摘要
目的评价胞磷胆碱钠片治疗急性脑出血的效果及其安全性。方法采用随机、双盲、双模拟、阳性药物平行对照的临床试验方法,将符合入选标准的患者随机分为两组:试验组18例,口服胞磷胆碱钠片0.2 g tid及胞磷胆碱钠模拟胶囊0.2 g tid;对照组18例,口服胞磷胆碱钠胶囊0.2 g tid及胞磷胆碱钠模拟片0.2 g tid。疗程均为21天。用美国国立卫生所卒中量表(N IH SS)和B arthel指数(B I)评价神经功能恢复状况。结果两组受试者治疗后的N IH SS量表评分和B arthel指数较治疗前均显著改善(P<0.01),改善程度组间比较差异无统计学意义(P>0.05)。两组均未发现明显不良反应,治疗前后两组的实验室指标无显著变化。结论胞磷胆碱钠片治疗急性脑出血所致的神经功能缺损效果及安全性良好,与胞磷胆碱胶囊相比较,两种剂型疗效和安全性基本一致。胞磷胆碱钠片为急性脑出血患者用药提供了一种有效且服用方便的选择。
Objective To evaluate the efficacy and safety of sodium citicoline tablets in the treatment of acute cerebral hemorrhage within 72 hours from the onset. Methods A randomized , double -blind, double-dummy, active control clinical study was performed. Patients who met the inclusion criteria were randomized into two groups. The treatment group （18 cases） received sodium citicoline tablets （0.2 g tid） and placebo capsule （0. 2 g tid）, while the control group （18 cases） received sodium citicoline capsule （0.2 g tid） and placebo tablets （0. 2 g tid）. The duration of treatment was 21 days for the two groups. National Institutes of Health Stroke Scale （NIHSS） and Barthel Index （BI） were used to evaluate the recovery of neurological functions. Results NIHSS and BI scores increased significantly in both groups after treatment （P 〈0. 01 ）. There was no statistical difference of the improvement between the two groups （P 〉0. 05）. No adverse drug reaction or significant change in laboratory norms was found in either group. Conclusions Sodium citicoline tablets is effective and relatively safe in the treatment of acute cerebral hemorrhage. The efficacy and safety of sodium citicoline tablets in the treatment of acute cerebral hemorrhage is similar to that of sodium citicoline capsule.
出处
《中国循证医学杂志》
CSCD
2005年第11期818-821,共4页
Chinese Journal of Evidence-based Medicine
关键词
胞磷胆碱
脑出血
随机对照试验
Citicoline
Cerebral hemorrhage
Randomized controlled trial
