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中等收入国家缺血性卒中患者获取依达赛珠单抗的障碍

Barriers in Access to Idarucizumab in Ischemic Stroke in a Middle-Income Country.

作者信息

Rivillas Julián, Llanos-Leyton Natalia, Moreno-Vargas Eder, Bayona Hernán, Jaramillo Eugenia, Kafury Daniel, Amaya Pablo

机构信息

Stroke Center, Neurology Department, Fundación Valle del Lili, Cali, Colombia.

Department of Clinical Sciences, Faculty of Health Sciences, Universidad Icesi, Cali, Colombia.

出版信息

Neurohospitalist. 2024 Jan;14(1):44-51. doi: 10.1177/19418744231201198. Epub 2023 Sep 15.

Abstract

BACKGROUND AND PURPOSE

Current stroke guidelines contraindicate the use of thrombolytics if oral anticoagulants are taken within 48 hours of symptom onset. Idarucizumab is an alternative for patients on dabigatran who experience an acute stroke, so that alteplase may be used. However, this treatment may not be readily available in low/middle-income countries. Our objective is to describe barriers to access to the administration of idarucizumab.

METHODS

We applied a structured survey for health personnel, consulted databases of drug providers, and analyzed reports from the National Pharmacologic Surveillance Data to describe idarucizumab use and the related knowledge among prescribers and the drug distribution in health institutions in Colombia between January 2018 and January 2022.

RESULTS

In total, 23.6% of the 337 interviewed physicians' hospitals had access to idarucizumab, and 34.9% of the physicians were unaware of the use of this medication for ischemic stroke. Only 11 private institutions had access to this medication in Colombia. Four male patients with atrial fibrillation received thrombolytics for acute stroke, and two required subsequent mechanical thrombectomy. No fatal complications during hospitalization were observed. Complications included hematuria, hemorrhagic transformation and groin hematoma. None required transfusion or further intervention. All had favorable mRS scores at the 90-day follow-up.

CONCLUSIONS

There are multiple barriers to access idarucizumab in Colombia. The main factors identified are the low medication availability in provincial hospitals and the low medical knowledge. However clinical results in this limited group are satisfactory. Stronger public policies are needed to guarantee optimal stroke treatment in patients on DOACs in Colombia.

摘要

背景与目的

现行的卒中指南指出,如果在症状发作后48小时内服用了口服抗凝剂,则禁忌使用溶栓药物。对于服用达比加群酯并发生急性卒中的患者,艾达司珠单抗是一种替代药物,以便可以使用阿替普酶。然而,在低收入/中等收入国家,这种治疗可能无法轻易获得。我们的目的是描述获取艾达司珠单抗治疗的障碍。

方法

我们对卫生人员进行了结构化调查,查阅了药品供应商数据库,并分析了国家药物监测数据报告,以描述2018年1月至2022年1月期间哥伦比亚医疗机构中艾达司珠单抗的使用情况、处方者的相关知识以及药物分发情况。

结果

在接受访谈的337名医生所在的医院中,总计23.6%的医院能够获得艾达司珠单抗,34.9%的医生不知道这种药物可用于缺血性卒中。在哥伦比亚,只有11家私立机构能够获得这种药物。4名患有心房颤动的男性患者因急性卒中接受了溶栓治疗,其中2名随后需要进行机械取栓术。住院期间未观察到致命并发症。并发症包括血尿、出血性转化和腹股沟血肿。无人需要输血或进一步干预。在90天随访时,所有患者的改良Rankin量表(mRS)评分均良好。

结论

在哥伦比亚,获取艾达司珠单抗存在多重障碍。确定的主要因素是省级医院药物供应不足以及医学知识匮乏。然而该有限组患者的临床结果令人满意。需要更强有力的公共政策来确保哥伦比亚服用新型口服抗凝药(DOACs)的患者获得最佳的卒中治疗。

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