부산대학교 도서관

The efficacy and safety of tobramycin (TOB) administration at 90mg twice a day (90mg group) to patients with respiratory tract infections (RTI) were objectively investigated by means of a well-controlled comparative study.The results in this 90mg group were compared with the case of administering 3 times a day of 60mg each (60mg group) as the control.In both of these patient groups, TOB was administered by intramuscular injection for 10 consecutive days.This study included 85 patients (90mg group: 43 patients;60mg group: 42 patients).The Committee, however, excluded 19 patients consisting of 13 cases of infection other than RTI and 6 cases of out of protocol drug administration.Thus, 66 patients (90mg group: 32 patients; 60mg group: 34 patients) were used for the efficacy analysis.All 85 patients were used, however, for the evaluation of the safety of TOB and for the usefulness of TOB as judged by the physicians in charge.A brief summary of the results is presented below.1.The cases employed by the Committee consisted of 8 and 17 cases in the 90 mg and 60mg groups, respectively, with bacterial pneumonia and lung abscess, and 24 and 17 cases in the 90mg and 60mg groups, respectively, with chronic RTI.There was a tendency for the distribution of disease cases in the 2 drug groups to be significant.Within the chronic RTI disease classification, the number of patients with chronic bronchitis was almost equal in the 2 drug groups;16 cases in the 90mg group and 15 cases in the 60 mg group.However, secondary infections were diagnosed in 8 cases in the 90mg group and 2 cases in the 60mg group.2. The clinical efficacy judged for all cases investigated by the Committee showed efficacy ratios of 56.3% for the 90mg group and 70.6% for the 60mg group. The difference between the 2 drug groups was not statistically significant.In the treatment of bacterial pneumonia and lung abscess, the efficacy rate in the 90mg group was 87.5%, while it was 88.2% in the 60 mg group;these high values were practically identical. Against chronic RTI, the efficacy rates were 45.8% in the 90mg group and 52.9% in the 60 mg group;within that disease classification, the efficacy rates against the chronic bronchitis cases were nearly the same at 43.8% and 46.7%, respectively. These data showed no statistically significant differences between the 2 drug administration groups.3. The investigation of the bacteriological efficacy revealed no statistically significant differences between the 2 drug administration groups.4. With regard to the safety of these drug administration regimens, there were no cases of side effects in either of the drug groups. In addition, there were only 2 patients found to develop abnormal variations in the laboratory test values, both in the 60mg group;1 patient with RBCs in the urine, and 1 patient with elevated GOT and GPT values. There was again no statistically significant difference observed between the 2 administration groups.5. Concerning the usefulness of the drug regimens as judged by the Committee, an evaluation of quite useful or useful was given to 56.3% of the cases in the 90mg group and 70.6% of the cases in the 60mg group. This difference between the 2 administration groups was not statistically significant. In addition, the results for the usefulness as judged by the physicians in charge for all of the patients showed a pattern similar to that obtained by the Committee, with no statistically significant difference between them.Based on the above results, the 90mg and 60mg TOB administration regimens were concluded to be equivalent in terms of their efficacy and safety.