Table 1-1. Criteria for evaluation Table 2. Criteria for bacteriological efficacy Table 1-2. Criteria for evaluation

Table 3. Reasons for exclusion and drop-out from evaluation (clinical efficacy) Table 4. Background characteristics of subjects

OCT. 1995 Table 5. Clinical efficacy Table 6. Clinical efficacy related to severity Table 7. Clinical efficacy related to daily dose of treatment

Pseudomonas aeruginosa Stapylococcus aureus coaglase-negative Stapylococci (CNS )100 % (22/22), Streptococcus pneumoniae S. aureus 80.5 % (66/82), CNS 100% (29/29), Corynebacterium epp. Table 8. Bacteriological efficacy classified by isolated organism : eradicated + replaced/no. of natients GPB: gram positive bacteria GNB: gram negative bacteria MRSA: methicillin resistant S. aureus CNS: coagulase negative staphylococci GNF-GNR: glucose-non-fermentative gram-negative rods

OCT. 1995 Table 9. Bacteriological response classified by isolated organism : eradicated/no. of patients GPB: gram-positive bacteria GNB: gram negative bacteria MRSA: methicillin resistant S. aureus CNS: coagulase negative staphylococci GNF-GNR: glucose non-fermentative gram-negative rods GPR: gram positive rods aeruginosa

Table 10. Susceptibility distribution of isolated organisms GPB: gram-positive bacteria GNB: gram-negative bacteria MRSA: methicillin-resistant S. aureus CNS: coagulase-negative staphylococci GNF GNR: glucose-non-fermentative gram-negative rods GPR: gram-positive rods Table 11. Side effects

OCT. 1995 S. pneurnoniae, H. influenzae, S. aureus, Moraxella catarrhalis H. influenzae aureus B. catarrhalis S. aureus P. aeruginosa, Proteus sp. Table 12. Abnormal laboratory findings Table 13. Safety Table 14. Utility

80.5%, 56.9 %, 37.5 Vi), cefcamate pivoxil; 78.6 %, 63.9 %, 53.8 %7), cefditoren pivoxil; 85.7 %, 50.0%, 75.0%, cefotiam hexetil ; 84.4%, 64.8%, 50.0%9), cefteram pivoxil; 68.2%, 58.3%, 56.7%0) Table 15. Susceptibility distribution of main isolated organisms CNS: coagulase negative staphylococci RIPM: ritipenem CCL : cefaclor CTM: cefotiam CPDX: cefpodoxime CFTM: cefteram ABPC: ampicillin

Table 16. Bacteriological response classified by Ĉ -lactamase -producing strains CNS: coagulase negative staphylococci GPB: gram positive bacteria GNB: gram negative bacteria

385 Evaluation of clinical efficacy of ritipenem acoxil for the treatment of otitis media and external otitis Shunkichi Baba, Naoya Miyamoto and Satoaki Hojo Department of Otorhinolaryngology, School of Medicine, Nagoya City University 1 Kawasumi, Mizuho cho, Mizuho ku, Nagoya 467, Japan Takatsugu Itabashi Department of Otorhinolaryngology, Koto Hospital Masahiro Nishiya and Ginichiro Ichikawa Department of Otorhinolaryngology, School of Medicine, Juntendo University Masashi Wada Department of Otorhinolaryngology, Tokyo Rosai Hospital Shinjiro Onishi Department of Otorhinolaryngology, Kanto Teishin Hospital Atsushi Shinkawa, Hideshige Kimura, Makoto Sakai and Hirosato Miyake Department of Otorhinolaryngology, School of Medicine, Tokai University Yutaka Sakamoto Department of Otorhinolaryngology, Kawasaki City Hospital Takehiro Kobayashi Department of Otorhinolaryngology, Kasugai City Hospital Akira. Yokota and Hiromi Ito Department of Otorhinolaryngology, Nagoya City Higashi General Hospital Shinji Kato Department of Otorhinolaryngology, Koseiren Bisai Hospital Junichiro Shimada and Tetsuya Kasashima Department of Otorhinolaryngology, Koseiren Kamo Hospital Tamotsu Harada and Toru Matsunaga Department of Otorhinolaryngology, Medical School, Osaka University Shinichi Okumura and Yasuo Mishiro Department of Otorhinolaryngology, Osaka Rosai Hospital Mahito Ito, Toru Sawada and Kazutoshi Fujii Department of Otorhinolaryngology, Kansai Rosai Hospital Ryoji Sasaki, Minoru Haga and Keijiro Fukazawa Department of Otorhinolaryngology, Kinki Central Hospital Yasuo Harada, Mamoru Suzuki and Katsuhiro Hirakawa Department of Otorhinolaryngology, School of Medicine, Hiroshima University

Tetsuya Tsuda Department of Otorhinolaryngology, Mitsubishi Mihara Hospital Yuko Kobayashi Department of Otorhinolaryngology, Hiroshima Mitsubishi Hospital Ototaka Kaki Department of Otorhinolaryngology, Koseiren Yoshida General Hospital Masako Miura and Toru Sekitani Department of Otorhinolaryngology, School of Medicine, Yamaguchi University Tetsuyasu Hirata Department of Otorhinolaryngology, Saiseikai Yamaguchi General Hospital Keiko Kanesada Department of Otorhinolaryngology, Yamaguchi Prefectural Central Hospital Keiji Moriya Department of Otorhinolaryngology, Nagato General Hospital Masaru Ohyama, Tsutomu Matsuzaki and Yasuhiro Miyazaki Department of Otorhinolaryngology, School of Medicine, Kagoshima University Hiroshi Tsurumaru and Hiromi Yano Department of Otorhinolaryngology, Saiseikai Sendai Hospital Hirofumi Nishizono and Kaneaki Haraguchi Department of Otorhinolaryngology, Kagoshima Seikyo Hospital Kozo Fukami Department of Otorhinolaryngology, Kagoshima Prefectural Hokusatsu Hospital Soiku Watanabe Department of Otorhinolaryngology, Satsuma County Medical Association Hospital The purpose of this study was to evaluate the clinical efficacy of ritipenem acoxil for the treatment of otitis media and external otitis. The patients enrolled in this study consisted of 130 patients with otitis media and 34 with external otitis. The dose of ritipenem acoxil orally administered to these patients ranged from 300 mg to 1200 mg/day. The clinical efficacy rate, as determined by the physician in charge, was 71.4% for otitis media and 90.3% for external otitis. The eradication rates regarding gram positive cocci, gram negative bacteria anaerobic bacteria, and all bacterial strains were 87%, 69.2%, 100% and 83.3%, respectively. Diarrhea was observed in 2 of 154 patients taking the test antibiotic. Laboratory abnormalities were noted in 4 of 62 patients. However, none of these adverse events were of clinical importance. The overall utility rate of ritipenem acoxil for treating otitis media was 68.4%, that for external otitis was 90.3%. Our findings have shown that ritipenem acoxil is highly useful in treating otitis media and external otitis.