細菌性肺炎に対するTazobactam/PiperacillinとPiperacillinの薬効比較試験成績  [in Japanese] A COMPARATIVE STUDY OF TAZOBACTAM/PIPERACILLIN AND PIPERACILLIN IN BACTERIAL PNEUMONIA  [in Japanese]

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Author(s)

    • 大泉 耕太郎 OIZUMI KOTARO
    • 久留米大学医学部第一内科および関連施設 The First Department of Internal Medicine, Kurume University School of Medicine and Affiliated Hospital
    • 武部 和夫 TAKEBE KAZUO
    • 弘前大学医学部第三内科および関連施設 The Third Department of Internal Medicine, Hirosaki University School of Medicine and Affiliated Hospital
    • 副島 林造 SOEJIMA RINZO
    • 川崎医科大学呼吸器内科 Division of Respiratory Diseases, Department of Medicine, Kawasaki Medical School
    • 守屋 修 MORIYA OSAMU
    • 川崎医科大学呼吸器内科 Division of Respiratory Diseases, Department of Medicine, Kawasaki Medical School
    • 木村 丹 KIMURA MAKOTO
    • 川崎医科大学附属川崎病院第二内科 The Second Department of Internal Medicine, Kawasaki Medical School, Kawasaki Hospital
    • 田村 豊一 TAMURA TOYOKAZU
    • 弘前大学医学部第三内科および関連施設 The Third Department of Internal Medicine, Hirosaki University School of Medicine and Affiliated Hospital
    • 原 耕平 HARA KOHEI
    • 長崎大学医学部第二内科および関連施設 The Second Department of Internal Medicine, Nagasaki University, School of Medicine and Affiliated Hospitals
    • 古賀 宏延 KOGA HIRONOBU
    • 長崎大学医学部第二内科および関連施設 The Second Department of Internal Medicine, Nagasaki University, School of Medicine and Affiliated Hospitals
    • 李 嘉明 RI YOSHIAKI
    • 長崎大学医学部第二内科および関連施設 The Second Department of Internal Medicine, Nagasaki University, School of Medicine and Affiliated Hospitals
    • 増山 泰治 MASUYAMA TAIJI
    • 長崎大学医学部第二内科および関連施設 The Second Department of Internal Medicine, Nagasaki University, School of Medicine and Affiliated Hospitals
    • 吉本 正彦 YOSHIMOTO MASAHIKO
    • 長崎大学医学部第二内科および関連施設 The Second Department of Internal Medicine, Nagasaki University, School of Medicine and Affiliated Hospitals
    • 下口 和矩 SHIMOGUCHI KAZUNORI
    • 長崎大学医学部第二内科および関連施設 The Second Department of Internal Medicine, Nagasaki University, School of Medicine and Affiliated Hospitals
    • 奥野 一裕 OKUNO KAZUHIRO
    • 長崎大学医学部第二内科および関連施設 The Second Department of Internal Medicine, Nagasaki University, School of Medicine and Affiliated Hospitals
    • 福島 喜代康 FUKUSHIMA KIYOYASU
    • 長崎大学医学部第二内科および関連施設 The Second Department of Internal Medicine, Nagasaki University, School of Medicine and Affiliated Hospitals
    • 松本 慶蔵 MATSUMOTO KEIZO
    • 長崎大学熱帯医学研究所内科および関連施設 Department of Internal Medicine, Institute for Tropical Medicine, Nagasaki University and Affiliated Hospitals
    • 永武 毅 NAGATAKE TSUYOSHI
    • 長崎大学熱帯医学研究所内科および関連施設 Department of Internal Medicine, Institute for Tropical Medicine, Nagasaki University and Affiliated Hospitals
    • 大石 和徳 OISHI KAZUNORI
    • 長崎大学熱帯医学研究所内科および関連施設 Department of Internal Medicine, Institute for Tropical Medicine, Nagasaki University and Affiliated Hospitals
    • 堀 彰宏 HORI AKIHIRO
    • 長崎大学熱帯医学研究所内科および関連施設 Department of Internal Medicine, Institute for Tropical Medicine, Nagasaki University and Affiliated Hospitals
    • 坂本 翊 SAKAMOTO TASUKU
    • 長崎大学熱帯医学研究所内科および関連施設 Department of Internal Medicine, Institute for Tropical Medicine, Nagasaki University and Affiliated Hospitals
    • 田中 宏史 TANAKA HIROFUMI
    • 長崎大学熱帯医学研究所内科および関連施設 Department of Internal Medicine, Institute for Tropical Medicine, Nagasaki University and Affiliated Hospitals
    • 森戸 俊博 MORITO TOSHIHIRO
    • 長崎大学熱帯医学研究所内科および関連施設 Department of Internal Medicine, Institute for Tropical Medicine, Nagasaki University and Affiliated Hospitals
    • 藤下 幹夫 FUJISHITA MIKIO
    • 長崎大学熱帯医学研究所内科および関連施設 Department of Internal Medicine, Institute for Tropical Medicine, Nagasaki University and Affiliated Hospitals
    • 安藤 正幸 ANDO MASAYUKI
    • 熊本大学医学部第一内科 The First Department of Internal Medicine, School of Medicine, Kumamoto University
    • 菅 守隆 SUGA MORITAKA
    • 熊本大学医学部第一内科 The First Department of Internal Medicine, School of Medicine, Kumamoto University
    • 税田 直樹 SAITA NAOKI
    • 熊本大学医学部第一内科 The First Department of Internal Medicine, School of Medicine, Kumamoto University
    • 那須 勝 NASU MASARU
    • 大分医科大学第二内科および関連施設 The Second Department of Internal Medicine, Oita Medical University and Affiliated Hospital
    • 山崎 透 YAMASAKI TOHRU
    • 大分医科大学第二内科および関連施設 The Second Department of Internal Medicine, Oita Medical University and Affiliated Hospital
    • 後藤 純 GOTO JUN
    • 大分医科大学第二内科および関連施設 The Second Department of Internal Medicine, Oita Medical University and Affiliated Hospital
    • 北川 和生 KITAGAWA KAZUO
    • 大分医科大学第二内科および関連施設 The Second Department of Internal Medicine, Oita Medical University and Affiliated Hospital
    • 斉藤 厚 SAITO ATSUSHI
    • 琉球大学医学部第一内科 The First Department of Internal Medicine, School of Medicine, Ryukyu University
    • 大湾 勤子 OWAN ISOKO
    • 琉球大学医学部第一内科 The First Department of Internal Medicine, School of Medicine, Ryukyu University
    • 稲留 潤 INADOME JUN
    • 琉球大学医学部第一内科 The First Department of Internal Medicine, School of Medicine, Ryukyu University
    • 小原 秋穂 OHARA AKIHO
    • 岩手県立中央病院呼吸器内科 Department of Respiratory Diseases, Iwate Prefectural Central Hospital
    • 大野 高義 OHNO TAKAYOSI
    • 久留米大学医学部第一内科および関連施設 The First Department of Internal Medicine, Kurume University School of Medicine and Affiliated Hospital
    • 白土 邦男 SIRATO KUNIO
    • 東北大学医学部第一内科および関連施設 The First Department of Internal Medicine, School of Medicine, Tohoku University and Affiliated Hospital
    • 丹野 恭夫 TANNO YASUO
    • 東北大学医学部第一内科および関連施設 The First Department of Internal Medicine, School of Medicine, Tohoku University and Affiliated Hospital
    • 遠野 正人 TOHNO MASATO
    • 東北大学医学部第一内科および関連施設 The First Department of Internal Medicine, School of Medicine, Tohoku University and Affiliated Hospital
    • 小野 康夫 ONO YASUO
    • 東北大学医学部第一内科および関連施設 The First Department of Internal Medicine, School of Medicine, Tohoku University and Affiliated Hospital
    • 鈴木 沢耶 SUZUKI TAKUYA
    • 東北大学医学部第一内科および関連施設 The First Department of Internal Medicine, School of Medicine, Tohoku University and Affiliated Hospital
    • 渡辺 彰 WATANABE AKIRA
    • 東北大学抗酸菌病研究所内科および関連施設 Department of Internal Medicine, Research Institute for Chest Diseases and Cancer (Institute of Development, Aging and Cancer), Tohoku University and Affiliated Hospitals
    • 貫和 敏博 NUKIWA TOSHIHIRO
    • 東北大学抗酸菌病研究所内科および関連施設 Department of Internal Medicine, Research Institute for Chest Diseases and Cancer (Institute of Development, Aging and Cancer), Tohoku University and Affiliated Hospitals
    • 今野 淳 KONNO KIYOSHI
    • 東北大学抗酸菌病研究所内科および関連施設 Department of Internal Medicine, Research Institute for Chest Diseases and Cancer (Institute of Development, Aging and Cancer), Tohoku University and Affiliated Hospitals
    • 志田 國治 SHIDA KUNIHARU
    • 東北大学抗酸菌病研究所内科および関連施設 Department of Internal Medicine, Research Institute for Chest Diseases and Cancer (Institute of Development, Aging and Cancer), Tohoku University and Affiliated Hospitals
    • 川原 正士 KAWAHARA MASAO
    • 久留米大学医学部第一内科および関連施設 The First Department of Internal Medicine, Kurume University School of Medicine and Affiliated Hospital
    • 佐山 恒夫 SAYAMA TSUNEO
    • 東北大学抗酸菌病研究所内科および関連施設 Department of Internal Medicine, Research Institute for Chest Diseases and Cancer (Institute of Development, Aging and Cancer), Tohoku University and Affiliated Hospitals
    • 佐藤 和男 SATO KAZUO
    • 東北大学抗酸菌病研究所内科および関連施設 Department of Internal Medicine, Research Institute for Chest Diseases and Cancer (Institute of Development, Aging and Cancer), Tohoku University and Affiliated Hospitals
    • 安西 吉行 ANZAI YOSHIYUKI
    • 東北大学抗酸菌病研究所内科および関連施設 Department of Internal Medicine, Research Institute for Chest Diseases and Cancer (Institute of Development, Aging and Cancer), Tohoku University and Affiliated Hospitals
    • 穴沢 予識 ANAZAWA YOSHIKI
    • 東北大学抗酸菌病研究所内科および関連施設 Department of Internal Medicine, Research Institute for Chest Diseases and Cancer (Institute of Development, Aging and Cancer), Tohoku University and Affiliated Hospitals
    • 吉田 進 YOSHIDA SUSUMU
    • 東北大学抗酸菌病研究所内科および関連施設 Department of Internal Medicine, Research Institute for Chest Diseases and Cancer (Institute of Development, Aging and Cancer), Tohoku University and Affiliated Hospitals
    • 島田 馨 SHIMADA KAORU
    • 東京大学医科学研究所感染症研究部および関連施設 Department of Infectious Diseases, Institute of Medical Science, University of Tokyo and Affiliated Hospital
    • 佐野 靖之 SANO YASUYUKI
    • 東京大学医科学研究所感染症研究部および関連施設 Department of Infectious Diseases, Institute of Medical Science, University of Tokyo and Affiliated Hospital
    • 秋山 法久 AKIYAMA NORIHISA
    • 東京大学医科学研究所感染症研究部および関連施設 Department of Infectious Diseases, Institute of Medical Science, University of Tokyo and Affiliated Hospital
    • 川口 信三 KAWAGUCHI SHINZO
    • 久留米大学医学部第一内科および関連施設 The First Department of Internal Medicine, Kurume University School of Medicine and Affiliated Hospital
    • 荒井 康男 ARAI YASUO
    • 東京大学医科学研究所感染症研究部および関連施設 Department of Infectious Diseases, Institute of Medical Science, University of Tokyo and Affiliated Hospital
    • 大友 守 OHTOMO MAMORU
    • 東京大学医科学研究所感染症研究部および関連施設 Department of Infectious Diseases, Institute of Medical Science, University of Tokyo and Affiliated Hospital
    • 最所 正純 SAISHO MASAZUMI
    • 久留米大学医学部第一内科および関連施設 The First Department of Internal Medicine, Kurume University School of Medicine and Affiliated Hospital
    • 小山 優 KOYAMA MASARU
    • 国家公務員等共済組合連合会総合病院東京共済病院内科 Department of Internal Medicine, Tokyo Kyosai Hospital
    • 松本 文夫 MATSUMOTO FUMIO
    • 神奈川県衛生看護専門学校付属病院内科 Department of Internal Medicine, Kanagawa Prefecture Midwives and Nurses Training School Hospital
    • 今井 健郎 IMAI TAKEO
    • 神奈川県衛生看護専門学校付属病院内科 Department of Internal Medicine, Kanagawa Prefecture Midwives and Nurses Training School Hospital
    • 光武 良幸 MITUTAKE YOSHIYUKI
    • 久留米大学医学部第一内科および関連施設 The First Department of Internal Medicine, Kurume University School of Medicine and Affiliated Hospital
    • 小田切 繁樹 ODAGIRI SHIGEKI
    • 神奈川県立循環器呼吸器病センター呼吸器科 Department of Respiratory Diseases, Kanagawa Prefectural Cardiovascular and Respiratory Disease Center
    • 小倉 高志 OGURA TAKASHI
    • 神奈川県立循環器呼吸器病センター呼吸器科 Department of Respiratory Diseases, Kanagawa Prefectural Cardiovascular and Respiratory Disease Center
    • 平居 義裕 HIRAI YOSHIHIRO
    • 神奈川県立循環器呼吸器病センター呼吸器科 Department of Respiratory Diseases, Kanagawa Prefectural Cardiovascular and Respiratory Disease Center
    • 荒川 正昭 ARAKAWA MASAAKI
    • 新潟大学医学部第二内科およびその関連施設 The Second Department of Internal Medicine, Niigata University, School of Medicine and Affiliated Hospital
    • 星野 重幸 HOSHINO SHIGEYUKI
    • 新潟大学医学部第二内科およびその関連施設 The Second Department of Internal Medicine, Niigata University, School of Medicine and Affiliated Hospital
    • 塚田 弘樹 TSUKADA HIROKI
    • 新潟大学医学部第二内科およびその関連施設 The Second Department of Internal Medicine, Niigata University, School of Medicine and Affiliated Hospital
    • 泉 三郎 IZUMI SABURO
    • 富山県立中央病院内科 Department of Internal Medicine, Toyama Prefectural Central Hospital
    • 佐藤 篤彦 SATO ATSUHIKO
    • 浜松医科大学第二内科およびその関連施設 The Second Department of Internal Medicine, Hamamatsu University School of Medicine and Affiliated Hospital
    • 服部 忠和 HATTORI TADAKAZU
    • 浜松医科大学第二内科およびその関連施設 The Second Department of Internal Medicine, Hamamatsu University School of Medicine and Affiliated Hospital
    • 齋藤 玲 SAITO AKIRA
    • 北海道大学医学部第二内科および関連施設 The Second Department of Internal Medicine, Hokkaido University, School of Medicine and Affiliated Hospital
    • 中野 豊 NAKANO YUTAKA
    • 浜松医科大学第二内科およびその関連施設 The Second Department of Internal Medicine, Hamamatsu University School of Medicine and Affiliated Hospital
    • 高木 健三 TAKAGI KENZO
    • 名古屋大学医学部第二内科および関連施設 Department of Internal Medicine II, Nagoya University School of Medicine and Affiliated Hospital
    • 野田 康信 NODA YASUNOBU
    • 名古屋大学医学部第二内科および関連施設 Department of Internal Medicine II, Nagoya University School of Medicine and Affiliated Hospital
    • 権田 秀雄 GONDA HIDEO
    • 名古屋大学医学部第二内科および関連施設 Department of Internal Medicine II, Nagoya University School of Medicine and Affiliated Hospital
    • 武内 俊彦 TAKEUCHI TOSHIHIKO
    • 名古屋市立大学医学部第一内科および関連施設 The First Department of Internal Medicine, School of Medicine, Nagoya City University and Affiliated Hospital
    • 山田 保夫 YAMADA YASUO
    • 名古屋市立大学医学部第一内科および関連施設 The First Department of Internal Medicine, School of Medicine, Nagoya City University and Affiliated Hospital
    • 花木 英和 HANAKI HIDEKAZU
    • 名古屋市立大学医学部第一内科および関連施設 The First Department of Internal Medicine, School of Medicine, Nagoya City University and Affiliated Hospital
    • 川上 誠 KAWAKAMI MAKOTO
    • 名古屋市立大学医学部第一内科および関連施設 The First Department of Internal Medicine, School of Medicine, Nagoya City University and Affiliated Hospital
    • 富沢 磨須美 TOMIZAWA MASUMI
    • 北海道大学医学部第二内科および関連施設 The Second Department of Internal Medicine, Hokkaido University, School of Medicine and Affiliated Hospital
    • 久世 文幸 KUZE FUMIYUKI
    • 京都大学胸部疾患研究所附属病院第一内科および関連施設 The First Department of Internal Medicine, Chest Disease Research Institute, Kyoto University and Affiliated Hospitals
    • 坂東 憲司 BANDO KENJI
    • 京都大学胸部疾患研究所附属病院第一内科および関連施設 The First Department of Internal Medicine, Chest Disease Research Institute, Kyoto University and Affiliated Hospitals
    • 大山 眞一郎 OHYAMA SHINICHIRO
    • 京都大学胸部疾患研究所附属病院第一内科および関連施設 The First Department of Internal Medicine, Chest Disease Research Institute, Kyoto University and Affiliated Hospitals
    • 日下 昌平 KUSAKA SHOHEI
    • 京都大学胸部疾患研究所附属病院第一内科および関連施設 The First Department of Internal Medicine, Chest Disease Research Institute, Kyoto University and Affiliated Hospitals
    • 石田 直 ISHIDA TADASHI
    • 京都大学胸部疾患研究所附属病院第一内科および関連施設 The First Department of Internal Medicine, Chest Disease Research Institute, Kyoto University and Affiliated Hospitals
    • 望月 吉郎 MOCHIZUKI YOSHIRO
    • 京都大学胸部疾患研究所附属病院第一内科および関連施設 The First Department of Internal Medicine, Chest Disease Research Institute, Kyoto University and Affiliated Hospitals
    • 河南 里江子 KANAN RIEKO
    • 京都大学胸部疾患研究所附属病院第一内科および関連施設 The First Department of Internal Medicine, Chest Disease Research Institute, Kyoto University and Affiliated Hospitals
    • 露口 一成 TSUYUGUCHI KAZUSHIGE
    • 京都大学胸部疾患研究所附属病院第一内科および関連施設 The First Department of Internal Medicine, Chest Disease Research Institute, Kyoto University and Affiliated Hospitals
    • 小池 隆夫 KOIKE TAKAO
    • 北海道大学医学部第二内科および関連施設 The Second Department of Internal Medicine, Hokkaido University, School of Medicine and Affiliated Hospital

Abstract

新しく開発されたβ-ラクタマーゼ阻害剤であるTazobactam (TAZ) と広域ペニシリン系抗生物質Piperacillin (PIPC) を1: 4の割合で配合した注射用ペニシリン系複合抗生物質であるTazobactam/Piperacillin (TAZ/PIPC) の細菌性肺炎および肺化膿症に対する有効性, 安全性および有用性をPIPCを対照薬とし, 多施設2群間比較試験により比較検討した。<BR>TAZ/PIPCは1回2.5g (力価) を1日2回, PIPCは1回2.0g (力価) を1日2回, 原則として14日間点滴静注した。<BR>成績は以下のとおりであった。<BR>1. 臨床効果はTAZ/PIPC群94% (80/85) に対し, PIPC群89% (70/79) の有効率であり, 両薬剤群間に有意差は認められなかった (P=0.562; U-test)。<BR>2. 臨床症状・所見および臨床検査値の改善度の比較において, 一部, 胸部ラ音の3日後でTAZ/PIPC群が有意に優れた成績 (P=0.028; U-test) を示した以外は両薬剤群間に有意差は認められらなかった。<BR>3. 細菌学的効果はTAZ/PIPC群98% (40/41) の菌消失率に対し, PIPC群は80% (28/35) であり, TAZ/PIPC群が有意に優れていた (P=0.021; Fisher's exact probability method)。なお, 菌の消長においてもTAZ/PIPC群が有意に優れていた (P=0.020; Fisher's exact probabilitymethod)。推定起因菌検出例80例 (TAZ/PIPC群;43例, PIPC群;37例) 中, 起因菌のβ-ラクタマーゼ産生性が確認出来た症例は両薬剤群ともに11例にすぎず, これらの症例における細菌学的効果には有意差は認められなかった。なお, β-ラクタマーゼの産生が確認出来た菌に対するTAZ/PIPCとPIPCの最小発育阻止濃度 (MIC) を比較すると明らかにTAZ/PIPCがPIPCに比べ優れていた。<BR>4. 副作用はTAZ/PIPC群10% (10/96), PIPC群7% (7/95), 臨床検査値異常はTAZ/PIPC群22% (20/92), PIPC群18% (17/93) の発現率であり, いずれについても両薬剤群間に有意差は認められなかった<BR>。5. 有用性に関しては, TAZ/PIPC群87% (75/86), PIPC群85% (67/79) の有用率であり, 有意差は認められなかった (P=0.905; U-test)。<BR>以上の成績より, TAZ/PIPCの1回2.5g (力価), 1日2回投与は, 細菌性肺炎の治療において, PIPCの1回2.0g (力価), 1日2回投与と比較し同等以上に有用な薬剤であると考えられた。

The efficacy, safety and usefulness of tazobactam/piperacillin (TAZ/PIPC), in bacterial pneumonia and lung abscess were determined with PIPC as the control in a multi-institutional comparative study a penicillin antibiotic for injection prepared by combining a newly developed β-lactamase inhibitor, tazobactam (TAZ), with a broad spectrum penicillin antibiotic, piperacillin (PIPC), at a ratio of 1: 4.<BR>TAZ/PIPC was intravenously injected at a dose of 2.5 g (titer) twice a day, and PIPC at a dose of 2.0 g (titer) twice a day as a rule for 14 days.<BR>The following results were obtained:<BR>1. The efficacy rates for bacterial pneumonia and lung abscess were 94% (80/85) in TAZ/PIPC group and 89% (70/79) in PIPC group, showing no significant difference between the twogroups.<BR>2. In a comparison of degrees of improvement in clinical symptoms, signs and laboratory findings, there were no significant differences between the two groups except for results on thoracic rales after three days of administration.<BR>3. As for bacteriological effects, the elimination rates of causative organisms were 98% (40/41) in the TAZ/PIPC group and 80% (28/35) in the PIPC group. Thus, the TAZ/PIPC group was significantly superior to the PIPC group. The TAZ/PIPC group showed significantly better eradication of bacateria as well. Bacteria considered to be pyogenic were detected in 80 patients (43 administered TAZ/PIPC and 37 administered PIPC), but β-lactamase production was confirmed in only 11 patients of each group. There were no significant differences in bacteriological effects among these patients. Minimum inhibitory concentrations of TAZ/PIPC against β-lactamase producing organisms were distinctly superior to those of PIPC.<BR>4. Side effects occurred in 10% (10/96) of the TAZ/PIPC group and 7% (7/95) of the PIPC group. Abnormal clinical laboratory test values were observed in 22% (20/92) of the TAZ/PIPC group and 18% (17/93) of the PIPC group. Thus, there were no significant differences between the two administration groups.<BR>5. The usefulness rate in the TAZ/PIPC group was 87% (75/86) and it was 85% (67/79) in the PIPC group, showing no significant difference between them.<BR>The results suggest that TAZ/PIPC administered at a dose of 2.5 g (titer) twice a day is more useful than PIPC administered at a dose of 2.0g (titer) twice a day in the treatment of bacterial pneumonia.

Journal

  • The Japanese Journal of Antibiotics

    The Japanese Journal of Antibiotics 48(4), 449-481, 1995

    Japan Antibiotics Research Association

Codes

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