Systematic Review Of Randomized Controlled Trials Of Oral Drugs In The Treatment Of Onychomycosis

BACKGROUND: Onychomycosis is an infection of the nail apparatus by pathogenic fungi that include dermatophytes, nondermatophyte moulds and yeasts. The incidence of onychomycosis in our country is approximately 4% to 7%, and trichophyton rubrum is the main cause of onychomycosis. The approved oral agents for onychomycisis include griseofulvin, ketoconazole, itraconazole, terbinafine and fluconazole, in which the most frequently used theraputical agents are itraconazole, terbinafine and fluconazole. Management of onychomycosis needs enough courses, 12 months for toenail onychomycosis and 6 months for fingernail. A success of therapy is often taken to be fully clearance of the affected nail, so a long term follow-up is necessary and the cost of therapy is high. Therefore, it is important to select a safe, effective and economic regiment to treat onychomycosis.OBJECTIVE: To evaluate the clinical efficacy, safety, cost-effectiveness of terbinafine, itraconazole and fluconazole in the treatment of onychomycosis.METHODS: The randomized controlled trials on terbinafine, itraconazole and fluconazole in the treatment of onychomycosis were collected through searching the Cochrane Controlled Trials Register (Issue 2, 2006) , MEDLINE(1966-2006) and Embase(1974-2006), onychomycosis AND (itraconazole OR terbinafine OR fluconazole) as the keywords, no language limit. Two reviewers extracted the data and assessed the quality of included literature independently. Meta-analysis was conducted by Revman 4.2.8 and cost-effectiveness was calculated.RESULTS: Ultimately 46 literatures were identified, in which there were 23 literatures including 21 randomized controlled trials (RCTs) on itraconazole, 37 literatures including 34 RCTs on terbinafine, and 7 literatures including 6 RCTs on fluconazole. The patient numbers in the trials of fluconazole, itraconazole and terbinafine were 4722, 6961 and...