@article{oai:nagasaki-u.repo.nii.ac.jp:00012508,
 author = {河野, 茂 and 青木, 信樹 and 二木, 芳人 and 渡辺, 彰},
 issue = {1},
 journal = {日本化学療法学会雑誌, Japanese Journal of Chemotherapy},
 month = {Jan},
 note = {マクロライド系抗菌薬であるazithromycin（AZM）の新剤型，経口懸濁液用の徐放性製剤（単回投与製剤）の急性気管支炎および慢性呼吸器疾患の二次感染患者を対象とした第3相，多施設共同，非盲検非対照試験を実施し，AZM単回投与製剤2 g単回経口投与時の有効性および安全性を検討した。　主要評価項目である臨床効果解析対象集団の第8日目の臨床効果（有効率）は，全体で93.3％（42/45例）であり，疾患別では急性気管支炎が97.0％（32/33例），慢性呼吸器疾患の二次感染が83.3％（10/12例）であった。第15日目および第29日目の有効率は，全体で97.7％（42/43例）および95.5％（21/22例）であった。　細菌学的効果解析対象集団の細菌学的効果（菌消失率）は，全体で第4日目が78.9％，第8日目が84.2％，第15日目および第29日目ともに100％であった。疾患別の菌消失率は治療期間を通じて急性気管支炎は83.3％～100％，慢性呼吸器疾患の二次感染は71.4％～100％であった。　安全性について，因果関係を否定できない有害事象の発現率は53.1％（34/64例）であり，主な有害事象は下痢であったが，全例で回復が確認された。重度の有害事象および死亡例は認められなかった。　以上の成績から，AZM単回投与製剤は，呼吸器感染症（急性気管支炎および慢性呼吸器疾患の二次感染）の治療に対して2 g単回経口投与により，優れた臨床効果および良好な忍容性を示し，実際の臨床現場では，服薬コンプライアンスを含め，高い有用性が期待できる抗菌薬と考えられた。, A phase 3 multicenter open-label study was conducted to confirm the efficacy and safety of a single 2.0 g dose of a new formulation of a macrolide antibiotic azithromycin, i.e., the sustained-release formulation for oral suspension (azithromycin SR), in patients with acute bronchitis or secondary infection in chronic respiratory disease. Clinical efficacy on day 8, evaluated as the primary end point in the clinical per protocol set, was 93.3% (42/45 subjects) for the entire population. Clinical efficacy by disease was 97.0% (32/33 subjects) in acute bronchitis and 83.3% (10/12 subjects) in secondary infection in chronic respiratory disease. Clinical efficacy for the entire population was 97.7% (42/43 subjects) on day 15 and 95.5% (21/22 subjects) on day 29. The bacteriological response (eradication) in the "bacteriologic per protocol set" was 78.9% on day 4, 84.2% on day 8, and 100% on days 15 and 29 for the entire population. Eradication by disease ranged from 83.3% to 100% for acute bronchitis and from 71.4% to 100% for secondary infection in chronic respiratory disease throughout the study. In safety, the incidence of treatment-related adverse events was 53.1% (34/64 subjects). The most frequent adverse event was diarrhea, for which all cases were confirmed to have recovered. No severe adverse events or deaths were reported during the study. Based on these results, we concluded that azithromycin SR administered as a single 2.0 g oral dose is highly effective and well tolerated in the treatment of acute bronchitis and secondary infection in chronic respiratory disease. Azithromycin SR is therefore considered very useful for treating of respiratory tract infection in clinical practice from various aspects, including drug compliance., 日本化学療法学会雑誌, 57(1), pp.15-25; 2009},
 pages = {15--25},
 title = {急性気管支炎および慢性呼吸器病変の二次感染に対するazithromycin単回投与製剤の多施設共同非盲験非対照試験},
 volume = {57},
 year = {2009}
}