RESUMO
Background: Chitosan has a biocompatible, biodegradable and nontoxic nature. The effectiveness of nano-chitosan films in the treatment of cutaneous leishmaniasis has been confirmed previously in susceptible laboratory animals. Aims: The aim of this study is to evaluate the safety and efficacy of a chitosan-based biocompatible dressing in patients with cutaneous leishmaniasis who were either nonresponsive to or had medical contraindications for conventional treatments. Materials and Methods: A total of 10 eligible patients were included in this single arm, single center study. The sterile chitosan film was immersed in saline serum and was cautiously extended over the wound to avoid air occlusion. Sterile Vaseline gauze was then applied and the film was kept on the wound site for 7 days and was repeated every week until the healing was completed. Complete clinical response was defined as complete re-epithelialization of the skin lesion as well as microscopic negative results for amastigote forms of Leishmania sp. Results: All patients showed either significant (30%) or complete (70%) improvement after 8 weeks of therapy and at 16 weeks post treatment all cases were completely cured. It was well tolerated and there were no product-related adverse events such as allergic reaction or infection. Moreover, no recurrences were observed in any patients after 6 months follow-up. Limitations: The lack of a control group, relatively small sample size and failure to evaluate the histological and molecular effects of chitosan were the limitations of this study. Conclusion: Our findings confirmed that chitosan can be safely and effectively used for the treatment of cutaneous leishmaniasis. We were unable to find any previous clinical study in evaluating the efficacy of chitosan for cutaneous leishmaniasis on human subjects. Further studies are recommended to design a randomized, double-blinded clinical trial with more volunteers who infected with different species of Leishmania and various clinical forms of cutaneous leishmaniasis.
RESUMO
INTRODUCTION: Various methods are used for the diagnosis of visceral leishmaniasis (VL), such as microscopic examination, culture and inoculation of laboratory animals; however, serological assays are commonly used for the detection of antibodies in serum samples with a wide range of specificity and sensitivity. METHODS: The purpose of this study was to compare three serological methods, including rA2-ELISA, the recombinant KE16 (rKE16) dipstick test and the direct agglutination test (DAT), for the detection of antibodies against VL antigens. The assays utilized 350 statistically based random serum samples from domestic dogs with clinical symptoms as well as samples from asymptomatic and healthy dogs from rural and urban areas of the Meshkinshahr district, northwestern Iran. RESULTS: Samples were assessed, and the following positive rates were obtained: 11.5% by rKE16, 26.9% by DAT and 49.8% by ELISA. The sensitivity among symptomatic dogs was 32.4% with rKE16, 100% with DAT and 52.9% with ELISA. Conversely, rA2-ELISA was less specific for asymptomatic dogs, at 46.5%, compared with DAT, at 88.9%. CONCLUSIONS : This study recommends rA2-ELISA as a parallel assay combined with DAT to detect VL infection among dogs. Further evaluations should be performed to develop an inexpensive and reliable serologic test for the detection of Leishmania infantum among infected dogs. .