Fig. 1 Chemical structure Lomefloxacin(LFLX,NY-198) Pipemidic acid(ppa)

Key words : Lomefloxacin (LFLX, NY-198), Infectious enteritis, Double blind method

Fig. 1 Chemical structure Lomefloxacin(LFLX,NY-198) Pipemidic acid(ppa)

Fig. 2 Package of test drugs LFLX group PPA group LFLX inactive placebo

Table 1 Criteria for evaluation of effectiveness in bacterial elimination

Fig. 3 Case distribution Table 2 Reasons for exclusion and drop-out

Table 3 Background of cases evaluated for effectiveness and usefulness Exact probability Wilcoxon rank sum test Table 4 Number of strains

Table 5 Drug susceptibility distribution of clinical isolates (106CFU/ml) Fig. 4 Drug susceptibility distribution of clinical isolates of Shigella spp. 144 strains (106CFU/ml) Drug: Drug used for determination of MIC Group: group of cases administered

Table 6 Clinical effect Fig. 5 Days required for defeverscence Total cases Bacillary dysentery Fig. 6 Days required for disappearance of bloody stool Total cases Bacillary dysentery

Fig. 7 Days required for improvement of stool character Total cases Bacillary dysentery Fig. 8 Days required for decrease in number of defecation (2 times/day) Total cases Bacillary dysentery Table 7 Bacteriological effect

Fig. 9 Days required for eradication of organisms Total organisms Shigella spp Fig. 10 Days required for eradication of Shigella spp. S. flexneri S. sonnei

Table 8 Global clinical effect Table 9 Side effect Table 10 Laboratory finding

Table 11 Clinical usefulness

Fig. 11 Correlogram of MIC between LFLX and PPA against Shigella spp. 144 strains were tested: Inoculum size 108 CPU/m1

Comparison of Cinical Efficacy of Lomefloxacin (LFLX, NY-198) and Pipemidic Acid (PPA) in the Treatment of Infectious Enteritis by a Double-Blind Method The Japan Research Committee of Lomefloxacin (Manager: Takakazu AOKI) Takakazu AOKI Research Group Enteritis Infectious Disease Center, Osaka municipal Momoyama Hospital, Osaka Department Nagayo SHIMIZU of Infectious Diseases, Tokyo Metropolitan Ebara Hospital, Tokyo Isao TOMIZAWA & Yoshihiko TAKIZAWA Department of Infectious Diseases, Minamigaoka Branch, Sapporo City General Hospital, Sapporo Yoshio MATSUBARA, Yoshiro NITTA, Hiroko SAGARA, Takehisa SE0 & Naoko KANEHISA Department of Infectious Diseases, Tokyo Metropolitan Toshima Hospital, Tokyo Misako MURATA, Gohta MASUDA, Masayoshi NEGISHI & Chenden YOUNG Department of Infectious Diseases, Tokyo Metropolitan Komagome Hospital, Tokyo Yatsuka IMAGAWA & Kenji OHNISHI Department of Infectious Diseases, Tokyo Metropoliatn Bokuto Hospital, Tokyo Tsuyoshi YAMAGUCHI, Masachika TSUJI & Jun-ichiro HOSOYA Department of Infectious Disease, Tokyo Metropolitan Ebara Hospital, Tokyo Jyuji HOSHINO Department of Infectious Diseases, Yokohama Municipal Manji Hospital, Yokohama Department Department Fukiko AMANO, Chie NAKAMURA & Akira MURAMOTO of Infectious Diseases, Nagoya City Higashi General Hospital, Nagoya Yoshio KOBAYASHI, Chihiro IMAI & Yong-ki KIM Department of Infectious Diseases, Kyoto City Hospital, Kyoto Mitsuru AKAO Infectious Disease Center, Osaka Municipal Momoyama Hospital, Osaka Akio TODO, Yasuyoshi IBUKI, Hideshi KOMORI, Syusuke TOMITA & Hiroshi KASHIDA Department of Gastroenterology, Kobe City General Hospital, Kobe Tadakazu AISAKA, Masanobu NIIMI & Masayoshi NAKAMURA Department Department Department Department of Internal Medicine, Hiroshima City Funairi Hospital, Hiroshima Toshiko MATSUO of Internal Medicine, Asahigaoka Municipal Hospital, Kita-kyusyu Makoto SAITO School of Medicine, Showa University, Tokyo Rintaro NAKAYA, Sankichi HORIUCHI, Yoshio INAGAKI, Hideko TAKANO & Nobuichi GOTO of Microbiology, School of Medicine, Tokyo Medical and Dental University, Tokyo Yoshio KOBAYASHI of Central Clinical Laboratory, School of Medicine, Keio University, Tokyo Kazue SAKU of Clinical Laboratory, Tokyo Metropolitan Bokuto Hospital, Tokyo Controller: Yoshifumi TAKEDA The Institute of Medical Science, The University of Tokyo The clinical efficacy, safety and usefulness of lomefloxacin (LFLX, NY-198), a new quinolone

antimicrobial agent, were compared with those of pipemidic acid (PPA) in the treatment of infectious enteritis (bacillary dysentery, enteropathogenic Eschericia coli enteritis and Campylobacter enteritis) by a double blind method. Daily dosage of LFLX and PPA was 600 mg and 2000 mg, respectively administered orally divided into 4 doses. The duration of the treatment was 5 days. Of 290 cases studied, 100 cases were excluded and 21 cases were dropped from analysis of effectiveness and usefulness. The effectiveness and usefulness was evaluated in 169 cases (LFLX group: 83, PPA group: 86). There was no significance difference between the two groups in any background characteristics. The results obtained were as follows: 1. In 73 symptomatic patients (LFLX group: 35, PPA group: 38) on the day of the beginning of administration, the clinical effect was 91.4% in the LFLX group and 84.2% in the PPA group with no significant difference between the two groups. 2. In a total of 184 strains (LFLX group: 90, PPA group: 94), the bacteriological effects of LFLX (93.3%) was superior to that of PPA (80.9%) with a significant difference (p=0.0153). 3. In 169 evaluable patients, the global clinical effects of LFLX (92.8%) wassuperior to that of PPA (79.1%) with a significant difference (P=0.0144). 4. Side effects were observed in 1 (0.7%) of the 141 patients in the LFLX group and none of the 143 patients in the PPA group. Abnomal laboratory test values were noted in 10 (7.6%) of the 132 patients treated with FLLX and 7 (5.1%) of the 136 patients treated with PPA,but they as no significant difference between the two groups. 5. In 169 evaluable patients, the clinical usefulness of LFLX (91.6%) was superior to that of PPA (76.7%) with a significant difference (P=0.0111). From these results, LFLX is considered to be a clinically useful medicine in the treatment of infectious enteritis including bacillay dysenstery.