呼吸器感染症に対するT-1220 (Piperacillin) とAmpicillinの二重盲検法による薬効比較試験成績

抄録

The clinical effectiveness and safety of T-1220 (Piperacillin) and ABPC (Ampicillin) were compared in this randomized, double-blind multi-clinical study of 297 patients with respiratory tract infections. Patients were assigned to treatment with either 4g/day of T-1220 or 2g/day of ABPC by drip infusion for 7 to 14 days.
The results obtained were as follows :
1. Two hundreds and twenty-eight patients were selected for evaluation by committee members. Among these patients, 117 were treated with T-1220 and 111 were treated with ABPC.
Each number of patients administered either T-1220 or ABPC was 35 and 33 in bacterial pneumonia, 28 and 22 in mycoplasmal pneumonia, 16 and 10 in primary atypical pneumonia (PAP), and 38 and 46 in chronic respiratory tract infections, respectively.
2. On the other hand, two hundreds and fifty-eight patients were selected, excepting that was remarkably against the rule, the number of cases adopted as able as possible by doctors in charge. Among these patients, 127 were treated with T-1220 and 131 were treated with ABPC.
Each number of patients administered either T-1220 or ABPC was 65 and 50 in bacterial pneumonia, and 40 and 53 in chronic respiratory tract infections, respectively.
3. The overall clinical efficacy rate (excellent and good results) in all cases adopted by committee members was 65. 8% in T-1220 group and 58. 6% in ABPC group, respectively.
In the cases of bacterial pneumonia the efficacy rate was 77.2% in T-1220 group and 60.6% in ABPC group. The effectiveness in T-1220 group was significantly to that in ABPC group. In the cases of chronic respiratory tract infections the efficacy rate was 67.5% in T-1220 group and 47.2% in ABPC group.
4. The overall clinical efficacy rate in all cases adopted by doctors in charge was 71.7% in T-1220 group and 53.4% in ABPC group, respectively. The effectiveness in T-1220 group was significantly to that in ABPC group.
In the cases of bacterial pneumonia the efficacy rate was 81.5% in T-1220 group and 64.0% in ABPC group. In the cases of chronic respiratory tract infections the efficacy rate was 67.5% in T-1220 group and 47.2% in ABPC group. The effectiveness in T-1220 group was significantly to that in ABPC group for both diseases.
5. T-1220 showed an excellent effect for improvement of symptoms and findings of chest roentgenogram, cough and volume of sputum in bacterial pneumonia, and dyspnea, chest pain, rales and cyanosis in chronic respiratory tract infections. The results obtained in T-1220 group was significantly to that in ABPC group.
6. No significant difference was observed in the frequency of side effect between both groups. 7. From the results obtained in all the patients, the utility of T-1220 was considered to be significantly to that of ABPC. In particular, the utility of T-1220 against bacterial pneumonia and chronic respiratory tract infections was judged to be superior to that of ABPC.