VOL.31 S-2 CHEMOT HERAPY 101 Table 1 Breakdown of cases Table 2 List of excluded cases Table 3 List of drop-out cases

102 CHEMOT HERAPY JULY 1983 Table 4 Background factors of suppurative otitis media

VOL.31 S-2 CHEMOT HERAPY 103 Table 5 Background characteristis

104 CHEMOT HERAPY JULY 1983 Table 6 Doctor's judge

VOL.31 S-2 CHEMOT HERAPY 105 Table 7 Committee judge

106 CHEMOT HERAPY JULY 1983 Table 8 Bacteriological effect Table 9 Bacteriological effect of fl-lactamase producing strains

VOL.31 5-2 CHEMOT HERAPY 107 Table 10 Bacteriological effect Table 11 Overall safety rating 1: Continued without specific treatment 2: Continued with specific treatment 3: Discontinued Table 12 Classification of utility of drug

108 CHEMOT HERAPY JULY 1983 Table 13 Side effects Side effect duplicate or triplicate (1) Laboratory findings Table 14 Laboratory test (2) Cases with laboratory test abnormalities

VOL.31 S-2 CHEMOT HERAPY 109 Fig. 1 Sensitivity distribution of S. aureus

110 CHEMOT HERAPY JULY 1983 against clinical isolates resistant to beta-lactam antibiotics. Antimicr. Agents & Chemoth. 15: 315 `317, 1979 1 ) WISE, R.; J. M. ANDREWS & K. A. BEDFORD: In vitro study of clavulanic acid in combination with penicillin, amoxycillin, and carbenicillin. Antimicr. Agents & Chemoth. 13 (3): 389 `393, 1978 2 ) DUMON, L.; P. ADRIANS, J. ANNE & H. EYSSEN: Effects of clavulanic acid on the minimum inhibitory concentration of benzylpenicillin, ampicillin, carbenicillin, or cephalothin

CHEMOT HERAPY 111 EVALUATION OF BRL25000 (CLAVULANIC ACID-AMOXICILLIN) IN ACUTE PURULENT OTITIS MEDIA AND ACUTE EXACERBATION OF CHRONIC PURULENT OTITIS MEDIA SHUNKICHI BABA, KANETAKA MURAI and HARUJI KINOSHITA Department of Otorhinolaryngology, Nagoya City University, School of Medicine TAKEHIKO IWASAWA Department of Otorhinolaryngology, Sapporo Teishin Hospital HISAKAZU SUGIMORI Department of Otorhinolaryngology, National Sapporo Hospital TAKUJI TOMURA Department of Otorhinolaryngology, Sapporo Tetsudo Hospital TOHRU SASAKI Department of Otorhinolaryngology, Asahikawa City Hospital KAZUTOMO KAWAMOTO and KENJI OHYAMA Department of Otorhinolaryngology, Tohoku University, School of Medicine ICHIRO FURUUCHI, KOUTARO BABA and YOSHIYASU KIYA Department of Otorhinolaryngology, Dokkyo University, School of Medicine SHOZO KAWAMURA, RINYA SUGITA and YUTAKA FUJIMAKI Department of Otorhinolaryngology, Juntendo University, School of Medicine MASASHI WADA Department of Otorhinolaryngology, Tokyo Rosai Hospital HIROKAZU SHIBUI and KIMIAKI KATORI Department of Otorhinolaryngology, Asoka Hospital BUEMON SANBE and RYOHO UEDA Department of Otorhinolaryngology, Kanto Teishin Hospital CHISATO TAKETA, TADAO KONNO, TETSU NISHIYAMA and TETSURO HONDA Department of Otrohinolaryngology, Tokyo Medical College YUTAKA SAKAMOTO, YOSHIO HOMMURA and YASUKO URAO Department of Otorhinolaryngology, Kawasaki Municipal Hospital HIROSATO MIYAKE and MAKOTO SAKAI Department of Otorhinolaryngology, Tokai University, School of Medicine MASAO TSUKIYAMA Department of Otorhinolaryngology, Tokai Teishin Hospital ISAO TAKIMOTO and TAKAHIKO NOMURA Department of Otorhinolaryngology, Aichi Medical College

112 CHEMOT HERAPY JULY 1983 YASUO SAKAKURA, MIKIKAZU YAMAGIWA and YOKO SUGIYAMA Department of Otorhinolaryngology, Mie University, School of Medicine TOYOJI MIYOSHI Department of Otorhinolaryngology, Kyoto University, School of Medicine KAZUO TAKETA and ISAO UNO Department of Otorhinolaryngology, Osaka Medical College TOHRU MATSUNAGA and HIROMITSU TAMAKI Department of Otorhinolaryngology, Osaka University, School fo Medicine NOBUO TAKASUKA and KouHo TANAKA Department of Otorhinolaryngology, Ehime Prefectural Central Hospital YASUO HARADA and Koji YAJIN Department of Otorhinolaryngology, Hiroshima University, School of Medicine TOHRU SEKITANI and YOSHIHIKO OKINAKA Department of Otorhinolaryngology, Yamaguchi University, School of Medicine MASARU OHYAMA and ETSURO OBATA Department of Otorhinolaryngology, Kagoshima University, School of Medicine TSUNEO TANAKA Department of Health Administration, School of Health Sciences, Faculty of Medicine, University of Tokyo KOICHI DEGUCHI Laboratory Section, Tokyo Clinical Research Center We conducted a randomized, double-blind comparison between BRL25000 and amoxicillin in acute purulent otitis media and chronic purulent otitis media acute exacerbation. 259 patients received orally either 1,125 mg of BRL25000 or 750 mg of amoxicillin three times a day for 7 days. The clinical responses were obtained in 62.7% (52/83) of patients with acute exacerbation of chronic purulent otitis media treated with BRL25000 and in 46.5% (46/99) of patients treated with amoxicillin, as judged by doctors in charge. BRL25000 was found to be significantly more effective than amoxicillin in this study. Bacteriologically, the percentage eradication of causal organisms was 60.0% (57/95) for BRL25000 and 49. 5% (48/97) for amoxicillin. There was no significant difference in percentage eradication between BRL25000 and AMPC. The percentage eradication of Ĉ-lactamase producing strains of BRL25000 and amoxicillin was 56. 4% (44/78) for BRL25000 and 36.8% (25/68) for amoxicillin: There was a difference of satistical significance. As to safety of the drugs, the incidence of side effect was 6.4% (8/125) for BRL25000 and 7.0% (9/128) for amoxicillin : There was no significant difference in incidence of side effects. It was concluded that BRL25000 is significantly more useful than amoxicillin, as judged according to the number of cases with clinical responses "very satisfactory" and "satisfactory" (75 cases for BRL25000 vs. 62 cases for amoxicillin)