Intravenous liposomal amphotericin B efficacy and safety for cutaneous and mucosal leishmaniasis: a systematic review and meta-analysis protocol

Abstract

IntroductionTreatment of cutaneous and mucosal leishmaniasis (CL and ML, respectively) must be individualised as there is no universal therapeutic approach. Intravenous liposomal amphotericin B (L-AmB) is an accessible and relatively safe treatment that has been increasingly used for the treatment of CL and ML. While several descriptive studies have been published on the efficacy and safety of L-AmB, there are no interventional studies. Moreover, the findings from published studies have not yet been integrated and synthesised. Therefore, we aim to evaluate and consolidate the descriptive evidence on the efficacy and the safety of Intravenous L-AmB treatment for CL and ML in both the New and Old World.Methods and analysesA systematic review of all relevant study types with no restriction on date or language of publication will be conducted. Online databases including MEDLINE, The Cochrane Library, EMBASE, EBSCO, Scopus, Ovid and WHO databases were searched on 3 April 2020. The search included all study types that assess Intravenous L-AmB treatment for CL and ML in humans. The Population, Intervention, Comparison, Outcome and Study Design strategy and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines will be used to determine which studies will be selected for final inclusion. The quality of included case series and case reports will be assessed using modified quality assessment tools. A narrative synthesis of the findings will be provided and the primary outcome and secondary outcome of interest, response rate and adverse events rate, respectively, and the 95% CI will be ascertained. Estimates from individual studies will be pooled using random-effects model.Ethics and disseminationThis systematic review does not require formal ethical approval since no primary data will be collected. Findings will be disseminated through a peer-reviewed publication and relevant conferences.PROSPERO registration numberCRD42020173440.

Intravenous Liposomal Amphotericin B Efficacy and Safety for Cutaneous and Mucosal Leishmaniasis: A Systematic Review and Meta-analysis

“…This systematic review has been registered in the PROSPERO database (registration number CRD42020173440) and was prepared in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines [ 10 ]. The systematic review protocol was published in BMJ Open [ 11 ].…”

Polyene Antibiotics Physical Chemistry and Their Effect on Lipid Membranes; Impacting Biological Processes and Medical Applications

“…), doses of liposomal AmB may reach up to 60 mg/kg [ 429 ]. A systematic review of the use of liposomal AmB for the treatment of visceral leishmaniasis has shown evidence not only of its efficacy but, more importantly, of its safety, even in the case of very high doses [ 430 ]. In another recent retrospective study, the different AmB formulations were compared for efficacy and safety.…”

Treatment of pediatric cutaneous leishmaniasis with liposomal amphotericin B

“…[9][10][11] In studies conducted with adult patients, the efficacy of Intravenous (IV) L-AmB in CL treatment ranges from 46% to 100%. 9,[12][13][14][15] It has been stated that the difference in success rates in these treatments depends on the type of causative parasite, the dose, and duration of use of the drug. 12,[14][15][16][17] There are few data on the efficacy and safety of IV L-AmB in pediatric CL patients.…”

“…9,[12][13][14][15] It has been stated that the difference in success rates in these treatments depends on the type of causative parasite, the dose, and duration of use of the drug. 12,[14][15][16][17] There are few data on the efficacy and safety of IV L-AmB in pediatric CL patients. 10,17 It has been reported that Leishmania tropica is associated with a low treatment response rate in pediatric patients.…”

“…The use of liposomal amphotericin B (L‐AmB) is preferred in the treatment of CL due to its less nephrotoxic effect 9–11 . In studies conducted with adult patients, the efficacy of Intravenous (IV) L‐AmB in CL treatment ranges from 46% to 100% 9,12–15 . It has been stated that the difference in success rates in these treatments depends on the type of causative parasite, the dose, and duration of use of the drug 12,14–17 .…”