Hisao Takayasu Department of Urology, Faculty of Medicine, University of Tokyo Masaaki Ohkoshi Department of Urology, Tokai University School of Medic
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1 COMPARATIVE CLINICAL EFFECT OF AMIKACIN AND GENTAMICIN ON COMPLICATED URINARY TRACT INFECTIONS BY DOUBLE-BLIND METHOD Tsuneo Nishiura and Yukimichi Kawada Department of Urology, Gifu University School of Medicine Tokuji Ichikawa Director, National Medical Center Hospital Iwao Nakano Department of Urology, National Medical Center Hospital Ichiro Tsuji Department of Urology, Hokkaido University School of Medicine Yoshiaki Kumamoto Department of Urology, Sapporo Medical College Sentaro Shishido Department of Urology, Tohoku University School of Medicine (Present Institute, Sendai Social Insurance Hospital)
2 Hisao Takayasu Department of Urology, Faculty of Medicine, University of Tokyo Masaaki Ohkoshi Department of Urology, Tokai University School of Medicine Hiroshi Kawai Department of Urology, Nippon Medical School Shudo Takai Department of Urology, Yokohama City University School of Medicine Yorio Naide Department of Urology, Fujita Gakuen University School of Medicine Kazuo Kurokawa Department of Urology, School of Medicine, Tokushima University Tadao Niijima Department of Urology, Okayama University Medical School Shunro Momose Department of Urology, Faculty of Medicine, Kyushu University Akira Sakuma Department of Clinical Pharmacology, Medical Research Institute, Tokyo Medical and Dental University Yoshiro Terawaki Department of Bacteriology, Shinshu University, School of Medicine In order to evaluate objectively clinical efficacy and appearance of adverse reactions of amikacin (AMK), a double-blind controlled trial was carried out in patients with complicated urinary tract infections in comparison with gentamicin (GM). The results obtained are follows: 1) Of 212 patients given AMK and GM, 24 were excluded due to inadequacy for entry criteria, and 14 were due to discontinuation of therapy and other incompliances. The remaining 174 patients were completely eligible for evaluation, each of the 87 patients being treated by AMK or GM. 2) No significant differences were noted between the two treated groups, so far as the background factors and baseline data of the patients are concerned. The two drug groups are considered to be similar and comparable. 3) Clinical evaluation was made after five day administration of 400mg/day of AMK and 80mg/day of GM in two divided intramuscular doses. The overall favorable response rate was 58.6% for AMK treated group and 54.0% for GM treated group, and no significant difference at 5% level was observed. The effect on pyuria and bacteriuria, bacteriological response and improvement in subjective symptoms were also comparable each other. 4) No significant differences were noted between the two treated groups in the stratified analyses. It was, however, noteworthy to see relatively higher cure rate by AMK in such patients generally supposed to be refractory as with the indwelling catheter, mixed infection, and post-prostatectomy infection. Also, AMK is characterized by being effective on the urinary tract infections induced by GM-resistant organisms. 5) Adverse reactions were assessed in 106 patients of each of two treated groups. Frequency of subjective adverese reactions and that of abnormal values in laboratory examination were 1. 9% for the two treated groups. however, when AMK is to be given to aged patients or patients with impaired kidney function, careful observation is mandatory as with other aminoglycoside antibiotics. 6) As to the utility assessed by the attending physcians no significant difference was noted between the two drug groups. 7) On the basis of the results AMK is considered to be an agent widely indicated for the treatment of complicated urinary tract infections, whatever the types of infections, morbid conditions and pathogens might be.
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8 to= (=143)(P=0. 615)A = C= B:D to= (P=143)(P=0. 482) B= D= AD to= (=143)(P<0. 001; A= D= A+C:B+D to= (4=288)(P<0. G01) A+C= B+D= to= (=143)(P=0. 321) A= C= B:D t0= (5=143)(P=0. 950)B = D= A:D to= (=143)(P<0. 00D A= D = A+C : B+D to= (=288)(P<0. 001) A+C= B+D=4. 779
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17 1) Kawaguchi, H., Naito, T., Nakagawa, S. and Fujisawa, K.: J. Antibiotics, 25, 695, 1972.
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