Citicoline for acute ischemic stroke in Mexican hospitals: a retrospective postmarketing analysis.

C Leon-Jimenez, E Chiquete, C Cantu, M J Miramontes-Saldana, M A Andrade-Ramos, J L Ruiz-Sandoval
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引用次数: 10

Abstract

Some neuroprotective agents have shown benefits in animal models, but disappointing results in humans. Citicoline is used in several countries as coadjuvant treatment in acute ischemic stroke (AIS) patients; however, there are no retrospective postmarketing surveillances on the experience of citicoline in Mexico. The aim of this study was to evaluate the correlation between citicoline exposure and functional outcome at discharge and at 30 and 90 days post-stroke, in a retrospective case-control design on systematic descriptive databases from three referral hospitals. Clinical records of 173 consecutively registered patients were analyzed, 86 of whom were treated with citicoline within the first 48 h after AIS and the remaining 87 were untreated, randomly selected controls matched for age (+/- 5 years), gender and NIHSS (+/- 1 point) at hospital admission. Pretreatment conditions were similar between groups. Compared with controls, exposure to citicoline was associated with a significantly lower 30-day mean and median modified Rankin score (in both, P < 0.05). After paired multivariate analyses (controlled for NIHSS, age, gender, hospital arrival in < 24 h, thrombolysis and comorbidities) citicoline was independently associated with a lower 90-day mortality risk (P = 0.047) and with fewer in-hospital complications (mainly infections and sepsis, P = 0.001). In this observational study, citicoline use was associated with a better functional status and lower rates of short-term mortality, possibly due to fewer in-hospital systemic complications. The putative benefits should be interpreted as clinical associations, since this is not a randomized, controlled clinical trial.

胞磷胆碱治疗墨西哥医院急性缺血性脑卒中:回顾性上市后分析
一些神经保护剂在动物模型中显示出益处,但在人类身上的结果令人失望。胞胆碱在一些国家被用作急性缺血性卒中(AIS)患者的辅助治疗;然而,在墨西哥没有针对胞胆碱的回顾性上市后监管。本研究的目的是通过对三家转诊医院系统描述性数据库的回顾性病例对照设计,评估出院时、中风后30天和90天暴露于胞胆碱与功能结局之间的相关性。分析了173例连续登记的患者的临床记录,其中86例在AIS后最初48小时内接受了胞胆碱治疗,其余87例未接受治疗,随机选择年龄(+/- 5岁)、性别和入院时NIHSS(+/- 1分)相匹配的对照组。两组间预处理条件相似。与对照组相比,暴露于胞胆碱与30天平均和中位修正Rankin评分显著降低相关(两者均P < 0.05)。经多因素配对分析(对照NIHSS、年龄、性别、入院时间< 24小时、溶栓和合并症),胞胆碱与较低的90天死亡风险(P = 0.047)和较少的院内并发症(主要是感染和败血症,P = 0.001)独立相关。在这项观察性研究中,胞胆碱的使用与较好的功能状态和较低的短期死亡率相关,这可能是由于较少的院内系统性并发症。假定的益处应该被解释为临床关联,因为这不是一个随机的、对照的临床试验。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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