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依达鲁珠单抗在紧急情况下的应用:达比加群酯在临床常规中的逆转(MR REPAIR)慕尼黑注册研究。

Idarucizumab administration in emergency situations: the Munich Registry of Reversal of Pradaxa® in clinical routine (MR REPAIR).

机构信息

Department of Neurology, Ludwig Maximilians University, Campus Großhadern, Marchioninistraße 15, 81377, Munich, Germany.

German Center for Vertigo and Balance Disorders, Ludwig Maximilians University, Munich, Germany.

出版信息

J Neurol. 2019 Nov;266(11):2807-2811. doi: 10.1007/s00415-019-09492-w. Epub 2019 Aug 2.

Abstract

OBJECTIVES

To evaluate daily life management and functional outcome of Idarucizumab administration in case of emergency situations in patients with Dabigatran treatment.

DESIGN

Multicenter observational registry study.

SETTING

All hospitals with full neurological departments (n = 6) in Munich, Germany INCLUDED PATIENTS: All patients treated with Idarucizumab from 01/2016 to 03/2019.

ANALYZED DATA

Indication and application of Idarucizumab, demographics and clinical parameters, and further interventions and treatments; clinical outcome was assessed with the modified Rankin scale (mRS) at 3 months after Idarucizumab administration RESULTS: Idarucizumab was administered to 32 patients for severe bleeding complications and ischemic strokes, more precisely for the following specific indications: intracranial bleeding (17 patients, 53%), ischemic stroke (8 patients, 25%), gastrointestinal bleeding (3 patients, 9%), femoral fracture, aortic dissection, and abdominal trauma and ileus (1 patient each, 3%). Additional coagulation management was performed in 7 patients (22%). Nine patients (28%) underwent emergency surgery. Seven patients (22%) received Idarucizumab before intravenous thrombolysis due to ischemic stroke and 4 of these 7 patients (13%) received mechanical thrombectomy in addition. Indication was mainly based on the history of Dabigatran intake and was irrespective of laboratory testing. At follow-up, 25% of the investigated patients had a mRS 0-2, while 25% had an unfavorable outcome (mRS 4-5). Mortality was 31%.

CONCLUSION

In our study, we have shown that the administration of Idarucizumab is a rare intervention and restricted to patients with severe bleeding complications or ischemic stroke. The clinical outcome of patients who received Idarucizumab in emergency situations was poor.

摘要

目的

评估达比加群酯治疗患者在紧急情况下使用依达鲁单抗进行日常生活管理和功能预后的情况。

设计

多中心观察性注册研究。

地点

德国慕尼黑所有拥有完整神经科的医院(n=6)

纳入患者

所有 2016 年 1 月至 2019 年 3 月期间接受依达鲁单抗治疗的患者。

分析数据

依达鲁单抗的适应证和应用,人口统计学和临床参数,以及进一步的干预和治疗;临床结果采用改良 Rankin 量表(mRS)在依达鲁单抗给药后 3 个月进行评估。

结果

依达鲁单抗因严重出血并发症和缺血性卒中而被 32 例患者使用,更具体地说是用于以下特定适应证:颅内出血(17 例,53%)、缺血性卒中(8 例,25%)、胃肠道出血(3 例,9%)、股骨骨折、主动脉夹层、腹部创伤和肠梗阻(各 1 例,3%)。7 例患者(22%)进行了额外的凝血管理。9 例患者(28%)接受了紧急手术。7 例(22%)因缺血性卒中在静脉溶栓前接受了依达鲁单抗治疗,其中 4 例(13%)还接受了机械血栓切除术。适应证主要基于达比加群酯的用药史,而与实验室检查无关。随访时,25%的患者 mRS 评分为 0-2,而 25%的患者预后不良(mRS 4-5)。死亡率为 31%。

结论

在我们的研究中,我们表明依达鲁单抗的给药是一种罕见的干预措施,仅限于严重出血并发症或缺血性卒中患者。在紧急情况下接受依达鲁单抗治疗的患者的临床结局较差。

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