Field Efficacy of Topical Nano-Liposomal Amphotericin B (Sina Ampholeish®) Alone or in Combination with Glucantime® and Cryotherapy on Human Cutaneous Leishmaniasis
-
Zahra Alizadeh
,
Mohammad Reza Shirzadi
,
Gholam Reza Hassanpour
,
Hossein Keshavarz
,
Fatemeh Mohebali
,
Seyed Ebrahim Skandari
,
Mohammad Zeinali
,
Sedigheh Shirmohammad
,
Mehdi Mohebali
Abstract
Background: Cutaneous leishmaniasis (CL) is a parasitic disease that presents a broad spectrum of clinical features. Treatment of CL is problematic. We aimed to compare the field therapeutic efficacy of topical nanoliposomes containing 0.4% amphotericin B (Nano Lip-AmB) alone and in combination with cryotherapy and/or Glucantime® on human CL in the endemic areas of Iran.
Methods: This retrospective study was performed based on the results of using Nano Lip-AmB alone or with Glucantime® and/or cryotherapy in the treatment of zoonotic cutaneous leishmaniasis (ZCL) in patients referred to health centers of Isfahan, Golestan and Ilam Provinces of Iran as endemic foci of ZCL caused by Leishmania major besides Mashhad and Bam cities as endemic foci of anthroponotic cutaneous leishmaniasis (ACL) caused by with L. tropica.
Results: Two hundred and seventy-eight patients with CL were included in the current study. All of the patients (100%) who received Nano Lip-AmB alone or in combination with Glucantime® and/or cryotherapy based on guideline of Iranian national committee for the treatment of CL. Two patients with 7 skin lesions, who was resident in ACL endemic area and received Nano Lip-AmB plus Glucantime® and another patient was a resident of ZCL endemic area and received Nano Lip-AmB plus cryotherapy showed clinical relapses after treatment.
Conclusion: Sina Ampholeish® in combination with other standard protocols of treatment of CL is well tolerated and with acceptable clinical efficacy rate.
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2. Razavi MR, Shirzadi MR, Mohebali M, et al. Human cutaneous leishmaniosis in Iran, up to date-2019. J Arthropod Borne Dis. 2021;15(2):143-51.
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4. Tabasi M, Alesheikh AA, Sofizadeh A, et al. A spatio-temporal agent-based approach for modeling the spread of zoonotic cutaneous leishmaniasis in northeast Iran. Parasit Vectors. 2020;13(1):572.
5. Nieva CB, Cid AG, Romero AI, et al. An appraisal of the scientific current situation and new perspectives in the treatment of cutaneous leishmaniasis. Acta Trop. 2021;221:105988.
6. Asilian A, Sadeghinia A, Faghihi G, Momeni A. Comparative study of the efficacy of combined cryotherapy and intralesional meglumine antimoniate (Glucantime®) vs. cryotherapy and intralesional meglumine antimoniate (Glucantime®) alone for the treatment of cutaneous leishmaniasis. Int J Dermatol Venereol. 2004;43(4):281-3.
7. Mayrink W, Botelho ACdC, Magalhães PA, et al. Immunotherapy, immunochemoth-erapy and chemotherapy for American cutaneous leishmaniasis treatment. Rev Soc Bras Med Trop. 2006;39(1):14-21.
8. Currie MA. Treatment of cutaneous leishmaniasis by curettage. British Med J (Clinical research ed). 1983; 287(6399): 1105–1106.
9. Thornton SJ, Wasan KM. The reformulation of Amphotericin B for oral administration to treat systemic fungal infections and visceral leishmaniasis. Expert Opin Drug Deliv. 2009;6(3):271-84.
10. Wortmann G, Zapor M, Ressner R, et al. Lipsosomal Amphotericin B for treatment of cutaneous leishmaniasis. Am J Trop Med Hyg. 2010;83(5):1028-33.
11. Solomon M, Pavlotsky F, Leshem E, et al. Liposomal Amphotericin B treatment of cutaneous leishmaniasis due to Leishmania tropica. J Eur Acad Dermatol Venereol. 2011;25(8):973-7.
12. Shirzadi MR. Lipsosomal Amphotericin B: a review of its properties, function, and use for treatment of cutaneous leishmaniasis. Res Rep Trop Med. 2019;10:11-18.
13. Reithinger R, Dujardin JC, Louzir H, et al. Cutaneous leishmaniasis. Lancet Infect Dis. 2007;7(9):581-96.
14. Sabzevari S, Teshnizi SH, Shokri A, et al. Cutaneous leishmaniasis in Iran: A systematic review and meta-analysis. Microb Pathog. 2021;152:104721.
15. Azim M, Khan SA, Ullah S, et al. Therapeutic advances in the topical treatment of cutaneous leishmaniasis: A review. PLoS Negl Trop Dis. 2021;15(3):e0009099.
16. Postigo JAR. Leishmaniasis in the world health organization eastern mediterranean region. Int J Antimicrob Agents. 2010;36:S62-S5.
17. Eiras DP, Kirkman LA, Murray HW. Cutaneous leishmaniasis: current treatment practices in the USA for returning travelers. Curr Treat Options Infect Dis. 2015;7(1):52-62.
18. Brito NC, Rabello A, Cota GF. Efficacy of pentavalent antimoniate intralesional infiltration therapy for cutaneous leishmaniasis: A systematic review. PLoS One. 2017;12(9):e0184777.
19. . Blum J, Lockwood DN, Visser L, et al. Local or systemic treatment for New World cutaneous leishmaniasis? Re-evaluating the evidence for the risk of mucosal leishmaniasis. Int Health. 2012;4(3):153-63.
20. Koff AB, Rosen T. Treatment of cutaneous leishmaniasis. J Am Acad Dermatol. 1994;31(5):693-708.
21. Palumbo E. Current treatment for cutaneous leishmaniasis: a review. Am J Ther. 2009;16(2):178-82.
22. Ramos H, Valdivieso E, Gamargo M, et al. Amphotericin B kills unicellular leishmanias by forming aqueous pores permeable to small cations and anions. J Membr Biol. 1996;152(1):65-75.
23. Laniado-Laborín R, Cabrales-Vargas MN. Amphotericin B: side effects and toxicity. Rev Iberoam Micol. 2009;26(4):223-7.
24. Rocio C, Amato VS, Camargo RA, et al. Liposomal formulation of Amphotericin B for the treatment of mucosal leishmaniasis in HIV-negative patients. Trans R Soc Trop Med Hyg. 2014;108(3):176-8.
25. Solomon M, Pavlotzky F, Barzilai A, Schwartz E. Liposomal Amphotericin B in comparison to sodium stibogluconate for Leishmania braziliensis cutaneous leishmaniasis in travelers. J Am Acad Dermatol. 2013;68(2):284-9.
26. Goyonlo VM, Vosoughi E, Kiafar B, et al. Efficacy of intralesional Amphotericin B for the treatment of cutaneous leishmaniasis. Indian J Dermatol. 2014;59(6):631.
27. Eskandari SE, Firooz A, Nassiri-Kashani M, et al. Safety evaluation of nano-liposomal formulation of Amphotericin B (sina ampholeish) in animal model as a candidate for treatment of cutaneous leishmaniasis. J Arthropod Borne Dis. 2018;12(3):269-75.
28. Eskandari SE, Firooz A, Nassiri-Kashani M, et al. Safety evaluation of topical application of nano-liposomal form of Amphotericin B (SinaAmpholeish) on healthy volunteers: phase I clinical trial. Iran J Parasitol. 2019;14(2):197-203.
29. Jaafari MR, Hatamipour M, Alavizadeh SH, et al. Development of a topical liposomal formulation of Amphotericin B for the treatment of cutaneous leishmaniasis. Int J Parasitol Drugs Drug Resist. 2019;11:156-65.
30. Eskandari SE, Khamesipour A, Jaafari MR, et al. Combination of topical liposomal Amphotericin B and Glucantime in comparison with glucantime alone for the treatment of anthroponotic cutaneous leishmaniasis (ACL) caused by Leishmania tropica: study protocol for a randomized, controlled trial. Iran J Microbiol. 2021;13(5):718-23.
31. Khamesipour A, Mohammadi A, Jaafari M, et al. Pilot study of safety and efficacy of topical liposomal Amphotericin B for cutaneous leishmaniasis caused by Leishmania major in Islamic Republic of Iran. East Mediterr Health J. 2022;28(9):658-63.
32. Guery R, Henry B, Martin-Blondel G, et al. Liposomal Amphotericin B in travelers with cutaneous and muco-cutaneous leishmaniasis: Not a panacea. PLoS Negl Trop Dis. 2017;11(11):e0006094.
33. Yardley V, Croft SL. Activity of liposomal Amphotericin B against experimental cutaneous leishmaniasis. Antimicrob Agents Chemother. 1997;41(4):752-6.
34. Hohl CM, Small SS, Peddie D, et al. Why clinicians don’t report adverse drug events: qualitative study. JMIR Public Health And Surveillance. 2018;4(1):e9282.
35. Santos CR, Tuon FF, Cieslinski J, et al. Comparative study on liposomal Amphotericin B and other therapies in the treatment of mucosal leishmaniasis: A 15-year retrospective cohort study. Plos One. 2019;14(6):e0218786.
2. Razavi MR, Shirzadi MR, Mohebali M, et al. Human cutaneous leishmaniosis in Iran, up to date-2019. J Arthropod Borne Dis. 2021;15(2):143-51.
3. Sharifi I, Khosravi A, Aflatoonian MR et al. Cutaneous leishmaniasis situation analysis in the Islamic Republic of Iran in preparation for an elimination plan. Front. Public Health. 2023; 11: 1091709. doi: 10.3389/fpubh.2023.1091709.
4. Tabasi M, Alesheikh AA, Sofizadeh A, et al. A spatio-temporal agent-based approach for modeling the spread of zoonotic cutaneous leishmaniasis in northeast Iran. Parasit Vectors. 2020;13(1):572.
5. Nieva CB, Cid AG, Romero AI, et al. An appraisal of the scientific current situation and new perspectives in the treatment of cutaneous leishmaniasis. Acta Trop. 2021;221:105988.
6. Asilian A, Sadeghinia A, Faghihi G, Momeni A. Comparative study of the efficacy of combined cryotherapy and intralesional meglumine antimoniate (Glucantime®) vs. cryotherapy and intralesional meglumine antimoniate (Glucantime®) alone for the treatment of cutaneous leishmaniasis. Int J Dermatol Venereol. 2004;43(4):281-3.
7. Mayrink W, Botelho ACdC, Magalhães PA, et al. Immunotherapy, immunochemoth-erapy and chemotherapy for American cutaneous leishmaniasis treatment. Rev Soc Bras Med Trop. 2006;39(1):14-21.
8. Currie MA. Treatment of cutaneous leishmaniasis by curettage. British Med J (Clinical research ed). 1983; 287(6399): 1105–1106.
9. Thornton SJ, Wasan KM. The reformulation of Amphotericin B for oral administration to treat systemic fungal infections and visceral leishmaniasis. Expert Opin Drug Deliv. 2009;6(3):271-84.
10. Wortmann G, Zapor M, Ressner R, et al. Lipsosomal Amphotericin B for treatment of cutaneous leishmaniasis. Am J Trop Med Hyg. 2010;83(5):1028-33.
11. Solomon M, Pavlotsky F, Leshem E, et al. Liposomal Amphotericin B treatment of cutaneous leishmaniasis due to Leishmania tropica. J Eur Acad Dermatol Venereol. 2011;25(8):973-7.
12. Shirzadi MR. Lipsosomal Amphotericin B: a review of its properties, function, and use for treatment of cutaneous leishmaniasis. Res Rep Trop Med. 2019;10:11-18.
13. Reithinger R, Dujardin JC, Louzir H, et al. Cutaneous leishmaniasis. Lancet Infect Dis. 2007;7(9):581-96.
14. Sabzevari S, Teshnizi SH, Shokri A, et al. Cutaneous leishmaniasis in Iran: A systematic review and meta-analysis. Microb Pathog. 2021;152:104721.
15. Azim M, Khan SA, Ullah S, et al. Therapeutic advances in the topical treatment of cutaneous leishmaniasis: A review. PLoS Negl Trop Dis. 2021;15(3):e0009099.
16. Postigo JAR. Leishmaniasis in the world health organization eastern mediterranean region. Int J Antimicrob Agents. 2010;36:S62-S5.
17. Eiras DP, Kirkman LA, Murray HW. Cutaneous leishmaniasis: current treatment practices in the USA for returning travelers. Curr Treat Options Infect Dis. 2015;7(1):52-62.
18. Brito NC, Rabello A, Cota GF. Efficacy of pentavalent antimoniate intralesional infiltration therapy for cutaneous leishmaniasis: A systematic review. PLoS One. 2017;12(9):e0184777.
19. . Blum J, Lockwood DN, Visser L, et al. Local or systemic treatment for New World cutaneous leishmaniasis? Re-evaluating the evidence for the risk of mucosal leishmaniasis. Int Health. 2012;4(3):153-63.
20. Koff AB, Rosen T. Treatment of cutaneous leishmaniasis. J Am Acad Dermatol. 1994;31(5):693-708.
21. Palumbo E. Current treatment for cutaneous leishmaniasis: a review. Am J Ther. 2009;16(2):178-82.
22. Ramos H, Valdivieso E, Gamargo M, et al. Amphotericin B kills unicellular leishmanias by forming aqueous pores permeable to small cations and anions. J Membr Biol. 1996;152(1):65-75.
23. Laniado-Laborín R, Cabrales-Vargas MN. Amphotericin B: side effects and toxicity. Rev Iberoam Micol. 2009;26(4):223-7.
24. Rocio C, Amato VS, Camargo RA, et al. Liposomal formulation of Amphotericin B for the treatment of mucosal leishmaniasis in HIV-negative patients. Trans R Soc Trop Med Hyg. 2014;108(3):176-8.
25. Solomon M, Pavlotzky F, Barzilai A, Schwartz E. Liposomal Amphotericin B in comparison to sodium stibogluconate for Leishmania braziliensis cutaneous leishmaniasis in travelers. J Am Acad Dermatol. 2013;68(2):284-9.
26. Goyonlo VM, Vosoughi E, Kiafar B, et al. Efficacy of intralesional Amphotericin B for the treatment of cutaneous leishmaniasis. Indian J Dermatol. 2014;59(6):631.
27. Eskandari SE, Firooz A, Nassiri-Kashani M, et al. Safety evaluation of nano-liposomal formulation of Amphotericin B (sina ampholeish) in animal model as a candidate for treatment of cutaneous leishmaniasis. J Arthropod Borne Dis. 2018;12(3):269-75.
28. Eskandari SE, Firooz A, Nassiri-Kashani M, et al. Safety evaluation of topical application of nano-liposomal form of Amphotericin B (SinaAmpholeish) on healthy volunteers: phase I clinical trial. Iran J Parasitol. 2019;14(2):197-203.
29. Jaafari MR, Hatamipour M, Alavizadeh SH, et al. Development of a topical liposomal formulation of Amphotericin B for the treatment of cutaneous leishmaniasis. Int J Parasitol Drugs Drug Resist. 2019;11:156-65.
30. Eskandari SE, Khamesipour A, Jaafari MR, et al. Combination of topical liposomal Amphotericin B and Glucantime in comparison with glucantime alone for the treatment of anthroponotic cutaneous leishmaniasis (ACL) caused by Leishmania tropica: study protocol for a randomized, controlled trial. Iran J Microbiol. 2021;13(5):718-23.
31. Khamesipour A, Mohammadi A, Jaafari M, et al. Pilot study of safety and efficacy of topical liposomal Amphotericin B for cutaneous leishmaniasis caused by Leishmania major in Islamic Republic of Iran. East Mediterr Health J. 2022;28(9):658-63.
32. Guery R, Henry B, Martin-Blondel G, et al. Liposomal Amphotericin B in travelers with cutaneous and muco-cutaneous leishmaniasis: Not a panacea. PLoS Negl Trop Dis. 2017;11(11):e0006094.
33. Yardley V, Croft SL. Activity of liposomal Amphotericin B against experimental cutaneous leishmaniasis. Antimicrob Agents Chemother. 1997;41(4):752-6.
34. Hohl CM, Small SS, Peddie D, et al. Why clinicians don’t report adverse drug events: qualitative study. JMIR Public Health And Surveillance. 2018;4(1):e9282.
35. Santos CR, Tuon FF, Cieslinski J, et al. Comparative study on liposomal Amphotericin B and other therapies in the treatment of mucosal leishmaniasis: A 15-year retrospective cohort study. Plos One. 2019;14(6):e0218786.
| Files | ||
| Issue | Vol 18 No 4 (2023) | |
| Section | Original Article(s) | |
| DOI | https://doi.org/10.18502/ijpa.v18i4.14241 | |
| Keywords | ||
| Cutaneous leishmaniasis Treatment SinaAmpholeish® Glucantime® Cryotherapy Human Iran | ||
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How to Cite
1.
Alizadeh Z, Shirzadi MR, Hassanpour GR, Keshavarz H, Mohebali F, Skandari SE, Zeinali M, Shirmohammad S, Mohebali M. Field Efficacy of Topical Nano-Liposomal Amphotericin B (Sina Ampholeish®) Alone or in Combination with Glucantime® and Cryotherapy on Human Cutaneous Leishmaniasis. Iran J Parasitol. 2023;18(4):419-426.
