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. 2015 Jan-Mar;10(1):1-8.

Comparison between Combination Therapy of Oral Terbinafine and Cryotherapy versus Systemic Meglumine Antimoniate and Cryotherapy in Cutaneous Leishmaniasis: A Randomized Clinical Trial

Saeedeh Farajzadeh  1 , Iraj Esfandiarpour  1 , Ali Akbar Haghdoost  2 , Saman Mohammadi  3 , Azadeh Mohebbi  3 , Elham Mohebbi  4 , Mahshid Mostafavi  1
Affiliations

Comparison between Combination Therapy of Oral Terbinafine and Cryotherapy versus Systemic Meglumine Antimoniate and Cryotherapy in Cutaneous Leishmaniasis: A Randomized Clinical Trial

Saeedeh Farajzadeh et al. Iran J Parasitol. 2015 Jan-Mar.

Abstract

Background: Leishmaniasis is a parasitic infection that may lead to a variety of manifestations. In Iran, cutaneous leishmaniasis (CL) has a high prevalence. There are many treatment modalities for CL. The use of oral terbinafine in the treatment of CL has recently been considered. The aim of this study was to compare combination of oral terbinafine plus cryotherapy versus systemic meglumine antimoniate plus cryotherapy in CL.

Methods: Patients with proven direct smear for CL were divided randomly in 2 groups of 40 cases. For the first group systemic glucantime prescribed (IM, 15 mg/kg/day) for 3 weeks. For the second group oral terbinafine as two folds of usual dose in the treatment of fungal diseases prescribed [125 mg/day for body weight (BW) <20 kg, 250 mg/day for BW 20-40 kg, 500 mg/day for BW>40 kg] for 4 weeks. Both groups received cryotherapy every 2 weeks for 4 weeks. The patients were followed monthly for 3 months after the treatment.

Results: Partial (HR= 0.55, CI 95%= 0.3-1.1) and complete (HR= 0.53, CI 95%= 0.3-0.98) clinical improvement in terbinafine group was much slower than glucantime group, although at the end of treatment protocols no significant difference between groups were statistically observed (P=0.27).

Conclusion: Considering more convenient suitable route of administration and approximately comparable results, it seems that terbinafine can be used as an alternative treatment, especially in the case of allergy or resistance to systemic glucantime.

Keywords: Cryotherapy; Iran; Leishmaniasis; Oral terbinafine; Systemic glucantime.

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Figures

Fig. 1:
Fig. 1:
Median of initial lesion size in glucantime and terbinafine groups / * since each patient could have more than one lesion, lesion codes are more than 80 (the total number of subjects)
Fig. 2:
Fig. 2:
Development of Partial (Fig. a) and Complete (Fig. b) response to treatment in glucantime and terbinafine groups
See this image and copyright information in PMC

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