复方司帕沙星滴耳液家兔药效学试验及临床观察

Rabbit's Pharmacodynamic and Clinical Study by Compound Sparfloxacin Ear Drops

目的:评价复方司帕沙星滴耳液的药效学与临床疗效。方法:本品与复方氧氟沙星滴耳液对比,用15只家兔作耳部刺激性和药效学试验,并临床观察细菌混合感染35例(耳炎、中耳炎)患者,治疗剂量为5次/d,1～2滴/次,疗程7～14d。结果:家兔细菌清除率试验组与对照组分别为91.43%和91.30%,患者临床有效率两组分别为91.43%和88.57%,细菌清除率分别为93.55%和93.33%,均无显著性差异(P<0.05),未见刺激性反应和其他不良反应。结论:复方司帕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 compound sparfloxacin ear drops(CSED).Methods:To compare the compound ofloxacin ear drops (COED) and CSED,and to perform the stimulation and pharmacodynamic test with 15 rabbits ear and to observe clinical efficacy treated for 35 patients(otitis and otitis media)with moderate-to-severe bacterial infections.The dosage was 1～2 drops five times daily for 7 d to 14 d.Efficacy evaluations included bacterial eradication rates and clinical response.Results:The bacterial eradication rates were 91.43% for CSED and 91.30% for COED respectively in rabbit ear with moderate-to-severe bacteria infections.Of 70 treated patients,35 received CSED and 35 received COED.The overall efficacy rates(i.e.cure or markedly improved)were 91.43% for the sparfloxacin group and 88.57% for the ofloxacin group:the bacterial eradication rates were 93.55% for CSED and 93.33% for COED(P < 0.05),respectively.Both drug regimens were well tolerated,the stimulation and adverse events were few and mild.Conclusion:CSED is safe and effective for the treatment of moderate-to-severe bacterial infections.