摘要
目的:验证和评价奥拉西坦治疗器质性脑综合征的有效性和安全性。方法:本研究采用多中心、随机、双盲双模拟、平行对照的方法,分别给予试验组(n=107)和对照组(n=107)病人奥拉西坦6 g或吡拉西坦6 g,均用氯化钠注射液250 mL溶解后iv,gtt,qd,连续使用21 d。结果:试验组总有效率78．9％明显优于对照组62．5％(P＜0．05);2组在治疗前后NDS、GCS、MMSE及Blessed-Roth总评分差值和评分变化率相比有非常显著差异(P＜0．01);试验组在治疗后MMSE、Blessed-Roth总评分差值及变化率与对照组比较有非常显著差异(P＜0．01);2组治疗前后NDS、GCS总评分值及评分差值和变化率组间比较无显著差异(P＞0．05)。2组不良反应发生率均为2．8％(p＞0．05)。结论:奥拉西坦对器质性脑综合征疗效优于吡拉西坦,安全性好。
AIM： To confirm and evaluate the efficacy and safety of oxiracetam in treatment of the organic brain syndrome. METHODS： The patients of trial group （n = 107） and control group （n = 107） were enrolled to have a multiple-center, randomized, double-blind, double-simulate, parallel study with either oxiracetam 6 g or piracetam 6 g, dissolving in NS （250 mL） iv, gtt, qd, for 21 d, individually. RESULTS： Total effective rate of trial group was obviously higher than that of control group （P 〈 0.05） with a significant difference. Rates of score changes of patients＇ NDS, CCS, MMSE and Bless-Roth before and after therapy between the two groups were obviously significant （P 〈 0.01 ） . Total score and change rate differences of patients＇ MMSE and Bless-Roth in the two groups after therapy also had a significant difference （P 〈 0.01 ）. There was no significant difference in total score, score difference and change rate of NDS and GCS before and after therapy between both groups （P 〉 0.05）. The adverse reactions rates of the two groups were equal 2.8 % （P 〉 0.05）. CONCLUSION： Oxiracetam possesses obvious effectiveness and high safety in the treatment of organic brain syndrome, more powerful than piracetam,
出处
《中国新药与临床杂志》
CAS
CSCD
北大核心
2007年第4期267-271,共5页
Chinese Journal of New Drugs and Clinical Remedies
关键词
奥拉西坦
谵妄
痴呆
遗忘
认知障碍
药物疗法
多中心研究
随机对照试验
双盲法
oxiracetam
delirium, dementia, amnesic, cognitive disorders
drug therapy
muhicenter studies
randomized controlled trials
double-blind method
