| Background and objectiveOnychomycosis is a common chronic infectious disease which is difficult to cure.Current treatment options mainly include systemic antifungal agents and topical nail lacquer.Oral antifungal agents is the mainstay of therapy for onychomycosis because of its good curative effect[1-2].However,long-term response and more side effects influence the compliance and limit the application in pregnant women,teenagers,elders and patients with systemic disease.Topical antifungal cream,by contrast,is more convenient and suitable for a wide range of groups with fewer side effects.But those have poor clinical and mycological effects and high recurrence rates.Nowadays,laser treatment for onychomycosis becomes becoming a new promising approach.Some researchers have applied fractional carbon-dioxide laser in the treatment of onychomycosis and they have achieved a certain effect[3].Besides,Studies have shown that the combination of fractional carbon-dioxide laser with topical nail lacquer may produce even better outcomes in the treatment of onychomycosis[4-5].The mechanism of fractional carbon-dioxide laser for treating onychomycosis includes:①The fractional carbon-dioxide laser beaming on the nail plate kills fungi directly.②The microscopic treatmentzones(MTZ)created by the fractional carbon-dioxide laser provides a direct tunnel for the topical agents to reach the nail bed,which could enhance the penetration of topical agents significantly.However,the amount of current study,especially large sample of prospective controlled study,which in regard to the efficacy comparison between the two therapies was still relatively small.Most of the clinical studies focused on the total diseased nails.However,as the fungal disease can be involved in one or more fingernails or toenails in a single patient,the outcome of the analysis could be interfered.Some researchers selected target nails as the objects of their studies(The target nail was chosen as the only diseased nail on the patient or the most severe diseased nail if the patient has more than one infected nails).This modification may minimize the chance for error and bias when observing the clinical efficacy of the treatments.On the other hand,in the clinical application of laser therapy,we often treat burning sensation as the end of each laser treatment.This kind of treatment behavior potentially increases the incidence of pain,which may affect the patients’ treatment compliance and therapeutic efficacy.How to avoid the adverse reaction of pain demands urgent and immediate attention.In our study,we aimed to assess the clinical effect,improvement of severity index and mycological clearance rate of combined therapy of fractional carbon-dioxide laser and topical 1%luliconazole cream,compared with laser therapy alone.Moreover,by observing the relationship between laser energy accumulation and nail plate penetration,we tried to answer the question that how to avoid laser irradiation as much as possible while achieving therapeutic effect,which may guide the clinical application of laser and reduce the incidence of pain.Methods(1)A total of 60 subjects were included in the study after the direct microscopic examination and fungal culture.The number of total diseased nails was 223,while the number of target nails was 60.We randomly divided patients into two treatment groups:Laser group and Combination group.The patients in laser group were treated with fractional carbon-dioxide laser for 6 months with 2-week interval.The patients in combination group were treated with fractional carbon-dioxide laser for 6 months with 2-week interval and daily topical 1%luliconazole cream for 6 months.Then,respectively,the total diseased nails and the target nails were chosen for the therapeutic effect analysis.We evaluated the clinical effect at the end of treatment,1 month,3 months and 6 months after completion of treatment.We also analyzed the mycological clearance rate at 3 months after completion of treatment.For further analysis,the comparison between the two groups was assessed by using single factor analysis of variance,and intra-group comparison was assessed by using multivariate logistic regression analysis.In the comparison between the two groups,we focused on the effects of different factors(such as age and sex)on the clinical efficacy.In the intra-group comparison,multivariate logistic regression analysis was performed by using therapeutic effect as dependent variable and the probable influences(such as age and gender)as the independent variables.Moreover,we evaluated the patients’ satisfaction and made detailed records of side effects during the treatment.(2)A total of 40 specimens of fingernails or toenails were gathered.After measuring the thickness of the nails,the samples were randomly divided into two groups:lower energy laser irradiation group(12.5mJ/cm2,n=20)and higher energy laser irradiation group(15mJ/cm2,n=21).Different thicknesses of the nails were used to accept laser radiation until they were totally penetrated.The study was performed to evaluate the relationship between the thickness of nail and the total laser irradiation energy required for penetrating the nail plate.ResultsSixty patients with total 223 nails and 60 target nails completed the treatment and follow-up.1.At the 1 month,3 months and 6 months after the completion of treatment,the clinical efficacy of the total nails in laser group was about 46.3%,50.9%and 52.8%.The clinical efficacy of the target nails in laser group was about 32.3%,38.7%and 38.7%.In combination group,the clinical efficacy of the total nails was about 66.1%,69.6%and 73.0%.The clinical efficacy of the target nails was about 62.1%,65.5%,69.0%.At the same time node,there was a significant difference in the clinical efficacy between the two groups(P<0.05).2.At the 1 month,3 months and 6 months after the completion of treatment,the improvement of onychomycosis severity index of the total nails in laser group was about 15.79±10.86,13.17±10.30 and 12.60±10.40.The improvement of OST of the target nails in laser group was about 22.74±13.03,18.42±11.03 and 17.77±11.21.In combination group,the improvement of OST of the total nails was about 11.47±9.05,8.72±9.20 and 8.04±9.01.The improvement of OST of the target nails was about 14.62±11.10,11.59±11.87 and 10.90±11.60.At the same time,the improvement of OSI in combination group was much better than that in laser group.3.The mycological clearance rate of the total nails in laser group was about 38.9%whereas that in combination group was about 57.4%.The MCR of the target nails in laser group was about 25.8%whereas that in combination group was about 51.7%.There was a significantly difference in the mycological clearance rate between the two groups(P<0.05).4.In some groups(male,age≥50 years old,course of disease≥10 years,total dystrophy types,thickness of nails<2mm,non-thumb nails category),the clinical efficacy in combination group was significantly higher than that in laser group(P<0.05).In other groups,the clinical efficacy in combination group was also higher than that in laser group.However,there was no statistical difference between the two groups.5.In laser group,factors including thickness,clinical types and finger/toe category of nails influenced the efficacy.In combination group,factors including thickness and clinical types of nails influenced the efficacy.6.The comprehensive satisfactory rate was about 87.1%in laser group A while it was about 93.1%in combination group.The comprehensive satisfactory rate was significantly higher than that in laser group(Z=5.048,P=0.025<0.05).7.In addition to slight tolerable pain,there were no obvious side effects noticed in both the groups.8.Under the same laser energy,the thickness of nail is positively related to the total laser irradiation energy required for penetrating the nail.In clinical practice,we may avoid the side effect of pain by predicting the laser energy required for laser irradiation treatment.ConclusionsSuperpulse-mode fractional carbon-dioxide(CO2)laser combined with 1%luliconazole cream was a safe and effective method for the treatment of onychomycosis,and the clinical efficacy was much better than the laser treatment only.The nail thickness is positively correlated with the amount of laser irradiation required to penetrate the nail plate.In clinical practice,we may avoid the side effect of pain by predicting the laser energy required for laser irradiation treatment. |
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