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早期选择性5-羟色胺再摄取抑制剂用于卒中后康复:一项Meta分析和试验序贯分析

Early Selective Serotonin Reuptake Inhibitors for Recovery after Stroke: A Meta-Analysis and Trial Sequential Analysis.

作者信息

Gu Si-Chun, Wang Chang-De

机构信息

Department of Neurology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.

Department of Neurology, TCM-Integrated Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.

出版信息

J Stroke Cerebrovasc Dis. 2018 May;27(5):1178-1189. doi: 10.1016/j.jstrokecerebrovasdis.2017.11.031. Epub 2017 Dec 21.

DOI:10.1016/j.jstrokecerebrovasdis.2017.11.031
PMID:29276014
Abstract

BACKGROUND

Potential benefits and risks of early (≤30 days from stroke onset) selective serotonin reuptake inhibitors (SSRIs) treatment for neurologic functional recovery after stroke are not fully understood.

METHODS

We searched PubMed, Embase, and the Cochrane Library to identify randomized controlled trials that assessed SSRI medications during the initial ictus after stroke versus placebo. Primary outcome was decrease in National Institutes of Health Stroke Scale (NIHSS) score. Secondary outcomes included the improvement of Barthel index, functional independence (modified Rankin Scale score 0-2 at the end of follow-up), the incidence of depression, and adverse events including diarrhea, insomnia, hepatic enzyme disorders, seizure, and intracranial hemorrhage. We used fixed effects models or random effects models to estimate weighted mean differences (WMDs) and relative risks (RRs) with 95% confidence intervals (CIs) according to heterogeneity.

RESULTS

Eight trials were included, with 1549 patients. Compared with placebo, decrease in NIHSS was greater in SSRI-treated patients (WMD, 0.82; 95% CI, 0.31-1.33; P = .002). Trial sequential analysis showed that the cumulative z curve crossed the trial sequential monitoring boundary for benefit, establishing sufficient and conclusive evidence. Early SSRI treatment also promoted Barthel index (WMD, 5.32; 95% CI, 1.65-8.99; P = .005) and functional independence (RR, 2.54; 95% CI, 1.82-3.55; P < .0001). There was no difference in the incidence of depression and adverse events between groups. No evidence of publication bias was detected.

CONCLUSIONS

The early SSRIs treatment reduces the defective neurologic function in patients undergoing rehabilitation after stroke.

摘要

背景

早期(卒中发作后≤30天)使用选择性5-羟色胺再摄取抑制剂(SSRI)治疗对卒中后神经功能恢复的潜在益处和风险尚未完全明确。

方法

我们检索了PubMed、Embase和Cochrane图书馆,以确定评估卒中发作后初期使用SSRI药物与安慰剂对照的随机对照试验。主要结局为美国国立卫生研究院卒中量表(NIHSS)评分降低。次要结局包括Barthel指数改善、功能独立性(随访结束时改良Rankin量表评分为0 - 2)、抑郁发生率以及不良事件,包括腹泻、失眠、肝酶紊乱、癫痫发作和颅内出血。我们根据异质性使用固定效应模型或随机效应模型来估计加权平均差(WMD)和相对风险(RR)以及95%置信区间(CI)。

结果

纳入8项试验,共1549例患者。与安慰剂相比,接受SSRI治疗的患者NIHSS评分降低更明显(WMD,0.82;95% CI,0.31 - 1.33;P = 0.002)。试验序贯分析显示,累积z曲线越过了试验序贯监测获益边界,确立了充分且确凿的证据。早期SSRI治疗还促进了Barthel指数(WMD,5.32;95% CI,1.65 - 8.99;P = 0.005)和功能独立性(RR,2.54;95% CI,1.82 - 3.55;P < 0.0001)。两组之间抑郁发生率和不良事件无差异。未检测到发表偏倚的证据。

结论

早期SSRI治疗可减轻卒中后接受康复治疗患者的神经功能缺损。

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