Well controlled comparative clinical trial of sulbactam/cefoperazone (SBT/CPZ) and cefotaxime (CTX) in the treatment of respiratory infections

Kohei Hara, Atsushi Saito, You Suzuyama, Yoshiteru Shigeno, Hironobu Koga, Takashi Watanabe, Mikio Oka, Yoshiaki Fukuda, Tadashi Ohara, Kazuhiro Okuno, Kenji Mori, Kozo Yamada, Masao Sai, Nobuko Imafuji, Kyoko Yamashita, Akira Saito, Masumi Tomizawa, Ichiro Nakayama, Akira Sasaki, Masataka ItoTadashi Irie, Yömei Hiraga, Koki Kikuchi, Asako Yamamoto, Fumio Nagahama, Shinya Yasuda, Takehito Nakabayashi, Kazuo Takebe, Norihiko Hirota, Hitoshi Yashiro, Shuichi Takahashi, Shoichiro Yoshida, Teruo Nakamura, Tatsuro Irie, Naoyoshi Masaiu, Toyoichi Tamura, Katsuhiro Okamoto, Masao Tamura, Ryoji Ito, Hiroaki Ito, Tamotsu Takishima, Shiro Ida, Ichiyo Honda, Kiyoshi Konno, Kōtaro Ōizumi, Akira Watanabe, Seiichi Aonuma, Izumi Hayashi, Tsuguji Ito, Osamu Sekine, Yoshimaru Usuda, Nobuki Aoki, Isao Nitta, Kyoko Watanabe, Fusanosuke Yamasaku, Yasutoshi Suzuki, Sadatomo Watanabe, Akio Aoyagi, Masataka Katsu, Masanori Adachi, Hisashi Takizuka, Yasushi Ueda, Tadashi Miyahara, Atsushi Saito, Jingoro Shimada, Kōya Shiba, Takehisa Yamaji, Toshio Hōjō, Masanobu Kaji, Hiroyuki Kobayashi, Kenji Takamura, Kōta Kono, Hideo Ikemoto, Kazuyoshi Watanabe, Keimei Mashimo, Sumio Yamaoka, Tetsuro Ukai, Kazuaki Hanaoka, Kentaro Watanabe, Masaru Koyama, Fukuo Iijima, Hiroshi Fukui, Hiroichi Tanimoto, Hirotaka Nakamori, Naohiko Chonabayashi, Kunihiko Yoshimura, Tatsuo Nakatani, Koichiro Nakada, Junzaburo Kabe, Hiroyoshi Ishibashi, Tetsuzo Watanabe, Kazuo Fuzieda, Masaru Suzuki, Ryozo Yoneda, Tokuyuki Kurashima, Makoto Saito, Tatsuro Kuroki, Akira Yamabe, Jun Takizawaan, Yukio Yabata, Genichi Tanaka, Syoichi Ōkubo, Ippei Fujimori, Yoshio Kobayashi, Sew Mita, Takeshi Mitsui, Hideyon Noguchi, Kazukiyo Nakagami, Tadashi Takigami, Kaoru OŌyama, Kuninori Suzuki, Nobuo Ōya, Mitsuru Hayase, Gorō Sugioka, Yoshinori Kibe, Toshiyuki Yamamoto, Kanzō Suzuki, Akihiko Kishimoto, Hiromichi Umeda, Susumu Suetsugu, Nobuo Maekawa, Michiyasu Nakanishi, Nobuo Sakurai, Kotaro Kozasa, Yasuko Marui, Hiroyuki Tsujino, Kouhei Aoki, Nobuo Inaba, Akira Kagioka, Yasutaka Shibata, Riichiro Mikami, Masayoshi Sawaki, Yuruko Okamoto, Keigo Maehara, Yuube Iida, Muneto Yoshioka, Hiroshoi Ōkubo, Yoshihiro Ueda, Fumio Miki, Kenji Takamatsu, Osamu Miyamoto, Rinzō Soejima, Yoshihito Niki, Toshio Kishimoto, Yukio Nishimoto, Michio Yamakido, Kanji Takahashi, Osamu Kurimura, Yoshihiko Aratani, Hideo Sasaki, Hirofumi Fukuhara, Eiro Tsubura, Masakazu Tamura, Yoshiro Sawae, Kaoru Okada, Hitoshi Nagano, Reiko Kishikawa, Atsushi Shinoda, Tsuneo Ishibashi, Masahiro Takamoto, Yoshiya Kitahara, Yasuko Harada, Keizō Matsumoto, Mikio Taguchi, Masakazu Takasugi, Tasuku Sakamoto, Tsunetoshi Koteda, Shigeru Kono, Takeshi Ishisaki, Shukuro Araki, Masayuki Ando, Mineharu Sugimoto, Moritaka Suga, Tatsuo Matsuura, Shogo Tokuda, Osamu Kono, Tsuyoshi Maeda, Kiyoshi Shima, Sadanobu Higuchi, Yoichi Hokamura, Sinobu Takenaka, Takashi Itoga, Masaru Nasu, Jun Goto, Yoiciiiro Goto, Takayoshi Tashiro, Kazumine Kobari, Masao Nakatomi, Yuei Irabu, Masahide Tomisato, Kosei Kurosaka, Sadayori Hoshina

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6 Citations (Scopus)

Abstract

The clinical efficacy and safety of sulbactam/cefoperazone (SBT/CPZ), a combinations of cefoperazone and a new β-lactamase inhibitor sulbactam, were objectively compared with those of cefotazime (CTX) in patients with respiratory tract infections in a well controlled study. Drugs were administered by intravenous drip infusion twice a day for 14 days, at a daily dose of either 2.0 g of SBT/CPZ (S2 : one vial containing 0.5 g of SBT and 0.5 g of CPZ), 4.0 g of SBT/CPZ (S4 one vial containing 1.0 g of SBT and 1.0 g of CPZ) or 2.0 g of CTX (C2 : one vial containing 1.0 g of CTX). The following results were obtained. 1.On the basis of committee judgement the overall clinical efficacy rates were 86.1% in 115 patients treated with S2, 77.3% in 110 treated with S4, and 78.7% in 108 treated with C2. No statistically significant differences were found among the three drug groups. 2. The overall clinical efficacy rates judged by the investigators were 82.9% in 117 patients treated with S2 79.6% in 113 treated with S4 and 73.0% in 111 treated with C2. Again, no significant differences were observed among the three groups. 3. The bacteriological elimination rates of causative organisms as judged by the committee were 84.2% for S2, 81.4% for S4 and 85.3% for C2, respectively, There were no significant differences among these three drug groups. 29.6% of the strains whose β-lactamase productivity was measured were high producers of β-lactamase, however, there were few strains which showed high resistance to β-lactam antibiotics based upon MIC. 4. No significant differences were observed among the three drug groups in regard to the incidence of side effects or abnormal laboratory findings. 5. As judged by the committee, the respective usefulness rates for the S2, S4 and C2 groups were 78.2% (93 of 119 cases), 72.3% (81 of 112 cases) and 77.1% (84 of 109 cases). The rates of usefulness as judged by the investigators were 80.2% (93 of 116 cases) for S2, 76.8% (86 of 112 cases) for S4 and 73.1% (79 of 108 cases) for C2. These rates were not significantly different among the three drug groups. From the above results, we conclude the clinical safety and efficacy of SBT/CPZ are equal to those of CTX in the treatment of respiratory tract infections.

Original languageEnglish
Pages (from-to)159-188
Number of pages30
JournalChemotherapy
Volume33
Issue number2
DOIs
Publication statusPublished - 1985
Externally publishedYes

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Infectious Diseases
  • Pharmacology
  • Drug Discovery
  • Oncology

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