呼吸器感染症に対するlevofloxacin注射剤の臨床試験（第II/III相試験）
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キノロン系薬であるlevofloxacin（LVFX）注射剤の呼吸器感染症（市中肺炎または慢性呼吸器病変の二次感染）に対する有効性および安全性を検討する目的で，非盲検非対照臨床試験を実施した。用法・用量および投与期間は，LVFX 500 mgを1日1回，7～14日間点滴静注とした。 臨床効果：投与終了・中止時の呼吸器感染症全体の有効率は95.6％（173/181例）であり，診断名別には市中肺炎で95.9％（140/146例），慢性呼吸器病変の二次感染で94.3％（33/35例）であった。また，呼吸器感染症の主要な原因菌であるStreptococcus pneumoniaeが分離された患者での有効率は100％（35/35例）であった。 細菌学的効果：投与終了・中止時の陰性化率は97.6％（80/82例），菌消失率は97.8％（91/93株）であった。 安全性：全体の副作用発現率は44.2％（91/206例）であり，80歳以上の高齢者での副作用発現率は25.0％（4/16例）であった。5％以上に発現した副作用は，注射部位紅斑13.6％（28/206例），ALT増加9.7％（20/206例），AST増加8.7％（18/206例）であった。特に，注射部位反応（注射部位紅斑，注射部位そう痒感，注射部位疼痛，注射部位腫脹，および注射部位硬結）は高頻度に認められ，その発現率は16.5％（34/206例）であった。なお，注射部位反応は，すべて軽度であり，いずれも処置を必要とせず発現日当日に消失し，投与を中止した症例はなかった。 以上の成績から，LVFX注射剤500 mg 1日1回7～14日間点滴静注は，呼吸器感染症に対して十分な治療効果が期待でき，安全性に大きな問題はないと考えられた。This open-label study evaluated the efficacy and safety of an injectable preparation of levofloxacin(LVFX), a quinolone antibacterial, in the treatment of respiratory tract infection(RTI). Subjects with communityacquired pneumonia or secondary infection of chronic respiratory disease were enrolled and treated with LVFX administered at 500 mg once daily by intravenous infusion for 7―14 days. Clinical efficacy: Of 181 evaluable subjects with RTI, 173 (95.6％) showed a clinical response at the end of treatment. Clinical response rate by diagnosis was 95.9％ (140 146) for community-acquired pneumonia and 94.3％ (33 35) for secondary infection of chronic respiratory disease. A clinical response was achieved in 35 35 subjects (100％) with isolates of Streptococcus pneumoniae the predominant RTI causative organism. Bacteriological efficacy: Bacteriological response rate per subject was 97.6％ (80 82) and overall pathogen eradication rate was 97.8％ (91 93), at the end of treatment. Safety: The adverse drug reaction incidence was 44.2％ (91 206) in the overall population and 25.0％ (4 16) in the elderly ( 80 years of age). Adverse drug reactions reported in at least 5％ of those treated and evaluable for safety included injection site erythema (13.6％ [28 206]), ALT increased (9.7％ [20 206]), and AST increased (8.7％ [18 206]). Injection site reactions―erythema, pruritus, pain, swelling, and induration―were especially frequent, occurring in 34 of 206 subjects (16.5％). All injection site reactions were mild and resolved within the day of onset without treatment. None required treatment discontinuation. In conclusion, LVFX administered by intravenous infusion at 500 mg once daily for 7―14 days is effective and safe in RTI treatment.
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