目的验证和评价奥拉西坦注射液(欧兰同)治疗脑器质性综合征的有效性和安全性。方法采用多中心、随机双盲、平行对照的研究方法,分别给予试验组(n=110)和对照组(n=110)病人奥拉西坦注射液6g或吡拉西坦注射液6g,均用氯化钠注射液250mL稀释后iv.gtt,qd,连续使用21d。观察两组病人在治疗前后神经功能缺损程度评分(NDS)、格拉斯哥昏迷量表(GCS)、简易智能状态检查量表(MMSE)及Blessed-Roth评分差值的变化;同时观察两组病人不良反应并进行实验室检查。结果奥拉西坦组对NDS、MMSE、Blessed-Roth改善程度明显优于吡拉西坦组(P<0.01),GCS量表总评分变化值组间比较无显著性差异(P>0.05)。奥拉西坦组无不良事件发生,吡拉西坦组不良事件发生率0.909%,两组比较差别无统计学意义,两组均无严重不良事件发生。结论奥拉西坦注射液(欧兰同)对脑器质性综合症疗效显著优于吡拉西坦注射液,安全性好。

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.