Preparation of Kushen Antifungal Ear Drops and its clinical efficacy in the treatment of fungal otitis externa
Objective To investigate the preparation process and quality control standards of Kushen Antifungal Ear Drops(KAED)and its clinical efficacy in the treatment of fungus otitis externa(FOE).Methods KAED was prepared by using conventional preparation process,with quality control process established at the same time following standard operating procedures set up.Then,300 patients with FOE were collected from outpatient department in our hospital,randomly divided into the observation group(OG)and control group(CG).Cases in CG were treated by 4%boric acid alcohol in a form of ear canal soaking,while those in OG were treated by KAED,also in the form of ear canal soaking,both given twice a day and 7 days for a therapeutic course,two courses in total.Then,the therapeutic efficacy and safety of these two kinds of therapy were evaluated among these cases in a comparative way.Results The production process of the preparation was feasible and the quality control was satisfied.The total effective rate of OG was 95.43%,significantly higher than that of 80.74%in CG(P<0.01).Conclusion The preparation process and quality control standards of Kushen Ear Drops are practically feasible,with definite therapeutic effect on fungal otitis externa and no obvious toxic side effects when applied topically.
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