RESUMO
BACKGROUND: Intravenous artesunate (AS) is the first-line treatment for patients with severe imported malaria (SIM) worldwide. However, after 10 years of use in France, AS hasn't yet received marketing authorization.The purpose of this study was to assess the real-life effectiveness and safety of AS in the treatment of SIM in two Hospitals in France. METHODS: We performed a bicenter retrospective and observational study. All patients treated with AS for SIM between 2014 and 2018 and 2016-2020 were included. The effectiveness of AS was evaluated by parasite clearance, number of deaths, and the length of hospital stay. The real-life safety was assessed by related adverse events (AE) and monitoring of biological blood parameters during the hospital stay and follow-up period. RESULTS: 110 patients were included during the six-year study period. 71.8% of patients were parasite-negative of their day 3 thick and thin blood smears after AS treatment. No patients discontinued AS due to an AE and no serious AE were declared. Two cases of delayed post-artesunate hemolysis occurred and required blood transfusions. CONCLUSION: This study highlights effectiveness and safety of AS in non-endemic areas. Administrative procedures must be accelerated in order to obtain full registration and facilitate access to AS in France.
Assuntos
Antimaláricos , Artemisininas , Malária Falciparum , Malária , Humanos , Artesunato/uso terapêutico , Antimaláricos/efeitos adversos , Estudos Retrospectivos , Artemisininas/efeitos adversos , Hospitais Universitários , Malária/tratamento farmacológico , França , Malária Falciparum/parasitologiaRESUMO
OBJECTIVES: The economic impact of Patient blood management (PBM) must be assessed beyond the acquisition cost of blood products alone. The estimate of indirect costs may vary depending on the organization and the elements taken into account. The transposition of data from the literature into a specific local context is therefore delicate. The objective of this work was to evaluate the overall cost of red blood cell concentrate (RBC) transfusion from a French healthcare establishment point of view. METHODS: We carried out an activity based costing analysis in our hospital for the year 2018. The steps of the transfusion process and additional costs were detailed and cumulated (resource consumption, labor time, frequency) to populate the ABC model. Several scenarios were developed focusing either on RBC, all blood products or the surgical activity, and a univariate sensitivity analysis was conducted. RESULTS: The average total cost of transfusion, including acquisition cost, was 339,64 euros per RBC transfused. The cost of administration was 138.41 euros/RBC. Focusing only on surgical activities increased this cost (152.43 euros) while taking all blood products into account reduced it (92.49 euros). CONCLUSION: The difference in our results with the literature confirms the local variability in the cost of transfusion, which may affect the economic impact of PBM. Our study related to the specific context of a single French institution has limitations that a multicenter study would clarify in order to carry out economic modelling of transfusion optimization and alternatives and to guide the choice of PBM strategies at the national level.