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市中肺炎に対するtelithromycin の臨床評価 ―Levofloxacin を対照薬とした第Ⅲ相二重盲検比較試験―

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Title: 市中肺炎に対するtelithromycin の臨床評価 ―Levofloxacin を対照薬とした第Ⅲ相二重盲検比較試験―
Other Titles: Clinical evaluation of telithromycin for community-acquired pneumonia - Phase III double-blind comparative study of telithromycin versus levofloxacin
Authors: 河野, 茂 / 渡辺, 彰 / 青木, 信樹 / 二木, 芳人
Authors (alternative): Kohno, Shigeru / Watanabe, Akira / Aoki, Nobuki / Niki, Yoshihito
Issue Date: Sep-2003
Publisher: 日本化学療法学会 / Japanese Society of Chemotherapy
Citation: 日本化学療法学会雑誌, 51(S1), pp.255-278; 2003
Abstract: 新規の経口ケトライド系抗菌薬であるtelithromycin(TEL)の市中肺炎に対する有効性,安全性を検討する目的でlevofloxacin(LVFX)を対照薬として二重盲検,無作為化,他薬対照,並行群間,非劣性比較試験を実施した。TEL を1 回600 mg,1 日1 回(TEL 群),またはLVFX を1 回100 mg,1日3 回(LVFX 群)いずれも7 日間投与した。得られた成績は以下のとおりである。1. 臨床効果臨床効果解析対象207 例に対する有効率は,TEL 群93.6%(102/109),LVFX 群87.8%(86/98)であり,TEL 群のLVFX 群に対する臨床効果の非劣性が検証された。2. 細菌学的効果細菌学的効果解析対象205 例のうち判定不能例119 例を除く86 例における消失率は,TEL 群73.9%(34/46)およびLVFX 群100.0%(40/40)であった。TEL 群で消失が認められなかった菌種は,主としてHaemophilus influenzae であった。耐性肺炎球菌に対して,TEL 群ではerythromycin 耐性肺炎球菌1 株を除き,すべて消失した。3. 安全性安全性解析対象244 例のうち,不明例4 例を除く副作用発現率は,TEL 群33.6%(42/125),LVFX群33.9%(39/115)であり,副作用発現率において両群間に有意差は認められなかった。以上の成績より,TEL 1 回600 mg 1 日1 回7 日間投与は市中肺炎の治療に対し,高い臨床的有用性が期待できるものと考えられた。 / The clinical efficacy and safety of telithromycin(TEL),a new ketolide antibiotic,were evaluation in community.acquired pneumonia in a double.blind,randomized,drug.controlled,two.groups parallel. group,non.inferiority comparative study versus levofloxacin(LVFX).The dose and dosage of TEL was 600 mg once daily(TEL group)and those of LVFX was 100 mg 3 times daily(LVFX group).The treatment period was either 7 days. The following results were obtained in this trial. 1. Clinical efficacy Two hundred seven patients were evaluated for clinical efficacy. The clinical efficacy rates against pneumonia were 93.6%(102/109)in TEL group and 87.8%(86/98)in LVFX group. The difference of clinical efficacy rate(TEL group-LVFX group)was 5.8% and its 2.sided 95% confidence interval was [-3.1,14.7]. The lower limit of the confidence interval provided by the clinical trial protocol was not less than -15%,and so the fact that TEL is not inferior to LVFX was verified. 2. Bacteriological efficacy The eradication rate excluding indeterminate 119 cases out of 205 cases for bacteriological efficacy analysis was respectively 73.9%(34/46)in TEL group and 100.0%(40/40)in LVFX group. Bacterial species not eradicated in TEL group was mainly Haemophilus influenzae,but clinical efficacy rates of TEL and LVFX against cases whose causative organism was this bacteria were respectively 96.8%(30/31)and 86.7%(13/15).In TEL group,resistant Streptococcus pneumoniae strains were all eradicated except for 1 strain of erythromycin.resistant S. pneumoniae. 3. Safety Case number for the safety analysis was 244. The incidence rates of side effects excluding uncertain 4 cases were respectively 33.6%(42/125)in TEL group and 33.9%(39/115)in LVFX group. No significant difference was found between the groups with respect to the incidence rate of side effects. Considering from above results,it was suggested that 600 mg TEL administered once a day for 7 days could be expected to be clinically very useful in the treatment of community.acquired pneumonia.
Keywords: telithromycin / levofloxacin / 市中肺炎 / 二重盲検比較試験 / ketolides
URI: http://hdl.handle.net/10069/26665
ISSN: 13407007
Type: Journal Article
Text Version: publisher
Appears in Collections:Articles in academic journal

Citable URI : http://hdl.handle.net/10069/26665

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