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1 Key words: pazufloxacin, infectious enteritis, antibacterial activity, fecal concentration, fecal microflora
2
3 : Table 1-1 Criteria for bacteriological efficacy of pazufloxacin on Shigella spp. and V. cholerae 01 : administration of PZFX : administration of another antimicrobial agent : culture positive culture negative (): culture after discharge from hospital E: discharge from hospital ex: example PZFX, ofloxacin (OFLX), ciprofloxacin
4 Table 1-2 Criteria for bacteriological efficacy of pazufloxacin on the causative isolates except for Shigella spp. and V. cholerae 01
5 Table 2 Number of cases analysed Table 3 Age and sex distribution of the cases evaluated for clinical and/or bacteriological efficacy
6 Table 4-1 List of cases evaluated for clinical and bacteriological efficacy Table 4-2 List of polymicrobial infection Table 5 Clinical efficacy of pazufloxacin
7 Table 6 Bacteriological efficacy of pazufloxacin Table 7 Side effects Table 8 Abnormal changes in laboratory findings *Abnormal value
8 Table 9 Clinical usefulness of pazufloxacin Table 10-1 Minimum inhibitory concentrations of pazufloxacin and other quinolones against clinical isolates *Đg/ml (inoculum size; 106 cells/ml)
9 Table 10-2 Minimum inhibitory concentrations of pazufloxacin and other quinolones against clinical isolates (inoculum size; 106 cells/m1) Table 11 Concentration of pazufloxacin in the feces : not detected NT: not tested
10 Fig. 1 Effects of PZFX on fecal microflora
11 1) Muratani T, Inoue M & Mitsuhashi S : In vitro activity of T-3761, a new fluoroquinolone. Antimicrob Agents Chemother 1992; 36: ) Fukuoka Y, Ikeda Y, Yamashiro Y, Takahashi M, Toda Y & Narita H : In vitro and in vivo antibacterial activities of T-3761, a new quinolone derivative. Antimicrob Agents Chemother 1993 ; 37: ) Segreti J, Gootz TD, Goodman LJ et al.: High-level quinolone resistance in clinical isolates of Carnpylobacter jejuni. J Infect Dis 1992, 165:
12 Basic and Clinical Studies of Pazufloxacin on Infectious Enteritis Research Group of T-3761 on Infectious Enteritis (Manager; Shoichiro IRIMAJIRI) Hiroko SAGARA & Kouji YOSHIKAWA Department of Infectious Diseases, Yokohama Municipal Citizen's Hospital Isao TOMIZAWA & Yoshihiko TAKIZAWA Department of Infectious Diseases, Minamigaoka Branch, Sapporo City General Hospital Yoshiro NITTA, Takafumi TSUNODA & Hiroyuki FUKUDA Department of Infectious Diseases, Tokyo Metropolitan Toshima General Hospital Tsuyoshi YAMAGUCHI, Gohta MASUDA, Masayoshi NEGISHI & Atsushi AJISAWA Department of Infectious Diseases, Tokyo Metropolitan Komagome General Hospital Misako MURATA & Kenji OHNISHI Department of Infectious Diseases, Tokyo Metropolitan Bokutoh General Hospital Shoichiro IRIMAJIRI & Mitsuo OBANA Department of Internal Medicine, Kawasaki Municipal Hospital Fumio MATSUMOTO, Takero IMAI, Iwao SAKURAI & Takayuki TAKAHASHI Department of Internal Medicine, Kanagawa Prefectural Midwives Nurses Training Hospital Masamiki MORI, Yoshiki MIZUNO & Kohji KATOH Department of Communicable Diseases, Nagoya City Higashi General Hospital Shiro HOSODA, Tadao BAMBA & Masaya SASAKI Second Department of Internal Medicine, Shiga Univresity of Medical Science Kunio YOSHIKAWA & Shuichi HIROTANI Department of Internal Medicine, Nagahama Red Cross Hospital Takeshi OGASAWARA, Hitoshi SAKUMOTO & Yasunobu KOMAI Department of Internal Medicine, Otsu Municipal Hospital
13 Shinobu NAKAJO & Hirozumi OBATA Department of Internal Medicine, Osaka Prefectural Saiseikai Suita Hospital Hideo OOKUBO & Young Ki KIM Department of Communicable Diseases, Kyoto City Hospital Yoshihiro SAKAUE, Hideki YOSHIDA & Tetsushi GOTO Infectious Disease Center, Osaka City General Hospital Tadakazu AISAKA & Motoko MIKAMI Department of Internal Medicine, Hiroshima City Funairi Hospital Kazunori KAGAWA Department of Internal Medicine, Kure National Hospital Yatsuka IMAGAWA & Masafumi FUKUYAMA College of Enviromental Health, Azabu University Yoshio MATSUBARA Department of Internal Medicine, Kiyose Jogu Hospital Makoto SAITO Showa University A clinical study was carried out on pazufloxacin (PZFX) in 137 patients including shigellosis, Salmonella enteritis, enteropathogenic Esherichia coli enteritis and cholera, and carriers of these pathogens. Antibacterial activity of PZFX against clinical isolates, fecal concentration of PZFX and effects of PZFX on fecal microflora were also investigated. The overall clinical efficacy rate was 97.2%. The bacteriological efficacy rates were 98.2% against Shigella spp., 81.8% against Salmonella spp., 50% against Vibrio cholerae 01, and 100% against E. coli, V. parahaemolyticus, Aer - onomas spp., Plesionomas shigelloides and V. cholerae non-01, respectively. Side effect (epigastralgia) was observed in 1 of 130 cases (0.8%). The rate of abnormal laboratory findings was 11.2% (11/98). These were mainly elevation of GOT and/or GPT and increased eosinophils. The clinical usefulness rate was 95.2%. The MICH values of PZFX against Shigella spp., Salmonella spp. and E. coli were 0.025, and 0.025,ug/ml, respectively. The results of fecal drug concentration and the effects on fecal microflora in one patient were compatible with those obtained in healthy volunteers.
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