Sharma Jyoti, Kaushal Jyoti, Aggarwal Kamal
Department of Pharmacology, Pt. B. D. Sharma PGIMS, Rohtak, Haryana, India.
Department of Skin, VD and Leprosy, Pt. B. D. Sharma PGIMS, Rohtak, Haryana, India.
Indian J Dermatol. 2018 Jan-Feb;63(1):53-56. doi: 10.4103/ijd.IJD_126_17.
Tinea versicolor (TV) is characterised by the appearance of maculosquamous lesions sometimes associated with mild erythema and pruritus in characteristic areas of the body. Eberconazole and terbinafine though drugs of different classes provide both mycological and clinical cure.
This study aims to compare the efficacy and safety of eberconazole versus terbinafine in patients of TV.
An open-label, randomised, comparative clinical trial was conducted on 60 patients. The patients were randomly divided into two study groups. Group A: Eberconazole 1% cream once daily and Group B: Terbinafine 1% cream once daily for 2 weeks. Efficacy assessment was done by observing signs and symptoms, i.e., Physician assessment 4-point scale, microscopic KOH examination, Wood's lamp examination, global clinical response assessment, and patient's assessment on visual analog scale at the end of 2 weeks and subsequently patients were reassessed at the end of 4 and 8 weeks to check any relapse. Safety assessment was also done.
There was a significant improvement in all the parameters in both groups over a period of 2 weeks. Both the treatment groups, i.e., eberconazole and terbinafine were found to be safe and efficacious at the end of 2 weeks, and no statistically significant difference was observed between the two groups regarding complete cure, i.e., mycological and clinical cure (80% vs. 63.33%), respectively. However, early response (at the end of week 1) was observed with eberconazole. No relapse was seen with eberconazole, but one patient had relapse at 8 weeks with terbinafine. Both drugs had similar safety profile.
Although both the drugs cured the disease, eberconazole showed better response as clinical cure and mycological cure were observed earlier and no patient relapsed in the follow-up.
花斑糠疹(TV)的特征是在身体的特定部位出现斑片状鳞屑性损害,有时伴有轻度红斑和瘙痒。伊曲康唑和特比萘芬虽属于不同类别药物,但均可实现真菌学和临床治愈。
本研究旨在比较伊曲康唑和特比萘芬治疗花斑糠疹患者的疗效和安全性。
对60例患者进行了一项开放标签、随机、对照临床试验。患者被随机分为两个研究组。A组:每日一次外用1%伊曲康唑乳膏;B组:每日一次外用1%特比萘芬乳膏,疗程2周。通过观察体征和症状进行疗效评估,即医师评估4级量表、显微镜下KOH检查、伍德灯检查、整体临床反应评估,以及在2周结束时患者采用视觉模拟量表进行自我评估,随后在4周和8周结束时对患者进行重新评估以检查是否复发。同时也进行了安全性评估。
在2周的时间里,两组的所有参数均有显著改善。两个治疗组,即伊曲康唑组和特比萘芬组在2周结束时均被发现安全有效,在完全治愈方面,即真菌学和临床治愈方面,两组之间未观察到统计学显著差异(分别为80%和63.33%)。然而,伊曲康唑组在第1周结束时出现了早期反应。伊曲康唑组未见复发,但特比萘芬组有1例患者在8周时复发。两种药物的安全性概况相似。
虽然两种药物均治愈了疾病,但伊曲康唑显示出更好的反应,因为其临床治愈和真菌学治愈出现得更早,且在随访中无患者复发。