ABSTRACT
The efficay and safety of short course ceftibuten (400 mg od for 5 days; n = 163) were compared with that of amoxycillin/clavulanate (AMX/CA) (250/125 mg tds for 10 days; n = 172) in a multicentre, single-blind, parallel-group trial in 335 adults with acute exacerbations of chronic bronchitis (AECB). Clinical response was equivalent, with cure or improvement in 134/145 (92.4%) ceftibuten-treated patients and 139/150 (92.7%) AMX/CA-treated patients (95% CI: -7.00%, +6.50%). The overall eradication rates were similar (ceftibuten 88.3%; AMX/CA 87.5%) and also the incidence of adverse events which occurred in 24/163 (14.7%) ceftibuten-treated and 27/172 (15.5%) AMX/CA-treated patients. Ceftibuten 400 mg od for 5 days is as effective and well tolerated as AMX/CA 250 mg tds for 10 days in the treatment of AECB.
Subject(s)
Amoxicillin/therapeutic use , Bronchitis/drug therapy , Cephalosporins/therapeutic use , Clavulanic Acid/therapeutic use , Drug Therapy, Combination/therapeutic use , Acute Disease , Adult , Amoxicillin/adverse effects , Bronchitis/physiopathology , Ceftibuten , Cephalosporins/adverse effects , Chronic Disease , Clavulanic Acid/adverse effects , Confidence Intervals , Double-Blind Method , Drug Therapy, Combination/adverse effects , Female , Humans , Male , Treatment OutcomeABSTRACT
The manufacture of Therapeutic BCG can and should be a controlled process, to ensure adequate treatment doses are received by CIS patients. Standardization of production methods and CFU potency testing methods are essential to ensure continued successful treatment of CIS. Stability data can be used to validate assumptions about Therapeutic BCG potency used in clinical trials. Accelerated heat degradation studies of Therapeutic BCG should not be used for predictions of shelf life, but can be used for comparative purposes.
