{"@context":{"@vocab":"https://cir.nii.ac.jp/schema/1.0/","rdfs":"http://www.w3.org/2000/01/rdf-schema#","dc":"http://purl.org/dc/elements/1.1/","dcterms":"http://purl.org/dc/terms/","foaf":"http://xmlns.com/foaf/0.1/","prism":"http://prismstandard.org/namespaces/basic/2.0/","cinii":"http://ci.nii.ac.jp/ns/1.0/","datacite":"https://schema.datacite.org/meta/kernel-4/","ndl":"http://ndl.go.jp/dcndl/terms/","jpcoar":"https://github.com/JPCOAR/schema/blob/master/2.0/"},"@id":"https://cir.nii.ac.jp/crid/1390282680025679104.json","@type":"Article","productIdentifier":[{"identifier":{"@type":"DOI","@value":"10.11150/kansenshogakuzasshi1970.59.605"}},{"identifier":{"@type":"PMID","@value":"3932547"}},{"identifier":{"@type":"NDL_BIB_ID","@value":"3048813"}},{"identifier":{"@type":"URI","@value":"http://id.ndl.go.jp/bib/3048813"}},{"identifier":{"@type":"URI","@value":"https://ndlsearch.ndl.go.jp/books/R000000004-I3048813"}},{"identifier":{"@type":"NAID","@value":"130004329059"}},{"identifier":{"@type":"NAID","@value":"40000566339"}},{"identifier":{"@type":"URI","@value":"https://search.jamas.or.jp/link/ui/1986072598"}}],"resourceType":"学術雑誌論文(journal article)","dc:title":[{"@language":"en","@value":"Comparative Study of the Effectiveness of Lenampicillin and Bacampicillin on Bacterial Pneumonia by Double Blind Method"},{"@language":"ja","@value":"細菌性肺炎を対象としたLenampicillin (KBT-1585) とBacampicillinの薬効比較試験成績"},{"@language":"ja-Kana","@value":"サイキンセイ ハイエン オ タイショウ ト シタ Lenampicillin"}],"description":[{"type":"abstract","notation":[{"@language":"en","@value":"The clinical efficacy and safety of Lenamicillin (KBT-1585, LAPC) were compared with those of Bacampicillin (BAPC) as the control drug in patients with bacterial pneumonia by double blind study.<BR>Patients over 16 years old with apparent clinical signs and symptoms of pneumonia were administered LAPC (at a daily dose of 1 g) or BAPC (at a daily dose of 1 g) orally for 14 days in principle. Then the clinical and bacteriological efficacy, improvement in symptoms, side effects, abnormal changes in laboratory findings, and utility were assessed.<BR>After excluding the patients which did not fit the protocol from the total 209 patients admitted to the study, clinical efficacy, side effects and abnormal changes in laboratory findings were analyzed statistically in 187 patients, in 199 and in 193 patients respectively.<BR>Basides, clinical efficacy was analyzed in the patients with bacterial pneumonia which were completely adapted to the protocol and also in the total patients including those with non-bacterial pneumonia and other respiratory tract infections.<BR>1) On the basis of committee judgement, the clinical efficacy rate in the patients with bacterial pneumonia was 86.9% for the LAPC group and 86.7% for the BAPC group, respectively. As for the total cases, the rate was 80.2% for the LAPC group and 85.4% for the BAPC group, respectively.<BR>In both analyses, no significant differences were found between the two groups.<BR>2) According to the judgement by doctors in charge, the clinical efficacy rate in the patients with bacterial pneumonia was 90.0% for the LAPC group and 84.0% for the BAPC group, respectively.<BR>As for the total cases, the efficacy rate was 81.6% for the LAPC group and 81.7% for the BAPC group, respectively.<BR>In both analyses, there were no significant differences between the two groups.<BR>3) As for the bacteriological efficacy, there was no significant difference between the two groups.<BR>4) The incidence of side effects was 4.1% in the LAPC group and 7.8% in the BAPC group, respectively. The incidence of the abnormal changes in laboratory findigs was 19.4% for the LAPC group and 22.0% for the BAPC group, respectively. There was no significant difference between the two groups.<BR>5) The utility rate in the patients with bacterial pneumonia judged by the committee was 86.9% for the LAPC group and 80.0% for the BAPC group, respectively. The rate in the total cases was 80.2% for the LAPC group and 79.2% for the BAPC group. No significant differences between the two groups were noted. In the utility rate judged by doctors in charge, no significant difference was found between the two groups, too.<BR>As described above, any significant differences were found between LAPC (at a daily dose of 1 g) and BAPC (at a daily dose of 1 g) neither in the efficacy rates nor in their safety. From these results, LAPC as well as BAPC are considered to be highly useful antibacterial agents for the treatment of respiratory tract infections."},{"@language":"ja","@value":"Lenampicillin (KBT-1585, 以下LAPCと略す) の細菌性肺炎に対する有効性と安全性をBacampicillin (以下BAPCと略す) を対照薬剤とし, 二重盲検法により比較的検討した.<BR>肺炎の存在明確な16歳以上の患者を対象とし, LAPC (1日1g) またはBAPC (1日1g) を原則として14日間経口投与し, 臨床効果, 細菌学的効果, 症状改善度, 副作用・臨床検査値異常化の有無, 有用性を判定した.<BR>薬剤投与症例209例中, プロトコールに基づいて違反例を除外し, 有効性の解析は187例, 副作用の解析は199例, 臨床検査値異常化の解析は193例について実施した.なお, 有効性の解析はプロトコールに厳密に合致した肺炎・肺化膿症症例と, これに非細菌性肺炎, 気道感染症を加えた全症例の双方について実施した.得られた成績は下記のとおりである.<BR>1) 肺炎・肺化膿症症例では膿性痰喀出例が, 全症例では膿性痰喀出例と, 咳嗽の強い症例が, それぞれLAPC投与群に有意に多数存在した以外, 他の背景因子に関して両薬剤群間に有意差は認められなかった.<BR>2) 小委員会判定臨床効果 (著効と有効を合わせた有効率) は細菌性肺炎・肺化膿症ではLAPC投与群86.9%, BAPC投与群86.7%, 全症例ではLAPC投与群80.2%, BAPC投与群85.4%で, 両薬剤群間に有意差を認めなかった.<BR>3) 主治医判定臨床効果 (著効と有効を合せた有効率) は細菌性肺炎・肺化膿症ではLAPC投与群90.0%, BAPC投与群84.0%, 全症例ではLAPC投与群81.6%, BAPC投与群81.7%で, 両薬剤群間に有意差を認めなかった.<BR>4) 細菌性肺炎・肺化膿症症例における症状改善率に関して, 胸痛の3日後, 7日後の改善度はBAPC投与群がLAPC投与群より高く, 改善度の差に有意の傾向が認められた.<BR>5) 細菌学的効果は細菌性肺炎・肺化膿症症例では46例, 全症例では65例について解析された.細菌性肺炎・肺化膿症症例における除菌率はLAPC投与群78.3%, BAPC投与群85.0%, 全症例における除菌率はLAPC投与群75.0%, BAPC投与群80.0%で, 両薬剤群間に有意差を認めなかった.<BR>6) 副作用発現率はLAPC投与群4.1%, BAPC投与群7.8%, 臨床検査値異常化出現率はLAPC投与群19.4%, BAPC投与群22.0%であり, いずれも両薬剤群間に有意差は認められなかった.<BR>7) 有用性に関して, 小委員会判定の有用率は細菌性肺炎・肺化膿症症例ではLAPC投与群86.9%, BAPC投与群80.0%, 全症例ではLAPC投与群80.2%, BAPC投与群79.2%で, 両薬剤群間に有意差は認められなかった. 主治医判定有用性についても両薬剤投与群間に有意差は認められなかった.<BR>以上のように, LAPC1日1gの細菌性肺炎に対する有効性はBAPC1日1gの有効性と比較して有意差なく, 安全性に関してもLAPC, BAPC間に有意差が認められなかった結果, LAPCはBAPC同様に, 呼吸器感染症の治療に有用性の高い抗菌薬と考えられる."}],"abstractLicenseFlag":"disallow"}],"creator":[{"@id":"https://cir.nii.ac.jp/crid/1410282680025679393","@type":"Researcher","foaf:name":[{"@language":"en","@value":"UJIIE Akira"},{"@language":"ja","@value":"氏家 昭"}],"jpcoar:affiliationName":[{"@language":"ja","@value":"北海道大学第2内科およびその協力施設"},{"@language":"en","@value":"The Second Department of Internal Medicine, School of Medicine, Hokkaido 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健"}],"jpcoar:affiliationName":[{"@language":"en","@value":"The Third Department of Internal Medicine, Hirosaki University School of Medicine and Related Hospitals"},{"@language":"ja","@value":"弘前大学第3内科およびその協力施設"}]},{"@id":"https://cir.nii.ac.jp/crid/1410282680025679255","@type":"Researcher","foaf:name":[{"@language":"en","@value":"MAEDA Toshikazu"},{"@language":"ja","@value":"前田 俊一"}],"jpcoar:affiliationName":[{"@language":"en","@value":"The Third Department of Internal Medicine, Hirosaki University School of Medicine and Related Hospitals"},{"@language":"ja","@value":"弘前大学第3内科およびその協力施設"}]},{"@id":"https://cir.nii.ac.jp/crid/1410282680025679113","@type":"Researcher","foaf:name":[{"@language":"en","@value":"SASAKI Kazuo"},{"@language":"ja","@value":"佐々木 和雄"}],"jpcoar:affiliationName":[{"@language":"ja","@value":"弘前大学第3内科およびその協力施設"},{"@language":"en","@value":"The Third Department of Internal Medicine, Hirosaki University School of Medicine and Related 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磨須美"}],"jpcoar:affiliationName":[{"@language":"en","@value":"The Second Department of Internal Medicine, School of Medicine, Hokkaido University and Related Hospitals"},{"@language":"ja","@value":"北海道大学第2内科およびその協力施設"}]},{"@id":"https://cir.nii.ac.jp/crid/1410282680025679252","@type":"Researcher","foaf:name":[{"@language":"en","@value":"AONUMA Seiichi"},{"@language":"ja","@value":"青沼 清一"}],"jpcoar:affiliationName":[{"@language":"ja","@value":"東北大学抗酸菌病研究所内科およびその協力施設"},{"@language":"en","@value":"Department of Internal Medicine, The Research Institute for Chest Disease and Cancer, Tohoku University and Related Hospitals"}]},{"@id":"https://cir.nii.ac.jp/crid/1410282680025678988","@type":"Researcher","foaf:name":[{"@language":"en","@value":"SAKAI Hirozumi"},{"@language":"ja","@value":"酒井 宏純"}],"jpcoar:affiliationName":[{"@language":"en","@value":"Department of Internal Medicine, Tane General 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