Clinical Observation Of 5% Amorolfine Liniment In The Treatment Of 68 Cases Of Distal Lateral Subungual Onychomycosis

Background and objective:Onychomycosis is the common onychopathy in clinical dermatology,with long cure course.Due to the involvement of the anatomical structure and composition of the nail plate,the infiltration of topical drugs is poor,resulted in poor the curative effect.Systemic treatment has high curative effect,but the adverse reactions and drug interactions are more,so clinical application is limited.5% amorolfine,as the generally used topical drugs,has broad-spectrum antibacterial and bacteriostasis effects.There have been many clinical trials of single or combined application of 5% amorolfine for onychomycosis at home and abroad.This study is a single-center,open trial,recruiting patients with distal lateral subungual onychomycosis to topical use of 5% amorolfine provided by Hubei Heng An Fulin Pharmaceutical Co.Ltd.This study observed the curative efficacy and safety of 5% amorolfine in the treatment of distal lateral subungual onychomycosis,evaluated the benefit and risk relationship of topical drugs in general or special populations through subjective and objective evaluation,and clarified the pathogens types and composition of onychomycosis in Jilin area,to expound the disease epidemiology.Methods:Recruit patients with typical clinical manifestations of distal lateral subungual onychomycosis,and fungal microscopy or fungal culture was positive.Topical application of 5% amorolfine liniment for 36 weeks(once a week).Follow-ups were conducted every 4 weeks,total 9 times,meanwhile,the target nail was examined by fungal microscopy,and pictures before and after treatment were taken.Calculate the clinical effective rate and mycological clearance rate after treatment.Calculate the severity index of onychomycosis,onychomycosis severity index,and dermatology life quality index before and after treatment.Record adverse reactions and patient satisfaction during treatment.In addition,collect diseased tissues for fungal culture and identify to identify pathogenic bacteria strains.Results:In this study,a total of 68 patients were recruited,19 patients(27.9%)were completed improvement,26 patients(38.2%)were moderate improvement,15 patients(22.1%)were mild improvement,and the overall clinical improvement rate was 66.2%.The scoring clinical index for onychomycosis of patients before and after treatment were 10.80 ± 6.58 and 6.32 ± 4.50,respectively,and the difference was statistically significant.The onychomycosis severity index before and after treatment were 11.01 ±5.64 and 5.77 ± 5.15,and the difference was statistically significant.56 patients(82.4%)had complete fungal clearance,and the fungal clearance rate was 82.4%;Patients with2～5 toenail involvement had higher clinical efficacy and fungal clearance rate.During the treatment,all patients were tolerated except slight descaling,burning and erythema.76.47% of the patients were satisfied with the terminal efficacy.The dermatology life quality index patients before and after treatment were 6.19 ± 4.89 and 2.57 ± 2.34,respectively,and the difference was statistically significant.A total of 36 strains were cultured,and the culture rate was about 52.9 %,including 25 strains of Trichophyton rubrum(69.4 %),3 strains of Trichophyton mentagrophytes(8.3 %),and 8 strains of Candida albicans(22.2 %).Conclusion:5% amorolfine is a safe and effective external medicine to treat distal lateral subungual onychomycosis.It can be used for patients who resist or are not suitable for systemic medication.The pathogens of onychomycosis in Jilin area are still dermatophytes are dominant,among which Trichophyton rubrum is the dominant strain.