伊曲康唑与特比萘芬治疗皮肤真菌病的疗效比较

Farhana Yeasmin, Shahin Ara, L. Khondker, Md. Nazrul Islam, Ibrahim Md. Sharaf, Nelofar Yasmin, Gulam Kazem Ali Ahmad
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引用次数: 0

摘要

据观察,世界各地的皮癣负担日益加重。大量隐匿和未确诊的病例仍未得到治疗,这些患者成为 "蓄水池",再次感染周围人群,造成群体性感染,对社区构成严重威胁。这项随机临床试验于 2021 年 7 月至 2022 年 6 月在孟加拉国拉杰沙希医学院药理学与治疗学系、拉杰沙希医学院附属医院皮肤病与性病学系和达卡班加班杜-谢赫-穆吉布医科大学(BSMMU)合作开展,旨在比较伊曲康唑和特比萘芬治疗皮肤真菌病的疗效和安全性。这项研究是在获得拉杰沙希医学院机构审查委员会(IRB)的伦理许可和患者同意后进行的。根据预先确定的资格标准,共有 180 名皮肤癣菌病患者被纳入研究。研究对象根据药物分配分为两组(A 组和 B 组)。在 A 组中,90 名患者接受伊曲康唑治疗,剂量为 5 毫克/公斤/天(研究组);在 B 组中,90 名患者接受特比萘芬治疗,剂量为 3-6 毫克/公斤/天(对照组),为期 6 周。红斑、脱屑和瘙痒在基线时进行测量,并在用药第 3 周和第 6 周结束时再次测量。从基线到用药后第二次随访,伊曲康唑组的平均红斑、脱屑和瘙痒的总体减轻程度高于特比萘芬组,且有统计学意义(分别为 p < 0.001、p=0.003 和 p=0.001)。伊曲康唑组的治愈率为 62.20%,特比萘芬组为 28.90%。治愈两周后,伊曲康唑组和特比萘芬组的复发率分别为 8.93% 和 30.77%。研究结果表明,与特比萘芬相比,伊曲康唑是一种更好的抗真菌药物(P < 0.05)。
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Comparison on Efficacy between Itraconazole and Terbinafine in the Treatment of Cutaneous Dermatophytosis
The increasing burden of dermatophytosis has been observed all over the world. The vast numbers of hidden and undiagnosed cases remain untreated and these patients act as reservoirs and reinfect their surroundings, contributing to communal infection, a significant threat to the community. This randomized clinical trial was conducted to compare efficacy & safety between Itraconazole and Terbinafine in the treatment of cutaneous dermatophytosis, in the Department of Pharmacology and Therapeutics at Rajshahi Medical College, Rajshahi in collaboration with department of Dermatology & Venereology at Rajshahi Medical College Hospital, Rajshahi and Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka, Bangladesh from July 2021 to June 2022. The study was conducted after obtaining ethical clearance from the Institutional Review Board (IRB) of Rajshahi Medical College and consent from the patients. Based on predefined eligibility criteria, a total number of 180 patients with dermatophytosis were included in the study. The study population was divided into two groups (Group-A and Group-B) on the basis of drug allocation. In Group-A, 90 patients were treated with Itraconazole at a dose of 5 mg/kg/day (study group) and in Group-B 90 patients were treated with Terbinafine at a dose of 3–6 mg/kg/day (control group) for 6 weeks. Erythema, scaling and pruritus were measured initially at baseline and again at the end of the 3rd and 6th week of drug administration. The overall reduction of mean erythema, scaling and pruritus from baseline to the 2nd follow-up of drug administration was more in Itraconazole group than Terbinafine group and it was statistically significant (p < 0.001, p=0.003 and p=0.001, respectively). The cure rate was 62.20% in Itraconazole group and 28.90% in Terbinafine group. Two weeks after cure, the relapse rates were 8.93% and 30.77%, respectively in the Itraconazole and Terbinafine groups. The findings of the study showed that Itraconazole is a better antifungal drug in comparison to Terbinafine (p < 0.05).
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