加替沙星氯化钠注射液与盐酸左旋氧氟沙星注射液双盲随机对照治疗急性细菌性感染

目的 对国产加替沙星氯化钠注射液治疗中、重度急性细菌感染的有效性和安全性进行评价。方法 用多中心随机双盲对照试验设计,以加替沙星氯化钠注射液为试验药,以左旋氧氟沙星注射液为对照药,治疗急性呼吸系统和泌尿系统感染,加替沙星和左旋氧氟沙星剂量均为每次200 mg,每日2次,静脉滴注,疗程5～14天。结果 本研究得可评价病例204例,加替沙星与左旋氧氟沙星分别治疗98例及106例细菌性感染,加替沙星总体有效率和痊愈率为91.84％和66.33％,细菌清除率为96.39％;左旋氧氟沙星总体有效率和痊愈率为90.57％和67.92％,细菌清除率为95.48％。加替沙星和左氧氟沙星药物不良反应发生率分别为14.29％和14.02％。两组比较均无显著差异(P>0.05)。结论 加替沙星氯化钠注射液治疗急性呼吸系统感染和泌尿系统感染疗效确切,患者耐受性良好。

Double-blind randomized controlled clinical trial on gatifloxacin versus levofloxacin injection for treating acute bacterial infections

Objective To compare the clinical efficacy and safety of gatifloxacin and levofloxacin injection in the treatment of moderate to severe bacterial infections. Methods A randomized controlled clinical trial was conducted for the treatment of patients with respiratory tract infection, urinary tract infection. The dosing of both agents was 200 mg twice daily intravenously. The duration of treatment was 5~14 days in both groups. Results The results showed that the overall efficacy rates and cure rate were 91.84% and 66.33% for the gatifloxacin group, 90.57% and 67.94% for the levofloxacin group, whereas the bacterial clearance rates were 96.39% and 95.48%, respectively. The adverse drug reaction rates were 14.29%and 14.02%, respectively. Conclusion Gatifloxacin injection was effective and safe for the treatment of bacterial infections. There were no statistical differences between the two groups (P>0.05).