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使用机械取栓术进行卒中后早期康复的安全性和有效性:一项前瞻性随机对照试验

Safety and Efficacy of Early Rehabilitation After Stroke Using Mechanical Thrombectomy: A Pilot Randomized Controlled Trial.

作者信息

Wang Wei, Wei Ming, Cheng Yuanyuan, Zhao Hua, Du Hutao, Hou Weijia, Yu Yang, Zhu Zhizhong, Qiu Lina, Zhang Tao, Wu Jialing

机构信息

Clinical College of Neurology, Neurosurgery and Neurorehabilitation, Tianjin Medical University, Tianjin, China.

Tianjin Key Laboratory of Cerebral Vascular and Neurodegenerative Diseases, Department of Neurorehabilitation and Neurology, Tianjin Neurosurgical Institute, Tianjin Huanhu Hospital, Tianjin, China.

出版信息

Front Neurol. 2022 Apr 8;13:698439. doi: 10.3389/fneur.2022.698439. eCollection 2022.

Abstract

BACKGROUND

Early rehabilitation (ER) has been reported to be both safe and feasible for patients' post-stroke. To date, however, ER-related outcomes concerning patients who have undergone mechanical thrombectomy (MT) have not been investigated. This study aimed to determine the feasibility of ER and whether it improves prognosis in such patients.

METHODS

In this single-center, double-blinded, randomized controlled study involving 103 patients who met the study criteria (i.e., has undergone MT), we randomly divided patients (1:1) into ER and conventional rehabilitation groups. The primary outcome was mortality, while secondary outcomes included favorable outcomes (modified Rankin scale of 0-2), the incidence of non-fatal complications, and Barthel Index (BI) scores. We assessed outcomes at 3 months and 1-year post-stroke.

RESULTS

No significant between-group differences were found in terms of mortality and favorable outcomes at 3 months and 1-year post-stroke. At 3 months, 15 (28.8%) patients in the ER group and 29 (56.9%) in the conventional rehabilitation group ( = 0.002) had non-fatal complications. The BI in the ER and conventional rehabilitation groups was 100 (85-100) and 87.5 (60-100), respectively, ( = 0.007). At 1 year, the incidence of non-fatal complications was similar between both groups [BI in the ER group, 100 (90-100), = 0.235; BI in the conventional rehabilitation group, 90 (63.8-100); = 0.003].

CONCLUSION

Early rehabilitation (ER) reduces the incidence of early immobility-related complications and effectively improves patients' activities of daily living on a short- and long-term basis. Our results indicate that MT contributes to ER in patients with stroke.

CLINICAL TRIAL REGISTRATION

www.chictr.org.cn, identifier: ChiCTR1900022665.

摘要

背景

据报道,早期康复(ER)对中风患者而言既安全又可行。然而,迄今为止,尚未对接受机械取栓术(MT)的患者的早期康复相关结果进行研究。本研究旨在确定早期康复的可行性以及其是否能改善此类患者的预后。

方法

在这项单中心、双盲、随机对照研究中,纳入了103例符合研究标准(即接受了机械取栓术)的患者,我们将患者按1:1随机分为早期康复组和传统康复组。主要结局是死亡率,次要结局包括良好结局(改良Rankin量表评分为0 - 2)、非致命并发症的发生率以及Barthel指数(BI)评分。我们在中风后3个月和1年评估结局。

结果

在中风后3个月和1年时,两组在死亡率和良好结局方面未发现显著的组间差异。在3个月时,早期康复组有15例(28.8%)患者出现非致命并发症,传统康复组有29例(56.9%)(P = 0.002)。早期康复组和传统康复组的Barthel指数分别为100(85 - 100)和87.5(60 - 100)(P = 0.007)。在1年时,两组非致命并发症的发生率相似[早期康复组的Barthel指数为100(90 - 100),P = 0.235;传统康复组的Barthel指数为90(63.8 - 100);P = 0.003]。

结论

早期康复可降低早期与活动减少相关并发症的发生率,并在短期和长期内有效改善患者的日常生活活动能力。我们的结果表明,机械取栓术有助于中风患者的早期康复。

临床试验注册

www.chictr.org.cn,标识符:ChiCTR1900022665。

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