Clinical evaluation of pazufloxacin mesilate for chronic respiratory tract infections. Phase III comparative study of pazufloxacin mesilate versus ceftazidime.
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Accession number;00A0674203
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| Title;Clinical evaluation of pazufloxacin mesilate for chronic respiratory tract infections. Phase III comparative study of pazufloxacin mesilate versus ceftazidime. |
| Author;
SHIMADA KAORU
(Tokyo Senbai Hosp.)
ABE SHOSAKU
(Sapporo Med. Coll.)
SHIRATO KUNIO
(Tohoku Univ., Sch. of Med.)
WATANABE AKIRA
(Res. Inst. Tuberculosis and Cancer, Tohoku Univ.)
KOBAYASHI HIROYUKI
(Kyorin Univ., Fac. of Med.)
HOSOYA TATSUO
(Jikei Univ. School of Medicine)
SEKINE OSAMU
(Suibarago Byoin)
OIZUMI KOTARO
(Kurume Univ., Fac. 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.6;PAGE.464-494(2000)
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| Figure&Table&Reference;FIG.1, TBL.26, REF.17 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;The clinical efficacy, safety and usefulness of pazufloxacin mesilate, a new quinolone for injection, were evaluated in chronic respiratory tract infections in a comparative study versus ceftazidime(CAZ). As a rule, patients received either 500mg (as pazufloxacin) of pazufloxacin mesilate b.i.d. or 1,000mg (potency) of CAZ b.i.d., intravenously, for 14 days (28 vials). The following results were obtained in this trial. 1. A total of 203 patients were evaluated in this study, and 155 of them, were evaluated for clinical efficacy. Cases evaluated for adverse effects, abnormal laboratory findings, overall safety and usefulness numbered 185, 172, 177 and 153, respectively. 2. The clinical efficacy rate were 93.2% (68/73) in the pazufloxacin mesilate group and 91.5% (75/82) in the CAZ group. Both groups showed high efficacy. Since the 90% confidence interval of the efficacy rate difference between the two groups was -6.6-10.0%, clinical equivalency (non-inferiority) of the pazufloxacin mesilate group to the CAZ group was demonstrated at .DELTA.=10%. 3. Among the cases evaluated for clinical efficacy, the 84 cases in which causative organisms were isolated, were evaluated for bacteriological effects. The bacteriological eradication rate was 65.0% (26/40) in the pazufloxacin mesilate group and 90.2% (37/41) in the CAZ group, and the difference between the groups was statistically significant (p=0.014, x'2' test). 4. The incidence of side effects was 6.8% (6/88) in the pazufloxacin mesilate and 11.3% (11/97) in the CAZ group, and the difference between the groups was not siginificant. The incidence of abnormal laboratory findings was 14.3% (12/84) in the pazufloxacin mesilate group and 27.3% (24/88) in the CAZ group, and the difference was statistical significant (p=0.041, Fisher's exact probability method).... (author abst.) |
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