氟嗪酸滴耳剂治疗耳部化脓感染的双盲法临床试验

Clinical Study of Ofloxacin Otic Solution in Patients with Purulen Otitis Media or Otitis Externa

５９例诊断为耳部化脓性感染的门诊病人按随机分组，双盲法给药，分别接受氟嗪酸滴耳剂和氯霉素眼液滴耳治疗，显效率分别为７１．１％和３８．１％，有显著差异（Ｐ＜０．０１）．包括两名儿童在内的所有病人均未出现头晕、耳鸣、耳聋加重等副反应。２９例细菌学结果显示，氟嗪酸组细菌阴转率为９４．７％，远高于氯霉素组（５５．６％）。

A double-blind,controlled study was made in the patients with purulent otitis media or otitis externatreated by 0.3% ofloxacin otic solution or0. 25% chloromycetin ophthanlmic solution,Total of 59 cases wereevaluated by the doctors .1)The overall rate of“excellent”was 71.1% and 38.1%for 0.3% ofloxacin oticsolution and 0.25%chlormycetin ophthalmic solution respectively.There is significant difference between thetwo groups(P<0.01).2)No side effects were seen in any of these cases evaluated,including two children.3)The results of bacterial culture made in 29 cases showed the negative-rate of the ofloxucin otic solutiontreating group(94.7%)is significantly higher than the controls(55.6%).