Clarithromycin-controlled randomized double-blind studies of azithromycin in chronic respiratory tract infection

Hiroyuki Kobayashi, Susumu Sakayori, Yoshikazu Kawakami, Yoshinori Otsuka, Yohmei Hiraga, Mitsuhide Ohmichi, Gen Yamada, Yosei Inoue, Kazuki Konishi, Kunio Shirato, Yasuo Tanno, Toshihiro Nukiwa, Akira Watanabe, Akira Ohishi, Kohtaro Kaneko, Satoshi Kitamura, Yoichi Hirakata, Kaoru Shimada, Yasuyuki Sano, Yasuo AraiKoichiro Kudo, Naohito Suzuki, Izumi Hayashi, Masaru Koyama, Mamoru Chida, Harumi Shishido, Keiko Dobashi, Koichiro Nakata, Tatsuo Nakatani, Eiyasu Tsuboi, Shoji Kudo, Arata Azuma, Fumio Matsumoto, Takeo Imai, Iwao Sakurai, Shigeki Odagiri, Kaneo Suzuki, Yoshihiro Hirai, Masashi Akahori, Takao Okubo, Hirotada Ikeda, Hiroshi Matsumoto, Masanori Nishikawa, Masaaki Arakawa, Koichi Wada, Hiroki Tsukada, Nobuki Aoki, Osamu Sekine, Yasutoshi Suzuki, Shigeo Takizawa, Kenji Yanase, Shoko Tagami, Atsuhiko Sato, Kingo Chida, Shiro Imokawa, Junji Morita, Katsunori Tsukamoto, Ryoji Tamura, Jun Sato, Hideki Suganuma, Jinichiro Akiyama, Kazuo Yasuda, Yasuo Yamada, Kazuo Yoshitomo, Toru Matsuura, Toshiyuki Yamamoto, Toshinobu Yamamoto, Nobuhiro Narita, Masayoshi Sawaki, Keiichi Mikasa, Fumio Mik, Eiro Tsubura, Takehiko Kobayasi, Rinzo Soejima, Yoshihito Niki, Niro Okimoto, Susumu Kawahara, Michio Yamakido, Shinichi Ishioka, Yoshiro Sawae, Ikuo Sumida, Takatoshi Inoue, Masamitsu Kido, Yoshihiko Nikaido, Kikuo Arakawa, Kenji Kohno, Seiji Takeda, Ichiro Tatara, Kotaro Oizumi, Toru Rikimaru, Tsuneaki Shiraishi, Masashi Kawahara, Tsuneo Ishibashi, Masahiro Takamoto, Yoshinari Kitahara, Kohei Hara, Shigeru Kohno, Hironobu Koga, Keizo Matsumoto, Tsuyoshi Nagatake, Yoshiaki Utsunomiya, Kiyoshi Shima, Shinobu Takenaka, Masaru Nasu, Yoichiro Goto, Toru Yamasaki, Atsushi Saito, Hiroshi Fukuhara, Katsuyoshi Shimoji, Mitsuyoshi Nakashima

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    Abstract

    The efficacy, safety and usefulness of a newly developed oral macrolide antibiotic, azithromycin (AZM). for treatment of chronic respiratory infection were investigated using a randomized double blind trial with clarithromycin (CAM) as the control drug. AZM wasa dministered at a dose of 500 mg (titer) once a day for 3 days, and CAM was administered at a dose of 200 mg (titer) twice a day for 14 days. The following results were obtained: 1. The efficacy rate (proportion of patients in whom the clinical efficacy was excellent or good) was determined in a total of 144 patients in whom clinical efficacy could be analyzed, out of a total of 171 patients to whom the drug had been administered. The rate was 94.5%(69/73) in the AZM group, and 83.1%(59/71) in the CAM group. There was no significant difference between the two groups, and the clinical equivalency of AZM to CAM was demonstrated (Δ=10%, p<0.001). 2. The elimination rate of isolated bacteria was 75.8%(25/33) in the AZM group, and 68.2%(15/22) in the CAM group (no significant difference). 3. The incidences of adverse reactions were 7.6%(6/79), in the AZM group, and 5.1% (4/78), in the CAM group (no significant difference). 4. The incidences of abnormal changes in clinical laboratory test values were 13.5% (10/74), in the AZM group, and 9.3% (7/75), in the CAM group (no significant difference). 5. The rate of safety (proportion of patients in whom the drug was not problematic) was determined in 149 patients in whom the degree of general safety could be analyzed. The rate was 79.7% (59/74) in the AZM group, and 86.7% (65/75) in the CAM group (no significant difference). 6. The rate of usefulness (proportion of patients in whom the drug was very useful or useful) was determined in 138 patients in whom the degree of usefulness could be analyzed. The rate was 92.9% (65/70), in the AZM group, and 79.4% (54/68), in the CAM group (no significant difference). These results suggest that AZM is very useful for chronic respiratory infection and iscomparable to CAM.

    Original languageEnglish
    Pages (from-to)775-792
    Number of pages18
    JournalJapanese Journal of Chemotherapy
    Volume43
    Issue number8
    DOIs
    Publication statusPublished - 1995

    Keywords

    • azithromycin
    • chronic respiratory tract infection
    • clarithromycin
    • comparative study

    ASJC Scopus subject areas

    • Pharmacology
    • Pharmacology (medical)

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