COMPARATIVE STUDY ON THE EFFICACY OF RITIPENEM ACOXIL AND CEFOTIAM HEXETIL IN CHRONIC LOWER RESPIRATORY TRACT INFECTIONS BY THE DOUBLE-BLIND METHOD

• Published in: Japanese journal of antibiotics 1996/03/25, Vol.49(3), pp.219-249
• Main Authors: KAWAKAMI, YOSHIKAZU, ABE, SHOSAKU, OHMICHI, MITSUHIDE, INOUE, HIROSHI, YOSHIDA, MASAMI, KOBAYASHI, HITOSHI, ITO, TAKASHI, BANDO, TAKESHI, TAKEUCHI, KENICHI, HIRANO, HARUTO, TANNO, YASUO, SAKAMOTO, MASAHIRO, NUKIWA, TOSHIHIRO, YANASE, KENJI, ITO, NOBUO, FUKUDA, KIYOSHI, KOBA, HIROYUKIYASHI, WATANABE, HIDEHIRO, INAMATSU, TAKASHI, SANO, YASUYUKI, KURAKI, TAKASHIGE, SHISHIDO, HARUMI, TANOUE, SHOKO, KOYAMA, MASARU, KUDO, KOICHIRO, KOSHINO, TAKESHI, OKUBO, TAKAO, TANI, KENJI, SHOJI, AKIRA, CHIBA, JUN, IKEHARA, KUNIHIKO, SAKURAI, IWAO, TAKAHASHI, HIROSHI, ARAKAWA, MASAAKI, WADA, KOICHI, IWATA, FUMIHIDE, TSUKADA, HIROKI, SUZUKI, YASUTOSHI, SATO, ATSUHIKO, IWATA, MASATOSHI, SHICHI, IZUMI, YASUDA, KAZUMASA, TAKAGI, KENZO, WATANABE, YOSHIAKI, TANIGUCHI, HIROYUKI, USUI, ISAO, BANDO, KENJI, KISHIMOTO, TADAMITSU, IKEDA, AKINORI, OKUMOTO, TAKESHI, MIKI, FUMIO, OKAWA, KENTARO, MIKASA, KEIICHI, HIGASHINO, KAZUYA, MAEBO, AKIO, NOMURA, SHIGEO, YAMAGUCHI, KAZUYUKI, HIRABAYASHI, MASATAKA, YOSHIDA, MASAO, MATSUSHIMA, TOSHIHARU, MATSUMOTO, YUKIO, ISHIOKA, SHINICHI, KUWAHARA, MASAO, MOCHIZUKI, NOBUHIRO, YANAGIDA, JITSURO, ARITA, KENICHI, DAIDO, KAZUHIRO, EJIMA, TSUYOSHI, MIKI, SATOSHI, SAWAE, YOSHIRO, YOSHIDA, MINORU, SHIRAISHI, TSUNEAKI, KAWAHARA, MASASHI, KAWAYAMA, TOMOTAKA, HONDA, YOSHIAKI, ISHIBASHI, TSUNEO, TAKAMOTO, MASAHIRO, KAJIKI, AKIRA, FUJISAWA, NOBUMITSU, SUGA, MORITAKA, DOI, TOSHINORI, TAKENAKA, SHINOBU, HARA, KOHEI, KOHNO, SHIGERU, KAKU, MITSUO, INOUE, YUICHI, YAMASHITA, YUKO, SAKATA, SHINGO, FUJII, TAKESHI, IRIFUNE, KENJI, MIYAZAKI, YOSHITSUGU, WATANABE, TAKASHI, MATSUMOTO, KEIZO, AKIYAMA, MORITOSHI, NAKAMA, KAORU, MATSUKURA, SHIGERU, MASHIMOTO, HIDEO, MUKAE, HIROSHI, DEGUCHI, KOICHI, NAKASHIMA, MITSUYOSHI
• Format: Article
• Language: Japanese
• Subjects: Adult; Aged; Aged, 80 and over; Bacterial Infections - drug therapy; Bacterial Infections - microbiology; Carbapenems - adverse effects; Carbapenems - therapeutic use; Cefotiam - adverse effects; Cefotiam - therapeutic use; Cephalosporins - adverse effects; Cephalosporins - therapeutic use; Chronic Disease; Double-Blind Method; Female; Humans; Japan; Male; Middle Aged; Respiratory Tract Infections - drug therapy; Respiratory Tract Infections - microbiology
• ISSN: 0368-2781; 2186-5477
• DOI: 10.11553/antibiotics1968b.49.219

To objectively evaluate the efficacy, safety and usefulness of the newly developed penem oral antibiotic, ritipenem acoxil (RIPM-AC), against chronic lower respiratory tract infections, we conducted a multi-center double-blind comparative study using cefotiam hexetil (CTM-HE) as a control drug. RIPM-AC was orally administered at 200 mg, and CTM-HE at 400 mg, t.i.d. for 14 days, in principle. The results were as follows: The total number of patients enrol led in this trial was 202, of which 151 cases (RIPM-AC group: 75, CTM-HE group: 76) were evaluable for clinical efficacy. 1. The clinical efficacy rates (excellent+good) were 85.3% (64/75) in the RIPM-AC group and 80.3% (61/76) in the CTM-HE group. There was no significant difference between the two groups, hence the clinical equivalency of RIPM-AC to CTM-HE was demonstrated. 2. In the patients enrolled in the evaluation of clinical efficacy, the eradication rates of the causative organisms were 50.0% (13/26) in the RIPM-AC group and 75.0% (18/24) in the CTM-HE group, with no significant difference between the two groups. 3. Side effects were noted in 10 cases (11.0%) of the RIPM-AC group and 10 cases (10.9%) of the CTM-HE group. Abnormal laboratory test findings were observed in 8 cases(9.5%) of the RIPM-AC group and in 14 cases (16.7%) of the CTM-HE group. There were no significant differences between the two groups in the incidence of side effects and abnormal laboratory test findings. In the safety evaluation, RIPM-AC was judged to be safe in 73 cases (80.2%) and CTM-HE in 71 cases (77.2%), with no significant difference. 4. The usefulness rates (markedly useful+useful) were 79.5% (62/78) in the RIPM-AC group and 76.9% (60/78) in the CTM-HE group. There was no significant difference between the two groups. Since RIPM-AC showed clinical efficacy similar to those of CTM-HE and posed no particular safety problems, it is expected to be a useful antibiotic for the treatment of chronic lower respiratory tract infCctions.