右美托咪定可降低颈动脉支架术后脑过度灌注的发生率:双盲随机对照试验。

IF 12.8 Q1 MEDICINE, RESEARCH & EXPERIMENTAL
Med Pub Date : 2024-10-22 DOI:10.1016/j.medj.2024.09.012
Enqiang Chang, Lingzhi Wu, Xinyi Li, Jinpeng Zhou, Hui Zhi, Min Sun, Guanyu Chen, Jiaqi Bi, Li Li, Tianxiao Li, Daqing Ma, Jiaqiang Zhang
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引用次数: 0

摘要

背景:脑过度灌注综合征(CHS)是颈动脉支架置入术(CAS)后的一种严重并发症。右美托咪定(Dex)是一种α2肾上腺素受体激动剂,具有镇静、镇痛和神经保护作用。这项随机、双盲、安慰剂对照试验(ChiCTR1900024416)旨在研究预防性低剂量Dex是否能减轻CAS术后CH诱导的脑损伤:在获得书面知情同意后,2019年7月至2022年10月期间,年龄在18-80岁之间、接受CAS手术的患者入组。患者被随机分配接受静脉注射Dex(0.1 μg/kg/h,直至术后第3天)(n = 80)或安慰剂(生理盐水)(n = 80)。主要终点是术后第三天的CH和CHS发生率。次要终点包括术后30天内的美国国立卫生研究院卒中量表(NIHSS)和改良Rankin量表(mRS)评分、拔管时间、术后7天内出院情况、术后住院时间和30天内全因死亡率。手术前后采集血液样本,用于脂质组学、脑源性神经营养因子(BDNF)和神经丝轻链(Nfl)的测量。通过 Cox 模型和逻辑模型评估了可接受性、安全性和有效性:在接受安慰剂治疗的 80 名患者中,有 30 人(37.5%)发生了颅内压增高,而在服用 Dex 的 80 名患者中,有 9 人(11.2%)发生了颅内压增高(发生率:几率比 [OR]:0.21,95% 置信区间 [CI]:0.088-0.467;P低剂量预防性地塞米松可显著降低CAS后72小时内CH和CHS的发生率:本研究得到了国家自然科学基金(编号:82271288)和河南省科技攻关项目(编号:242300421192和JQRC2023004)的资助。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Dexmedetomidine decreases cerebral hyperperfusion incidence following carotid stenting: A double-blind, randomized controlled trial.

Background: Cerebral hyperperfusion syndrome (CHS) is a severe complication after carotid artery stenting (CAS). Dexmedetomidine (Dex) is an α2 adrenoceptor agonist with sedative, analgesic, and neuroprotective properties. This randomized, double-blind, placebo-controlled trial (ChiCTR1900024416) aims to investigate whether prophylactic low-dose Dex decreases CH-induced brain injury following CAS.

Methods: After obtaining written informed consent, patients aged 18-80 who underwent CAS were enrolled between July 2019 and October 2022. Patients were randomly assigned to receive either intravenous Dex (0.1 μg/kg/h, until post-operative day 3) (n = 80) or placebo (normal saline) (n = 80). The primary endpoint was the incidence of CH and CHS assessed up to the third post-operative day. The secondary endpoints included National Institute of Health Stroke Scale (NIHSS) and Modified Rankin Scale (mRS) scores within 30 days of operation, extubation time, discharge from the hospital within 7 days post-operation, length of hospital stay post-operation, and all-cause 30-day mortality. Blood samples were collected before and after surgery for lipidomics, brain-derived neurotrophic factor (BDNF), and neurofilament light chain (Nfl) measurements. Acceptability, safety, and efficacy were evaluated by Cox model and logistic model.

Findings: CH occurred in 30 (37.5%) of 80 patients who received a placebo compared to 9 (11.2%) of 80 patients given Dex (prevalence: odds ratio [OR]: 0.21, 95% confidence interval [CI]: 0.088-0.467; p < 0.001; incidence: hazard ratio [HR]: 0.27, 95% CI: 0.14-0.50; p < 0.001). CHS was significantly higher in the placebo group (13.75%) than in the Dex group (2.5%) (prevalence: [OR]: 0.161, 95% CI: 0.024-0.626; p = 0.020; incidence: [HR]: 0.17, 95% CI: 0.06-0.52; p = 0.009). Dex significantly upregulated BDNF, decreased Nfl, and uniquely increased lysophosphatidylethanolamine.

Conclusions: A low prophylactic dose of Dex significantly reduced the incidence of CH and CHS up to 72 h after CAS.

Funding: This work was funded by National Natural Science Foundation of China (no. 82271288) and the Henan Provincial Science and Technology Research Project (nos. 242300421192 and JQRC2023004).

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来源期刊
Med
Med MEDICINE, RESEARCH & EXPERIMENTAL-
CiteScore
17.70
自引率
0.60%
发文量
102
期刊介绍: Med is a flagship medical journal published monthly by Cell Press, the global publisher of trusted and authoritative science journals including Cell, Cancer Cell, and Cell Reports Medicine. Our mission is to advance clinical research and practice by providing a communication forum for the publication of clinical trial results, innovative observations from longitudinal cohorts, and pioneering discoveries about disease mechanisms. The journal also encourages thought-leadership discussions among biomedical researchers, physicians, and other health scientists and stakeholders. Our goal is to improve health worldwide sustainably and ethically. Med publishes rigorously vetted original research and cutting-edge review and perspective articles on critical health issues globally and regionally. Our research section covers clinical case reports, first-in-human studies, large-scale clinical trials, population-based studies, as well as translational research work with the potential to change the course of medical research and improve clinical practice.
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