左氧氟沙星与氧氟沙星滴耳液治疗中耳炎、外耳道炎的比较

Levofloxacin eardrops versus ofloxacin eardrops in treating otitis media or otitis externa

目的评价左氧氟沙星滴耳液联用头孢拉定治疗中耳炎、外耳道炎的疗效和安全性,并与氧氟沙星滴耳液比较。方法采用随机、双盲、平行对照的多中心研究。受试者分别应用左氧氟沙星滴耳液或氧氟沙星滴耳液(每次6～10滴,bid),并予头孢拉定0.5g,po,tid,疗程7～14d。共入选中耳炎病人123例,外耳道炎病人121例,均完成120例,试验组和对照组各60例。结果治疗后,试验组和对照组中耳炎和外耳道炎病情总积分均下降,与治疗前比较差异显著(P<0.05),而组间无显著差异(P>0.05)。按符合方案集分析,中耳炎病人对照组和试验组的总有效率分别为100%和98%;外耳道炎病人2组总有效率均为100%,2组临床疗效无显著差异(P>0.05)。2组均无严重不良反应发生。结论在联合应用头孢拉定基础上,左氧氟沙星滴耳液治疗中耳炎和外耳道炎的疗效和安全性与氧氟沙星滴耳液相当,临床应用安全有效。

AIM To evaluate the efficacy and safety of levofloxacin eardrops combined with cefradine in patients blinded, with otitis media or otitis externa and compared with ofloxacin. METHODS A randomized, double- parallel-controlled, multicenter clinical trial was conducted including patients in the test group and control group with administration of levofloxacin eardrops （6 - 10 drops, bid） and ofloxacin eardrops （6 - 10 drops, bid） for 7 - 14 d, respectively. The cefradine capsule （0.5 g, tid） was routinely used in all patients. One hundred and twenty-three patients with otitis media and 121 patients with otitis externa were enrolled; with 120 patients completed the trial for each of the forementioned otitis media and otitis externa patients, including 60 patients for test group and control group, respectively. RESULTS After the treatment, the statistics of otitis media score and the otitis externa score were decreased significantly than those before the treatment in both groups （P 〈 0.05） , but there was no significant difference between the two groups （P 〉 0.05）. According to the analysis of the coincided per protocol （PP） set, the total effective rates of otitis media were 100% and 98% in the control and test group, and were 100% for otitis externa in both groups, respectively. There was no significant difference concerning the clinical effects between the two groups （P 〉 0.05）. No severe adverse reactions occurred in both groups. CONCLUSION Combined with cefradine, the levofloxacin eardrops is safe and effective in clinical application for otitis media and otitis externa similar as ofloxacin eardrops.