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目的评价加替沙星对急性细菌感染患者的有效性和安全性。方法采用多中心、随机、单盲、对照试验。选择呼吸道和泌尿道急性细菌性感染患者205例,随机分为加替沙星组102例,左氧氟沙星组103例。两组分别用加替沙星200mg或左氧氟沙星200mg,加入5%葡萄糖注射液100mL,静脉滴注,bid。疗程均为7～10d。结果加替沙星组、左氧氟沙星组治疗结束后痊愈率分别为68.63%和65.05%,总有效率分别为93.14%和91.26%,两组均差异无显著性(均P>0.05)。加替沙星组、左氧氟沙星组的细菌清除率分别为92.86%,91.86%,;两组治疗前后的血液学及生化指标无明显变化,加替沙星组和左氧氟沙星组不良反应发生率分别为5.88%,6.80%(P>0.05)。结论加替沙星治疗敏感病原体引起的呼吸道感染、泌尿道感染,疗效显著,不良反应发生率较低。
Objective To evaluate the efficacy and safety of gatifloxacin in patients with acute bacterial infection. Methods Multi-center, randomized, single-blind, controlled trials. A total of 205 patients with acute bacterial infections of the respiratory tract and urinary tract were randomly divided into gatifloxacin group (n = 102) and levofloxacin group (n = 103). Two groups were gatifloxacin 200mg or levofloxacin 200mg, add 5% glucose injection 100mL, intravenous infusion, bid. Treatment are 7 ~ 10d. Results The cure rates of gatifloxacin group and levofloxacin group after treatment were 68.63% and 65.05%, respectively. The total effective rates were 93.14% and 91.26% respectively. There was no significant difference between the two groups (all P> 0.05). The bacterial clearance rates of gatifloxacin group and levofloxacin group were 92.86% and 91.86% respectively. There was no significant change in the hematological and biochemical indexes before and after treatment in the gatifloxacin group and the incidence of adverse reactions in the gatifloxacin group and levofloxacin group were 5.88 %, 6.80% (P> 0.05). Conclusion Gatifloxacin treatment of respiratory tract infections caused by sensitive pathogens, urinary tract infections, significant effect, the incidence of adverse reactions is low.