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4 Table 1.Concentration of gatifloxacin (Middle-ear) Table 2.Concentration of gatifloxacin (Paranasal sinuses)

5 Table 3.Concentration of gatifloxacin (Tonsil) Table 4.No.of patients studied

6 Table 5.Background characteristics Table 6.Clinical efficacy by severity

7 Table 7.Clinical efficacy by diagnosis Table 8.Clinical efficacy by daily dose

8 Table 9.Clinical efficacy by isolated organism Table 10.Bacteriological effect

9 Table 11.Elimination rate by isolated organism

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11 Table 12-2.Sensitivity distribution of clinical isolates (Đg/ml)mic (Đg/ml:106 CFU/mL) Table 13.Side effects Table 14.Abnormal laboratory findings

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13 3) Hosaka M, Yasue T, Fukuda H, et al.: In vitro and in vivo antibacterial activities of AM- 1155, a new 6-fluoro-8-methoxy quinolone. Antimicrob Agents Chemother 36: , ) Wakabayashi E, Mitsuhashi S: In vitro antibacterial activity of AM-1155, a novel 6-fluoro-8-methoxy quinolone. Antimicrob Agents Chemother 38: , ) Hosaka M, Kinoshita S, Toyama A, et al.: Antibacterial properties of AM-1155, a new 8-methoxy quinolone. J Antimicrob Chemother 36: , 1995

14 Pharmacokinetic and clinical studies of gatifloxacin on otorhinolaryngological infections Shunkichi Baba1),Naoya Miyamoto1),Takekazu Mishima2),Ichiro Ando3), Ginichiro Ichikawa4),Takuya Yamakawa4),Takatsugu Itabashi5),Hirosato Miyake6), Mutsumi Sato6),Hiroshi Watanabe7),Makoto Sakai8),Atsushi Shinkawa8),Tadashi Akitaya9), Yuko Miyamoto9),Akira Yokota10),Kaoru Kato10)Takehiro Kobayashi11),Kunimitsu Sakai11), Isato Tsuge12),Toshio Yamashita13),Nobuo Kubo13),Yasuo Harada14),Koji Yajin14), Katsuhiro Hirakawa14),Nobuharu Tagashira15),Yuko Kobayashi16),Masaya Takumida17), Ototaka Kaki18)Masaru Ohyama19),Tsutomu Matsuzaki19),Takuo Nobori20), Yasuhiro Mouazaki20)Ichiro Moriyama21),Kunihiko Sakamoto22),Hiromi Yano23), Koichi Deguchi24) 1 Department of Otorhinolaryngology,Nagoya City University,Medical School 1 Kawazumi,Mizuho-cho,Mizuho-ku,Nagoya ,Japan 2 Department of Otorhinolaryngology,Koshigaya Municipal Hospital 3 Department of Otorhinolaryngology,Juntendo University Juntendo Urayasu Hospital 4 Department of Otorhinolaryngology,Juntendo University,School of Medicine 5 Department of Otorhinolaryngology,Koto Hospital 6 Department of Otorhinolaryngology,Tokai University Tokyo Hospital 7 Department of Otorhinolaryngology,Taketani Hospital 8 Department of Otorhinolaryngology,Tokai University,School of Medicine 9 Department of Otorhinolaryngology,Tokai University Ohiso Hospital 10 Department of Otorhinolaryngology,Nagoya City Higashi Municipal Hospital 11 Department of Otorhinolaryngology,Kasugai Municipal Hospital 12 Department of Otorhinolaryngology,Toyohashi Municipal Hospital 13 Department of Otorhinolaryngology,Kansai College of Medicine 14 Department of Otorhinolaryngology,Hiroshima University,School of Medicine 15 Department of Otorhinolaryngology,Hiroshima Red Cross and Atomic Bomb Survivor Hospital 16 Department of Otorhinolaryngology,Hiroshima Mitsubishi Hospital 17 Department of Otorhinolaryngology,W.F.A.C,Hiroshima General Hospital 18 Department of Otorhinolaryngology,W.F.A.C,Yoshida General Hospital 19 Department of Otorhinolaryngology,Kagoshima University,School of Medicine 20 Department of Otorhinolaryngology,Imakiire General Hospital 21 Department of Otorhinolaryngology,Kagoshima PrefecturalHokusatsu Hospital 22 Department of Otorhinolaryngology,Kagoshima PrefecturalOshima Hospital 23 Department of Otorhinolaryngology,Sendai Hospital 24 Research Section,Tokyo Clinical Research Center Pharmacokinetic and clinical studies were carried out with gatifloxacin (GFLX)in otorhinolaryngological infections.the results were as follows: 1.The concentration of GFLX in the mucous membrane of the middle ear was 2.68 `3.64ƒÊg/g, in the mucous membrane of paranasal sinuses was 0.30 `2.49ƒÊg/g,and in the tonsils,0.06 ` 3.12ƒÊg/g. 2. Clinical efficacy rates were 77.8%(28/36)in otitis media,96.4%(27/28)in paranasal sinusitis,and 81.8%(18/22)in tonsillitis.overall clinical efficacy was assessed as excellent in 48 cases,good in 33,fair in 10 and poor in 5,the efficacy rate being 84.4%(81/96).

15 Bacteriological elimination rates were 85.7% (60/70) for Gram-positive bacteria and 88.9% (24/27) for Gram-negative bacteria. The rate for anaerobes was 100% (11/11). Side effects were observed in eight of 138 cases (5.8 %), but they were slight. Abnormal laboratory findings were recorded in 2 cases (2.1 %). All were mild in degree. From the above results, we conclude that GFLX is a useful drug for the treatment of otorhinolaryngological infections.

Table 1. Serum and tissue levels after a single oral administrsion of gatiflozacin ND: not detected(0. 05 ug/g or 0. 05 ug/eml) Table 2. Reason for exclusion and dropped out from evaluation VOL.47 NO.10

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