1.Department of Neurology,Qilu Hospital of Shan dong University,Jinan 250012,China;2.Department of Neurology,Shandong Province Hospital,Jinan 250021,China;3.First Affiliated Hospital of Zhejiang Medical University,Hangzhou 310003,China;4.Affiliated Hospital of Qingdao Medical College,Qingdao 266003 ,China;5.Qingdao Shili Hospital,Qingdao 266011,China;6.Drug Clinical Evaluate Center of Anhui Province,Wuhu 241001,China
OBJECTIVE To comfirm and evaluate the efficacy and safety of oxiracetam in treatment of organic brain syndrome. METHODS The patients in trial group(n=110) and control group(n=110) were enrolled to a multiple-center,randomized,double-blind,double-simulate,parallel study. Patients were treated with either oxiracetam 6 g or domestic piracetam 6 g ivgtt qd for 21 d.The score changes of the patients′s core of neurological funetional damage(NDS),Glasgow Coma Scale(GCS),Mini-metal state examination(MMSE) and Blessed-Roth before and after therapy were obtained between the two groups. Meanwhile, adverse event and laboratory examination were obserred in the two groups. RESULTS There was a significant difference in total score and improvement of the patient NDS,MMSE and Bless-Roth after therapy between the two groups(P<0.01).Total effective rate of trial group was obviously higher than that of control group. There was no significant difference in GCS score change before and after therapy between the both groups(P>0.05).There was no adverse event in trial group,The incidence rate of adverse event in the control group was 0.909%. There was no statistics difference between the two groups. CONCLUSION Oxiracetam has obvious effect and good security in the treatment of organic brain syndrome,and the effect is better than piracetam.
WNG Shu-zhen;CHI Zho-fu;GUO Hong-zhi;ZHNG Yong;LUO en-yn;PEI Hi-to;XING Cheng-ming;SUN Rui-run.
A Randomized Double-Blind Controlled Multicenter Study with Oxiracetam in Treatment of Organic Brain Syndrome [J]. Chinese Pharmaceutical Journal, 2007, 42(15): 1194-1196
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