浅在性化膿性疾患に対するDL-8280とCefaclorとの二重盲検比較臨床試験成績

藤田 恵一; 中野 峰生; 野波 英一郎; 紫芝 敬子; 勝俣 道夫; 堀江 道茂; 渡辺 亮治; 久木田 淳; 渡辺 晋一; 染谷 通; 下妻 直郎; 古江 増隆; 岩田 充; 高橋 久; 竹島 真徳; 三浦 祐晶; 小林 仁; 野平 千賀子; 小野塚 役; 伊藤 正俊; 細野 久美子; 富沢 尊儀; 山口 淳子; 木下 三和子; 本田 光芳; 佐藤 元泰; 楠 万左子; 藤岡 三千; 西脇 宗一; 日野 治子; 北島 拓彌; 安西 喬; 佐藤 昌三; 実川 久美子; 笹川 正二; 新村 眞人; 戸沢 孝之; 辻 和男; 朝田 康夫; 菱川 秀夫; 野原 望; 梅村 茂夫; 荒田 次郎; 山本 康生; 占部 治邦; 仁位 泰樹; 陣内 恭子; 小川 暢也

doi:10.11150/kansenshogakuzasshi1970.58.793

Comparative Clinical Study of DL-8280 and Cefaclor for Suppurative Skin and Soft Tissue Infections by a Double-Blind Method

Keiichi FUJITA, Mineo NAKANO, Eiichiro NONAMI, Takako SHISHIBA, Michio KATSUMATA, Naoshige HORIE, Ryoji WATANABE, Atsushi KUKITA, Shinichi WATANABE, Toru SOMEYA, Michiro SHIMOTSUMA, Masutaka FURUE, Mitsuru IWATA, Hisashi TAKAHASHI, Masanori TAKESHIMA, Yusho MIURA, Hitoshi KOBAYASHI, Chikako NOHIRA, Takeshi ONOZUKA, Masatoshi ITO, Kumiko HOSONO, Takanori TOMIZAWA, Junko YAMAGUCHI, Miwako KINOSHITA, Mitsuyoshi HONDA, Motoyasu SATO, Masako KUSUNOKI, Michi FUJIOKA, Munekazu NISHIWAKI, Haruko HINO, Takuya KITAJIMA, Takashi ANZAI, Shozo SATO, Kumiko JITSUKAWA, Shoji SASAGAWA, Michihito NIIMURA, Takayuki TOZAWA, Kazuo TSUJI, Yasuo ASADA, Hideo HISHIKAWA, Nozomi NOHARA, Shigeo UMEMURA, Jiro ARATA, Yasuo YAMAMOTO, Harukuni URABE, Yasuki NII, Kyoko JINNAI, Nobuya OGAWA

Author information

Keiichi FUJITA
Department of Dermatology, National Defense Medical College
Mineo NAKANO
Department of Dermatology, National Defense Medical College
Eiichiro NONAMI
Department of Dermatology, The Kanto Teishin Hospital
Takako SHISHIBA
Department of Dermatology, The Kanto Teishin Hospital
Michio KATSUMATA
Department of Dermatology, The Kanto Teishin Hospital
Naoshige HORIE
Department of Dermatology, The Kanto Teishin Hospital
Ryoji WATANABE
Department of Dermatology, The Kanto Teishin Hospital
Atsushi KUKITA
Department of Dermatology, Faculty of Medicine, University of Tokyo
Shinichi WATANABE
Department of Dermatology, Faculty of Medicine, University of Tokyo
Toru SOMEYA
Department of Dermatology, Faculty of Medicine, University of Tokyo
Michiro SHIMOTSUMA
Department of Dermatology, Faculty of Medicine, University of Tokyo
Masutaka FURUE
Department of Dermatology, Faculty of Medicine, University of Tokyo
Mitsuru IWATA
Department of Dermatology, Faculty of Medicine, University of Tokyo
Hisashi TAKAHASHI
Department of Dermatology, Teikyo University, School of Medicine
Masanori TAKESHIMA
Department of Dermatology, Teikyo University, School of Medicine
Yusho MIURA
Department of Dermatology, Hokkaido University, School of Medicine
Hitoshi KOBAYASHI
Department of Dermatology, Hokkaido University, School of Medicine
Chikako NOHIRA
Department of Dermatology, Hokkaido University, School of Medicine
Takeshi ONOZUKA
Department of Dermatology, Tonan Hospital
Masatoshi ITO
Department of Dermatology, School of Medicine, Toho University
Kumiko HOSONO
Department of Dermatology, School of Medicine, Toho University
Takanori TOMIZAWA
Department of Dermatology, Kanto-Rosai Hospital
Junko YAMAGUCHI
Department of Dermatology, Kanto-Rosai Hospital
Miwako KINOSHITA
Department of Dermatology, Kanto-Rosai Hospital
Mitsuyoshi HONDA
Department of Dermatology, The 2nd Hospital, Nippon Medical School
Motoyasu SATO
Department of Dermatology, The 2nd Hospital, Nippon Medical School
Masako KUSUNOKI
Department of Dermatology, The 2nd Hospital, Nippon Medical School
Michi FUJIOKA
Department of Dermatology, The 2nd Hospital, Nippon Medical School
Munekazu NISHIWAKI
Department of Dermatology, Kanto Chuo Hospital
Haruko HINO
Department of Dermatology, Kanto Chuo Hospital
Takuya KITAJIMA
Department of Dermatology, Kanto Chuo Hospital
Takashi ANZAI
Department of Dermatology, Japanese Red Cross Medical Center
Shozo SATO
Department of Dermatology, Japanese Red Cross Medical Center
Kumiko JITSUKAWA
Department of Dermatology, Japanese Red Cross Medical Center
Shoji SASAGAWA
Department of Dermatology, The Jikei University School of Medicine
Michihito NIIMURA
Department of Dermatology, The Jikei University School of Medicine
Takayuki TOZAWA
Department of Dermatology, The Jikei University School of Medicine
Kazuo TSUJI
Department of Dermatology, The Jikei University School of Medicine
Yasuo ASADA
Department of Dermatology, Kansai Medical University
Hideo HISHIKAWA
Department of Dermatology, Kansai Medical University
Nozomi NOHARA
Department of Dermatology, Okayama University Medical School
Shigeo UMEMURA
Department of Dermatology, Okayama University Medical School
Jiro ARATA
Department of Dermatology, Kochi Medical University
Yasuo YAMAMOTO
Department of Dermatology, Kochi Medical University
Harukuni URABE
Department of Dermatology, Faculty of Medicine, Kyushu University
Yasuki NII
Department of Dermatology, Faculty of Medicine, Kyushu University
Kyoko JINNAI
Department of Dermatology, Faculty of Medicine, Kyushu University
Nobuya OGAWA
Department of Pharmacology, Ehime University, School of Medicine

Keywords: DL-8280, Cefaclor, Suppurative Skin and Soft Tissue Infections, Double-Blind Method

JOURNAL FREE ACCESS

1984 Volume 58 Issue 9 Pages 793-819

DOI https://doi.org/10.11150/kansenshogakuzasshi1970.58.793

Details

Abstract

The effectiveness, safety and utility of DL-8280, a pyridonecarboxylic acid derivative, in the field ofsuppurative skin and soft tissue infections were compared with those of Cefaclor (CCL) by a double-blindmethod.
DL-8280 was orally administered in daily dose of 600 mg and CCL was orally administered in dailydose of 750 mg. Each group was treated for 14 days. The results were as follows:
1) Final global improvement rate of DL-8280 was evaluated in 121 patients and out of them “Cured” was marked in 67, “Remarkably improved” in 28, “Moderately improved” in 12, “Slightlyimproved” in 8, “Unchanged” in 2 and “Aggravated” in 4. The percentage of “Cured” and “Remarkably improved” was 78.5%, and increased to 88.4% when “Moderately improved” was included. “Aggravated” and “Remarkably aggravated” shared 3.3%.
For the global improvement rate of CCL, “Cured” was noted in 56, “Remarkably improved” in 27, “Moderately improved” in 23, “Slightly improved” in 5, “Unchanged” in 7, “Aggravated” in 1 and “Remarkably aggravated” in 1 out of 120 patients. The percentage of “Cured” and “Remarkably improved”was 69.2%, increased to 88.3% by addition of “Moderately improved”, whereas “Aggravated”and “Remarkably aggravated” rated 1.7%.
No significant difference was shown between two drug groups.
2) Side effect was noted in 2.3% of 129 patients treated with DL-8280 and 5.4% of 130 patientstreated with CCL, showing no statistically significant difference between two drug groups.
3) In regard to global utility rate of DL-8280, “Remarkably useful” was noted in 65 cases, “Useful” in 39, “Slightly useful” in 11, “Not useful” in 6 out of 121 patients. “Remarkably useful”shared 53.7% and the total of “Remarkably useful” and “Useful” shared 86.0%.In the CCL group, “Remarkably useful” was noted in 55, “Useful” in 41, “Slightly useful” in 14, “Not useful” in 11, “Harmful” in 1 out of 122 patients. “Remarkably useful” shared 45.1%, and thetotal of “Remarkably useful” and “Useful” shared 78.7%.
No significant difference was shown between two drug groups.
4) In regard to global improvement rate by evaluation day, DL-8280 group was significantlysuperior to CCL group on days 3, 10 and 14.
Especially in the group 1, DL-8280 group was significantly superior to CCL group throughout thestudy period.
Taking together, DL-8280 has tendency to superior to CCL in treatment of suppurative skin and softtissue infections. Because of the result obtained and that no resistant bacteria was observed so far, DL-8280 can be expected as useful drug for this field.

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