摘要
目的:验证脑活素治疗血管性痴呆(VD)的疗效。方法:为多中心双盲随机平行对照研究。脑活素与安慰剂的剂量均为100ml的注射剂,安慰剂为生理盐水,研究药含30毫升脑活素。治疗方法静脉滴注,共4周20次。结果:共入组并完成观察147例VD病人,脑活素组和安慰剂对照组分别为75例和72例。治疗4周后,脑活素组简明智力检查量表(MMSE)平均总分比治疗前提高了2.7分,两组具有显著性差异(P<0.05)。连线测验(ZVT1和ZVT2)在治疗4周后两组的减分值的差异具显著性(P<0.05),脑活素治疗组的连线速度明显加快。治疗期间两组病人不良反应的出现频率无显著性差异(P>0.05)。结论:脑活素能快速改善轻中度VD病人的认知功能。研究期间未观察到严重不良反应,具较好的治疗安全性。
Objective:To evaluate the efficacy of cerebrolysin in the treatment of mild to moderately severe vascular dementia. Method:The study involved a multi centre,double blind and paralled group design trial.A total of 147 patients age 55 to 85 suffering from mild to moderately severe vascular dementia were randomised to treatment with either 30ml cerebrolysin (75 subjects) or placcbo normal saline (72 subjects) iv drip once daily for four weeks. Results:Patients treated with cerebrolysin showed significantly more improvement in the MMSE scores and ZYT test over the placebo group.There was increase of 2 7 points in the MMSE over the baseline with the cerebrolysin group.The incidence of adverse side effects was low and comparable to the placebo group. Conclusion:Cerebrolysin is effective in the treatment of vascular dementia with rapid clinical response and few side effects.
出处
《临床精神医学杂志》
1999年第1期1-3,共3页
Journal of Clinical Psychiatry
基金
卫生部药政局课题
奥地利依比威药厂资助