Key words: Norfloxacin (NFLX), Infectious enteritis, Double-blind method

Key words: Norfloxacin (NFLX), Infectious enteritis, Double-blind method

Fig. 1 Chemical structure Norfloxacin (NFLX) Pipemidic acid (PPA)

Fig. 2 Package of test drugs

Table 1 Criteria for evaluation of effectiveness in bacterial elimination

Table 2 Case distribution

Table 3 Number of subjects analysed Table 4 Reasons for exclusion and dropped-out

Table 5 Background of cases evaluated for effectiveness

Table 6 Sensitivity distribution of clinical isolates Fig. 3 Sensitivity distribution of clinical isolates of Shigella spp. to NFLX (106cfu/ml) Sensitivity distribution of clinical isolates of Shigella spp. to PPA (106cfu/ml)

Table 7 Clinical effect judeged by docters in charge Table 8 Days required for defervescence Fig. 4 Days required for defeverscence

Table 9 Days required for disappearance of bloody stool Fig. 5 Days required for disappearance of bloody stool Table 10 Days required for decrease in number of defecation

Fig. 6 Days required for decrease in number of defecation Table 11 Days reauired for improvement of stool character Fig. 7 Days required for improxement of stool character

Table 12 Bacteriological effect Table 13 Effect of NFLX and PPA against NA resistance strains 106cfu/ml

Table 14 Days required for eradication of organisms

Fig. 9 Days required for eradication of Shigella spp.

Table 15 Laboratory findings. Table 16 Evaluation of usefulness

Comparison of Clinical Efficacy of Norfloxacin (NFLX) and Pipemidic Acid (PPA) in the Treatment of Infectious Enteritis by a Double-Blind Method The Japan Research Committee of Norfloxacin Research Group Enteritis (Manager: Takakazu AOKI) Nagayo SHIMIZU Tokyo Metropolitan Ebara Hospital Isao TOMIZAWA & Yoshihiko TAKIZAWA Sapporo City General Hospital Yoshio MATSUBARA, Takehisa SEO, Hiroko SAGARA & Keiko TAGAWA Tokyo Metropolitan Toshima Hospital Gohta MASUDA, Masayoshi NEGISHI & Chenden YOUNG Tokyo Metropolitan Komagome Hospital Yatsuka IMAGAWA & Misako MURATA Tokyo Metropolitan Bokuto Hospital Tsuyoshi YAMAGUCHI, Masachika TSUJI & Jun-ichiro HOSOYA Tokyo Metropolitan Ebara Hospital Ippei FUJIMORI & Yoshio KOBAYASHI Kawasaki Municipal Hospital Jyuji HOSHINO Yokohama Municipal Hospital Fukiko AMANO, Chie NAKAMURA & Akira MURAMOTO

Nagoya City Higashi General Hospital Yoshio KOBAYASHI, Chihiro IMAI & Ryuki KIN Kyoto City Hospital Mitsuru AKAO Osaka Infectious Disease Center, Osaka Municipal Momoyama Hospital Okisuke TSUNODA, Akio TODO, Katsuhiko FUJIMI, Akihiro HIRASA & Kan HASEGAWA Kobe Central Municipal Hospital Tadakazu AISAKA, Masanobu NIIMI, Masao TAKEMOTO & Motoko MIKAMI Hiroshima City Funairi Hospital Toshiko MATSUO Asahigaoka Municipal Hospital Makoto SAITO The First Department of Internal Medicine, Showa University School of Medicine Rintaro NAKAYA, Nobuichi GOTO, Sankichi HORIUCHI, Noboru OKAMURA, Yoshio INAGAKI & Kayoko OZAWA Department of Microbiology, Tokyo Medical and Dental University School of Medicine Yoshifumi TAKEDA Controller: The Institute of Medical Science, The University of Tokyo The effect of norfloxacin (NFLX), a new quinolone agent, was compared with that of pipemidic acid (PPA) on infectious enteritis (bacillary dysentery, Campylobacter enteritis and enteropathogenic E. coli enteritis etc.) by a double-blind method. NFLX was administrated orally in a dose of 600mg/day, and PPA was administrated orally, 2,000 mg/day. The duration of the treatment was five days. Of 227 cases studied, 68 cases were excluded from analysis of effectiveness. The effectiveness was evaluated in 159 cases; 80 reveived NFLX and 79 reveived PPA. There was no statistical significance beteeen NFLX group and PPA group in terms of the background characteristics and MIC distribution for each drug. The results obtained were as follow: 1. NFLX group was as same as PPA group in clinical effect judged by docters in charge. There was no significnat difference between both groups in defeverscence, disappearance of blood stool, decrease in number of defecation and improvement of stool character. 2. In bacillary dysentery, the bacteriological effect of NFLX (100%) was superior to that of PPA (88.9%). Days required for eradication of organisms for NFLX group were shorter than those for PPA group with significant difference in Shigella spp. 3. No subjective side effect was observed in both groups. Slightly abnormal laboratory findings were seen in 11 cases of NFLX group and 7 cases of PPA group. 4. On clinical usefulness judged by the docters the ratio of usefulness were 100% in NFLX group and 86.0% in PPA group with significans difference in bacillary dysentery. From these results, NFLX is considered to be very useful medicine in the treatment of patients with infectious enteritis or carriers.