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Master Thesis

Évaluation de l’administration précoce du natrium thiosulfate sur la réduction de la mortalité des patients atteints de calciphylaxie : étude de cohorte rétrospective nationale de patients traités entre 2012 et 2016 dans le cadre d’une ATU nominative

Abstract : Introduction: calciphylaxis is a cutaneous thrombotic arteriolar arteriolar microangiopathy mainly observed in patients with severe end-stage renal disease and dialysis, but may also affect normal renal patients or those with moderate renal impairment more sporadically. It is a rare pathology with a formidable prognosis, mortality at 1 year can reach 80%, mainly due to superinfection of ulcero-necrotic skin lesions. It therefore requires early diagnosis and the rapid introduction of multimodal management, usually including the administration of sodium thiosulfate. Objectives: the main objective was to evaluate the influence of the time to introduce natrium thiosulfate on the reduction of calciphylaxis-related mortality. The secondary objectives were to evaluate the efficacy of natrium thiosulfate in reducing analgesic consumption and injury progression, as well as safety with respect to reported adverse reactions. Methods: all patients treated with natrium thiosulfate for calciphylaxis as part of cohort ATUs in France between 2012 and 2016 were included retrospectively. A questionnaire was developed to collect clinical, biological and therapeutic data from patients at the onset of lesions, the different treatments used, possible side effects, as well as the evolution of the lesions and the patient's living or deceased status at 1 year from the start of natrium thiosulfate therapy. Results: 175 patients were included, divided into 2 subgroups uremic calciphylaxis of 155 patients and non-uremic of 9 patients. 11 patients could not be classified into either of these 2 subgroups due to missing data but were included in the overall analysis of 175 patients. 35.8% of patients experienced natrium thiosulfate-related adverse events but 32.8% had no serious adverse events. The most frequent adverse reactions were nausea (25.6%), with or without vomiting (12%), increased anionic hole (5.3%), and metabolic acidosis (5.3%). No side effects caused death, disability or disability. The percentage of patients consuming analgesics at 1 year after the introduction of natrium thiosulfate (47.9%) was lower than at 3 months (55.9%). Discontinuation of antiepileptics and reduction of 1 or 2 levels of analgesics was the most common. The evolution of the lesions was not unfavourable for more than half of the patients; 37% recovered, 22.9% remained stable and regressed in 8.4% of cases. The all-cause mortality rate at 1 year of initiation of natrium thiosulfate treatment was 51.3% in the general population (of which 45.3% were calciphylaxis-related), 50.4% in the ACU group, and 71.4% in the ACNU group where no deaths were calciphylaxis-related. 45% of patients who died of calciphylaxis died within 35 days of the onset of the lesions, and this threshold was 32 days for all-cause mortality. The most frequent causes of death related to calciphylaxis were septic complications in 32.4% of cases, and altered general condition and/or discontinuation of care, which also accounted for 32.4% of additional cases. Conclusion: the influence of early natrium administration on calciphylaxis-related mortality could not be determined due to insufficient numbers and missing data, and was therefore investigated for all-cause mortality. The results show that early administration of natrium thiosulfate does not have an impact on all-cause death, after adjusting for age, diabetes and injury status.
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Isabelle Mousnier. Évaluation de l’administration précoce du natrium thiosulfate sur la réduction de la mortalité des patients atteints de calciphylaxie : étude de cohorte rétrospective nationale de patients traités entre 2012 et 2016 dans le cadre d’une ATU nominative. Médecine humaine et pathologie. 2019. ⟨dumas-02498932⟩

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