Clinical evaluation of pazufloxacin mesilate for bacterial pneumonia. Phase III comparative study of pazufloxacin mesilate versus ceftazidime.
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Accession number;00A0674202
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| Title;Clinical evaluation of pazufloxacin mesilate for bacterial pneumonia. 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.)
TAKEDA HIROAKI
(Saiseikai Yamagata Saisei Hosp.)
KOBAYASHI HIROYUKI
(Kyorin Univ., Fac. of Med.)
MIKI FUMIO
(Kikkokai Tane Hosp.)
SOEJIMA RINZO
(Kawasaki Univ. Medical Welfare)
KONO SHIGERU
(Nagasaki 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.6;PAGE.433-463(2000)
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| Figure&Table&Reference;FIG.1, TBL.28, REF.20 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;The clinical efficacy, safety, and usefulness of pazufloxacin mesilate, a new quinolone for injection, were evaluated in bacterial pneumonia or lung abscess 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 232 patients were evaluated in this study, and 185 of them (bacterial pneumonia: 173 cases; lung abscess: 12 cases) were evaluated for clinical efficacy. The cases evaluated for adverse effects, abnormal laboratory findings, overall safety, and usefulness amounted to 225, 208, 210, and 182, respectively. 2. The clinical efficacy rate was 90.7% (78/86) in the pazufloxacin mesilate group and 89.9% (89/99) in the CAZ group. Both groups showed high efficacy. Since the 90% confidence interval of the efficacy rate difference between the two groups was -7.5-9.1%, the clinical equivalency (non-inferiority) of the pazufloxacin mesilate group to the CAZ group was demonstrated at .DELTA.=10%. Although significant bias was found between the two groups in the patient background factors concerning "sex", "concomiutant drugs", "body temperature", "ESR", "CRP", and "chest X-ray findings", clinical equivalency of the pazufloxacin mesilate group to the CAZ group was conclued after correction for these biases too. 3. Among the cases evaluated for clinical efficacy, 85 cases in which the causative organisms were isolated were evaluated for bacteriological effects. The bacteriological eradication rate was 81.1% (30/37) in the pazufloxacin mesilate group and 100% (48/48) in the CAZ group, and the difference between the two groups was statistically significant (p=0.002, Fisher's exact probability method).... (author abst.) |
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