A randomized dose-response trial of citicoline in acute ischemic stroke patients
A randomized dose-response trial of citicoline in acute ischemic stroke patients
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DOI：
10.1212/wnl.49.3.671
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发表时间：
1997-09-01
期刊：
影响因子：
9.9
通讯作者：
Sabounjian, LA
中科院分区：
文献类型：
--
作者：
Clark, WM;Warach, SJ;Sabounjian, LA
胞二磷胆碱（CDP-胆碱）是磷脂酰胆碱生物合成的关键中间体，磷脂酰胆碱是内皮细胞膜的重要组分。它已被证明在动物模型和非美国临床中风试验中产生有益效果。本研究包括在21个美国中心进行的随机（3个剂量的胞磷胆碱对1个安慰剂）、溶剂对照、双盲试验。在卒中发作后24小时内开始治疗，并持续口服6周。最终结局评估在12周时进行。共入组259例患者，四组中每组约65例。从卒中发作到治疗的平均时间为14.5小时，除患者体重外，四组之间的基线特征无显著差异。两组之间在Barthel指数和兰金量表测量的功能结局、美国国立卫生研究院（NIH）卒中量表测量的神经学评估和简易精神状态检查测量的认知功能方面存在显著差异，胞磷胆碱治疗更有利。当基线NIH卒中量表用作协变量时，500 mg胞磷胆碱组和2，000 mg胞磷胆碱组在90天时Barthel指数良好结局的患者百分比方面均有显著改善。本研究中没有出现与药物相关的严重不良事件或死亡。这项研究表明，口服胞磷胆碱可以安全地用于急性脑卒中治疗，副作用最小。胞磷胆碱似乎改善功能结局并减少神经功能缺损，500 mg胞磷胆碱似乎是最佳剂量。
Citicoline (CDP-choline) is a key intermediary in the biosynthesis of phosphatidylcholine, an important component of the nem al cell membrane. It has been shown to produce beneficial effects in both animal models and non-US clinical stroke trials. This study comprised a randomized (3 doses of citicoline to 1 placebo), vehicle-controlled, double-blind trial at 21 US centers. Treatment was to be started within 24 hours of stroke onset and was continued orally for 6 weeks. Final outcome assessments were at 12 weeks. Two hundred fifty-nine patients were enrolled, with approximately 65 in each of the four groups. Mean time from stroke onset to treatment was 14.5 hours, and there were no significant differences in baseline characteristics between the four groups except for patient weight. A significant difference between the groups, favoring citicoline treatment, was seen in terms of functional outcome as measured by the Barthel Index and Rankin scale, neurologic evaluation as measured by the National Institutes of Health (NIH) stroke scale, and cognitive function as measured by the Mini Mental Status Examination. When the baseline NIH stroke scale was used as a covariate, both the 500-mg citicoline group and the 2,000-mg citicoline group had a significant improvement in terms of the percent of patients who had a favorable outcome on the Barthel Index at 90 days. There were no drug-related serious adverse events or deaths in this study. This study suggests that oral citicoline can be used safely with minimal side effects in acute stroke treatment. Citicoline appears to improve functional outcome and reduce neurologic deficit with 500 mg of citicoline appearing to be the optimal dose.