口服特比萘芬和伊曲康唑治疗足癣的疗效和安全性比较:一项具有临床-真菌学相关性的随机对照平行组开放标记试验

Sharmin Begum
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摘要

使用不同的抗真菌药物治疗足癣是非常关键的。本研究的目的是比较口服特比萘芬和伊曲康唑治疗足癣的疗效和安全性。本研究为双盲、随机、单中心临床试验。患者被随机分配接受每日剂量的特比那芬500 mg,连续4周(第一组)或200 mg伊曲康唑,连续4周(第二组)。主要疗效标准为真菌学治愈,定义为随访结束时显微镜和培养结果阴性,不需要二次干预治疗。次要疗效标准包括无二次干预治疗的临床治愈率、真菌学和临床复发率。本研究共纳入50例患者,观察到两组患者均以31-40岁为主。从研究患者的性别分布来看,两组均以男性为主,A组为20例(80.0%),b组为19例(76.0%)。角化过度患者均有100.0%的临床缓解。A组7例(100.0%)指间病变恢复,b组6例(85.7%)指间病变恢复。结论:两种药物对足癣均有显著改善,随访8周无显著差异。《中华医学杂志》2023年7月12期[02:15 . 15
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Comparison of Efficacy and Safety of Oral Use of Terbinafine and Itraconazole for the treatment of Tinea paedis: A Randomized Controlled Parallel Group Open Labeled Trial with Clinico-Mycological Correlation
Treatment of tinea paedis is very crucial with the different antifungal drugs. The purpose of the present study was to compare the efficacy and safety of oral use of terbinafine and itraconazole for the treatment of tinea paedis. This study was a double-blind, randomized, single-center clinical trial. The patients were randomly allocated to receive a daily dose of terbinafine 500 mg daily for 4 weeks (Group I) or 200 mg of itraconazole for 4 weeks daily (Group II). The primary efficacy criterion was mycological cure, defined as negative results on microscopy and culture at the end of follow-up and no requirement of second intervention treatment. Secondary efficacy criteria included clinical cure without second intervention treatment and mycological and clinical relapse rates. A total of 50 patients were included in this study, it was observed that majority patients were age belonged to 31-40 years in both groups. Regarding gender distribution of the study patients, it was observed that male were predominant in both groups, which was 20(80.0%) in group A and 19(76.0%) in group B. All hyperkeratotic patients were shown 100.0% cases of clinical response. However, interdigital lesion were recovered in 7(100.0%) cases in group A and 6(85.7%) cases in group B. In conclusion, tinea paedis is significantly improved by both drugs, without significant difference after 8 weeks follow-up. CBMJ 2023 July: vol. 12 no. 02 P: 150-156
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