EVALUATION OF THE EFFICACY OF CEFTRIAXONE IN ACUTE SUPPURATIVE OTITIS MEDIA AND ACUTE EXACERBATION OF CHRONIC SUPPURATIVE OTITIS MEDIA A COMPARATIVE STUDY WITH CEFOTIAM AS THE CONTROL

• Published in: Japanese journal of antibiotics Vol. 42; no. 1; pp. 212 - 247
• Main Authors: BABA, SHUNKICHI, MORI, YOSHITO, SUZUKI, KENJI, UNNO, TOKUJI, KAWABORI, SHINICHI, YANAI, TORU, NONAKA, SATOSHI, TAKASAKA, TOMONORI, AWATAGUCHI, TOSHIICHI, FURUUCHI, ICHIRO, TANIGAITO, YOSHIYUKI, GOTOH, HIRONORI, KIYONO, JIN, KAWABATA, ISUZU, KAWAMURA, SHOUZO, UEHARA, NORIO, ITABASHI, TAKATSUGU, FUJIMAKI, YUTAKA, NOMURA, YASUYA, MIZUNO, MASAHIRO, INOUE, NORIFUMI, SHOUJI, MINORU, ISHII, TETSUO, TAKAYAMA, MIKIKO, MIYAKE, HIROSATO, SHINKAWA, ATSUSHI, SAKAI, MAKOTO, KOMATSU, NOBUYUKI, MATSUKAWA, JUNICHI, KAN, SHIMEI, KIMURA, HIDENARI, MARUO, TAKESHI, ITOH, HARUO, KINOSHITA, HARUJI, KOBAYASHI, TAKEHIRO, KAWAI, TAKASHI, TAKANO, TSUYOSHI, MATSUNAGA, TORU, OGINO, HITOSHI, ASAI, HIDEYO, SHIRAISHI, TAKAYUKI, SENBA, OSAMU, NOTAKE, KEIKO, TAMAKI, HIROMITSU, KIMU, SONJIN, TSUDA, MAMORU, FURUKAWA, YUTAKA, TAKEMOTO, ICHIE, ISHIDA, MINORU, TAYA, NAOZO, NOIRI, TERUHISA, HORI, TETSUJI, MATSUNAGA, TAKASHI, TANAKA, OSAMU, OKASAKA, TOSHIAKI, YANAGAWA, AKIHISA, HYOU, YUKIKAZU, KITAOKU, NORIYUKI, KITAMURA, HIROYUKI, NISHIKAWA, ATSUKO, FUJITA, NOBUYA, KASHIWAGI, NORIKO, YANE, KATSUNARI, HARADA, YASUO, YAJIN, KOUJI, TAGASHIRA, NOBUHARU, SUZUKI, MAMORU, TAKEBAYASHI, SYUBUN, YASHIKI, TAKEO, CHIKUIE, DAISUKE, NODA, MASUHIRO, OKAZAKI, HIDETO, YOSHIOKA, TATSUO, NINOMIYA, YUKO, KIKUYA, YOSHINORI, KUROKAWA, MICHINORI, MURAKAMI, YUZURU, MOGI, GORO, KURONO, YUICHI, YUMISAKI, AKITERU, MORIMITSU, TAMOTSU, SAKU, KAZUAKI, HAYASHI, AKITOSHI, MATSUMOTO, ICHIRO, KASANO, FUJIHIKO, OYAMA, MASARU, FURUTA, SHIGERU, NOBORI, TAKUO, FUKAMI, KOZO, FUKUDA, KATSUNORI, HIROTA, TSUNEHARU, MURANO, KENZO, HASHIMOTO, MAKOTO, HARAGUCHI, KANEAKI, OHORI, YASUICHI, IIDA, FUMIKO, MATSUNAGA, SHINYA, HANADA, TAKEHIRO, DEGUCHI, KOUICHI, NAKASHIMA, MITSUYOSHI
• Format: Journal Article
• Language: Japanese
• Published: Japan Japan Antibiotics Research Association 01.01.1989
• Subjects: Adolescent; Adult; Aged; Aged, 80 and over; Bacterial Infections - drug therapy; Bacterial Infections - microbiology; Cefotiam - administration & dosage; Cefotiam - adverse effects; Cefotiam - therapeutic use; Ceftriaxone - administration & dosage; Ceftriaxone - adverse effects; Ceftriaxone - therapeutic use; Drug Eruptions - etiology; Drug Evaluation; Female; Humans; Japan; Male; Middle Aged; Multicenter Studies as Topic; Otitis Media - drug therapy; Otitis Media, Suppurative - drug therapy; Otitis Media, Suppurative - microbiology; Thrombocytopenia - chemically induced; Vomiting - chemically induced; Japan
• ISSN: 0368-2781; 2186-5477
• DOI: 10.11553/antibiotics1968b.42.212

In order to objectively evaluate the efficacy and the safety of ceftriaxone (CTRX) using once daily administration of 1g to cases of acute suppurative otitis media and acute exacerbation of chronic suppurative otitis media, a group comparison study by the envelope method was conducted using cefotiam (CTM) as the control drug (2g twice daily). The results obtained are summarized as follows. 1. Clinical efficacies evaluated by the committee were 71% in the CTRX group and 86% in the CTM group for acute suppurative otitis media, and 63% and 60%, respectively, for chronic suppurative otitis media. When all cases were considered both groups evidenced a clinical efficacy of 64%, and no significant difference was observed between the 2 groups. 2. Clinical efficacies evaluated by the physician in charge were 65% in the CTRX group and 86% in the CTM group for acute suppurative otitis media, and 72% and 60%, respectively, for chronic suppurative otitis media. When all cases were considered efficacies were, respectively, 70% and 64%, showing no significant difference between the 2 groups. 3. Bacteriological efficacies were 88% in the CTRX group and 86% in the CTM group for acute suppurative otitis media, and 74% and 62%, respectively, for chronic suppurative otitis media. With all cases bacterial eradication rates were, respectively, 76% and 67%. Bacterial eradication rates were always higher for the CTRX group than for the CTM group, but the difference was not significant between the 2 groups. 4. Against infections caused by Staphylococcus aureus alone, CTRX showed equal clinical and bacteriological efficacies to CTM. 5. As side effects, dermatitis, vomiting, and malaise were observed in 5 cases (4%) of the CTRX group and 3 cases (3%) of the CTM group. As clinical testing abnormalities, elevations of GOT, GPT, and Al-P, and thrombocytopenia were noted only in 3 cases (5%) of the CTRX group. Furthermore, all of these abnormalities were temporary and of moderate degree or mild, thus the safety of either drug was considered high. 6. Clinical utilities were 71% in the CTRX group and 86% in the CTM group for acute suppurative otitis media, and 72% and 62%, respectively, for chronic suppurative otitis media. When all cases were included, they were 72% and 66%, respectively, and there was no significant difference between the 2 groups. It is concluded from the above results that CTRX is a highly useful drug with once daily administration of 1g in the treatment of suppurative otitis media.