細菌性肺炎に対するritipenem acoxilの用量比較試験成績

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  • Dose-finding comparative study of ritipenem acoxil in bacterial pneumonia by the double-blind method

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To evaluate the clinically optimal dose of ritipenem acoxil (RIPM-AC), a new oral penem antibiotic, in respiratory tract infections, a dose-finding comparative study was conducted by the double-lind method in patients with bacterial pneumonia using cefotiam hexetil (CTM-HE) as a control drug. Patients were given 200 mg t. i. d. of RIPM-AC (L-group), 300 mg t. i. d. of RIPM-AC (H-group) or 200 mg t. i. d. of CTM-E (C-group). In principle, these drugs were administered for 14 days.<BR>The total number of patients enrolled in this trial was 118, of which 99 cases (L-group: 33, H-group: 31, C-group: 35) were evaluable for clinical efficacy. There were no significant differences in the distribution of background factors.<BR>1) The clinical efficacy rates were 87.9%(29/33) in the L-group and 80.6%(25/31) in the H-group. There was no significant difference between the two groups. The clinical efficacy rate in the C-group was 91.4%(32/35).<BR>2) The bacterial eradication rates (Eradicated+Replaced) were 70.0%(7/10) in the L-group and 72.7%(8/11) in the H-group. There was no significant difference between the two groups. The eradication rate in the C-group was 75.0%(9/12).<BR>3) There were no cases of side effects in the L-group, but there were 2 cases (5.6%) in the H-group. Abnormal laboratory test findings were observed in 8 cases (21.6%) in the L-group and 11 cases (32.4%) in the H-group. There were no significant differences between the two groups in the incidence of side effects and abnormal laboratory test findings. The safety rates were 78.4%(29/37) in the L-group and 63.9%(23/36) in the H-group, with no significant difference. In the C-group, there were no patients with side effects. Abnormal laboratory test findings were observed in 10 cases (26.3%), and the safety rate was 74.4%(29/39).<BR>4) The usefulness rates were 87.9%(29/33) in the L-group and 78.1%(25/32) in the H-group. There was no significant difference between the two groups. The usefulness rate in the C-group was 91.4%(32/35).<BR>From the above findings, we concluded that a daily dose of 200 mg t. i. d. was the clinically optimal dose for RIPM-AC in the treatment of bacterial pneumonia.

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