Randomized Clinical Trial to Evaluate the Efficacy and Safety of Combination Therapy with Short-Pulsed 1,064-nm Neodymium-Doped Yttrium Aluminium Garnet Laser and Amorolfine Nail Lacquer for Onychomycosis
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Background: Onychomycosis is one of the most prevalent fungal diseases in the general population. However, treatment is of limited effectiveness and must be administered for long periods of time. Systemic antifungal agents are associated with adverse effects. Objective: We evaluated the clinical efficacy and safety of a 1,064-nm neodymium-doped yttrium aluminium garnet (Nd:YAG) laser with amorolfine nail lacquer to treat onychomycosis. Methods: The 128 patients were randomly divided to 2 groups: 64 in the experimental group were treated with 1,064-nm Nd:YAG laser therapy and amorolfine nail lacquer; the other 64 were in a control group treated with topical amorolfine lacquer monotherapy. The laser treatment was 4 sessions at 4-week intervals and amorolfine lacquer was applied once a week for 16 weeks. Efficacy was assessed as response rate from standardized photographs with ImageProⓇPlus (Media Cybernetics, Inc., USA) analysis, microscopic examination, and subjective evaluation. Results: At 16 weeks, the experimental group showed a significantly higher cumulative cure rate than the control group (71.88% vs. 20.31%, p ＜0.0001). Clinical therapeutic effects were linked to patient satisfaction. The percent of "very satisfied" or "satisfied" responses was higher in the test group than the control group (81.25% vs. 23.44%). The treatment regimen was well tolerated, with transient discomfort observed in the test group. Conclusion: The 1,064-nm Nd:YAG laser with amorolfine nail lacquer was effective and safe for treating onychomycosis. This therapy should be considered an alternative treatment, especially for patients with contraindications to systemic antifungal agents.
Abstract
Background: Onychomycosis is one of the most prevalent fungal diseases in the general population. However, treatment is of limited effectiveness and must be administered for long periods of time. Systemic antifungal agents are associated with adverse effects. Objective: We evaluated the clinical efficacy and safety of a 1,064-nm neodymium-doped yttrium aluminium garnet (Nd:YAG) laser with amorolfine nail lacquer to treat onychomycosis. Methods: The 128 patients were randomly divided to 2 groups: 64 in the experimental group were treated with 1,064-nm Nd:YAG laser therapy and amorolfine nail lacquer; the other 64 were in a control group treated with topical amorolfine lacquer monotherapy. The laser treatment was 4 sessions at 4-week intervals and amorolfine lacquer was applied once a week for 16 weeks. Efficacy was assessed as response rate from standardized photographs with ImageProⓇPlus (Media Cybernetics, Inc., USA) analysis, microscopic examination, and subjective evaluation. Results: At 16 weeks, the experimental group showed a significantly higher cumulative cure rate than the control group (71.88% vs. 20.31%, p ＜0.0001). Clinical therapeutic effects were linked to patient satisfaction. The percent of "very satisfied" or "satisfied" responses was higher in the test group than the control group (81.25% vs. 23.44%). The treatment regimen was well tolerated, with transient discomfort observed in the test group. Conclusion: The 1,064-nm Nd:YAG laser with amorolfine nail lacquer was effective and safe for treating onychomycosis. This therapy should be considered an alternative treatment, especially for patients with contraindications to systemic antifungal agents.
참고문헌 (23)
- Gupta AK, "Prevalence and epidemiology of onychomycosis in patients visiting physicians' offices: a multicenter canadian survey of 15,000 patients", J Am Acad Dermatol, 43, pp.244~248 (2000)
- Sigurgeirsson B, "The prevalence of onychomycosis in the global population: a literature study", J Eur Acad Dermatol Venereol, 28, pp.1480~1491 (2014)
- Nenoff P, "Laser therapy of onychomycosis", J Dtsch Dermatol Ges, 12, pp.33~38 (2014)
- Ledon JA, "Laser and light therapy for onychomycosis: a systematic review", Lasers Med Sci, 29, pp.823~829 (2014)
- Harris DM, "Laser treatment for toenail fungus", Proc SPIE, 7161, pp.1~7 (2009)
- Zhang RN, "Long-pulse Nd:YAG 1064-nm laser treatment for onychomycosis", Chin Med J (Engl), 125, pp.3288~3291 (2012)
- Hollmig ST, "Lack of efficacy with 1064-nm neodymium:yttrium-aluminum-garnet laser for the treatment of onychomycosis: a randomized, controlled trial", J Am Acad Dermatol, 70, pp.911~917 (2014)
- Carney C, "Treatment of onychomycosis using a submillisecond 1064-nm neodymium:yttrium-aluminum-garnet laser", J Am Acad Dermatol, 69, pp.578~582 (2013)
- Meral G, "Factors affecting the antibacterial effects of Nd:YAG laser in vivo", Lasers Surg Med, 32, pp.197~202 (2003)
- Vural E, "The effects of laser irradiation on Trichophyton rubrum growth", Lasers Med Sci, 23, pp.349~353 (2008)
- Xu ZL, "Effects of laser irradiation on Trichophyton rubrum growth and ultrastructure", Chin Med J (Engl), 125, pp.3697~3700 (2012)
- Xu Y, "Combined oral terbinafine and long-pulsed 1,064-nm Nd: YAG laser treatment is more effective for onychomycosis than either treatment alone", Dermatol Surg, 40, pp.1201~1207 (2014)
- Lim EH, "Toenail onychomycosis treated with a fractional carbondioxide laser and topical antifungal cream", J Am Acad Dermatol, 70, pp.918~923 (2014)
- Gupta AK, "Cumulative meta-analysis of systemic antifungal agents for the treatment of onychomycosis", Br J Dermatol, 150, pp.537~544 (2004)
- Schwartz RA, "Onychomycosis", Cutis, 57, pp.67~ (1996)
- Borgers M, "Mechanism of action of antifungal drugs, with special reference to the imidazole derivatives", Rev Infect Dis, 2, pp.520~534 (1980)
- Reinel D, "Topical treatment of onychomycosis with amorolfine 5% nail lacquer : comparative efficacy and tolerability of once and twice weekly use", Dermatology, 1(184 Suppl 1), pp.21~24 (1992)
- Helou J, "Evaluation of Nd:YAG laser device efficacy on onychomycosis: a case series of 30 patients", Mycoses, 59, pp.7~11 (2016)
- El-Tatawy RA, "A comparative clinical and mycological study of Nd-YAG laser versus topical terbinafine in the treatment of onychomycosis", J Dermatolog Treat, 26, pp.461~464 (2015)
- Hees H, "Laser treatment of onychomycosis: an in vitro pilot study", J Dtsch Dermatol Ges, 10, pp.913~918 (2012)
- Manevitch Z, "Direct antifungal effect of femtosecond laser on Trichophyton rubrum onychomycosis", Photochem Photobiol, 86, pp.476~479 (2010)
- Paasch U, "Antifungal efficacy of lasers against dermatophytes and yeasts in vitro", Int J Hyperthermia, 29, pp.544~550 (2013)
- Li RY, "In vitro susceptibility testing of amorolfine in pathogenic fungi isolated from dermatomycosis patients in China", Mycoses, 47, pp.402~406 (2004)