The efficacy of fractional carbon dioxide (CO2) laser combined with luliconazole 1% cream for the treatment of onychomycosis: A randomized, controlled trial.
The efficacy of fractional carbon dioxide (CO2) laser combined with luliconazole 1% cream for the treatment of onychomycosis: A randomized, controlled trial.
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%20功效%20of%20分数%20碳%20二氧化物%20(CO2)%20激光%20联合%20与%20卢立康唑%201%%20霜%20用于%20%20治疗%20of%20甲真菌病%20A%20随机、%20对照%20试验
DOI：
10.1097/md.0000000000005141
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发表时间：
2016-11
期刊：
影响因子：
1.6
通讯作者：
Xu Y
中科院分区：
文献类型：
--
作者：
Zhou BR;Lu Y;Permatasari F;Huang H;Li J;Liu J;Zhang JA;Luo D;Xu Y
目的：评价分次CO2激光联合1%卢立康唑乳膏治疗甲真菌病的疗效，并与单用分次CO2激光治疗甲真菌病进行比较。这是一项随机、平行组、2组、阳性对照、单中心、优效性试验，分配比为1：2。2015年3月至2015年5月，在中国南京市南京医科大学第一附属医院皮肤科入组了60例临床和真菌学诊断为甲真菌病的患者。患者按照简单的随机化程序（计算机随机数字发生器）随机分为2组; L组仅接受12次激光治疗，间隔2周，持续6个月; L + D组接受12次激光治疗，间隔2周，联合1%卢立康唑乳膏每日1次，持续6个月。 这不是一个盲目的审判。主要结果指标是根据完全和>60%正常外观指甲的百分比评估的临床疗效率（CER）和根据真菌显微镜检查阴性指甲的百分比评估的真菌学清除率（MCR）。审判开始后，审判结果衡量标准没有变化。共60例患者（N = 233枚髓内钉）完成治疗和随访，随机分为2组：L组（31例患者，N = 108枚髓内钉）和L + D组（29例患者，N = 115枚髓内钉）。 L + D组的CER和MCR分别为69.6%和57.4%。 L + D组的CER（69.6% vs 50.9%; χ2 = 8.1，P = 0.004）和MCR（57.4% vs 38.9%; χ2 = 7.6，P = 0.006）均显著高于L组。 一些患者在激光治疗期间出现轻微疼痛，但治疗期间或治疗后没有出血或渗血。观察期间未报告不良反应。1%卢立康唑乳膏联合分次CO2激光治疗甲真菌病6个月，疗效优于单用分次CO2激光治疗。
To evaluate the efficacy of fractional carbon dioxide (CO2) laser combined with luliconazole 1% cream for the treatment of onychomycosis and to compare it with that of fractional CO2 laser alone. This was a randomized, parallel group, 2-arm, positive-controlled, single-center, superiority trial with a 1:2 allocation ratio. Sixty patients with clinical and mycological diagnosis of onychomycosis were enrolled from the Dermatology Department of the First Affiliated Hospital of Nanjing Medical University in Nanjing, China from March 2015 to May 2015. Patients were randomized following simple randomization procedures (computerized random number generator) into 2 groups; L group only received 12 sessions of laser treatment at 2-week interval for 6 months, while L + D group received 12 sessions of laser treatment at 2-week interval combined with luliconazole 1% cream once daily for 6 months. This was not a blind trial. The main outcome measures were the clinical efficacy rate (CER) assessed from the percentage of fully and >60% normal-appearing nails and the mycological clearance rate (MCR) assessed from the percentage of nails with negative fungal microscopy. There were no changes to trial outcome measures after the trial commenced. A total of 60 patients (N = 233 nails) completed treatments and follow-up, and were randomized and divided into 2 groups: L group (31 patients, N = 108 nails) and L + D group (29 patients, N = 115 nails). The CER and MCR of L + D group were 69.6% and 57.4%, respectively. L + D group showed significantly higher CER (69.6% vs 50.9%; χ2 = 8.1, P = 0.004) and MCR (57.4% vs 38.9%; χ2 = 7.6, P = 0.006) compared with those in L group. Some patients experienced mild pain during laser treatment, but there was no bleeding or oozing during or after treatment. There were no adverse effects reported during the observation period. Fractional CO2 laser treatment combined with 1% luliconazole cream for 6 months was an effective and safe method for the treatment of onychomycosis, and had a higher efficacy than fractional CO2 laser treatment alone.