Comparison of Clinical Efficacy of Rokitamycin (RKM) and Ofloxacin (OFLX) for the Treatment of Campylobacter Enteritis by a Double-Blind Method

OBANA Mitsuo, TOMIZAWA Isao, TAKIZAWA Yoshihiko, NITTA Yoshiro, SAGARA Hiroko, SEO Takehisa, SATO Junichi, TSUNODA Takafumi, OTA Satomi, MACHII Akira, NAKAMURA Yoshitaka, KATANO Teiko, MURATA Misako, OHNISHI Kenji, YAMAGUCHI Tsuyoshi, MASUDA Gohta, NEGISHI Masayoshi, AJISAWA Atsushi, KITAHARA Mitsuo, LEE Keiko, IRIMAJIRI Shoichiro, MATSUOKA Yasuo, MATSUMOTO Fumio, IMAI Takeo, SAKURAI Iwao, TAKAHASHI Takayuki, AMANO Fukiko, MURAMOTO Akira, NAKAMURA Chie, KANOU Hideyuki, NARUSE Jun, KIM Yong-ki, INAMOTO Yasuhiko, AKAO Mitsuru, SAKAUE Yoshihiro, HOSODA Shiro, BAMBA Tadao, TATEWAKI Kenichi, YOSHIKAWA Kunio, MATSUSHITA Iwao, FUSE Kenji, SASAKI Masaya, KURISU Kuniko, NAKAGAWA Masao, KITOH Katsuyuki, KAWAJIRI Toshio, KIZU Minoru, SHIOMI Takehiko, KATAOKA Sadao, KAWAGUCHI Yoshio, FUKUMOTO Akira, TAMURA Kazuya, MURAI Masami, TANAKA Michio, KURIMURA Osamu, MATSUBARA Yoshio, SAITO Makoto, IMAGAWA Yatsuka, NAKAYA Rintaro, HORIUCHI Sankichi, INAGAKI Yoshio

doi:10.11150/kansenshogakuzasshi1970.65.1165

The clinical efficacy, safety and usefulness of Rokitamycin (RKM), a new macrolide antibiotic, were compared with those of Ofloxacin (OFLX) for the treatment of Campylobacter enteritis by a double blind method. The daily dose level of RKM or OFLX was 600 mg. They were orally administered in three divided doses for 5 days. Of 223 cases studied, 106 cases were diagnosed as Campylobacter enteritis. Ninety cases (RKM group: 50, OFLX group: 40) except for 16 excluded or drop-out cases were analysed. There was no significant difference between the two groups in any background factors. The effectiveness and usefulness was evaluated in 88 cases (RKM group: 48, OFLX group: 40). The results obtained were as follows: 1. In a total of 82 strains of Campylobacter jejuni/coli (RKM group: 42, OFLX group: 40), the bacteriological efficacy rate of RKM (95.2%) was superior to that of OFLX (70.0%) with a significant difference (p=0.006). 2. In 76 symptomatic patients (RKM group: 42, OFLX group: 34) on the day of the beginning of drug administration, the clinical efficacy rate was 97.6% in the RKM group and 85.3% in the OFLX group with no significant difference between the two groups. 3. In 88 evaluable patients, the global clinical efficacy rate of RKM (95.8%) was superior to that of OFLX (67.5%) with a significant difference (p=0.001). 4. Side effect was observed in 1 (1.9%) of the 54 patients in the RKM group and none of the 44 patients in the OFLX group. Slightly abnormal laboratory findings were seen in 4 (10.8%) of the 37 patients treated with RKM and 3 (9.7%) of the 31 patients treated with OFLX, but there was no significant difference between the two groups. 5. In 88 evaluable patients, the clinical usefulness of RKM (91.7%) was superior to that of OFLX (67.5%) with a significant difference (p=0.01). From these results, RKM is considered to be a very useful agent for the treatment of Campylobacter enteritis.

Comparison of Clinical Efficacy of Rokitamycin (RKM) and Ofloxacin (OFLX) for the Treatment of <I>Campylobacter</I> Enteritis by a Double-Blind Method

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