巴洛沙星片治疗急性泌尿系统感染105例的随机对照研究

A randomized and comparative control clinical study of balofloxacin tablets for treatment of 214 patients with acute urinary tract infections

目的:评价国产巴洛沙星治疗急性泌尿系统感染的有效性及安全性。方法:采用多中心、随机、双盲、阳性药物平行对照研究方法。214例急性泌尿系统感染病人随机分为2组。试验组(n=105)男性22例,女性83例,年龄(40±s 14)a;对照组(n=109)男性20例,女性89例,年龄(39±12)a。试验组予巴洛沙星100 mg,对照组予左氧氟沙星100 mg,均口服,bid,疗程5～14 d。观察2组治疗前后症状、体征、尿常规、尿细菌培养等的变化。结果:试验组和对照组总治愈率、有效率分别为77.1%、96.2%和81.8%、97.3%,2组差异无显著意义(P>0.05)。2组细菌清除率为95%和94%,无显著差异(P>0.05)。2组不良反应发生率为8.2%和8.9%(P>0.05),主要表现为恶心、腹泻和转氨酶暂时性升高。结论:国产巴洛沙星可有效治疗急性泌尿系统感染。

AIM： To evaluate the efficacy and safety of domestic balofloxacin tablets in the treatment of acute bacterial urinary tract infections. METHODS： A randomized and comparative control clinical study recruited from 214 patients with urinary tract infections dividing into 2 groups randomly; 105 patients （M 22, F 83, age （40 ± s 14） a） with balofloxacin 100 mg bid orally in the trial group and 109 patients （M 20, F 89, age （39 ± 12） a） with levofloxacin 100 mg bid orally in the control group, were under a course of 5 to 14 days. Symptoms, signs, urinary routine test and urinary germiculture were undertaken and compared before and after treatment for both groups. RESULTS： The totle cure rates and effective rates of trial and control group were 77.1% vs 96.2 % and 81.8 % vs 97.3 %; the bacterial eradication rates were 95 % vs 94 %, respectively; for the trial and control group showing no significant difference （P 〉 0.05） . The incidence of adverse reactions was 8.2 % vs 8.9 % （P 〉 0.05） for both groups, including nausea, vomiting, diarrhea and transient elevated transaminases. CONCLUSION： Domestic balofloxacin is effective for the treatment of acute urinary tract infections.