Chatterjee Dattatreyo, Ghosh Sudip Kumar, Sen Sukanta, Sarkar Saswati, Hazra Avijit, De Radharaman
Department of Pharmacology, M. G. M. Medical College and L. S. K. Hospital, Kishanganj, Bihar, India.
Department of Dermatology, Venerology and Leprosy, R. G. Kar Medical College and Hospital, Kolkata, West Bengal, India.
Indian J Pharmacol. 2016 Nov-Dec;48(6):659-664. doi: 10.4103/0253-7613.194850.
Epidermal dermatophyte infections most commonly manifest as tinea corporis or tinea cruris. Topical azole antifungals are commonly used in their treatment but literature suggests that most require twice-daily application and provide lower cure rates than the allylamine antifungal terbinafine. We conducted a head-to-head comparison of the effectiveness of the once-daily topical azole, sertaconazole, with terbinafine in these infections.
We conducted a randomized, observer-blind, parallel group study (Clinical Trial Registry India [CTRI]/2014/09/005029) with adult patients of either sex presenting with localized lesions. The clinical diagnosis was confirmed by potassium hydroxide smear microscopy of skin scrapings. After baseline assessment of erythema, scaling, and pruritus, patients applied either of the two study drugs once daily for 2 weeks. If clinical cure was not seen at 2 weeks, but improvement was noted, application was continued for further 2 weeks. Patients deemed to be clinical failure at 2 weeks were switched to oral antifungals.
Overall 88 patients on sertaconazole and 91 on terbinafine were analyzed. At 2 weeks, the clinical cure rates were comparable at 77.27% (95% confidence interval [CI]: 68.52%-86.03%) for sertaconazole and 73.63% (95% CI 64.57%-82.68%) for terbinafine ( = 0.606). Fourteen patients in either group improved and on further treatment showed complete healing by another 2 weeks. The final cure rate at 4 weeks was also comparable at 93.18% (95% CI 88.75%-97.62%) and 89.01% (95% CI 82.59%-95.44%), respectively ( = 0.914). At 2 weeks, 6 (6.82%) sertaconazole and 10 (10.99%) terbinafine recipients were considered as "clinical failure." Tolerability of both preparations was excellent.
Despite the limitations of an observer-blind study without microbiological support, the results suggest that once-daily topical sertaconazole is as effective as terbinafine in localized tinea infections.
表皮皮肤癣菌感染最常见的表现为体癣或股癣。局部用唑类抗真菌药常用于其治疗，但文献表明大多数此类药物需要每日应用两次，且治愈率低于烯丙胺类抗真菌药特比萘芬。我们对每日一次局部用唑类药物舍他康唑与特比萘芬在这些感染中的疗效进行了直接比较。
我们进行了一项随机、观察者盲法、平行组研究（印度临床试验注册 [CTRI]/2014/09/005029），纳入有局限性皮损的成年患者，性别不限。通过皮肤刮屑的氢氧化钾涂片显微镜检查确诊临床诊断。在对红斑、鳞屑和瘙痒进行基线评估后，患者每日使用两种研究药物中的一种，持续2周。如果2周时未出现临床治愈，但有改善，则继续用药2周。2周时被判定为临床治疗失败的患者改用口服抗真菌药。
共分析了88例使用舍他康唑和91例使用特比萘芬的患者。2周时，舍他康唑的临床治愈率为77.27%（95%置信区间 [CI]：68.52%-86.03%），特比萘芬为73.63%（95% CI 64.57%-82.68%），二者相当（P = 0.606）。两组各有14例患者病情改善，进一步治疗2周后完全愈合。4周时的最终治愈率也相当，分别为93.18%（95% CI 88.75%-97.62%）和89.01%（95% CI 82.59%-95.44%）（P = 0.914）。2周时，6例（6.82%）使用舍他康唑和10例（10.99%）使用特比萘芬的患者被视为“临床治疗失败”。两种制剂的耐受性都很好。
尽管这项无微生物学支持的观察者盲法研究存在局限性，但结果表明每日一次局部用舍他康唑在局限性癣菌感染中的疗效与特比萘芬相当。
