective, randomised, double blind stu
dy was the compare the clinical efficacy and safety of cefotiam hexeti
l (CTM) 400 mg bid versus amoxicillin/clavulanic acid (AAC) 1 g bid, d
uring a 10 day treatment for acute exacerbation of chronic bronchitis,
157 adult patients were enrolled by pneumologists. Population for bot
h regimens was comparable at inclusion according to demographic clinic
al data, At the end of the treatment, 92 % of CTM and 88 % of ACC pati
ents were healed, in intent to treat analysis; respectively 96 % versu
s 94 % in per protocol analysis. The incidence of adverse events was s
ignificantly less frequent in the CTM group (9 % versus 21 %). This di
fference is statistically significant (p = 0.03). Cefotiam hexetil 400
mg bid seems to be a good alternative treatment for acute exacerbatio
n of chronic bronchitis, with comparable efficacy and better tolerance
than amoxicillin/clavulanic acid 1 g bid.