A study of doripenem efficacy and safety in internal medicine

Accession number;05A0663322
Title;A study of doripenem efficacy and safety in internal medicine
Author; SAITO ATSUSHI (Ryukyudai Daigakuin'igakukenkyuka Kansenbyotaiseigyogaku Bunshibyotaikansenshogakubun'ya) SHIMADA JINGORO (St. Marianna Univ. School of Medicine, JPN) SHIBA KOYA (Tokyojikeikaiidai Naikagaku(kansenseigyobu)) INAMATSU TAKESHI (Tokyo Metropolitan Geriatric Medical Center, JPN)
Journal Title;Japanese Journal of Chemotherapy
Journal Code:F0608A
ISSN:1340-7007
VOL.53;NO.Supplement 1;PAGE.157-168(2005)
Figure&Table&Reference;TBL.15, REF.18
Pub. Country;Japan
Language;Japanese
Abstract;We conducted a late phase II study of doripenem (DRPM), a new earbapenem antibiotic for injection, in internal medicine. 1. Clinical efficacy: DRPM was administered at a dose of 250 mg b.i.d., 250 mg t.i.d., or 500 mg b.i.d. for 3 to 14 days in patients with chronic respiratory tract infection, pneumonia, pulmonary suppuration, pyothorax, peritonsillar abscess, and chotecystitis. 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. 2. Bacteriological effect: Bacterial eradication was observed in all 36 patients in whom changes in bacterial count from the baseline were investigated. Bacterial eradication was 100.0%. 3. Safety: Nonlaboratory adverse drug reactions occurred in two of 108 patients (1.9%) and laboratory adverse drug reactions in 32 of 106 patients (30.2%). These results suggest that DRPM at a dose of 250 mg b.i.d., 250 mg t.i.d., or 500 mg b.i.d. has sufficient therapeutic effect on patients with infection in internal medicine. (author abst.)