Comparison between Combination Therapy of Oral Terbinafine and Cryotherapy versus Systemic Meglumine Antimoniate and Cryotherapy in Cutaneous Leishmaniasis: A Randomized Clinical Trial.
AbstractBackground: 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 me-glumine 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 signifi-cant 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.
Sharifi F, Sharifi I, Zarean M, Hakimi Parizi M, Aflatoonian MR, Fasihi Harandi M, Zahmatkesh R, Mashayekhi M, Kermanizadeh AR. Spatial Distribution and Molecular Identification of Leishmania Species from Endemic Foci of South-Eastern Iran. Iran J Parasitol. 2012; 7(1):45-52.
Sharifi I, Nakhaei N, Aflatoonian MR, Hakimi Parizi M, Fekri AR, Safizadeh H, Shirzadi MR, Gooya MM, Khamesipour A, Nadim A. Cutane-ous Leishmaniasis in Bam: A Comparative Eval-uation of Pre- and Post- Earthquake Years (1999-2008). Iran J Public Health. 2011; 40(2):49-56.
Aflatoonian MR, Sharifi I, Hakimi Parizi M, Afla-toonian B, Sharifi M, Khosravi A, Fekri AR, Khamesipour A, Sharifi H. A Prospective Cohort Study of Cutaneous Leishmaniasis Risk and Opi-um Addiction in South Eastern Iran. PLOS ONE. 2014; 9(2): e89043.
Esfandiarpour I, Afsáneh A. Evaluating the effica-cy of allopurinol and meglumine antimoniate (glucantime) in the treatment of cutaneous leish-maniasis. Int J Dermatol. 2002; 41: 521 –4.
Lira R, Contreras LM, Rta RM, Urbina JA. Mechanism of action of anti-proliferative lyso-phospholipid analogues against protozoan para-site Trypanosoma cruzi: potentiation of in vitro activ-ity by the sterol biosynthesis inhibitor ketocona-zole. J Antimicrob Chemother. 2001; 47:37–46.
Zuffery R, Mamoun CB. Choline transport in Leishmania major promastigotes and its inhibition by choline and phosphocholine analogs. Mol Bi-ochem Parasitol. 2005; 125: 127–34.
Vanniersantons MA. Alternations induced by antifungal compound ketoconazole and terbinafin in leishmania. J Eukaryote Microbial. 1995; 42(4): 337-46.
Ryder N. Terbinafine: mode of action and properties of the squalene epoxidase inhibition. Br J Dermatol. 2006; 126(39): 2-7.
Ottevanger V, Petersen CS. Terbinafine. A new allylamine derivative for local and peroral use in fungal infections. Ugeskrift for Laeger.1991; 153(48):3421-4.
Consigli J, Danielo C, Gallerano V, Papa M, Guidi A, et l. Cutaneous leishmaniasis: successful treatment withitraconazole. Int J Dermatol. 2006; 45(1): 46-9.
Lee SA, Hasbun R. Therapy of cutaneous leishmaniasis. Int J Infect Dis .2003;7(2): 86-93.
Mohebali M, Fotouhi A, Hooshmand B, Zarei Z, Akhoundi B, Rahnema A, Razaghian AR, Kabir MJ, Nadim A. Comparison of miltefosine and meglumine antimoniate for the treatment of zo-onotic cutaneous leishmaniasis (ZCL) by a ran-domized clinical trial in Iran. Acta Tropica. 2007; 103:33–40.
Perez A. Terbinafine: broad new spectrum of indications in several subcutaneous and systemic and parasitic diseases. Mycoses. 1999; 42: 111.
Zakai HA, Zimmo SK. Effects of itraconazole and terbinafine on Leishmania major lesions in BALB/c mice. Ann Trop Med Parasitol. 2000;94(8): 787-91.
Bahamdan KA, Tallab TM, Johargi H, Nourad MM, PliD, Karam Ibrahim, CES, El Sherbini AH, Karkashan E, Khare AK, Nauri MM. Terbinafine in the treatment of cutaneous leishmaniasis: a pilot study. Int J Dermatol. 2008; 36(1): 59-60.
Gonzalés-Rupérez J, Morlius M, Carazo A. Remission of localized cutaneous leishmaniasis in a HIV-positive patient using systemic terbinafine. Dermatol; 1997: 194.
Alkhawajah AM, Larbi E, al-Gindan Y, Abahus-sein A, Jain S. Treatment of cutaneous antimony: intramuscular administration leishmaniasis with versus intralesional. Ann Trop Med Parasitol. 1997; 91(8): 899-906.
Mujtaba G, Khalid M, Weekly VS. fortnightly intralesional meglumine antimoniate in cutaneous leishmaniasis. Int J Dermatol. 2001; 38(8): 607-9.
Akhyani M, Tajsar S. Comparative study of cryotherapy and intralesional glucantime in the treatment of cutaneous leishmaniasis. J Med Univ. 1997; 34: 29–34.
Masmoudi A Maalej N, Boudaya S. Adverse effects of intralesional glucantime in the treatment of cutaneous leishmaniasis. Med Mal Infect. 2006; 36: 226–228.
Beheshti M, Ghotbi S, Amirizade S. Therapeutic and adverse effects of glucantime used for treatment of cutaneous leishmaniasis. Shiraz E Med J. 2007; 8: 155–161.
Esfandiarpour I, Farajzadeh S, Rahnama Z, Fath-abadi EA, Heshmatkhah A. Adverse effects of intralesional meglumine antimoniate and its influence on clinical laboratory parameters in the treatment of cutaneous leishmaniasis. Int J Der-matol. 2012; 51(10):1221-5.
Gupta AK,Adamiak A , Cooper E. The efficacy and safety of terbinafine in children. J Eur Acad Dermatol Venereol. 2003; 17(6): 627-40.
Michael H, Monka G, Krupp P, O'Sullivan D. Safety of Oral terbinafine Results of a Postmarketing Surveillance Study in 25 884 Patients. Arch Dermatol. 1997; 133(10):1213-9.
Reithinger R, Coleman PG. Treating cutaneous leishmaniasis patients in Kabul, Afghanistan: cost-effectiveness of an operational program in a complex emergency setting. BMC infectious diseases. 2007; 7(1): 3.
Vega JC, Sanchez BF, Montero LM, Montaña R, Del Pilar Mahecha M, Dueñes B, Baron AR, Reithinger R. Short communication: The cost‐effectiveness of cutaneous leishmaniasis patient management during an epidemic in Chaparral. Colombia in 2004. Trop Med Int Health. 2007; 12(12):1540-4.