Objective:To evaluate the dosing,efficacy and safety of the main antileishmanial agents amphotericin B(conventional or liposomal),pentavalent antimonials,miltefosine and paromomycin recommended for the treatment of vi...Objective:To evaluate the dosing,efficacy and safety of the main antileishmanial agents amphotericin B(conventional or liposomal),pentavalent antimonials,miltefosine and paromomycin recommended for the treatment of visceral leishmaniasis in children.Methods:The efficacy and safety of visceral leishmaniasis treatments in children were systematically reviewed using literature from PubMed,Cochrane,clinicaltrials.gov,and Google Scholar,focusing on randomised trials with separate pediatric data(published from 2000-2024).The risk of bias of selected trials was assessed using the revised Cochrane risk-of-bias tool for randomised trials(RoB 2).Reporting was done per the Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 checklist.Results:Of 1186 records,only 7 were eligible for qualitative synthesis.Three trials exclusively included children.The treatment regimens studied showed high heterogeneity and lacked sufficient data for a meta-analysis.Most trial arms reported efficacies over 94%for children across different regimens.Miltefosine monotherapy showed the highest rate of late treatment failures,highlighting that allometric dosing is crucial to ensure proper drug exposure in children.Safety data for children were available in only three studies with varied reporting systems of adverse events.Although regimens in this review were generally considered to be safe in children,antimonial-related cardiac toxicity remains a threat.Conclusions:This review highlights the need for pediatric-specific trials,clear presentation of pediatric data,and systematic documentation of adverse events to enhance evidence for policy-making and pediatric guideline development.展开更多
文摘Objective:To evaluate the dosing,efficacy and safety of the main antileishmanial agents amphotericin B(conventional or liposomal),pentavalent antimonials,miltefosine and paromomycin recommended for the treatment of visceral leishmaniasis in children.Methods:The efficacy and safety of visceral leishmaniasis treatments in children were systematically reviewed using literature from PubMed,Cochrane,clinicaltrials.gov,and Google Scholar,focusing on randomised trials with separate pediatric data(published from 2000-2024).The risk of bias of selected trials was assessed using the revised Cochrane risk-of-bias tool for randomised trials(RoB 2).Reporting was done per the Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 checklist.Results:Of 1186 records,only 7 were eligible for qualitative synthesis.Three trials exclusively included children.The treatment regimens studied showed high heterogeneity and lacked sufficient data for a meta-analysis.Most trial arms reported efficacies over 94%for children across different regimens.Miltefosine monotherapy showed the highest rate of late treatment failures,highlighting that allometric dosing is crucial to ensure proper drug exposure in children.Safety data for children were available in only three studies with varied reporting systems of adverse events.Although regimens in this review were generally considered to be safe in children,antimonial-related cardiac toxicity remains a threat.Conclusions:This review highlights the need for pediatric-specific trials,clear presentation of pediatric data,and systematic documentation of adverse events to enhance evidence for policy-making and pediatric guideline development.
