Vol.59 No.3 May 2011
An investigation of the efficacy and safety of doripenem for the treatment of severe intraabdominal infection
1)Department of Surgery, Toho University Medical Center Ohashi Hospital, 2-17-6 Ohashi, Meguro-ku, Tokyo, Japan
2)Department of Surgery, Nippon Medical School Chiba Hokusoh Hospital
(Present: Nippon Medical School Hospital)
3)Hino Municipal Hospital
4)Department of Infection Control and Prevention, Hyogo College of Medicine
5)Department of Digestive Surgery, Nihon University Itabashi Hospital
(Present: Tanaka Hospital)
6)Department of Surgery, The Jikei University School of Medicine Aoto Hospital
(Present: Tokyo Kousei Hospital)
Abstract
Doripenem(DRPM, Finibax 0.25 g IV Solution, Finibax 0.25 g IV Kit) is an injectable carbapenem antibiotic for which manufacturing and marketing approval was obtained in July 2005. In accordance with the provisions of Good Post-Marketing Study Practice(GPSP), we conducted the present study between April 2006 and March 2008 to elucidate the efficacy and safety of DRPM administered at 0.5 g 3 times/day for treatment of severe gastrointestinal perforative peritonitis or intraabdominal abscess (severity graded according to the SIRS criteria). One hundred-nineteen patients were enrolled from 33 medical centers, with 118 patients evaluated for safety, 89 evaluated for efficacy, and 15 evaluated for bacteriological efficacy.
The efficacy rate for DRPM among 89 cases of gastrointestinal perforative peritonitis (53 cases) and intraabdominal abscess (36 cases) was 77.5% (69/89). The incidence of adverse drug reactions (including abnormal changes in laboratory values) was 18.6%. Adverse drug reactions concerned with the hepatic function test values were most common. Serious adverse drug reactions noted were pseudomembranous colitis reported in 1 patient; increased AST and increased ALT in 2 patients each; and increased γ-GTP, increased blood bilirubin, increased platelet count and decreased platelet count in 1 patient each. The case of pseudomembranous colitis recovered following treatment with vancomycin hydrochloride(VCM). These results provided evidence for the usefulness of DRPM for severe intraabdominal infection.
Key word
doripenem, intraabdominal infection, gastrointestinal perforative peritonitis, intraabdominal abscess, systemic inflammatory response syndrome (SIRS)
Received
December 20, 2010
Accepted
March 10, 2011
Jpn. J. Chemother. 59 (3): 293-301, 2011
