A DOUBLE-BLIND COMPARATIVE STUDY ON S 6472 (A LONG ACTING CEFACLOR) VERSUS CONVENTIONAL CEFACLOR PREPARATION IN COMPLICATED URINARY TRACT INFECTIONS
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- ARAKAWA SOICHI
- Department of Urology, School of Medicine, Kobe University
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- TAKAGI SHINSUKE
- Department of Urology, School of Medicine, Kobe University
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- MATSUMOTO OSAMU
- Department of Urology, School of Medicine, Kobe University
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- KAMIDONO SADAO
- Department of Urology, School of Medicine, Kobe University
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- HIROOKA KUHEI
- Department of Urology, Kansai Rosai Hospital
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- HAMAMI GAKU
- Department of Urology, Hyogo Prefectural Amagasaki Hospital
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- MATSUMOTO HIROTO
- Department of Urology, Kobe Rosai Hospital
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- SAITO HIROSHI
- Department of Urology, Kobe Rosai Hospital
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- UMEZU KEIICHI
- Department of Urology, Kobe National Hospital
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- ISHIGAMI JOJI
- Department of Urology, Kobe National Hospital
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- FUJISAWA MASATO
- Department of Urology, Shinko Hospital
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- YAMANAKA NOZOMU
- Department of Urology, Shinko Hospital
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- SUGIMOTO MASAYUKI
- Department of Urology, Kobe Ekisaikai Hospital
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- OKAMOTO YASUYUKI
- Department of Urology, Shakaihoken Kobe Central Hospital
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- ITO NOBORU
- Department of Urology, Shakaihoken Kobe Central Hospital
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- OMAE HIROSHI
- Hara Urological Hospital
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- HARA SHINJI
- Hara Urological Hospital
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- OBE TORU
- Department of Urology, Akashi Municipal Hospital
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- MATSUSHITA MASAMI
- Department of Urology, Nishiwaki City Hospital
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- INABA YOKO
- Department of Urology, Nishiwaki City Hospital
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- KATAOKA NOBUO
- Department of Urology, Nishiwaki City Hospital
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- OGAWA TAKAYOSHI
- Department of Urology, Hyogo Prefectural Kaibara Hospital
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- OSHIMA HIDEO
- Department of Urology, Hyogo Prefectural Kakogawa Hospital
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- FUJII AKIRA
- Department of Urology, Himeji Red Cross Hospital
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- TOMIOKA OSAMU
- Department of Urology, Himeji Red Cross Hospital
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- OKADA YASUNAGA
- Department of Urology, Ako City Hospital
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- ITANI ATSUSHI
- Department of Urology, Hyogo Prefectural Awaji Hospital
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- KAWABATA GAKU
- Department of Urology, Fujiwara Hospital
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- MITA TOSHIHIKO
- Mita & Terasoma Urological Clinic
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- SHIBAHARA NOBUHISA
- Department of Urology, Osaka Medical College
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- HAMADA KATSUO
- Department of Urology, Osaka Medical College
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- MIYAZAKI SHIGERU
- Department of Urology, Osaka Medical College
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- FUKUHARA MASAYUKI
- Department of Urology, Otsu Red Cross Hospital
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- NODA HARUO
- Department of Urology, Otsu Red Cross Hospital
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- AZUMA HARUTO
- Department of Urology, Osaka Prefectural Saiseikai Nakatsu Hospital
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- SOWA NOBUMASA
- Department of Urology, Osaka Prefectural Saiseikai Nakatsu Hospital
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- KIRIME SHIGERU
- Department of Urology, Osaka Prefectural Saiseikai Nakatsu Hospital
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- HIRAI KEI
- Department of Urology, Hirakata City Hospital
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- OKANO HITOSHI
- Department of Urology, Hirakata City Hospital
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- YASUDA HIDEAKI
- Department of Urology, Sanko Hospital
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- ONO SHUTA
- Department of Urology, Sanko Hospital
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- HASEGAWA FUMIAKI
- Department of Urology, Takatsuki Red Cross Hospital
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- KOTANI TAMON
- Department of Urology, Saiseikai Ibaragi Hospital
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- DEMURA AKIRA
- Department of Urology, Hokusetsu Hospital
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- KANEDA KUNIHIRO
- Department of Urology, Ikoma General Hospital
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- FURUSAWA TARO
- Department of Urology, Kyoto Second Red Cross Hospital
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- KATAOKA NOBUMASA
- Department of Microbiology, School of Allied Medical Science, Kobe University
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- NAKASHIMA MITSUYOSHI
- Department of Pharmacology, School of Medicine, Hamamatsu University
Bibliographic Information
- Other Title
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- 雑性尿路感染症に対するS6472 (Cefaclor持続性製剤) とCefaclor通常製剤の二重盲検比較試験
Abstract
For an objective evaluation of the clinical efficacy, safety and usefulness of S 6472 (a long acting cefaclor) in non-catheterized patients with complicated urinary tract infections, a double-blind comparative study was performed using conventional cefaclor preparation (hereafter, CCL) as the control drug.<BR>S 6472 was administered orally at a single dose of 750 mg twice daily, and CCL at a single dose of 500 mg 3 time daily. The duration of the treatment was 5 days for either drug. Clinical efficacies were evaluated according to the criteria for evaluation of drug efficacy by the Japanese UTI Committee (3rd edition), and the following results were obtained.<BR>1. The initial distribution of the patients' background characteristics was not significantly different between the S 6472 and CCL groups.<BR>2. The overall clinical efficacy rates were 76.2% in the S 6472 group and 75.5% in the CCL group, indicating no significant difference between the 2 groups. When clinical efficacies evaluated according to different types of infections (UTI groups), the differences between the 2 drug groups were not significant in any of desease groups 2, 3, 4, and 6.<BR>3. Clinical efficacy rates as evaluated by attending physicians were not significantly different between the 2 groups, either.<BR>4. Bacteriological responses were evaluated as eradicated in 81.2% in the S 6472 group and 78.3% in the CCL group, suggesting no statistically significant difference.<BR>5. The incidences of side effects were 2.9% (4/139) in the S 6472 group and 0.7% (1/141) in the CCL group, thus no significant differences existed between the 2 groups. On laboratory examination, 4 and 5 abnormal test values, respectively, were detected in 3/94 patients in the S 6472 group and 5/100 patients in the CCL group, but the difference wes not significant between the 2 groups, either. All of these side effect symptoms and abnormal laboratory test values were mild in severity and transient. The results of the overall safety rating which was based on the evaluations of the side effects and laboratory test values indicated no significant difference between the 2 groups.<BR>6. According to judgement by the attending doctors, the clinical usefulness rates evaluated based on the results of the efficacy and safety ratings were not significantly different between the S 6472 and CCL groups. These findings suggest that S 6472 produces excellent therapeutic results in complicated noncatheter-indwelt UTI patients and its clinical efficacy, safety, and usefulness are equal to those of the conventional CCL.<BR>Taking into account the advantage of twice-daily dosing for S 6472 instead of 3 times dosing, S 6472 is considered to be a highly useful antibiotics for complicated UTIs.
Journal
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- The Japanese Journal of Antibiotics
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The Japanese Journal of Antibiotics 43 (11), 1873-1892, 1990
Japan Antibiotics Research Association