Résumé
Objective To evaluate the efficacy of niosomal dapsone gel and intralesional meglumine antimoniate with cryotherapy and intralesional meglumine antimoniate in cutaneous leishmaniasis
Methods This was a randomized clinical trial with 73 participants that were divided into two groups including, case group [weekly intralesional meglumine antimoniate and twice a day niosomal dapsone gel] and control group [weekly intralesional meglumine antimoniate with biweekly cryotherapy]. The treatment course continued until 16 weeks or complete cure, whatever occurred earlier and participants were followed up in 4th, 8th, 12th and 16th weeks of the treatment
Results Overall, 68 patients [33 males and 35 female] completed the study. Age, sex, size and duration of the lesions were not statistically different between two groups. At the end of the study, 82.9% of patients in case group showed complete response
Conclusion Niosomal dapsone gel has promising results with fewer adverse effects, so, it can be used as an alternative treatment modality, especially in children and patients with contraindication of systemic drugs
Résumé
Treatment of cutaneous leishmaniasis, especially when caused by L. tropica, is challenging. Meglumine antimoniate [Glucantime[R]] is used as the standard treatment, but multiple injectiond are necessary. The objective of this study was to compare the efficacy of weekly intralesional injections with twice weekly injections of Glucantime for the treatment of anthroponotic cutaneous leishmaniasis [ACL]. This randomized open clinical trial was conducted, in Bam, Kerman province, Iran. 96 eligible patients according to inclusion and exclusion criteria who were willing to participate were included. The included patients were randomly assigned into two groups, one group treated with weekly intralesional injections of Glucantime[R] and the other group treated with intralesional Glucantime[R] twice a week. Type and size of each lesion [induration, ulcer and scar] were recorded weekly. Complete healing was defined as complete re-epithelialization and absence of induration in all lesions and was considered as the primary outcome measure. A total of 48 patients completed the study; complete cure was seen in 24 of 27 [89%] patients who received weekly intralesional MA with a mean duration of healing equals to 70 +/- 10 days. Complete cure was seen in 24 of 31 [77%] patients who received intralesional MA twice a week, the mean duration of healing in the latter group was 58 +/- 5 days. There was no significant difference between the two groups [P=0.23]. It seems that the efficacy of intralesional injections of Glucantime[R] once a week is similar to efficacy of twice a week Glucantime[R] injections
Résumé
This study investigated the in vitro production of interferon-gamma, interleukin [IL]-10, IL-12, and IL-13, after antigenic stimulation of the cells [with Leishmania antigen and lipopolysaccharide] using whole blood from patients with cutaneous leishmaniasis lesions caused by Leishmania tropica and in normal volunteers with history of cutaneous leishmaniasis. ELISA results showed that the mean production of interferon-gamma by cells of whole blood in patients with lesions in response to Leishmania antigen was significantly lower than corresponding values in volunteers with history of cutaneous leishmaniasis [P< 0.05] and significantly higher levels of IL-10 production in patients with lesions were observed compared with cured volunteers of the disease [P<0.01]. A similar level of IL-12, including p40 subunit of IL-12, was detected in both groups tested in this study in response to stimulation of parasite antigen. The levels of the IL-13 after stimulation with Leishmania antigen were significantly more in patients compared with volunteers with history of cutaneous leishmaniasis [P< 0.01]. There was no significant difference in the mean production of IFN-gamma, IL-10, IL-12 and IL-13 by PHA or LPS stimulated cells from patients with lesions and volunteers with history of the disease, indicating that there was no qualitative defect in cytokine production in these patients. In this study, we have detected the decreased production of interferon- gamma by cells of patients with lesions of cutaneous leishmaniasis in response to parasite antigen and unbalanced production of regulatory cytokines such as IL-10 and IL-13 using the whole-blood stimulation assay technique. The required small volume of blood and the rapid set up time are the advantages in this assay technique. Using this assay for further immunodetection of cytokines may confirm its value for clinical investigation