奥拉西坦与吡拉西坦治疗血管性痴呆的随机双盲对照研究

目的 :比较奥拉西坦与吡拉西坦治疗轻、中度血管性痴呆 (VD)病人的疗效和安全性。方法 :随机双盲、阳性对照实验。疗效评价使用MMSE和Blessed Roth量表 ,在治疗前和 6 0d后进行。 6 0例轻、中度VD病人 (MMSE评分 10～ 2 1分 ) ,随机分为 2组 (奥拉西坦组和吡拉西坦组各 30例 )。分别给予奥拉西坦和吡拉西坦各 80 0mg ,po ,tid ,治疗6 0d。结果 :治疗前后比较 2组各指标除日常生活能力外均有改善 ,差异有非常显著和显著意义 (P <0 .0 1或 0 .0 5 ) ,奥拉西坦组在社会活动能力方面的改善 差值为 (0 .7±s 1.1)分 ],差异有非常显著意义 (P <0 .0 1) ,而吡拉西坦组病人在社会活动能力方面的改善 差值为 (0 .5± 1.1)分 ],差异有显著意义 (P <0 .0 5 )。但治疗前后 2组之间差值的t检验 ,差异无显著意义 (P >0 .0 5 )。结论 :奥拉西坦对血管性痴呆的疗效和安全性与吡拉西坦相近。

Randomized double-blind controlled study of oxiracetam vs piracetam in treatment of vascular dementia

AIM:To compare the therapeutic effect and safety of oxiracetam and piracetam in the treatment of mild or moderate vascular dementia (VD). METHODS: The multicenter, randomized, double blind, positive controlled clinical trial was applied. Sixty patients with mild or moderate vascular dementia (MMSE score:10 21) were divided into oxiracetam group ( n=30 ) and piracetam group ( n=30 ) randomly. The MMSE scale and Blessed Roth scale were applied in evaluating the therapeutic effect before and after treatment of oxiracetam or pricacetam 800 mg, po , tid, for 60 d. RESULTS: All the indexes, except that of daily life abitity improved after tretemnt in two groups compared with that of pre treatment, there were very significant or significomt differences ( P <0.01 or P <0.05). The amelioration of soial activity (difference value was 0.7± s 1.1 between pre and post therapy) had very significant difference ( P<0.01 ) in oxiracetam group, however, that in priacetam group (difference value was 0.5±1.1 between pre and post therapy) had only significant difference ( P < 0.05). But the extent of amelioration of these indexes had no significant difference ( P >0.05) in two groups. CONCLUSION: Oxiracetam and piracetam had similar therapeutic effect and safety on VD.