UMIN-CTR 臨床試験登録情報の閲覧

安全性解析対象は105例，有効性解析対象は71例であった。
1．非定型肺炎に対する有効性は94.8% (55/58例) であった。Chlamydophila pnemoniae検出例 (他の菌との混合感染1例を含む) での有効率は4/4であり，Mycoplasma pneumoniae検出例 (他の菌との混合感染2例のうち1例の無効を含む) での有効率は90% (9/10例) であった。
2. 副作用発現率 (臨床検査値異常を含む) は，4.8% (5/105例) であり，発現した副作用は胃腸障害，感染症および寄生虫症，神経障害，皮膚および皮下組織障害で，それぞれ2.9% (3/105例)，1.0% (1/105例)，1.0% (1/105例)，1.0% (1/105例) であった。

The safety in 105 patients and the efficacy in 71 patients were examined.
1. The efficacy rates among patients suspected of having atypical pneumonia and those with a confirmed diagnosis of atypical pneumonia were 94.8% (55/58 patients). The efficacy rate was 4/4 for patients in whom Chlamydophila pneumoniae was detected (including 1 patient with a polymicrobial infection with another bacterial strain) and 90% (9/10 patients) for patients in whom Mycoplasma pneumoniae was detected (garenoxacin was ineffective in 1 of 2 patients with a polymicrobial infection with another bacterial strain).
2. The incidence of adverse drug reactions (including abnormal laboratory tests) was 4.8% (5/105 patients). Among the adverse drug reactions, gastrointestinal disorders, infection and infestation, nervous
system disorder, and skin and subcutaneous tissue disorder were observed in 2.9% of patients (3/105), 1.0% (1/105), 1.0% (1/105), and 1.0% (1/105), respectively.