Abstract
To evaluate the appropriate dosage regimen for SY 5555, a new oral penem, in the treatment of bacterial pneumonia, a dose-finding comparative study, using cefotiam hexetil (CTM-HE) as the control drug, was conducted in various clinical institutes. Patients were given a daily dose of 600mg (L-group) of SY 5555, 900 mg of SY 5555 (H-group) or 600 mg of CTM-HE (C-group) for a period of 14 days. All dosages were divided into three administrations per day. 1. The clinical efficacy rates were 88.9%(24/27) in the L-group, 82.6%(19/23) in the H-group and 78.3%(18/23) in the C-group. There were no significant differences between the 3 groups. 2. Bacteriologically, the eradication rates were 57.1%(4/7) in the L-group, 81.8%(9/11) in the H-group and 75.0%(6/8) in the C-group. 3. As side effects, gastro-intestinal symptoms were mainly observed in 6 of 32 patients in the L-group and 2 of 29 patients in the H-group. No adverse reaction was observed in the C-group. 4. The incidence of abnormal changes in laboratory findings were 13.8%(4/29) in the L-group, 21.4%(6/28) in the H-group and 14.8%(4/27) in the C-group. 5. The total usefulness rates were 75.9%(22/29) in the L-group, 82.6%(19/23) in the H-group and 78.3%(18/23) in the C-group. There were no significant differences between the 3 groups. From the above findings, especially, the results of bacteriological effect and usefulness, we concluded that a daily dose of 300 mg t.i.d. was the suitable clinical dosage regimen for SY 5555 in the treatment of bacterial pneumonia.
| Original language | English |
|---|---|
| Pages (from-to) | 53-69 |
| Number of pages | 17 |
| Journal | Chemotherapy |
| Volume | 42 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - 1994 |
ASJC Scopus subject areas
- Pharmacology (medical)
- Infectious Diseases
- Pharmacology
- Drug Discovery
- Oncology