依达拉奉右莰醇预防脑卒中后抑郁的疗效及其炎症机制观察：一项前瞻性、随机对照试验。
Observations on the efficacy of edaravone dexborneol in preventing post-stroke depression and its inflammatory mechanism: a prospective, randomized, control trial.
作者信息
Xu Mingyuan, Li Lan, Xu Bu, Yuan Shanfang, Zheng Qin, Sun Wenjun
机构信息
Department of Neurology, Third Affiliated Hospital, Beijing University of Chinese Medicine, Beijing, China.
Cangzhou Hospital of Integrated Traditional Chinese Medicine and Western Medicine, Cangzhou, China.
出版信息
Front Neurosci. 2024 Sep 9;18:1451060. doi: 10.3389/fnins.2024.1451060. eCollection 2024.
OBJECTIVE
This study aimed to observe the effect of edaravone dexborneol (EDB) on the incidence of early post-stroke depression (PSD) and explore its inflammatory mechanisms.
METHODS
A prospective, randomized controlled study was conducted from January 2022 to June 2023, involving patients with acute ischemic stroke (AIS) at the Neurology Department of the Third Affiliated Hospital of Beijing University of Traditional Chinese Medicine. The control group received routine treatment, while the experimental group received routine combined EDB treatment. The main outcome measures included PSD incidence, Patient Health Questionnaire (PHQ-9) and Hamilton Depression Scale (HAMD) scores on days 14 and 30, and inflammatory factor levels on day 14.
RESULTS
A total of 93 patients were included in the study, 51 in the experimental group and 42 in the control group. On day 14, the PSD incidence was 13.7% in the experimental group, lower than 31.0% in the control group (95%CI 0.127-0.996; = 0.044). Compared to the control group, the experimental group showed significantly lower concentrations of pro-inflammatory cytokines IL-1β (95%CI 3.353-5.184), IL-6 (95%CI 2.694-3.426), TNF-α (95%CI 4.985-12.196), IFN-γ (95%CI 0.163-0.451), MCP-1 (95%CI 0.335-0.787), IL-17A (95%CI 0.543-1.024), and IL-23p19 (95%CI 1.677-1.959) (all < 0.001), and higher levels of anti-inflammatory cytokines IL-4 (95%CI -1.087 to -0.941), IL-10 (95%CI -6.125 to -1.662), and IL-13 (95%CI -6.078 to -2.953) (all ≤ 0.001). On day 30, the PSD incidence in the experimental group was 15.7%, lower than 40.5% in the control group (95%CI 0.103-0.725; = 0.007). Compared with the control group, the experimental group had lower PHQ-9 scores on day 14 (95%CI 0.034-1.577; = 0.041) and day 30 (95%CI 0.018-1.573; = 0.045), and also had lower HAMD scores on day 14 (95% CI 0.281-2.856; = 0.018) and day 30 (95% CI 0.647-3.482; = 0.005).
CONCLUSION
EDB could reduce the incidence of early PSD, reduce pro-inflammatory cytokine levels, and elevate anti-inflammatory cytokine levels, which was possibly related to the anti-inflammatory mechanism of EDB.
CLINICAL TRIAL REGISTRATION
http://www.chictr.org.cn/, identifier [ChiCTR2300067750].
目的
本研究旨在观察依达拉奉右莰醇（EDB）对脑卒中后早期抑郁（PSD）发生率的影响，并探讨其炎症机制。
方法
2022年1月至2023年6月进行了一项前瞻性随机对照研究，纳入北京中医药大学第三附属医院神经内科的急性缺血性脑卒中（AIS）患者。对照组接受常规治疗，试验组接受常规治疗联合EDB治疗。主要观察指标包括PSD发生率、第14天和第30天的患者健康问卷（PHQ-9）和汉密尔顿抑郁量表（HAMD）评分，以及第14天的炎症因子水平。
结果
本研究共纳入93例患者，试验组51例，对照组42例。第14天，试验组PSD发生率为13.7%，低于对照组的31.0%（95%CI 0.127 - 0.996；P = 0.044）。与对照组相比，试验组促炎细胞因子白细胞介素-1β（IL-1β，95%CI 3.353 - 5.184）、白细胞介素-6（IL-6，95%CI 2.694 - 3.426）、肿瘤坏死因子-α（TNF-α，95%CI 4.985 - 12.196）、干扰素-γ（IFN-γ，95%CI 0.163 - 0.451）、单核细胞趋化蛋白-1（MCP-1，95%CI 0.335 - 0.787）、白细胞介素-17A（IL-17A，95%CI 0.543 - 1.024）和白细胞介素-23p19（IL-23p19，95%CI 1.677 - 1.959）的浓度均显著降低（均P < 0.001），抗炎细胞因子白细胞介素-4（IL-4，95%CI -1.087至-0.941）、白细胞介素-10（IL-10，95%CI -6.125至-1.662）和白细胞介素-13（IL-13，95%CI -6.078至-2.953）的水平均升高（均P ≤ 0.001）。第30天，试验组PSD发生率为15.7%，低于对照组的40.5%（95%CI 0.103 - 0.725；P = 0.007）。与对照组相比，试验组在第14天（95%CI 0.034 - 1.577；P = 0.041）和第30天（95%CI 0.018 - 1.573；P = 0.045）的PHQ-9评分较低，在第14天（95%CI 0.281 - 2.856；P = 0.018）和第30天（95%CI 0.647 - 3.482；P = 0.005）的HAMD评分也较低。
结论
EDB可降低早期PSD的发生率，降低促炎细胞因子水平，提高抗炎细胞因子水平，这可能与EDB的抗炎机制有关。
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