| Objective Tinea pedis and tinea manuum are common cutaneous dermatophyte infections in department of dermatology,with a growing prevalence in recent years.Itraconazole capsule is an oral antifungal drug commonly prescribed for patients with tinea pedis and tinea manuum.In several clinical studies,pulse therapy of itraconazole has confirmed to have its advantages in the treatment of tinea pedis/manuum.However,it was not widely used by the dermatologists in the scenario of treating tinea pedis/manuum.This study was designed to compare the efficacy and safety of 2 antifungal schedules:(1)Oral itraconazole,200 milligrams,twice a day for 7 days + naftifine hydrochloride and ketoconazole cream,topically applied,twice a day for 14 days;(2)Oral itraconazole,200 milligrams,once a day for 14 days + naftifine hydrochloride and ketoconazole cream,topically applied,twice a day for 14 days.Method Randomly divided the patients with tinea pedis and tinea manuum into two groups,observation group and control group.Patients in observation group were given oral itraconazole,200 grams,twice a day for 7 days and topical naftifine hydrochloride and ketoconazole cream,twice a day for 14 days.Patients in control group were given oral itraconazole,200 grams,once a day for 14 days and topical naftifine hydrochloride and ketoconazole cream,twice a day for 14 days.The clinical efficacy,mycological efficacy,and safety of drugs were evaluated at week 2,week 4 and week 6.Any adverse events associated with the drugs will be recorded.Besides,questionnaires were carried out to investigate which schedule of oral treatment was preferred by the respondents.Result At 2 week,4 week,and 6 week after the beginning of treatment,the total efficacy rate of the observation group was 83.3%,95.0%,and 95.0% respectively,while it was 75.0%,93.3%,and 96.7% respectively in the control group;the clinical cure rate of the observation group was 66.7%,83.3%,and 91.7% respectively,while it was 65.0%,81.7%,and 91.7% respectively in the control group;the mycological cure rate of the observation group was 83.3%,95.0%,and 98.3% respectively,while it was 75.0%,93.3%,and 96.7% respectively in the control group.At 2 week,4 week,and 6 week after the beginning of treatment,the total efficacy rate of hyperkeratotic tinea pedis/tinea manuum in the observation group was 72.0%,88.0%,and 88.0% respectively,while it was 61.9%,85.7%,and 90.5% respectively in the control group;the clinical cure rate of hyperkeratotic tinea pedis/tinea manuum in the observation group was 32.0%,72.0%,and 80.0% respectively,while it was 38.1%,76.2%,and 81.0% respectively in the control group;the mycological cure rate of hyperkeratotic tinea pedis/tinea manuum in the observation group was 72.0%,88.0%,and 96.0% respectively,while it was 61.9%,85.7%,and 90.5% respectively in the control group.At 2 week,4 week,and 6 week after the beginning of treatment,the total efficacy rate of other types of tinea pedis/tinea manuum in the observation group was 91.4%,100.0%,and 100.0% respectively,while it was 82.1%,97.4%,and 100.0% respectively in the control group;the clinical cure rate of other types of tinea pedis/tinea manuum in the observation group was 91.4%,91.4%,and 100.0% respectively,while it was 79.5%,84.6%,and 97.4% respectively in the control group;the mycological cure rate of other types of tinea pedis/tinea manuum in the observation group was 91.4%,100.0%,and 100.0% respectively,while it was 82.1%,97.4%,and 100.0% respectively in the control group.After chi-square test,it was found that the parameters to determine the efficacy of antifungal treatment mentioned above did not show any significant difference between observation group and control group.But the onset of action was thought to be faster in the observation group.Except for that,the result of questionnaires showed that,much more people prefer pulse therapy of itraconazole rather than conventional therapy provided the efficacy and safety of these schedules did not have significant difference.Conclusion In the treatment of tinea pedis and tinea manuum,the efficacy between the schedule of oral itraconazole 200 milligrams,twice a day for 7 days with topically applied naftifine hydrochloride and ketoconazole cream and the schedule of oral itraconazole 200 milligrams,once a day for 14 days with topically applied naftifine hydrochloride and ketoconazole cream did not show significant difference.But the former schedule had a shorter duration of oral treatment,shorter onset of the drugs,and higher acceptance among people.Indeed,it was worthy of being recommended in patients with tinea pedis and tinea manuum.Discussion Both of two schedules of itraconazole are definitely efficient and safe for treatment of tinea pedis and tinea manuum.While used in combination with topical antifungal agents,the total efficacy will be improved.Pulse therapy of itraconazole lead to a higher concentration of it on the skin lesions,which could maintain for several weeks even after the discontinuation of treatment.Besides,the mycological clearance rate and clinical response reach a higher level within a shorter period of time after the beginning of therapy while treated with the schedule of pulse therapy,which could prevent spreading of superficial fungal infection to other part of the body,increase patients’ confidence for antifungal treatment and thereby ensure the compliance of patients.Except for that,the duration of pulse therapy is much shorter,so it may be more suitable for the patients from the pharmaco-economic perspective. |
