ABSTRACT
Objectives: Cutaneous leishmaniasis is a neglected disease, associated with high morbidity, which is partially due to the toxicity of available therapies. The pentavalent antimonial derivatives intralesional infiltration has proven to be as effective as the intravenous drug-based therapy, however, there is a lack of robust safety data.Methods: Phase II, uncontrolled, unicenter clinical trial to assess the safety profile of a standardized meglumine antimionate intralesional therapy, based on weekly infiltrations.Results: Fifty-three patients were studied, predominantly men (60%) and young adults (43.7 ± 17.1 years). Overall, 86.9% of the patients had at least one clinical adverse event. Local events were the most frequent (83%), followed by systemic ones (47.3%). Fourteen participants (26%) presented biochemical abnormalities. In all cases, laboratorial alterations were classified as mild and treatment discontinuation was not required. Differently, the two hypersensitivity (3.8%) reactions observed led to permanent treatment interruption. QTc interval prolongation was recorded in 14 patients (25.5%). The following risk associations to adverse events were identified in the multiple analysis: hypertension with systemic clinical events and smoking with QT interval prolongation.Expert commentary: In general, MA-IL was well tolerated and although associated with local and systemic adverse events, there was a low risk of high intensity or severe complications.
Subject(s)
Antiprotozoal Agents/administration & dosage , Leishmaniasis, Cutaneous/drug therapy , Meglumine Antimoniate/administration & dosage , Adult , Antiprotozoal Agents/adverse effects , Drug Hypersensitivity/etiology , Female , Humans , Injections, Intralesional , Male , Meglumine Antimoniate/adverse effects , Middle Aged , RiskABSTRACT
Central nervous system (CNS) involvement in Chagas disease (CD) is an uncommon complication that can result from direct involvement of the parasite or from thromboembolic phenomena. Direct involvement of CNS can occur in both acute and chronic forms of CD, and can also be secondary to reactivation. Reactivation of CD generally occurs in immunosuppressed patients such as those with human immunodeficiency infection or malignancies being rarely described in patients without apparent immunosuppression. We report a case of a patient living for many years in a nonendemic area for CD that presented to the emergency department with sudden onset of neurological symptoms as a result of reactivation of the disease. The microorganism was isolated from cerebrospinal fluid, and despite appropriate use of benznidazole, the patient died of sepsis after 22 days of treatment. Further investigation did not show any apparent cause of immunosuppression. This case report shows the importance of considering the diagnostic possibility of neurological complications from CD reactivation in patients that have ever lived in CD-endemic areas even without apparent underlying immunosuppression.