复方左氧氟沙星滴耳液家兔药效学试验及初步临床观察

Rabbit's Pharmacodynamic Experiment and Clinical Observation on Compound Levofloxacin Ear Drops

目的评价自制复方左氧氟沙星滴耳液的药效学与临床疗效。方法以复方氧氟沙星滴耳液对比,用15只大白兔作耳部刺激性和药效学试验并对细菌性混合感染(耳炎、中耳炎)30例患者进行初步临床观察,给药方法为每次1～2滴,每日5次,疗程7～14d。结果大白兔病原体转阴率试验组和对照组分别为91.18%和77.61%,临床观察试验组和对照组临床总有效率分别为93.33%和73.33%,病原体转阴率分别为92.59%和76.92%,均有显著性差异(P<0.05),未见刺激性反应和其他不良反应。结论自制复方左氧氟沙星滴耳液治疗细菌性感染的慢性弥漫性耳道炎安全、有效。

Objective To investigate the pharmacodynamics and efficacy of self-made Compound Levofloxacin Ear Drops（CLED）.Methods With Compound Ofloxacin Ear Drops（COED） as control,15 rabbits were performed the ear stimulation and pharmacopsychosis test and the clinical efficacies treated in 30 patients with mixed infections（otitis and otitis media） were observed.The administrating method was 1-2 drops each time,once every 5 h for 7-14 d.The efficacy evaluations included the bacterial eradication rates and clinical response.Results The negative conversion rate of pathogens in rabbits was 91.18% for CLED and 77.61% for COED respectively.The overall efficacy rate was 93.33% for the clinical observation group and 73.33% for the control group respectively.The negative conversion rate of pathogens was 92.59% for the clinical observation group and 76.92% for the control group（P 〈0.05）,respectively.Both drug regimens were well tolerated,the stimulation and adverse events were few and mild.Conclusion Self-made CLED is safe and effective for chronic diffuse otitis caused by bacterial infections.