Clinical Evaluation of Cefuroxime Axetil in Acute Tonsillitis A Double Blind Comparison with Cefaclor Shozo KAWAMURA*(1), Ichiro FURUUCHI and Yoshiyuk

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1 Clinical Evaluation of Cefuroxime Axetil in Acute Tonsillitis A Double Blind Comparison with Cefaclor Shozo KAWAMURA*(1), Ichiro FURUUCHI and Yoshiyuki TANIGAITO(2), Yutaka FUJIMAKI(3), Takatsugu ITABASHI(4), Hiroshi WATANABE(5), Haruhisa HORIKAWA(6), Yasuya NOMURA, Isuzu KAWABATA and Minoru SHOJI(7), Keiichi ICHIMURA, Meijin SHU and Yasushi MURAKAMI(8), Hirosato MIYAKE and Atsushi SHINKAWA(9), Junichi MATSUKAWA, Shimei KAN and Hideshige KIMURA(10), Makoto SAKAI, Nobuyuki KOMATSU and Mashiko ANDO(11), Tadashi AKITAYA and Yoshiyuki TAMURA(12), Masahiro IIDA and Mutsumi NAKAYAMA(13), Shunkichi BABA, Junichiro SHIMADA, Kaoru SOYANO, Yoshito MORI, Kenji SUZUKI and Mitsuaki INAGAKI(14), Yasuhiko OHYA(15), Jun HONDO and Ippei TAKAGI(16), Masao TSUKIYAMA(17), Tsuyoshi TAKANO(18), Takashi KAWAI(19), Haruji KINOSHITA(20), Takeshi MARUO and Haruo ITO(21), Sadayoshi MORITO and Hiromi ITO(22), Masaki WADA(23), Tsutomu HATANO, Shinji KATO and Toru KITAGAKI(24), Yasuo SUZUKI(25), Shigenobu IWATA, Mikio YAGISAWA and Akihiko TAKASU(26), Masashi YAITA(27), Toru MATSUNAGA, Hitoshi OGINO and Morihiro IRIFUNE(28), Ichiro OHKAWACHI(29), Yoshiaki KAWASAKI(30), Shinichi OKUMURA, Katsumi DOI and Kazuhiko SUGIMOTO(31), Shinji SATO(32), Minoru ISHIDA and Naozo TAYA(33), Masayoshi OZAKI and Masanobu KIN(34), Ryuzo ODA and Hideo MAEDA(35), Toshiyuki MIYOSHI(36), Yasuo HARADA, ouji YAJIN and Katsuhiro HIRAKAWA(37), Shubun TAKEBAYASHI and Hideki WADA(38), Daisuke CHIKUIE(39), Shofu NAKATA(40), Masuhiro NODA(41), Michinori KUROKAWA(42), Yuzuru MURAKAMI(43), Yoshinori KIKUYA(44), Yuko NINOMIYA(45), Masaru OHYAMA and

2 Hiromi YANO(46), Ryuji KIYOTA(47), Eriko TABUCHI(48), Hirofumi MATSUYAMA(49), Kozo FUKAMI(50), Ikuo OHNO(51), Mitsuyoshi NAKASHIMA õ(52), Koichi DEGUCHI(53) A double blind comparative study was performed on cefuroxime axetil (CXM-AX), to evaluate objectively its efficacy, safety and usefulness in acute tonsillitis, using cefaclor (CCL) as the comparator. Either of the drugs was administered in the dose of 250 mg tid., in principle for 7 days. 1. In the evaluation of clinical efficacy, the efficacy rates of CXM-AX and CCL were 90.5 % (95/105) and 88.2 % (90/102), respectively, in the assessment by doctors in charge, and 88.6 % (93/105) and 87.3 % (89/102), respectively, in the assessment by the committee, without statistically significant difference between the two treatment groups. 2. When the bacteriological response was evaluated in each case, the elimination rate was 98.0 % (96/ 98) in CXM-AX group and 98.9 % (91/92) in CCL group, and there was no significant difference between the two groups either in this comparison or in the evaluation on the bacteriological response classified by causative organisms. 3. In overall safety, no significant difference was observed between two treatment groups. Adverse events, all of which were gastrointestinal tract symptoms, were observed in 2.6 % (3/114) in CXM-AX group, and in 2.7 % (3/111) in CCL group. Either in adverse events or abnormal laboratory findings, the difference in incidences was not statistically significant between the two groups. 4. The usefulness rates of CXM-AX and CCL were 93.3 % (98/105) and 91.2 % (93/102), respectively, with no significant difference. The above results suggest that CXM-AX is a very useful drug for the treatment of acute tonsillitis. key words: Cefuroxime axetil, Cefaclor, Acute tonsillitis, Double blind comparative study

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17 Department of Otorhinolaryngology, Juntendo University, School of Medicine, Tokyo 113, Japan Department of Otorhinolaryngology, Dokkyo University, School of Medicine, Shimotsuga , Japan Department of Otorhinolaryngology, Katsunan Hospital, Urayasu , Japan Department of Otorhinolaryngology, Koto Hospital, Tokyo 136, Japan Department of Otorhinolaryngology, Taketani Hospital, Kiyose 204, Japan Horikawa Clinic of Otorhinolaryngology, Tokyo 114, Japan Department of Otorhinolaryngology, Faculty of Medicine, University of Tokyo, Tokyo 113, Japan Department of Otorhinolaryngology, Tokyo Metropolitan Fuchu Hospital, Fuchu 183, Japan Department of Otorhinolaryngology, Tokai University, School of Medicine, Isehara , Japan Department of Otorhinolaryngology, Nihon Kokan Hospital, Kawasaki 210, Japan Department of Otorhinolaryngology, Tokai University, Tokyo Hospital Tokyo 151, Japan Department of Otorhinolaryngology, Kosei Hospital, Tokyo 164, Japan Department of Otorhinolaryngology, Isehara Kyodo Hospital, Isehara , Japan Department of Otorhinolaryngology, Nagoya City University, School of Medicine, Nagoya 467, Japan Department of Otorhinolaryngology, Nagoya Municipal Midori City Hospital, Nagoya 458, Japan Department of Otorhinolaryngology, Nagoya Second Red Cross Hospital, Nagoya 466, Japan Department of Otorhinolaryngology, Tokai Teishin Hospital, Nagoya 460, Japan Department of Otorhinolaryngology, Kasugai City Hospital, Kasugai 486, Japan Department of Otorhinolaryngology, Ichinomiya City Hospital, Ichinomiya 491, Japan Department of Otorhinolaryngology, Atsumi Hospital, Atsumi , Japan Department of Otorhinolaryngology, Showa Hospital, Kounan 483, Japan Department of Otorhinolaryngology, Kainan Hospital, Kaifu 498, Japan Department of Otorhinolaryngology, Kamo Hospital, Toyota 471, Japan Department of Otorhinolaryngology, Toyohashi City Hospital, Toyohashi 440, Japan Department of Otorhinolaryngology, Toyokawa City Hospital, Toyokawa 442, Japan Department of Otorhinolaryngology, Fujita Gakuen Health University, School of Medicine, Toyoake , Japan Department of Otorhinolaryngology, Gamagori City Hospital, Gamagori 443, Japan

18 Department of Otorhinolaryngology, Osaka University, Medical Scho6l, Osaka 553, Japan Department of Otorhinolaryngology, Osaka Central Hospital, Osaka 530, Japan Department of Otorhinolaryngology, Osaka Teishin Hospital, Osaka 543, Japan Department of Otorhinolaryngology, Osaka Rosai Hospital, Sakai 591, Japan Department of Otorhinolaryngology, Otemae Hospital, Osaka 540, Japan Department of Otorhinolaryngology, Suita Municipal Hospital, Suita 564, Japan Department of Otorhinolaryngology, Toyonaka City Hospital, Toyonaka 560, Japan Department of Otorhinolaryngology, Meiwa Hospital, Nishinomiya 663, Japan Department of Otorhinolaryngology, Minoo City Hospital, Minoo 562, Japan Department of Otorhinolaryngology, Hiroshima University, School of Medicine, Hiroshima 734, Japan Department of Otorhinolaryngology, Hiroshima Prefectural Hospital, Hiroshima 734, Japan Department of Otorhinolaryngology, Hiroshima General Hospital, Saeki 738, Japan Department of Otorhinolaryngology, Kure National Hospital, Kure 737, Japan Department of Otorhinolaryngology, Hiroshima Red Cross Hospital, Hiroshima 730, Japan Department of Otorhinolaryngology, Onomichi General Hospital, Onomichi 722, Japan Department of Otorhinolaryngology, Mitsubishi Mihara Hospital, Mihara , Japan Department of Otorhinolaryngology, Chugoku Rosai Hospital, Kure , Japan Department of Otorhinolaryngology, Yoshida general Hospital, Takada , Japan Department of Otorhinolaryngology, Faculty of Medicine, Kagoshima University, Kagoshima 890, Japan Department of Otorhinolaryngology, Kagoshima Prefectural Hokusatsu Hospital, Oguchi , Japan Department of Otorhinolaryngology, Ichihino Onsen Hospital, Satsuma , Japan Department of Otorhinolaryngology, Miyanojo Central Hospital, Satsuma , Japan Department of Otorhinolaryngology, Kokubu Central Hospital, Kokubu , Japan Department of Otorhinolaryngology, Kagoshima Prefectural Ohshima Hospital, Naze 894, Japan Department of Pharmacology, Hamamatsu University, School of Medicine, Hamamatsu , Japan Tokyo clinical Research Center, Tokyo 120, Japan

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