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[翻译文章] 硫代硫酸钠治疗非尿毒症性钙化防御的多中心回顾性分析

[Translated article] Multicenter retrospective analysis of sodium thiosulfate as treatment for non-uremic calciphylaxis.

作者信息

Cardona-Roca Laura, Borràs Trias Laura, Bueno Uceda Rosario, Siles Adrià, Vilariño Seijas Adrián, Rudi Sola Nuria, Seguí-Solanes Carlos

机构信息

Servicio de Farmacia, Hospital General de Granollers, Barcelona, Spain.

Servicio de Farmacia, Hospital General de Granollers, Barcelona, Spain.

出版信息

Farm Hosp. 2025 Sep-Oct;49(5):T299-T303. doi: 10.1016/j.farma.2025.05.015. Epub 2025 Jun 18.

DOI:10.1016/j.farma.2025.05.015
PMID:40537301
Abstract

OBJECTIVES

To describe the results obtained in terms of effectiveness and safety of intravenous sodium thiosulfate in patients diagnosed with non-uremic calciphylaxis, to identify and analyse possible etiological factors of the disease, and to determine the associated morbidity and mortality.

METHOD

A multicenter and retrospective study was conducted with patients diagnosed with non-uremic calciphylaxis who received intravenous sodium thiosulfate between 2013 and 2023. Effectiveness was evaluated based on the status of the ulcers at the end of treatment, and safety was assessed according to the main reported adverse effects and the need for dosage adjustment.

RESULTS

A total of 33 patients from three university hospitals were evaluated (93.9% Caucasian, 78.8% women, mean age 80 [SD 8.1] years) with non-uremic calciphylaxis confirmed by skin biopsy. The localization pattern was 90.9% distal. The following complementary therapeutic measures were undertaken: topical wound care, removal of precipitating factors (mainly vitamin D supplements and vitamin K antagonists), medications to reduce calcification (bisphosphonates, cinacalcet), and techniques to promote ulcer healing. The main associated factors for developing calciphylaxis were: non-uremic chronic kidney disease (81.8%), vitamin D supplementation (72.7%), and hypoalbuminemia (66.7%). The most commonly used sodium thiosulfate dosage was 25 g (n = 26) three times per week (n = 28) intravenously, with a median treatment duration of 11.4 (IQR 5.7-18) weeks. A complete resolution or improvement of the ulcers was achieved in 78.8% of the cases. Adverse effects were observed in 96.7% of patients, with the most common being metabolic acidosis (n = 19) and nausea and/or vomiting (n = 18). Dosage adjustments due to toxicity were necessary in 9% of cases. The significant morbidity rate was 69.7% (n = 23). The main complications were: 57.6% ulcer superinfection and 24.3% poor pain control. The overall mortality rate was 66.7%; 42.4% within the first 6 months after diagnosis and 39.4% secondary to non-uremic calciphylaxis.

CONCLUSIONS

Sodium thiosulfate shows a potential benefit in the treatment of ulcers due to non-uremic calciphylaxis, with a similar safety profile to that reported for uremic calciphylaxis, considering the high morbidity and mortality associated with the condition. Further studies are needed to determine its efficacy and assess the specific contribution of the different treatments used.

摘要

目的

描述静脉注射硫代硫酸钠治疗非尿毒症性钙化防御患者的有效性和安全性结果,识别并分析该疾病可能的病因,以及确定相关的发病率和死亡率。

方法

对2013年至2023年间诊断为非尿毒症性钙化防御并接受静脉注射硫代硫酸钠治疗的患者进行了一项多中心回顾性研究。根据治疗结束时溃疡的状况评估有效性,并根据报告的主要不良反应和剂量调整需求评估安全性。

结果

对来自三家大学医院的33例患者(93.9%为白种人,78.8%为女性,平均年龄80[标准差8.1]岁)进行了评估,皮肤活检确诊为非尿毒症性钙化防御。溃疡定位模式为90.9%位于远端。采取了以下辅助治疗措施:局部伤口护理、去除诱发因素(主要是维生素D补充剂和维生素K拮抗剂)、减少钙化的药物(双膦酸盐、西那卡塞)以及促进溃疡愈合的技术。发生钙化防御的主要相关因素为:非尿毒症性慢性肾脏病(81.8%)、维生素D补充(72.7%)和低白蛋白血症(66.7%)。最常用的硫代硫酸钠剂量为25g(n=26),每周静脉注射3次(n=28),中位治疗持续时间为11.4(四分位间距5.7-18)周。78.8%的病例溃疡完全愈合或有所改善。96.7%的患者观察到不良反应,最常见的是代谢性酸中毒(n=19)和恶心和/或呕吐(n=18)。9%的病例因毒性反应需要调整剂量。显著发病率为69.7%(n=23)。主要并发症为:57.6%溃疡继发感染和24.3%疼痛控制不佳。总死亡率为66.7%;诊断后前6个月内死亡率为42.4%,继发于非尿毒症性钙化防御的死亡率为39.4%。

结论

考虑到非尿毒症性钙化防御相关的高发病率和死亡率,硫代硫酸钠在治疗非尿毒症性钙化防御所致溃疡方面显示出潜在益处,其安全性与尿毒症性钙化防御报告的相似。需要进一步研究以确定其疗效并评估所用不同治疗方法的具体作用。

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