莫西沙星注射剂治疗下呼吸道感染疗效观察

Evaluation of intravenous moxifloxacin in the treatment of lower respiratory tract infection

目的评价莫西沙星注射剂治疗下呼吸道感染的疗效及安全性。方法采用区组随机化、开放、左氧氟沙星对照和非对照试验设计。试验组（包括对照与非对照病例）均用莫西沙星400mg，静脉滴注，每日1次；对照组用左氧氟沙星200mg，静脉滴注，每日2次，疗程均为7～14d。结果临床痊愈率和有效率：治疗结束后第7天，总的莫西沙星临床痊愈率和有效率分别为33．3％和81．9％，其中对照病例和非对照病例分别为38．7％、87．1％和34．1％、78．0％；左氧氟沙星为43，3％和86，7％。细菌清除率：治疗结束后第7天，总的莫西沙星、对照组及非对照组莫西沙星、左氧氟沙星均为100％。安全性评价：莫西沙星及左氧氟沙星组药物不良反应发生率分别为14．9％和18．8％。两组差异无显著性。结论莫西沙星注射剂治疗敏感菌引起的下呼吸道感染的疗效确切，安全性好。

Objective To compare the efficacy and tolerability of moxifloxacin and levofloxacin in treating lower respiratory tract infections. Methods An open-label, randomized, levofloxacin controlled and non-controlled study was conducted. The treatment group （including controlled part and all patients of non-controlled part） were given moxifloxacin 400 mg, intravenous infusion, once daily. The patients in control group were treated with levofloxacin 200 mg intravenous infusion, bid. All patients were treated for 7-14 days. Results Seven days after end of treatment, the overall clinical cure rate and effective rate of moxifloxacin group were 33.3% and 81.9% （38.7% and 87. 1% in controlled part; 34. 1% and 78.0% in non-controlled part）. The corresponding rates were 43.3% and 86.7% in levofloxacin group. The bacterial eradication rate of all the three groups was 100%. The incidence of drug-related adverse reaction was 14.9% and 18.8% for moxifloxacin and levofloxacin respectively. Conclusions Once daily moxifloxacin intravenous infusion is as effective and safe as intravenous treatment with levofloxacin twice-daily.