奥拉西坦治疗血管性痴呆的临床研究

The safety and efficacy of oxiracetam in patients with Vascular Dementia

目的评价奥拉西坦治疗血管性痴呆(Vasculardementia ,VaD)的有效性和安全性。方法对89例VaD患者进行了随机、单盲12周临床试验、其中89例为单盲、安慰剂对照研究。结果随机、单盲、安慰剂对照组研究结果表明,每天2 .4克奥拉西坦治疗12周时,奥拉西坦组较安慰剂组简易智能状态量表(MMSE)、临床痴呆程度量表(CDR)及日常生活自理能力量表(ADL)分数显著改变(P <0 .0 1、0 .0 5 )。49例服用奥拉西坦的患者中,3例( 6.1% )出现轻度不良反应,40例安慰剂组中2例( 5 % )出现头昏、恶心,两组差异无显著意义(P >0 .0 5 )。结论奥拉西坦治疗轻、中度VaD患者,对患者的认知功能、痴呆程度和日常生活能力均有改善,耐受性好,安全性高。

Objective:To assess the efficacy and safety of oxiracetam in treatment of Vascular Dementia.Methods:89 patients with VaD were fallowed a singlebling with randomized study for 12 weeks.These patients had a single-blind,blacebo-controlled trial.Result:The result of randomized single-bling,placebo-controlled trial showed that the improvements in MMSE、CDR and ADL were statistically.Significantly greater with oxiracetam 2.4/d that with placebo(P value respectively>0.01,0.05).There are 3 patients(6.1%)showing side-effect in 49 cases with oxiracetam,and 2(5%)in 40 with placebo had dizziness and nause(P>0.05).Conclusion:Oxiracetam is effective in treating patients with mild to moderate VaD.It could produce improvements in cognition and ability of daily life.Oxiracetam was well tolerated and safe.