呼吸器感染症に対するCefotaximeとCefazolinの薬効比較試験

抄録

The clinical efficacy and safety of CTX for respiratory infections were objectively studied with CEZ as the control. In principle, 2 g/day of CTX and 4 g/day of CEZ were intravenously dripinfused for 14 days.
1. The rates of effectiveness for all the cases were 69.9% for CTX and 64.5% for CEZ, those for pneumonia were 70.1 % for CTX and 69.9% for CEZ, those for bacterial pneumonia were 75.9% for CTX and 75.4% for CEZ and those for the cases without pneumonia were 69.9% for CTX and 75.4 for CEZ. In the stratified analysis, the rates of effectiveness of CTX were significantly higher than those of CEZ in the cases having no underlying diseases or complications, in all the severe cases and in the cases with pneumonia.
2. The rates of effectiveness evaluated by the investigators were 78.8% for CTX and 72.8% for CEZ when all the cases were considered, 82.2% for CTX and 76.0% for CEZ in pneumonia, 87.9% for CTX and 82.8% for CEZ in bacterial pneumonia and 73.2% for CTX and 66.0% for CEZ in the cases without pneumonia. CTX displayed significantly higher rates of effectiveness than CEZ in all the cases (U-test).
3. CTX had generally higher rates of improvement than CEZ in individual symptoms, clinical findings and laboratory test results. Significant improvements were observed in 6 cases for CTX and in 3 cases for CEZ.
4. As for bacteriological effects, CTX showed a disappearance rate of 50.0% in 2 strains of gram positive bacteria and that of 80.0% in 31 strains of gram-negative bacteria, while the corresponding rates for CEZ were 100% in 3 strains of gram-positive bacteria and 76.7% in gram-negative bacteria. Although replacement of bacteria by Pseudomonas was observed in 2 cases with CEZ, there were no such cases with CTX.
5. The incidence of side effects was 3.5% for CTX and 4.1% for CEZ. Abnormal laboratory results were observed at the rate of 24.9% for CTX and 23.6% for CEZ. Side effects were all mild, including eruption and an increase in the level of transaminase, and there were no significant differences between CTX and CEZ.
6. Compared with CEZ, CTX showed generally superior values in the evaluation of usefulness, but there were no, significant differences between the two.
It may be concluded from these results that 2 g/day of CTX produced effects on respiratory infections which were equal to or better than the effects of CEZ, and that CTX had significantly higher rates of effectiveness than CEZ, especially in severe cases. CTX was relatively free from side effects and is considered to be useful for respiratory infections, especially for severe cases.