科研之友
微信
新浪微博
Facebook
分享链接
摘要
Objective: This study aimed to evaluate the efficacy and safety of the Meifute (R) antifungal solution on moccasin-type tinea pedis with optimal application time. Methods: A multicentered, randomized and open clinical trial was conducted by enrolling 267 patients with moccasin-type tinea pedis from 10 centers. 91 of these patients were treated with regimen A (foot bath twice per 7 days, 2 hours each time), 87 with regimen B (foot bath twice per 7 days, 1 hour each time) and 89 with regimen C (foot bath twice per 7 days, 0.5 hour each time). The evaluation of mycological effect, clinical efficacy and the overall therapeutic effect were achieved using fungus microscopic examination, fungus culture method and total symptom score. The initial valuation data were recorded as the baseline and further data were collected 1 week after the first administration (V1), 1 week after the second administration (V2) and 2 weeks after the withdrawal (V3). Results: At V3, the number of eligible patients in group A, B and C were 69, 78 and 80, respectively. There was no statistically significant difference in the fungal clearance rates (84.1%, 88.5% and 76.3%, respectively), clinical effective rate (14.5%, 28.2% and 24.1%, respectively) or integral effective rate (49.3%, 61.5% and 56.3%, respectively) among three groups. The adverse events including transient pain (31 cases, 11.6%), pain (20 cases, 7.5%), erosion (17 cases, 6.4%), pruritus (10 cases, 3.7%), burning (6 cases, 2.2%) and swelling (3 cases, 1.1%) be alleviated without any treatment. The incidence of pain and erosion in group A was significantly higher than that in group B and C. The only case of ulcer happened in group A which was cured after one-week application of Bactroban, Bifonazole, and Hirudoid. Because of the different incident of adverse reactions, there were significant difference in the dropout rates among group A, B and C (9.9%, 2.3% and 0.0%, respectively). Conclusion: The therapeutic efficacy of a 0.5 h treatment with antifungal liquid was found to be the same as that of standard application time of 2 hours. On the other hand, 0.5 h treatment protocol could reduce the incidence of adverse reactions and therefore improve the compliance of patients.
