内科領域におけるdoripenemの有効性および安全性

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  • A study of doripenem efficacy and safety in internal medicine

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We conducted a late phase II study of doripenem (DRPM), a new carbapenem antibiotic for injection, in internal medicine.<BR>1. Clinical efficacy<BR>DRPM was administered at a dose of 250mg b.i.d., 250mg t.i.d., or 500mg b.i.d. for 3 to 14 days in patients with chronic respiratory tract infection, pneumonia, pulmonary suppuration, pyothorax, peritonsillar abscess, and cholecystitis. Overall efficacy was 87.6%(92/105). By disease, efficacy for patients with secondary infections associated with chronic respiratory disease was 93.1%(27/29) and for those with pneumonia, etc., 84.9%(62/73). A clinical efficacy evaluation of “effective” or “highly effective” was obtained in two patients with acute upper respiratory tract infection and in one with biliary tract infection.<BR>2. Bacteriological effect<BR>Bacterial eradication was observed in all 36 patients in whom changes in bacterial count from the baseline were investigated. Bacterial eradication was 100.0%.<BR>3. Safety<BR>Nonlaboratory adverse drug reactions occurred in two of 108 patients (1.9%) and laboratory adverse drug reactions in 32 of 106 patients (30.2%).<BR>These results suggest that DRPM at a dose of 250mg b.i.d., 250mg t.i.d., or 500mg b.i.d. has sufficient therapeutic effect on patients with infection in internal medicine.

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