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成人の非定型病原体を除く細菌性市中肺炎に対するlevofloxacin（LVFX）注射剤の有効性，安全性を検討する目的で，ceftriaxone（CTRX）注射剤を対照薬として，多施設共同，無作為化（中央登録方式）, オープンラベル，非劣性検証試験を実施した。用法・用量および投与期間は，LVFX群は1回500 mg 1日1回，CTRX群は1回1 g 1日2回点滴静注，投与期間は7～14日間とした。 臨床効果：投与終了・中止時の有効率は，LVFX群で88.5％（92/104例），CTRX群で88.8％（79/89例），群間差は－0.3％（95％信頼区間：－9.3～8.7）であり，LVFXのCTRXに対する非劣性が検証された。 細菌学的効果：投与終了・中止時の陰性化率はLVFX群で96.7％（59/61例），CTRX群で97.8％（44/45例），群間差は－1.1％（95％信頼区間：－7.3～5.1）であった。 安全性：副作用発現率は，LVFX群で53.7％（73/136例），CTRX群で56.9％（70/123例）であり，群間差は－3.2％（95％信頼区間：－15.4～8.9）であった。 以上のことから，LVFX注射剤は，非定型病原体を除く細菌性市中肺炎に対して1回500 mg 1日1回投与でCTRX 1回1 g 1日2回投与と同様に十分な治療効果ならびに安全性の高い薬剤であることが確認された。, To evaluate the efficacy and safety of intravenous levofloxacin(LVFX) in adults with community-acquired bacterial but not atypical organismic pneumonia, we conducted a multicenter randomized open-label noninferiority study using ceftriaxone(CTRX) as a comparator. Subjects were randomized through central registration to be administered LVFX 500 mg once daily or CTRX 1 g twice daily as an intravenous infusion for 7 to 14 days. Clinical efficacy: At the end of treatment, clinical response was 88.5％ (92 104) in LVFX-treated and 88.8％ (79 89) in CTRX-treated. The intergroup difference was －0.3％ (95％ confidence interval, －9.3 to 8.7) and non-inferiority of LVFX versus CTRX was established. Microbiologic efficacy: Eradication at the end of treatment was achieved in 96.7％ (59 61) treated with LVFX and 97.8％ (44 45) treated with CTRX. The intergroup difference was －1.1％ (95％ confidence interval, －7.3 to 5.1). Safety: Adverse drug reactions were reported in 53.7％ (73 136) treated with LVFX and 56.9％ (70 123) treated with CTRX. The intergroup difference was －3.2％ (95％ confidence interval, －15.4 to 8.9). Our results showed that intravenous LVFX 500 mg once daily is as effective and safe as CTRX 1 g twice daily in treating community-acquired bacterial pneumonia.

成人の非定型病原体を除く細菌性市中肺炎に対するlevofloxacin（LVFX）注射剤の有効性，安全性を検討する目的で，ceftriaxone（CTRX）注射剤を対照薬として，多施設共同，無作為化（中央登録方式）, オープンラベル，非劣性検証試験を実施した。用法・用量および投与期間は，LVFX群は1回500 mg 1日1回，CTRX群は1回1 g 1日2回点滴静注，投与期間は7～14日間とした。 臨床効果：投与終了・中止時の有効率は，LVFX群で88.5％（92/104例），CTRX群で88.8％（79/89例），群間差は－0.3％（95％信頼区間：－9.3～8.7）であり，LVFXのCTRXに対する非劣性が検証された。 細菌学的効果：投与終了・中止時の陰性化率はLVFX群で96.7％（59/61例），CTRX群で97.8％（44/45例），群間差は－1.1％（95％信頼区間：－7.3～5.1）であった。 安全性：副作用発現率は，LVFX群で53.7％（73/136例），CTRX群で56.9％（70/123例）であり，群間差は－3.2％（95％信頼区間：－15.4～8.9）であった。 以上のことから，LVFX注射剤は，非定型病原体を除く細菌性市中肺炎に対して1回500 mg 1日1回投与でCTRX 1回1 g 1日2回投与と同様に十分な治療効果ならびに安全性の高い薬剤であることが確認された。, To evaluate the efficacy and safety of intravenous levofloxacin(LVFX) in adults with community-acquired bacterial but not atypical organismic pneumonia, we conducted a multicenter randomized open-label noninferiority study using ceftriaxone(CTRX) as a comparator. Subjects were randomized through central registration to be administered LVFX 500 mg once daily or CTRX 1 g twice daily as an intravenous infusion for 7 to 14 days. Clinical efficacy: At the end of treatment, clinical response was 88.5％ (92 104) in LVFX-treated and 88.8％ (79 89) in CTRX-treated. The intergroup difference was －0.3％ (95％ confidence interval, －9.3 to 8.7) and non-inferiority of LVFX versus CTRX was established. Microbiologic efficacy: Eradication at the end of treatment was achieved in 96.7％ (59 61) treated with LVFX and 97.8％ (44 45) treated with CTRX. The intergroup difference was －1.1％ (95％ confidence interval, －7.3 to 5.1). Safety: Adverse drug reactions were reported in 53.7％ (73 136) treated with LVFX and 56.9％ (70 123) treated with CTRX. The intergroup difference was －3.2％ (95％ confidence interval, －15.4 to 8.9). Our results showed that intravenous LVFX 500 mg once daily is as effective and safe as CTRX 1 g twice daily in treating community-acquired bacterial pneumonia., 日本化学療法学会雑誌, 59(S-1), pp.32-45; 2011

The purpose of this study was to evaluate the effect of work support program for people with schizophrenia. We conducted a randomized controlled trial (RCT) study design. Eighteen people with schizophrenia who agreed to the informed consent were randomly assigned to either an intervention group (n=10) or a control group (n=8). With regard to judgment scale of intervention effects, we conducted general Self-efficacy Scale (GSES), Self-Efficacy for Community Life Scale (SECL), Positive and Negative Syndrome Scale (PANSS), Life Assessment Scale for the Mentally Ill (LASMI) scale and Work-Personality scale (WP). As the results, the score of GSES in the control group increased significantly after 6 months, but that in the intervention group did not. The score of SECL and PANSS in both groups did not change significantly between before and after the training. The score of "Daily Living area" and "Interpersonal relations area" in LASMI in the intervention group decreased significantly after 3-months and 6-months. Moreover, "Self-Recognition area" in LASMI in the intervention group decreased significantly after 6-months, whereas that in the control group did not. The score of WP in the intervention group decreased significantly between first and second and between first and third, whereas that in the control group did not. Considering these results, this work support program has proved that it has learning effect on people with schizophrenia in terms of their current recognition and job skills., 精神科デイ・ケアに通院している統合失調症患者におけるデイ・ケア就労支援介入プログラムが，自己及び社会生活に関する効力感及び精神障害の陽性・陰性症状ならびに就労・社会生活に及ぼす影響について検証した．その結果，就労支援プログラムが対象者の日常生活や対人関係，自己認識の改善や社会生活能力の向上に関与することが示唆された．今後，対象者の拡大によるプログラム介入効果のさらなる検証や，患者の就労に対する動機づけや職務志向・就労能力に応じたプログラム内容の検討や社会資源の活用を包含した統合的介入プログラムの構築が課題として考えられた．

The purpose of this study was to evaluate the effect of work support program for people with schizophrenia. We conducted a randomized controlled trial (RCT) study design. Eighteen people with schizophrenia who agreed to the informed consent were randomly assigned to either an intervention group (n=10) or a control group (n=8). With regard to judgment scale of intervention effects, we conducted general Self-efficacy Scale (GSES), Self-Efficacy for Community Life Scale (SECL), Positive and Negative Syndrome Scale (PANSS), Life Assessment Scale for the Mentally Ill (LASMI) scale and Work-Personality scale (WP). As the results, the score of GSES in the control group increased significantly after 6 months, but that in the intervention group did not. The score of SECL and PANSS in both groups did not change significantly between before and after the training. The score of "Daily Living area" and "Interpersonal relations area" in LASMI in the intervention group decreased significantly after 3-months and 6-months. Moreover, "Self-Recognition area" in LASMI in the intervention group decreased significantly after 6-months, whereas that in the control group did not. The score of WP in the intervention group decreased significantly between first and second and between first and third, whereas that in the control group did not. Considering these results, this work support program has proved that it has learning effect on people with schizophrenia in terms of their current recognition and job skills., 精神科デイ・ケアに通院している統合失調症患者におけるデイ・ケア就労支援介入プログラムが，自己及び社会生活に関する効力感及び精神障害の陽性・陰性症状ならびに就労・社会生活に及ぼす影響について検証した．その結果，就労支援プログラムが対象者の日常生活や対人関係，自己認識の改善や社会生活能力の向上に関与することが示唆された．今後，対象者の拡大によるプログラム介入効果のさらなる検証や，患者の就労に対する動機づけや職務志向・就労能力に応じたプログラム内容の検討や社会資源の活用を包含した統合的介入プログラムの構築が課題として考えられた．, 論文