Kansenshogaku Zasshi
Online ISSN : 1884-569X
Print ISSN : 0387-5911
ISSN-L : 0387-5911
Double-Blind Comparative Study of Roxithromycin (RU 28965) and Midecamycin acetate (MOM) in the Treatment of Pneumonia
Rinzo SOEJIMA, Yoshihito NIKI, Jiro HINO, Toshio KISHIMOTO, Yoshihisa NAKAGAWA, Masaru SUMI, Akira SAITO, Ichiro NAKAYAMA, Masumi TOMIZAWA, Yomei HIRAGA, Susumu ITO, Masao TAMURA, Takashi ITO, Takashi TUSRUYA, Hitoshi KOBAYASHI, Hiroshi KURAMITSU, Kazutoshi GOMI, Tamotsu TAKISHIMA, Shiroh IDA, Isao OHNO, Kiyoshi KONNO, Kotaro OIZUMI, Akira WATANABE, Seiichi AONUMA, Yushi NAKAI, Kousaku NAGAI, Kazuo SATOH, Izumi HAYASHI, Osamu SEKINE, Nobuki AOKI, Masataka KATSU, Shinji OKUI, Hisashi TAKIZUKA, Koichiro ASANO, Rieko AMAGAI, Kaoru SHIMADA, Yasuyuki SANO, Yasuhumi MIYAMOTO, Tadashi MIYAHARA, Jingoro SHIMADA, Kohya SHIBA, Hideo IKEMOTO, Kazuyoshi WATANABE, Junzaburo KABE, Koichiro KUDOH, Hiroichi TANIMOTO, Koichiro NAKATA, Yoshitaka NAKAMORI, Tatsuo NAKATANI, Naohiko CHONABAYASHI, Kentaro WATANABE, Masaru KOYAMA, Tatsuo KATO, Toshiaki TOMI, Hiroyuki KOBAYASHI, Hiroaki TAKEDA, Masahide KAWAHIRA, Ippei FUJIMORI, Mitsuo OBANA, Takao OKUBO, Akira ITOH, Hirotada IKEDA, Fumio MATSUMOTO, Kaoru OYAMA, Toshihiko TAKEUCHI, Masahito KATO, Yoshihiro UEDA, Hiroshi OKUBO, Hidekazu HANAKI, Fumio MIKI, Keiji KOBAYASHI, Yoji SHIMIZU, Kenzo SHIOTA, Michio YAMAKIDO, Kenji HASEGAWA, Koichi AWAYA, Toyofumi MITSUYAMA, Osamu KURIMURA, Hideo SASAKI, Hirofumi FUKUHARA, Yoshiro SAWAE, Koji TAKAGI, Osamu KOHASHI, Nobuaki SHIGEMATSU, Masayuki MIYAZAKI, Katsuro YAGAWA, Ken-ichi OGATA, Toshihiko KOGA, Masahide TAKII, Hidenobu SHIGEOKA, Yoshihiro KATOH, Masaru NASU, Hideaki SHIGENO, Jun GOTO, Takayoshi TASHIRO, Kohei HARA, Keizo YAMAGUCHI, Shigeru KOHNO, Toshiaki HAYASHI, Hiroshi TOMITA, Naoshi SUYAMA, Akira YASUOKA, Kazuo SASAYAMA, Kiyokazu KOMORI, Toshiyuki OHE, Kin-ichi IZUMIKAWA, Hideo MASUMOTO, Mitsuo KAKU, Keizo MATSUMOTO, Naoto RIKITOMI, Tsuyoshi NAGATAKE, Masakazu TAKASUGI, Harumi SISIDO, Kiyoshi SHIMA, Taeo TAKENAKA, Atsushi SAITO, Yoshiteru SHIGENO, Yuei IRABU, Kazunori TAMAKI
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Keywords: RU 28965, roxithromycin, midecamycin acetate Pneumonia, double-blind method
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1989 Volume 63 Issue 5 Pages 501-529

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Abstract

The clinical efficacy and safety of Roxithromycin (RU) were compared with those of Midecamycin acetate (MOM) in patients with pneumonia in a double blind study. RU and MOM were administered orally for 14 days with daily doses of 300 mg (150 mg b.i.d.) and 600 mg (200 mg t.i.d.), respectively.
The following results were obtained.
1. RU and MOM were administered to a total of 204 patients (RU: 101, MOM: 103). The clinical efficacy was judged in 150 patients (RU: 70, MOM: 80), with 54 of the patients excluded from the total by the committee.
2. The clinical efficacy rates were 81.4% for RU and 70.0% for MOM on the basis of the committee's judgement. There was no significant difference between the two groups. In the evaluation of the clinical efficacy by the doctors in charge, the efficacy rates were 81.4% for RU and 67.5% for MOM, which constitutes a significant difference between the two groups (p<0.05).
3. No significant difference was found between the two drugs in bacteriological efficacy.
4. No significant differences were observed in either the incidence of side effects between RU (4.3%) and MOM (4.0%) or in abnormal changes in the laboratory findings.
5. Regarding the clinical usefulness judged by the committee, RU showed a significantly higher rate than MOM (79.2% vs. 67.9%). There was no significant difference in the judgement by the doctors in charge.
From the above results, it was concluded that a daily dosage of 300 mg of RU was equal in usefulness to 600 mg daily of MOM in the treatment of mild to moderate pneumonia.

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