奈非西坦治疗Alzheimer病随机双肓对照研究

A double - blind study on nefiracetam in the treatment of Alzheimer's disease.

目的 研究奈非西坦治疗轻、中度AD的有效性和安全性。方法 采用前瞻、随机、双盲、安慰剂对照法,奈非西坦组与安慰剂组各26例。总疗程32周(预备期2周、服药期24周、随访期6周)。以MMSE、ADL、CGI、WMS、ADS及GDS量表为评定指标,每6周评定一次。结果 奈非西坦组患者的认知功能及日常生活功能在治疗12周后开始显效。24周后,MMSE增分率>50％2例,增分率>25％22例,而安慰剂组在24周后仅1例好转。奈非西坦组ADL平均减分值为-3.88±3.02,安慰剂组为-0.32±2.68,差异非常显著(P<0.001)。奈非西坦组MQ提高分值10.34±9.92,安慰剂组为3.56±6.72,差异显著(P<0.01)。两组临床总体疗效(CGI),奈非西坦组有效23例,有效率88.45％,安慰剂组有效 2例,有效率8％。两组均无严重不良反应。结论 奈非西坦作为新一代吡咯烷类促智药是安全有效的,可应用于轻、中度AD患者的治疗。

Objective To study the efficacy and safety of nefiracetam in the treatment of mild and moderate Alzheimer' s disease. Methods Both study and control groups consisted 26 cases respectively. The trial lasted for 32 weeks, including preparing 2 weeks,medicating 24 weeks,and following- up 6 weeks. All the subjects were measured by MMSE, ADL,CGI,WMS,ADS and GDS every six weeks.Results The patients in nefircaetam group improved their understanding ability and life quality from 12th week. After 24 weeks,2 cases' MMSE incresing rate was more than 50% ,22 cases 25% .In control group,only one case was improved after 24 weeks. ADL average decreasing value in nefiracetam group is -3.88 ±3.02, the controal -0.32±2.68(P < 0.001) .MQ increasing value was 10.34 ±9.92 in nefiracetam and 3. 56±6.72 in control (P<0.01).No severe side - effects were found in both groups. Conclusions Nefiracetram is a new safe and efficient drug in treating mild and moderate Alzheimer's disease.