Comparación de tolerabilidad y fisico-química entre lotes de antimonial comercial y no comercializado (Glucantime® vs. Ulamina) en el tratamiento de la Leishmaniasis cutánea

A retrospective study done by means of the revision of 416 medical records from cutaneous leishmaniasis patients, treated exclusively with pentavalent antimony (Glucantime® and Ulamina) at the Centre of Parasitological Research “Jose Witremundo Torrealba”, at the University of Los Andes, in Trujillo, Venezuela, during a period between June 1989 and June 2002, with the objective of determinates the tolerability of these compounds in terms of local adverse reactions, systemic and of cutaneous hypersensibility. Additionally, some physical-chemical characteristics were quantified in lots of both of the pharmaceutics used during the appointed period with the aim of justify the observed differences. A local cutaneous reaction was presented (induration, edema, eritheme and itch) in 13% of 166 patients treated with Glucantime® and in 7% of 250 treated with Ulamina, the systemic reactions found were hypertension, tachycardia, disnea, hepatitis, fever, headache, dizziness, asthenia and systemic allergic reaction in 3% of (Glucantime® treated patients and in 2% of the Ulamina ones. The positiveness to the cutaneous hypersensibility test was significantly higher with Ulamina. The loss of Ulamina showed a lower concentration of total and pentavalent antimony, chlorates, density and similarity, the lasts three of statistical significance