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Randomized, double-blind, comparative clinical trial on the efficacy and safety of intralesional sodium stibogluconate and intralesional 7% hypertonic sodium chloride against cutaneous leishmaniasis caused by L. donovani.
J Dermatolog Treat. 2010 Sep; 21(5):286-93.JD

Abstract

INTRODUCTION

Since cutaneous leishmaniasis (CL) is a self healing disease, an ideal therapy should be rapidly effective, easily administered, cheap, available at all times at all centers and should have no side effects.

OBJECTIVES

To determine the efficacy and safety of intralesional 7% hypertonic saline in comparison to intralesional sodium stibogluconate against L. donovani CL.

METHODS

Intralesional hypertonic saline (HS) and sodium stibogluconate (SSG) were randomly allocated to 154 patients (229 lesions); these were followed-up for 18 months.

RESULTS

The M:F ratio was 1.8:1 (99:55). The average age of our population was 32 years. SSG was given to 87 patients (136 lesions); HS was given to 67 patients (93 lesions). SSG showed a 100% cure rate within one to six injections (average 3.24); HS showed a 92.2% cure rate within one to 10 injections (average 5.27). The average duration of treatment with SSG and HS was 5.11 and 8.78 weeks respectively. There was no difference in efficacy for both therapies with regard to ulcers or papules, and small or large, exposed or unexposed lesions. There was no association between the rapidity of clinical response and the duration and location of lesions. There were no local or systemic side effects except pain during injection. The lesions in the two groups showed post-inflammatory hyperpigmentation after treatment. During 18 months of follow-up there were no recurrences and no visceralization.

CONCLUSIONS

The most effective therapy for Leishmania donovani cutaneous leishmaniasis was intralesional SSG (average 3.24 injections). HS was effective, but needed an average of 5.27 injections in total per lesion. HS was cheap, with no risk of systemic side effects and was easily available at all centers.

Authors+Show Affiliations

Anuradhapura Teaching Hospital, Anuradhapura, Sri Lanka. ranthilaka37@yahoo.comNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

20438389

Citation

Ranawaka, Ranthilaka R., and Hema S. Weerakoon. "Randomized, Double-blind, Comparative Clinical Trial On the Efficacy and Safety of Intralesional Sodium Stibogluconate and Intralesional 7% Hypertonic Sodium Chloride Against Cutaneous Leishmaniasis Caused By L. Donovani." The Journal of Dermatological Treatment, vol. 21, no. 5, 2010, pp. 286-93.
Ranawaka RR, Weerakoon HS. Randomized, double-blind, comparative clinical trial on the efficacy and safety of intralesional sodium stibogluconate and intralesional 7% hypertonic sodium chloride against cutaneous leishmaniasis caused by L. donovani. J Dermatolog Treat. 2010;21(5):286-93.
Ranawaka, R. R., & Weerakoon, H. S. (2010). Randomized, double-blind, comparative clinical trial on the efficacy and safety of intralesional sodium stibogluconate and intralesional 7% hypertonic sodium chloride against cutaneous leishmaniasis caused by L. donovani. The Journal of Dermatological Treatment, 21(5), 286-93. https://doi.org/10.3109/09546630903287445
Ranawaka RR, Weerakoon HS. Randomized, Double-blind, Comparative Clinical Trial On the Efficacy and Safety of Intralesional Sodium Stibogluconate and Intralesional 7% Hypertonic Sodium Chloride Against Cutaneous Leishmaniasis Caused By L. Donovani. J Dermatolog Treat. 2010;21(5):286-93. PubMed PMID: 20438389.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Randomized, double-blind, comparative clinical trial on the efficacy and safety of intralesional sodium stibogluconate and intralesional 7% hypertonic sodium chloride against cutaneous leishmaniasis caused by L. donovani. AU - Ranawaka,Ranthilaka R, AU - Weerakoon,Hema S, PY - 2010/5/5/entrez PY - 2010/5/5/pubmed PY - 2010/12/18/medline SP - 286 EP - 93 JF - The Journal of dermatological treatment JO - J Dermatolog Treat VL - 21 IS - 5 N2 - INTRODUCTION: Since cutaneous leishmaniasis (CL) is a self healing disease, an ideal therapy should be rapidly effective, easily administered, cheap, available at all times at all centers and should have no side effects. OBJECTIVES: To determine the efficacy and safety of intralesional 7% hypertonic saline in comparison to intralesional sodium stibogluconate against L. donovani CL. METHODS: Intralesional hypertonic saline (HS) and sodium stibogluconate (SSG) were randomly allocated to 154 patients (229 lesions); these were followed-up for 18 months. RESULTS: The M:F ratio was 1.8:1 (99:55). The average age of our population was 32 years. SSG was given to 87 patients (136 lesions); HS was given to 67 patients (93 lesions). SSG showed a 100% cure rate within one to six injections (average 3.24); HS showed a 92.2% cure rate within one to 10 injections (average 5.27). The average duration of treatment with SSG and HS was 5.11 and 8.78 weeks respectively. There was no difference in efficacy for both therapies with regard to ulcers or papules, and small or large, exposed or unexposed lesions. There was no association between the rapidity of clinical response and the duration and location of lesions. There were no local or systemic side effects except pain during injection. The lesions in the two groups showed post-inflammatory hyperpigmentation after treatment. During 18 months of follow-up there were no recurrences and no visceralization. CONCLUSIONS: The most effective therapy for Leishmania donovani cutaneous leishmaniasis was intralesional SSG (average 3.24 injections). HS was effective, but needed an average of 5.27 injections in total per lesion. HS was cheap, with no risk of systemic side effects and was easily available at all centers. SN - 1471-1753 UR - https://www.unboundmedicine.com/medline/citation/20438389/Randomized_double_blind_comparative_clinical_trial_on_the_efficacy_and_safety_of_intralesional_sodium_stibogluconate_and_intralesional_7_hypertonic_sodium_chloride_against_cutaneous_leishmaniasis_caused_by_L__donovani_ L2 - https://www.tandfonline.com/doi/full/10.3109/09546630903287445 DB - PRIME DP - Unbound Medicine ER -