多奈哌齐和石杉碱甲治疗老年人轻度认知功能障碍的疗效对比研究

Comparative clinical effectiveness of donepezil versus huperzine in elderly patients with mild cognitive impairment

目的研究多奈哌齐和石杉碱甲治疗老年轻度认知功能障碍（MCI）患者的疗效。方法122例老年MCI患者分为两组：多奈哌齐组71例患者和石杉碱甲51例患者，多奈哌齐组予口服多奈哌齐5．0mg，1次／d；石杉碱甲组口服石杉碱甲0．1mg，2次／d。所有患者随访24周，用药前、用药12周及24周后分别进行认知功能的评定，包括简易智能状态量表检查（MMSE）、蒙特利尔认知评估（北京版）量表（MOCA）、阿尔茨海默病评定量表-记忆分量表（ADAS-cog）、临床痴呆量表（CDR）、总体衰退量表（GDS）、日常生活能力量表（ADL）、Hachinski缺血指数评分（HIS）和汉密尔顿抑郁量表（HAMD）。结果两组患者年龄、性别、受教育年限、用药前神经心理学量表评分差异均无统计学意义。与用药前比较，多奈哌齐组患者用药12周、24周后，MMSE评分均明显升高（t=4．47、6．16，均P〈0．01），ADAS-cog明显降低（t=2．33、3．68，均P〈0．05）；与用药前比较，多奈哌齐组患者用药24周后MOCA评分明显升高（t=2．56，P〈0．05）。石杉碱甲组用药24周后，MMSE评分较用药前明显升高（t=2．80，P〈0．05），石杉碱甲组用药后12周、24周MOCA、ADAS-cog评分与用药前比较差异均无统计学意义。用药24周后两组比较，多奈哌齐组患者MMSE评分较石杉碱甲组明显升高（t=2．01，P〈0．05），ADAS-cog较石杉碱甲组降低（t=2．09，P〈0．05）。多奈哌齐组治疗有效30例，总有效率42．3％，石杉碱甲组治疗有效9例，总有效率17．6％，两组有效率比较差异有统计学意义（χ^2=8．26，P〈0．01）。多奈哌齐组5例、石杉碱甲组3例患者出现轻微不良反应，继续用药或调整用药时间后消失。结论在老年MCI患者的治疗中，乙酰胆碱酯酶抑制剂多奈哌齐和石杉碱甲均安全有效，且多奈哌齐起效较石杉碱甲更快，作用更明显。

Objective To assess the effectiveness of donepezil versus huperzine in the treatment of elderly patients with mild cognitive impairment （MCI）. Methods Total 122 elderly patients with MCI were divided into two groups： donepezil treatment （5.0 mg once daily） （n=71） and huperzine treatment group （0.1 mg twice daily） （n= 51）. All the patients were followed up for 24 weeks. Before and 12 weeks, 24 weeks after drug treatment, the cognitive functions were evaluated, including MMSE, MOCA, ADAS-cog, CDR, GDS, ADL, HIS and HAMD. Results There was no significant difference in age, sex, education time and neuropsychology rating scales between the groups before drug use. As compared with the score before drug use, the donepezil group showed a significant increase in MMSE after 12-weeks （t=4.47） or 24-weeks （t= 6.16） （P〈0.01）, a decrease in the score of ADAS-cog after 12-weeks （t=2.33, P〈0.05） or 24-weeks（ t=3.68, P〈0.05） , and an increase in the score of MOCA after 24-weeks drug use （t=2.56, P〈0.05）. The huperzine group showed significant improvement in MMSE after 24-weeks drug use （t= 2.80, P〈0.05）, but there was no difference in other time points or in the score of MOCA and ADAS-cog as compared with the score before drug use. After 24 weeksr treatment, the donepezil group had higher MMSE （t= 2.01,P〈0.05） and lower ADAS-eog （t=2.09, P〈0.05） scores than the huperzine group. 30 patients （total effective rate was 42.3%） and 9 patients （total effective rate was 17.6%） became improved in donepezil and huperzine group, respectively, with significant difference （χ^2= 8.26, P〈0.01）. There were 5 cases in the donepezil group and 3 cases in the huperzine group getting slight side effects which disappeared by continuing to take drugs or by adjusting drug taking time. Conclusions Donepezil and huperzine as the cholinesterase inhibitors are effective and safe, and the efficacy of donepezil is faster and better in treating elderly patients with MCI.