复方伊曲康唑滴耳液的临床药效验证试验OA

This study was conducted to fully verify the therapeutic effect and optimal dosage regimen of compound itraconazole ear drops at the recommended dose for canine otitis externa caused by bacteria and fungi,a randomized controlled trial was conducted on dogs diagnosed with bacterial and fungal otitis externa at two sites(northern and southern regions),with 60 dogs enrolled at each location.The dogs were randomly divided into a test group treated with compound itraconazole ear drops and a control group treated with compound clotrimazole ointment,with 30 dogs per group at each site.All dogs were administered the corresponding medication twice daily for 14 consecutive days.Evaluations were performed before treatment(SD0),during treatment(SD2±1,SD4±1,SD7±1),and after treatment(SD14/SDn).General clinical conditions including body temperature,respiration,heart rate,mental status,appetite,and water intake were recorded,as well as specific clinical signs of otitis externa such as aural congestion,edema,pruritus,and ear discharge.Peripheral blood and lesion samples were collected before treatment(SD0),during treatment(SD7±1),and after treatment(SD14/SDn)for routine blood analysis,blood biochemistry,and microbiological examination,including quantitative culture and counting of indicator pathogens.The primary outcome measures included the specific symptom reduction index and the negative conversion rate of pathogenic bacteria and fungi,to further confirm the therapeutic efficacy of compound itraconazole ear drops at the recommended dose.The results showed that the main efficacy indicators in the compound itraconazole ear drops group improved continuously throughout the trial.Based on comprehensive evaluation using specific symptom scores,symptom reduction indices,and pathogen negative conversion rates,the curative effects of both the test drug and the control drug reached the marked effective standard(group cure rate≥80%)on day 7 of treatment,with cure rates of 95.00%and 91.67%,respectively.On day 14 of treatment,the cure rates were 98.33%for compound itraconazole ear drops and 95.00%for compound clotrimazole ointment,with no significant difference between the two groups.These results indicate that 14 consecutive days of administration at the recommended dose is the optimal regimen for compound itraconazole ear drops,which is effective and safe for the treatment of canine bacterial and fungal otitis externa.