目的:评估与安慰剂相比,局部使用咪康唑或阿莫罗芬治疗轻度至中度重度甲癣的疗效。
方法:随机,双盲,安慰剂对照试验,计算机生成的治疗分配比例为1:1:1。
方法:初级保健,2020年2月至2022年8月招募。
方法:193名疑似轻度至中度甲癣的患者通过一般实践和公众招募,其中111人符合研究标准。参与者的平均年龄为51岁(SD13.1),51%为女性,甲癣为中度重度(平均OSI12.1(SD8.0))。
方法:将每天一次的咪康唑20mg/g或每周一次的amorolfine5%指甲油溶液与安慰剂(苯甲酸地那铵溶液)进行比较。
方法:完成,6个月时的临床和真菌学治愈。次要结果是临床改善,症状负担,生活质量,不利影响,合规,患者感知的改善和治疗的可接受性。
结果:基于意向治疗分析,与安慰剂组的2例相比,接受咪康唑或amorolfine的参与者均未达到完全治愈(OR不可估计(n.e.),p=0.493和ORn.e.,分别为p=0.240)。没有证据表明两组之间在临床治愈方面存在显着差异(ORn.e.,p=0.493和OR0.47,95%CI0.04至5.45,p=0.615),而咪康唑和阿莫洛芬在达到两种真菌学治愈方面均不如安慰剂有效(OR0.25,95%CI0.06至0.98,p=0.037和OR0.23,95%CI0.06至0.92,p=0.029)和临床改善(OR0.26,95%CI分别为0.25至0.91,p=0.0没有证据表明疾病负担有显著差异,生活质量,不良反应,合规,患者感知的改善或治疗可接受性。
结论:外用咪康唑和阿莫罗芬不能有效地实现完整的,轻度至中度甲癣的临床或真菌学治疗,它们也没有显著减轻严重程度或症状负担。这些治疗方法应该,因此,不建议作为单药治疗甲癣。
背景:WHOICTRPNL8193。
OBJECTIVE: To evaluate the efficacy of topical miconazole or amorolfine compared to placebo for mild to moderately severe onychomycosis.
METHODS: Randomised, double-blind, placebo-controlled
trial, with computer-generated treatment allocation at a 1:1:1 ratio.
METHODS: Primary care, recruitment from February 2020 to August 2022.
METHODS: 193 patients with suspected mild to moderately severe onychomycosis were recruited via general practices and from the general public, 111 of whom met the
study criteria. The mean age of participants was 51 (SD 13.1), 51% were female and onychomycosis was moderately severe (mean OSI 12.1 (SD 8.0)).
METHODS: Once-daily miconazole 20 mg/g or once-weekly amorolfine 5% nail lacquer solution was compared with placebo (denatonium benzoate solution).
METHODS: Complete, clinical and mycological cure at 6 months. Secondary outcomes were clinical improvement, symptom burden, quality of life, adverse effects, compliance, patient-perceived improvement and treatment acceptability.
RESULTS: Based on intention-to-treat analysis, none of the participants receiving miconazole or amorolfine reached complete cure compared with two in the placebo group (OR not estimable (n.e.), p=0.493 and OR n.e., p=0.240, respectively). There was no evidence of a significant difference between groups regarding clinical cure (OR n.e., p=0.493 and OR 0.47, 95% CI 0.04 to 5.45, p=0.615) while miconazole and amorolfine were less effective than placebo at reaching both mycological cure (OR 0.25, 95% CI 0.06 to 0.98, p=0.037 and OR 0.23, 95% CI 0.06 to 0.92, p=0.029, respectively) and clinical improvement (OR 0.26, 95% CI 0.08 to 0.91, p=0.028 and OR 0.25, 95% CI 0.07 to 0.85, p=0.021, respectively). There was no evidence of a significant difference in disease burden, quality of life, adverse reactions, compliance, patient-perceived improvement or treatment acceptability.
CONCLUSIONS: Topical miconazole and amorolfine were not effective in achieving a complete, clinical or mycological cure of mild to moderately severe onychomycosis, nor did they significantly alleviate the severity or symptom burden. These treatments should, therefore, not be advised as monotherapy to treat onychomycosis.
BACKGROUND: WHO ICTRP NL8193.