Levodopa Added to Stroke Rehabilitation: The ESTREL Randomized Clinical Trial.

Levodopa is used in stroke rehabilitation despite mixed evidence for its effectiveness.

尽管对于其有效性证据不一，左旋多巴仍被用于中风康复。

Background

To determine whether levodopa compared with placebo, administered in addition to standardized rehabilitation based on active task-oriented training, is associated with enhanced motor recovery in patients with acute stroke.

确定左旋多巴与安慰剂相比，除了基于主动任务导向训练的标准康复治疗外，是否与急性中风患者运动恢复的增强有关。

DESIGN, SETTING, AND PARTICIPANTS: A double-blind, placebo-controlledrandomized clinical trial at 13 stroke units and centers and 11 collaborating rehabilitation centers in Switzerland.

设计、环境和参与者：在瑞士的13个中风单元和中心以及11个合作康复中心进行的一项双盲、安慰剂对照的随机临床试验。

Between June 14, 2019 (first patient, first visit), and August 27, 2024 (last patient, last visit), 610 patients with acute ischemic or hemorrhagic stroke with clinically meaningful hemiparesis (ie, a total score of ≥3 points on the following National Institutes of Health Stroke Scale items: motor arm, motor leg, or limb ataxia) were randomized 1:1 to receive levodopa or placebo.

在2019年6月14日（首位患者首次就诊）至2024年8月27日（最后一位患者最后一次就诊）期间，共有610名急性缺血性或出血性中风患者，且具有临床意义的偏瘫（即，以下美国国立卫生研究院中风量表项目的总分≥3分：手臂运动、腿部运动或肢体共济失调），被随机分为1:1接受左旋多巴或安慰剂治疗。

Statistical analyses were conducted from November 2024 to August 2025.

统计分析工作从2024年11月开始，一直持续到2025年8月。

intervention

Patients received levodopa/carbidopa (100 mg/25 mg; n = 307) or placebo (n = 303) 3 times daily for 39 days, alongside standardized rehabilitation therapy based on active task-oriented training.

患者接受左旋多巴/卡比多巴（100毫克/25毫克；n=307）或安慰剂（n=303）每日三次，持续39天，同时接受基于主动任务导向训练的标准康复治疗。

main_outcomes_and_measures

The primary outcome was the adjusted mean between-group difference in the Fugl-Meyer Assessment (FMA) total score (range, 0-100 points; fewer points indicate worse motor function; 6-point difference considered patient-relevant) at 3 months.

主要结果是在3个月时，两组间调整后的平均差异在Fugl-Meyer评估（FMA）总分（范围，0-100分；较少的分数表示运动功能较差；6分的差异被认为是患者相关的）。

Results

Among the 610 participants (median [IQR] age, 73 [64-82] years; 252 [41.3%] female; median baseline FMA total score, 34 [14-54]), 28 participants died by 3 months, leaving 582 (95.4%) participants eligible for the primary analysis.

在610名参与者中（中位年龄[四分位数间距]为73[64-82]岁；252名[41.3%]为女性；基线FMA总分中位数为34[14-54]），3个月内有28名参与者死亡，剩下582名（95.4%）参与者符合主要分析资格。

At 3 months, the median (IQR) FMA total score was 68 (42-85) points in the levodopa group and 64 (44-83) points in the placebo group.

在3个月时，左旋多巴组的FMA总分中位数（四分位数间距）为68（42-85）分，而安慰剂组为64（44-83）分。

The mean difference in the FMA total score between the levodopa and placebo groups was -0.90 points (95% CI, -3.78 to 1.98; P = .54).

左旋多巴组与安慰剂组在FMA总评分的平均差异为-0.90分（95%置信区间，-3.78至1.98；P = .54）。

There were 126 serious adverse events in the levodopa group and 129 in the placebo group; the most common was infection (levodopa, n = 55; placebo, n = 44).

左旋多巴组发生了126起严重不良事件，而安慰剂组发生了129起；最常见的不良事件是感染（左旋多巴组，n = 55；安慰剂组，n = 44）。

conclusions_and_relevance

In this randomized clinical trial, among patients receiving inpatient rehabilitation for acute stroke, levodopa added to standardized rehabilitation did not significantly improve motor function at 3 months compared with placebo plus standardized rehabilitation.

在这项随机临床试验中，对于接受急性中风住院康复治疗的患者，与安慰剂加标准化康复相比，左旋多巴加入标准化康复治疗并未显著改善3个月时的运动功能。

These results do not support the use of levodopa as an adjunct to rehabilitation therapy for enhancing motor recovery after acute stroke.

这些结果不支持将左旋多巴作为康复治疗的辅助药物，以增强急性中风后的运动恢复。

trial_registration

ClinicalTrials.gov Identifier: NCT03735901.

临床试验注册号：NCT03735901。