Double-blind dose range study on cefdinir in

Kohei Hara, Masaki Hirota, Shigeru Kohno, Yasumasa Doutsu, Kazuo Sasayama, Akira Yasuoka, Hiroshi Yamada, Shigefumi Maesaki, Yasukazu Kiya, Hiroshi Tomita, Kiyoshi Konno, Kotaro Oizumi, Akira Watanabe, Seichi Aonuma, Kohsaku Nagai, Yushi Nakai, Jun ichi Saito, Izumi Hayashi, Tadashi Miyahara, Jingoro ShimadaKohya Shiba, Atsushi Saito, Kaoru Shimada, Kazufuto Fukaya, Yasuyuki Sano, Yasufumi Miyamoto, Hiroyuki Kobayashi, Tatsuo Kato, Fumio Matsumoto, Iwao Sakurai, Toshio Hojo, Osamu Sekine, Nobuki Aoki, Toshihiko Takeuchi, Masahito Kato, Yoshimitsu Hayashi, Hidekazu Hanaki, Sakae Kan, Fumio Miki, Rinzo Soejima, Yoshihito Niki, Jiro Okimoto, Jiro Hino, Kuninori Tsukiyama, Toshiharu Matsushima, Masayoshi Kawanishi, Akira Sakuma, Keizo Yamaguchi, Kazuyuki Sugahara, Jun ichi Matsuda, Chikako Mochida, Chieko Hayashi, Yuji Migita

Research output: Contribution to journalArticlepeer-review

4 Citations (Scopus)

Abstract

We compared the efficacy and safety of cefdinir (CFDN), a new oral cephem, in bacterial pneumonia at two doses by the double-blind comparative method to determine the optimal dosage for respiratory tract infections. Patients with mild or moderate bacterial pneumonia were aged 15 to 70 years, of both sexes, and patients with either pulmonary tuberculosis or chronic airway infection were excluded. Patients given test drug in doses of 100 mg t.i.d. (L-group) or 200 mg t.i.d. (H-group) for 14 days as a rule were evaluated for clinical and bacteriological effects, safety and usefulness. Out of the 87 patients (42 at 100 mg t. i. d., 45 at 200 mg t. i. d.), 69 were evaluated for clinical efficacy and usefulness, 81 for safety and 75 for laboratory evaluation. A comparative evaluation of clinical efficacy and usefulness was performed mainly by the committee in patients with bacterial pneumonia and in all patients, including those with mycoplasmal pneumonia, primary atypical pneumonia, and psittacosis. The results were as follows. 1. There was no significant difference between the two groups in characteristics except the distribution of ESR values, which was higher in the H-group in the bacterial pneumonia group. 2. The overall clinical efficacy rate assessed by the committee in patients with bacterial pneumonia was 93.1% (27/29) in the L-group and 82.4% (28/34) in the H-group. There was no significant difference between the two groups. The clinical efficacy rate in all patients was 93.8% (30/32) in the L-group and 78.4% (29/37) in the H-group. There was a significant difference between the two groups. 3. The bacteriological eradication rate was 71.4% (5/7) in the L-group and 78.6% (11/14) in the H-group. There was no significant difference between the two groups. 4. The incidence of side effects was 2.6% (1/39) in the L-group and 4.8% (2/42) in the H-group. The incidence of abnormal laboratory findings was 22.9% (8/35) in the L-group and 22.5% (9/40) in the H-group. There was no significant difference between the two groups. Considering side effects and laboratory findings, the safety rate was 76.9% in the L-group and 76.2% in the H-group. There was no significant difference between the two groups. 5. In usefulness evaluation under consideration of clinical efficacy combined with safety evaluation, there was no significant difference between the two groups. As described above, there was no difference in safety evaluation between the two groups, and efficacy rate was high even in the L-group. From these results, it is concluded that CFDN 100 mg t. i. d. is very useful in the treatment of bacterial pneumonia.

Original languageEnglish
Pages (from-to)612-633
Number of pages22
JournalChemotherapy
Volume37
DOIs
Publication statusPublished - 1989
Externally publishedYes

Keywords

  • Cefdinir

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Infectious Diseases
  • Pharmacology
  • Drug Discovery
  • Oncology

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