Comparative study on biapenem and imipenem/cilastatin in complicated urinary tract infections.
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Accession number;00A0360412
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| Title;Comparative study on biapenem and imipenem/cilastatin in complicated urinary tract infections. |
| Author;
KAWADA YUKIMICHI
(Gifu Univ., Sch. of Med.)
TSUKAMOTO TAIJI
(Sapporo Med. Coll., Sch. of Med.)
KAWABE KAZUKI
(Univ. of Tokyo, Fac. of Med.)
KISHI HIROICHI
(International Medical Center of Japan)
OISHI YUKIHIKO
(Jikei Univ. School of Medicine)
KAWAMURA NOBUO
(Tokai Univ., Sch. of Med.)
NAIDE YORIO
(Fujita Health Univ., Sch. of Med.)
KAMIDONO SADAO
(Kobe Univ., Sch. of Med.)
NAKASHIMA MITSUYOSHI
(Hamamatsu Univ. Sch. of Med.)
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Journal Title;Japanese Journal of Chemotherapy
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Journal Code:F0608A
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ISSN:1340-7007
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VOL.48;NO.3;PAGE.218-232(2000)
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| Figure&Table&Reference;TBL.15, REF.12 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;To objectively evaluate the clinical value of biapenem (BIPM), a new parenteral carbapenem, in the treatment of complicated urinary tract infections, we performed a prospective, randomized, double-blind comparative study using imipenem/cilastatin (IPM/CS) as a control drug. Patients were randomly assigned to receive either 300 mg b.i.d. of BIPM or 500 mg/500 mg b.i.d. of IPM/CS for 5 days by intravenous drip infusion. All patients were shown to have pyuria of at least 5 WBCs/HPF, bacteriuria of at least 10'4'CFU/mL and an identifiable underlying urinary tract disease. Overall clinical efficacy was evaluated on the basis of criteria proposed by the Japanese UTI Committee as "excellent", "moderate" or "poor". Of the 151 patients evaluated for clinical efficacy, 75 patients received BIPM and 76 received IPM/CS. No significant differences were observed in the background characteristics of the patients between the two treatment groups except that the age distribution was higher in the IPM/CS group than in the BIPM group (p<0.15). Excellent and moderate responses were obtained in 94.7% of the 75 patients in the BIPM group and in 93.4% of the 76 patients in the IPM/CS group. The 90% confidence interval of the difference between the 2 groups was between -6.4 and 8.9%, and the clinical comparability of BIPM to IPM/CS was verified. The overall bacteriological eradication rate was 95.0% of 121 strains in the BIPM group and 94.4% of 124 strains in the IPM/CS group, with no statistically significant difference. Clinical adverse reactions were experienced in 2.2% of the 92 patients in the BIPM group and in 4.4% of the 90 patients in the IPM/CS group. Laboratory adverse reactions were observed in 14.8% of the 88 patients in the BIPM group and in 15.7% of the 89 patients in the IPM/CS group. No statistically significant differences in the incidences of both clinical and laboratory adverse reactions were noted. (author abst.) |
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