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《Chinese Journal of New Drugs and Clinical Remedies》 2007-04
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A randomized double-blind controlled multicenter study with oxiracetam for injection in treatment of organic brain syndrome

WANG Shu-zhen~(1*) CHI Zhao-fu~1 MA Lin~1 ZHANG Yong~2 DI Qing~3 HAN Zhao~4 YU Hao~5 HAN Ting~6 (1.Department of Neurology,Qilu Hospital of Shandong University,Ji-nan SHANDONG 250012,China:2.Department of Neurology,Shandong Provincial Hospital,Ji-nan SHANDONG 250021,China;3.Department of Brain Hospital of Nanjing Medical University,Nanjing JIANGSU 210029,China;4.The First Affiliated Hospital of Wenzhou Medical College,Wenzhou ZHEJIANG 325000,China;5.Department of Epidemiology and Biostatistics School of Public Health,Nanjing Medical University,Nanjing JIANGSU 210029,China;6.Shijiazhuang Pharmaceutical Group Ouyi Pharmaceutical Company,Shijiazhuang HEBEI 050051,China)  
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).CO- NCLUSION:Oxiracetam possesses obvious effectiveness and high safety in the treatment of organic brain syndrome,more powerful than piracetam.
【CateGory Index】: R749.1
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