胞胆碱在孟加拉国急性缺血性卒中患者中的安全性和有效性:一项随机对照试验

Journal of National Institute of Neurosciences Bangladesh Pub Date : 2023-10-04 DOI:10.3329/jninb.v9i1.68170

KM Ahasan Ahmed, Md Tauhidul Islam Chowdhury, Mohammad Sadekur Rahman Sarkar, Md Abdul Alim, Md Abdullah Yusuf, Mohammad Shah Jahirul Hoque Chowdhury, Uttam Kumar Saha, Md Badrul Alam

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引用次数: 0

摘要

背景:缺血性卒中是所有卒中事件中最常见的类型。每年约有270万人死于缺血性中风。超急性期再灌注治疗设备在我国并不普及。使用神经保护剂如胞胆碱可被认为是抗血小板药物的合理辅助。目的:评价胞胆碱作为神经保护剂治疗急性缺血性脑卒中的安全性和有效性。方法:这是一项随机对照试验，由国家神经科学研究所神经内科进行;2017年1月至2017年12月，孟加拉国达卡医院。急性缺血性脑卒中患者入选美国国立卫生研究院卒中量表(NIHSS)≥5分。研究人群分为两组，分别为研究组和对照组。对照组接受急性缺血性卒中标准治疗，而研究参与者则接受标准卒中药物和胞磷胆碱治疗。在治疗开始的第一周和第12周记录结果和不良事件。12周时采用NIHSS和mRS评估主要终点。NIHSS≤1和/或mRS≤2被认为是良好的功能结局。结果:共招募急性缺血性脑卒中患者109例，其中研究组53例，对照组56例。胞硫磷碱组功能预后良好(mRS≤2)的患者多于对照组，研究组和对照组分别为62.96%和37.03% (p=0.362)，但差异无统计学意义。随访1周和12周时，两组患者的生化指标、主要不良事件和次要不良事件均无明显变化。对照组患者在12周内的死亡率显著高于研究组，45.45%比23.8% (p=0.0483)。结论:本研究发现胞胆碱组功能预后较好。胞胆碱组与对照组相比，生存获益有统计学意义。孟加拉国国家神经科学研究所杂志，2023年1月;9(1):3-10

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Safety and Efficacy of Citicoline among Acute Ischemic Stroke Bangladeshi Patients: A Randomized Control Trial

Background: Ischemic stroke is the most common type of all stroke events. About 2.7 million people die each year from ischemic stroke. Facilities for reperfusion therapy in hyper-acute state is not widely available in our country. Use of neuro-protective agents like citicoline may be considered as a reasonable adjunct with antiplatelet agents. Objective: The objective of this study was to evaluate the safety and efficacy of citicoline in treatment of acute ischemic stroke as a neuro-protective agent. Methodology: This was a randomized controlled trial which was conducted in Neurology Unit of National Institute of Neurosciences & Hospital, Dhaka, Bangladesh from January 2017 to December 2017. Acute ischemic stroke patients presented with National Institute of Health Stroke Scale (NIHSS) ≥ 5 were recruited for this study. The study population were divided into 2 groups designated as study and control groups. Control group received standard treatment of acute ischemic stroke whereas study participants were treated with standard stroke medications along with citicoline. Outcome and adverse events were recorded at one week and at twelve weeks of treatment onset. The primary end points of outcome were assessed using NIHSS and mRS at twelve weeks. NIHSS ≤1 and/or mRS ≤2 were considered as good functional outcome. Results: A total number of 109 acute ischemic stroke patients were recruited for this study of which 53 cases in the study group and 56 cases in the control group. More number of patients achieved good functional outcome (mRS ≤2) in citicoline group in comparison to control group, 62.96% and 37.03% in study and control group respectively (p=0.362), though this difference was not statistically significant. There were no significant changes of biochemical parameters, major and minor adverse events between two groups at 1 week and 12 weeks follow up. A significant number of patients died in control group in comparison of study group, 45.45% vs. 23.8% (p=0.0483) within 12-week period. Conclusion: In this study, functional outcome is found better in citicoline group. Survival benefit is observed with citicoline group in comparison to control which is statistically significant. Journal of National Institute of Neurosciences Bangladesh, January 2023;9(1):3-10

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Journal of National Institute of Neurosciences Bangladesh

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