jibi to rinsho
Online ISSN : 2185-1034
Print ISSN : 0447-7227
ISSN-L : 0447-7227
A Comparative Double Blind Study of Norfloxacin and Pipemidic Acid in Suppurative Otitis Media
Syunkichi BABA, Haruji KINOSHITA, Tohru SASAKI, Hisakazu SUGIMORI, Yukihiro SASAKI, Jiro KURITA, Kazutomo KAWAMOTO, Akira HARA, Ichiro FURUUCHI, Kohtaro BABA, Daisuke NAGAE, Shozo KAWAMURA, Yutaka FUJIMAKI, Masashi WADA, Toshio UCHIDA, Hiroshi WATANABE, Takatsugu ITABASHI, Koichi SHIBUI, Tetsuo ISHII, Mikiko TAKAYAMA, Reiko YAMAMOTO, Shinjiro ONISHI, Yoriko ITOH, Yutaka SAKAMOTO, Toko TATEHARA, Shigeo OGAWA, Yoshihisa KAWASAKI, Hirosato MIYAKE, Atsushi SHINKAWA, Makoto SAKAI, Mashiko ANDO, Shigeaki SAITOH, Nobuyuki KOMATSU, Mutsumi NAKAYAMA, Masakatsu KASAGI, Yutaka OGAWA, Junichi MATSUKAWA, Shoji SAITO, Tadashi AKITAYA, Yoshiyuki TAMURA, Masaru NODA, Takehiro KOBAYASHI, Takeshi TAKANO, Takeshi MARUO, Haruo ITOH, Takashi KAWAI, Kenji MUKAI, Tsutomu HATANO, Kaoru SOYANO, Sinji KATOH, Kenji WADA, Mitsuaki INAGAKI, Jun HONDO, Tadao NISHIMURA, Mikio YAGIZAWA, Hitoki MATSUNAGA, Kiichi SATO, Kazuo TAKEDA, Itoji SHIBATA, Isao UNO, Kenji OHMORI, Tadami KUMAZAWA, Koichi USHIRO, Kageyuki KOHZUKI, Hikoemon MAEKAWA, Takeo KUMOI, Hiroshi IRIYA, Yuji MORI, Nobuo TAKASUGA, Yasuo HARADA, Nobuharu TAGASHIRA, Masuhiro NODA, Hideto OKAZAKI, Michinori KUROKAWA, Goro MOGI, Hideyuki KAWAUCHI, Takemoto SHIN, Hiroshi WATANABE, Masaru OHYAMA, Kenji KATSUDA, Shigeru FURUTA, Kiyoshi OHNO, Kunihiko SAKAMOTO, Takuo MAEYAMA, Ikuo OHNO, Ichiro MORIYAMA, Kozo FUKAMI, Koichi DEGUCHI, Tsuneo TANAKA
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Keywords: Norfloxacin
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1986 Volume 32 Issue 5Supplement2 Pages 843-867

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Abstract
In order to evaluate the clinical efficacy and safety of Norfloxacin (NFLX) in the treatment of acute suppurative otitis media (ASOM) and acute exacerbation of chronic suppurative otitis media (AECSOM), a double blind trial was carried out comparing NFLX with pipemidic acid (PPA). 800 mg/day of NFLX or 2, 000 mg/day of PPA was administered for seven days and the following results were obtained: 1 Clinical efficacy: (1) The clinical efficacy was able to be evaluated in 153 cases of the NFLX group and 155 cases of the PPA group.(2) When judged by the doctors, the overall clinical efficay rate (cases of excellent and good responses) was 68.0 % in the NFLX group and 53.5 % in the PPA group. The efficacy rate of the NFLX group was superior to the PPA group (p<0.01). In ASOM, the NFLX group (79.7 %) showed a higher rate than the PPA group (67.6 %) · (p<0.1). In AECSOM, the NFLX group (59.6 %) was superior to the PPA group (41.7 %) · (p<0.05).(3) When judged by a committee, the overall clinical efficacy rate was 71.2 % in the NFLX group and 51.0 % in the PPA group. The efficacy rate of the NFLX group was superior to the PPA group (p<0.001). In ASOM, no significant difference was found between the NFLX (79.7 %) and PPA group (69.6 %). In AECSOM, the NFLX group (65.2 %) was significantly superior to the PPA group (35.7 %) · (p<0.001). 2 Bacteriological efficacy: (1) As for bacteriological response, the elimination rate was 62.8 % in the NFLX group and 52.8 % in the PPA group. The NFLX group showed the higher rate than the PPA group (p<0.1).(2) In the rate of eradication of S. aureus and P. aeruginosa, the NFLX group showed a higher rate than the PPA group (p<0.1). 3 Safety: (1) Side effects were observed in 7 (4.1 %) of 169 cases in NFLX group and 12 (7.0 %) of 171 cases in PPA group. There was no significant difference between the two groups. From these results, NFLX is judged as a superior drug in the treatment of Suppurative Otitis Media.
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