The clinical effectiveness, safety and usefulness of HAPA-B, a new aminoglycoside, in the treatment of respiratory tract infections were compared with those of amikacin (AMK) ina double blind study.
The following diseases were included in this study; bacterial pneumonia, pulmonary suppression, infectious exacerbation of chronic bronchitis and diffuse panbronchiolitis and chronic respiratory tract diseases with infection (bronchiectasis, pulmonary emphysema, lung fibrosis, bronchial asthma).
HAPA-B and AMK were intramusculary administered twice a day for 14 days, at a daily dose of 400 mg of both drugs (one ampoule containing 200 mg).
The following results were obtained.
1) Case distribution
Total cases administered HAPA-B or AMK were 218 patients. Out of these cases, 185 patients (HAPA-B 98, AMK 87) were evaluated on clinical effectiveness, 207 (HAPA-B 108, AMK 99) on side effects, 193 (HAPA-B 102, AMK 91) on laboratory findings, 182 (HAPA-B 96, AMK 86) on usefulness.
2) Clinical effectiveness
Out of 98 patients in HAPA-B group, one patient was judged as “Excellent”, 65 as “Good”, 9 as “Fair”, 23 as “Poor” and the efficacy rate was 67.3%. On the other hand, out of 87patients in AMK group, one patient was judged as “Excellent”, 56 as “Good”, 10 as “Fair”, 20 as “Poor” and the efficacy rate was 65.5%. There was no significant difference between two groups.
However, the improvement rates of HAPA-B group in cough, dyspnea and volume of sputum were significantly superior to those of AMK at 3rd or 7th day after administration.
3) Bacteriological effect
Bacteriologically, the eradication rate of 60.6% was observed out of 66 clinical isolates in HAPA-B group and it was 59.5% in 42 clinical isolates in AMK group. There was no significant difference between two groups.
4) Side effects and abnormal changes in laboratory findings
Side effects were observed in 3 of 108 patients (2.8%) with HAPA-B and 6 of 99 patients (6.1%) with AMK. Allergic symptoms were observed in both groups but pain at the injection site and dizziness were observed only in AMK group. Abnormal changes in laboratory findings were observed in 20 of 102 patients (19.6%) with HAPA-B and 27 of 91 patients (29.7%) with AMK after administration. Elevations of BUN and s-creatinine were observed only in AMK group, while eosinophilia and elevation of transaminases were observed in both groups. There was no significant difference between two groups.
5) Usefulness
The usefulness of HAPA-B group was 65.6% and that of AMK was 62.8% judged by committee members. The usefulness judged by doctors in charge of HAPA-B group was 65.2% and that of AMK was 54.8%.
There was no significant difference between two groups.
6) From the above results, it was concluded that clinical effectiveness of HAPA-B was at least equal to that of AMK in the treatment of respiratory tract infections and because of no adverse reaction to renal and auditory functions, HAPA-B was considered to be a useful aminoglycoside.
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