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.
Citation：
ZHOU Muke ,HE Li,KONG Shuangyan,ZHOU Dong. Efficacy and Safety of Sodium Citicoline Tablets in the Treatment of Acute Cerebral Hemorrhage: A Randomized Controlled Trial. Chinese Journal of Evidence-Based Medicine, 2005, 05(11): 818-821. doi:
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Copyright © the editorial department of Chinese Journal of Evidence-Based Medicine of West China Medical Publisher. All rights reserved
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- 1. 阳清伟, 刘鸣. 胞二磷胆碱临床研究和应用的循证评价[J]. 中国循证医学杂志, 2003; 3(1): 68～69.
- 2. 张象麟. 主编. MCDEX药物临床信息参考[J]. 第1版. 成都: 四川科学技术出版社; 2004. 891～892.
- 3. 杨树声. 药物的剂型与其疗效、药效及毒副作用的关系[J]. 实用医技杂志, 1998; 5(6): 385.
- 4. 喻芳芳, 欧阳存, 沈利亚, 张晓琴. 胞磷胆碱治疗脑出血临床评价[J]. 药物流行病学杂志, 2004; 13(4): 178～179.
- 5. Yang QW, Liu M. Evidence-based evaluation on clinical trials and application of citicoline[J]. Chinese Journal of Evidence-Based Medicine, 2003; 3(1): 68-69.
- 6. Zhang XL. Editor-in-Chief. MCDEX clinical drug reference[J]. 1st ed. Chengdu: Sichuan Science & Technology Press; 2004. 891-892.
- 7. Yang SS. The dosage form of drug and its connection with the therapeutic effect, pharmacodynamic action and side effects[J]. Practical Medical Technology Journal, 1998; 5(6): 385.
- 8. Clark W, Gunion-Rinker L, Lessov N, Hazel K. Citicoline Treatment for Experimental Intracerebral Hemorrhage in Mice[J]. Stroke, 1998; 29(10): 2 136-2 140.
- 9. Yu FF, Ou-Yang C, Shen LY, Zhang XQ. Clinical Observation on Effect of Cytosine Dihosphate-choline Injection in Treating Patients with Intercerebral Hemorrhage[J]. Chin J Pharmacoepidemiol, 2004; 13(4): 178-179.
