RESUMO
Background: Post kala-azar dermal leishmaniasis (PKDL) is a recognized dermatologic complication of successfully treated visceral leishmaniasis (VL). PKDL lesions are suspected to be important reservoirs for VL transmission in Sudan. Prolonged treatment schedules, feeling of general well-being and the social stigmata of PKDL prevent most patients seeking treatment. The mainstay of treatment is cardiotoxic sodium stibogluconate (SSG) for 60-120 days. Recently, liposomal amphotericin B (Ambisome®) and immunochemotherapy gave promising results. Ambisome® is expensive and difficult to prepare under field conditions. Paromomycin/SSG combination has been shown to be safe, efficacious and can save time in VL treatment. This study aims to prove that Paromomycin/SSG combination can cure and reduce PKDL treatment duration. Methods: We are reporting nine cases of patients with PKDL lesions of ≥6 months duration who were diagnosed by clinical signs, histopathological/immunohistochemical and PCR. Results: Patients’ mean age was 11.7 ± 4.3 years. A third of the patients (3/9; 33.3%) who failed previous SSG treatment of 2-3 months duration responded completely to 40 days of paromomycin/SSG combination. The majority of patients (5/9; 55.6%) responded completely to 30 days of the combination. One patient (1/9; 11.1%) relapsed following 30 days paromomycin/SSG combination. Conclusion: It was concluded that paromomycin/SSG combination for 30 days is time-saving, safe and efficacious for PKDL treatment.
RESUMO
Descrevem-se o efeito terapêutico e os eventos adversos associados com o uso tópico de paromomicina 10 por cento em gel na leishmaniose cutânea. Quinze pacientes com leishmaniose cutânea cumpriram os critérios de inclusão descritos a seguir: contra-indicação para o uso de antimoniato de meglumina, intradermorreação de Montenegro positiva e até quatro lesões ulceradas. A fórmula foi prescrita duas vezes ao dia por 20 dias. Quatorze pacientes estiveram disponíveis para a avaliação do desfecho terapêutico e a proporção de cura foi de 21,4 por cento (3/14), 50 por cento melhoraram até a epitelização completa e a proporção de falha foi de 28,6 por cento. Nove pacientes que não apresentaram cura inicialmente foram re-tratados. Oito receberam uma nova série de paromomicina tópica e um foi tratado com antimoniato de meglumina. Dois pacientes não receberam novo tratamento e tiveram melhora lenta e contínua. Cinco de oito pacientes retratados com paromomicina tópica alcançaram a cura clínica, e três apresentaram falha, incluindo um paciente que tinha apresentado melhora com o primeiro tratamento. Os eventos adversos foram leves e locais em 53,3 por cento dos pacientes e nunca levaram à suspensão do tratamento.
The therapeutic effect of and adverse events associated with topical use of 10 percent paromomycin gel on cutaneous leishmaniasis are described. Fifteen patients with cutaneous leishmaniasis fulfilled the following inclusion criteria: contraindication for the use of meglumine antimoniate, positive Montenegro skin test and up to four ulcerated lesions. The formula was prescribed twice a day for 20 days. Fourteen patients were available for the therapeutic outcome evaluation. The cure rate was 21.4 percent (3/14); 50 percent improved as far as complete epithelialization; and the failure rate was 28.6 percent. Nine patients who did not initially present cure were retreated. Eight received a new series of topical paromomycin and one was treated with meglumine antimoniate. Two patients did not receive any new treatment and had continuous slow improvement. Five out of the eight patients retreated with topical paromomycin achieved clinical cure, and three presented failure, including one patient who had shown any improvement with the first treatment. For 53.3 percent of the patients, the adverse events were mild and local and never led to treatment suspension.