Kansenshogaku Zasshi
Online ISSN : 1884-569X
Print ISSN : 0387-5911
ISSN-L : 0387-5911
Clinical Evaluation of Carumonam in Chronic Respiratory Infections
Double-Blind Study Using Cefoperazone as a Positive Control
Kaoru SHIMADA, Yoshikazu KAWAKAMI, Shosaku ABE, Akira SAITO, Ichiro NAKAYAMA, Masumi TOMIZAWA, Akira SUZUKI, Tsugutami ONODERA, Naoya YASUDA, Tetsuji KOROKU, Yohmei HIRAGA, Kohki KIKUCHI, Asako YAMAMOTO, Susumu ITO, Akiji KASAGI, Masao TAMURA, Kazuki KONISHI, Takashi ITO, Masato HAYASHI, Kiyoshi KONNO, Kotaro OIZUMI, Seiichi AONUMA, Izumi HAYASHI, Masataka KATSU, Toshio FUKUI, Mieko KAWAI, Takashi YOKOSE, Yasushi UEDA, Atsushi SAITO, Tadashi MIYAHARA, Hideo IKEMOTO, Kazuyoshi WATANABE, Hiroyuki KOBAYASHI, Hiroaki TAKEDA, Keimei MASHIMO, Hiroichi TANIMOTO, Naohiko CHONABAYASHI, Kunihiko YOSHIMURA, Yoshitaka NAKAMORI, Kentaro WATANABE, Masaru KOYAMA, Yasuyuki SANO, Takashi INAMATSU, Kyoko URAYAMA, Takao OKUBO, Akira ITO, Ippei FUJIMORI, Yoshio KOBAYASHI, Yasuhisa KITAGAWA, Shigeki ODAGIRI, Masaaki ARAKAWA, Koichi WADA, Osamu SEKINE, Nobuki AOKI, Tatsuo SATAKE, Kenzo TAKAGI, Kenichi YAMAMOTO, Toshihiko TAKEUCHI, Masahito KATO, Hidekazu HANAKI, Joichi KATO, Toshiyuki YAMAMOTO, Kanzo SUZUKI, Kikuo SUGIMOTO, Fumiyuki KUZE, Takuya KURASAWA, Shunsaku OSHIMA, Takahide IZUMI, Koichi NISHIMURA, Hideo HAYASHI, Hideki ONODERA, Sadao IKEDA, Michio NAKAJIMA, Hitoshi ASAMOTO, Hiroshi OKUBO, Yoshihiro UEDA, Seibun YONEZU, Yube IIDA, Yuruko OKAMOTO, Kojiro YASUNAGA, Fumio MIKI, Shigenori NAKAJIMA, Aritomo TOHDA, Hisao TAKAHASI, Norio OCHI, Norio ITAKURA, Nobuhiro NARITA, Masayoshi SAWAKI, Keiichi MIKASA, Kazuya HIGASHINO, Kenji NABESHIMA, Rinzo SOEJIMA, Yoshihito NIKI, Yukio NISHIMOTO, Michio YAMAKIDO, Akimitsu KAMITSUNA, Kazumasa ITASAKA, Takao SASAKI, Yukio MATSUMOTO, Yoshiro SAWAE, Shinichiro HAYASHI, Hiroshi ASO, Nobuaki SHIGEMATSU, Masahide TAKII, Hidenobu SHIGEOKA, Hitoshi NAGANO, Torao INOUE, Shinichi MATSUO, Yuichi KASHIDA, Atsushi SHINODA, Tsuneo ISHIBASHI, Masahiro TAKAGI, Kohei HARA, Atsushi SAITO, Keizo YAMAGUCHI, Shigeru KOHNO, Naoki MIURA, Takashi IDE, Teruhiko RIKITAKE, Keizo MATSUMOTO, Naoto RIKITOMI, Masaru NASU, Jun GOTO, Yoichiro GOTO, Takayoshi TASHIRO, Masayuki ANDO, Moritake SUGA
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Keywords: Carumonam, Cefoperazone, Chronic respiratory infections, Double-blind comparative study
JOURNAL FREE ACCESS

1987 Volume 61 Issue 3 Pages 333-355

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Abstract

For an objective evaluation of the clinical efficacy and safety of carumonam (CRMN) in chronic respiratory infections due to gram-negative rod bacteria, a double-blind study was conducted using cefoperazone (CPZ) as a positive control. Either 1 g of CRMN or CPZ per dose was administered by the intravenous drip infusion twice a day and, as a rule, for 14 consecutive days. The results were as follows:
1) Homogeneity testing of background factors showed that P. aeruginosa as the causative organism was more frequently detected in the CRMN group with a significant difference (p<0.05) but no bias was found in any other background factor.
2) The clinical efficacy rate (excellent and good ratings combined) was: in the committee evaluation, 51.6%(32/62) for CRMA versus 58.2%(39/67) for CPZ, and in the presiding doctor evaluation, 65.1%(41/63) for CRMN versus 66.7%(44/66) for CPZ. Thus, both evaluations generated similar results.
As P. aeruginosa was detected more frequently in the CRMN group, the bias was corrected by the direct standardization method. The corrected efficacy rate was: in the committee evaluation, 55.0% for CRMN versus 54.2% for CPZ and in the presiding doctor evaluation, 66.9% for CRMN versus 62.8% for CPZ.
3) There was no intergroup difference in improvement rates for symptoms and laboratory findings. However, when the population for analysis was limited to cases with P. aeruginosa as a causative organism, the improvement rate for sputum property in the CRMN group was significantly higher than in the CPZ group (p<0.05).
4) As to bacteriological effect, the eradication rate was 56.5%(35/62) for CRMN versus 53.8%(35/65) for CPZ. In regard to P. aeruginosa which was most frequently isolated, the eradication rate was 51.4%(18/35) for CRMN versus 31.8%(7/22) for CPZ, thus being in favor of CRMN. A more remarkable difference was found when “decreased” ratings were included; thus 71.4% for CRMN versus 45.5% for CPZ (p<0.1).
5) The safety evaluation showed that the two drugs were almost equivalent in regard to the incidence of side effects and abnormal laboratory findings; 23.5%(23/98) for CRMN versus 24.4%(22/90) for CPZ.
With both drugs, allergic symptoms such as fever and eruption and gastrointestinal symptoms such as diarrhea were found as accompanying symptoms. Most of the abnormal laboratory findings were changes in liver function and hematology parameters for both drugs. No side effects were found with CRMN that are particularly different from those reported with the cephem drugs.
6) The clinical usefulness rate covering “useful” and higher ratings was: in the committee evaluation, 48.4%(31/64) for CRMN versus 54.5%(36/66) for CPZ and in the doctor evaluation, 61.9%(39/63) for CRMN versus 62.5%(40/64) for CPZ. Thus, the two drugs generated similar usefulness rates. However, the clinical usefulness rate after correction of the bias in the frequency of P. aeruginosa according to the same procedure as 2) was: in the committee evaluation, 51.9% for CRMN versus 51.0% for CPZ and in the presiding doctor evaluation, 64.2% for CRMN versus 58.7% for CPZ.
In efficacy and safety, CRMN was found to be equivalent to CPZ. In consideration of the fact that P. aeruginosa is frequently isolated in chronic respiratory infections, it is concluded that CRMN is an extremely useful drug in the treatment of these infections.

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