Comparison of Intralesional Meglumine Antimonite along with oral Itraconazole to Intralesional Meglumine Antimonite in the treatment of Cutaneous Leishmaniasis.
CL = Cutaneous leishmaniasis,
CMH = Combined Military Hospital
Cutaneous leishmaniasis
IL = Intralesional,
Intralesional meglumine antimoniate
Itraconazole
LD = Leishmania Donovan,
MA = Meglumine Antimoniate,
Journal
Pakistan journal of medical sciences
ISSN: 1682-024X
Titre abrégé: Pak J Med Sci
Pays: Pakistan
ID NLM: 100913117
Informations de publication
Date de publication:
Historique:
entrez:
29
11
2019
pubmed:
30
11
2019
medline:
30
11
2019
Statut:
ppublish
Résumé
Cutaneous leishmaniasis (CL) is endemic in developing countries like Pakistan. Pentavalent antimonials are still drug of choice, despite being toxic and intolerable for patients. Second line treatments have been extensively studied but the results of their efficacy are conflicting. This, to our knowledge, will be the first study in this regard. Our objective was to determine if combination of oral itraconazole with intralesional (IL) meglumine antimoniate (MA) reduces the duration of treatment for cutaneous leishmaniasis, as compared to intralesional MA alone. A randomized controlled trial (single blinded) was carried out from August 2017 till December 2017 on 69 patients who fulfilled inclusion criteria. They were assigned to Group-A or B by lottery method. Group-A patients received IL MA once a week while Group-B received oral itraconazole 200mg, once daily, for six weeks along with similar regimen of IL MA as Group-A. The patients were assessed every three weeks by the blinded assessor till clinical cure was achieved. A follow up visit, two months after clinical cure was done to look for relapse of the disease. Thirty patients in Group-A and 35 patients in Group-B completed the study. At 3, 6, 9 and 12 weeks the patients were assessed for: no, partial or complete response and results of the two groups were compared for statistical significance. The p-values of 0.20, 0.57 and 0.11 at 3, 6 and 9 weeks, respectively, depict that there was no significant difference at any step of assessment between the two groups in terms of healing. The p values of each t test was>0.05 refuting the hypothesis. Combination of oral itraconazole with intralesional MA offered no benefit over intralesional MA alone in the management of cutaneous leishmaniasis in terms of duration of therapy.
Sections du résumé
BACKGROUND & OBJECTIVE
OBJECTIVE
Cutaneous leishmaniasis (CL) is endemic in developing countries like Pakistan. Pentavalent antimonials are still drug of choice, despite being toxic and intolerable for patients. Second line treatments have been extensively studied but the results of their efficacy are conflicting. This, to our knowledge, will be the first study in this regard. Our objective was to determine if combination of oral itraconazole with intralesional (IL) meglumine antimoniate (MA) reduces the duration of treatment for cutaneous leishmaniasis, as compared to intralesional MA alone.
METHODS
METHODS
A randomized controlled trial (single blinded) was carried out from August 2017 till December 2017 on 69 patients who fulfilled inclusion criteria. They were assigned to Group-A or B by lottery method. Group-A patients received IL MA once a week while Group-B received oral itraconazole 200mg, once daily, for six weeks along with similar regimen of IL MA as Group-A. The patients were assessed every three weeks by the blinded assessor till clinical cure was achieved. A follow up visit, two months after clinical cure was done to look for relapse of the disease.
RESULTS
RESULTS
Thirty patients in Group-A and 35 patients in Group-B completed the study. At 3, 6, 9 and 12 weeks the patients were assessed for: no, partial or complete response and results of the two groups were compared for statistical significance. The p-values of 0.20, 0.57 and 0.11 at 3, 6 and 9 weeks, respectively, depict that there was no significant difference at any step of assessment between the two groups in terms of healing. The p values of each t test was>0.05 refuting the hypothesis.
CONCLUSION
CONCLUSIONS
Combination of oral itraconazole with intralesional MA offered no benefit over intralesional MA alone in the management of cutaneous leishmaniasis in terms of duration of therapy.
Identifiants
pubmed: 31777513
doi: 10.12669/pjms.35.6.363
pii: PJMS-35-1669
pmc: PMC6861503
doi:
Types de publication
Journal Article
Langues
eng
Pagination
1669-1673Informations de copyright
Copyright: © Pakistan Journal of Medical Sciences.
Déclaration de conflit d'intérêts
Conflict of interest: None.
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