巴洛沙星片治疗泌尿系统细菌性感染的多中心随机双盲对照临床试验

A multicenter,randomized,and double-blind controlled clinical trial of balofloxacin in treatment of bacterial urinary tract infections

目的评价巴洛沙星片治疗泌尿系统急性细菌性感染的安全性和有效性。方法采用多中心、双盲双模拟、随机、阳性药物平行对照试验设计。共入选221例,其中可评价疗效病例209例,巴洛沙星组102例,左氧氟沙星组107例。巴洛沙星组予巴洛沙星片200 mg,hid,左氧氟沙星组予左氧氟沙星片200 mg,bid,2组疗程均为7～14 d。结果巴洛沙星组临床总有效率和痊愈率分别为98.0%和87.2%,细菌清除率为100%;左氧氟沙星组临床总有效率和痊愈率分别为100.0%和87.9%,细菌清除率为100%。巴洛沙星组和左氧氟沙星组药物不良反应发生率分别为4.8%和0.9%。2组比较均无显著差异(P>0.05)。结论巴洛沙星治疗急性细菌性泌尿系统感染安全、有效。

AIM To evaluate the clinical efficacy and safety of domestic balofloxacin in the treatment of acute bacterial urinary tract infections. METHODS A randomized, double-blind controlled, and positive drug paralled clinical trial was conducted. Two hundred and twenty-one patients were enrolled with only 209 suitable for efficacy evalution including 102 patients in the balofloxacin group （balofloxacin 200 rag, bid） and 107 for the the levofloxacin group （levofloxacin 200 rag, bid） with 7 - 14 days as acourse for both groups. The overall clinical efficacy rates, cure rates, and bacterial clearance rates were 98.0 %, 87.2 % and 100 %; versus 100 %, 87.9 % and 100 % for balofloxacin group, levofloxacin group respectively; including the adverse drag reaction rates as 4.8 % and 0.9 % respectively. There were no statistical differences between the two groups （P 〉 0.05） . CONCLUSION Domestic balofloxacin is effective and safe for the treatment of acute bacterial urinary tract infections.