Elewski Boni E, Vlahovic Tracey C, Korotzer Andrew
Department of Dermatology, University of Alabama at Birmingham School of Medicine, Birmingham, Alabama.
Temple University School of Podiatric Medicine, Philadelphia, Pennsylvania.
J Clin Aesthet Dermatol. 2016 Nov;9(11):34-39. Epub 2016 Nov 1.
The current definition of complete cure is considered too stringent to reflect the true benefit of onychomycosis treatment seen in general practice and may limit the use of newer topical agents in mild-to-moderate disease. In addition, outcomes reported in clinical trials do not consistently report secondary endpoints, making data comparison difficult. The authors review the clinical data reported on two new topical antifungals, efinaconazole and tavaborole, in light of the latest thinking of more practical approaches to assess improvement and treatment success. Almost 20 percent (19.7%) of patients treated with efinaconazole had absence of clinical signs, and almost a third (31.6%) had ≤10 percent affected toenail and mycologic cure at Week 52. Cure rates for tavaborole (<10% affected toenail and mycologic cure) were 15.3 percent and 17.9 percent at week 52. With both topical treatments, cure rates were higher when only negative culture was considered. These clinical cure rates likely better reflect the efficacy we see in practice. It is probable that efficacy would be further improved with longer treatment courses and/or longer follow-up periods and appropriate prophylactic strategies. This clinical judgment is predicated by any risk of nonadherence or disease recurrence.
目前对完全治愈的定义被认为过于严格,无法反映在一般临床实践中所见的甲癣治疗的真正益处,并且可能会限制新型外用药物在轻至中度疾病中的应用。此外,临床试验报告的结果并未始终如一地报告次要终点,这使得数据比较变得困难。作者根据更实用的评估改善情况和治疗成功的方法的最新思路,回顾了关于两种新型外用抗真菌药物(艾氟康唑和他伏硼)的临床数据。接受艾氟康唑治疗的患者中,近20%(19.7%)没有临床症状,近三分之一(31.6%)在第52周时患甲受累面积≤10%且真菌学治愈。他伏硼在第52周时的治愈率(患甲受累面积<10%且真菌学治愈)分别为15.3%和17.9%。对于这两种外用治疗方法,仅考虑培养阴性时治愈率更高。这些临床治愈率可能更好地反映了我们在实践中看到的疗效。通过更长的疗程和/或更长的随访期以及适当的预防策略,疗效可能会进一步提高。这种临床判断是以不依从或疾病复发的任何风险为前提的。