复方海蛇胶囊预防遗忘型轻度认知功能障碍向阿尔茨海默病转化效果的研究

Preventive effects of Haishe capsules on the conversion of amnestic mild cognitive impairment to Alzheimer＇ s disease

目的探讨复方海蛇胶囊预防遗忘型轻度认知功能障碍（aMCI）转化为阿尔茨海默病（AD）的临床效果。方法在我院记忆门诊纳入120例aMCI患者，随机分为治疗组和对照组（各60例），治疗组给予复办海蛇胶囊治疗，对照组采取自然观察，不采取任何药物治疗，随访观察24个月，比较两组患者转化为AD的情况及记忆和认知功能。结果24个月末治疗组共脱落12例，对照组脱落15例，将完成全部检查的患者（共93例，治疗组48例，对照组45例）纳入统计分析，至研究终点．治疗组转化为AD的例数为6／48例（12．5％），对照组的转化例数为13／45例（28．8％），两组间差异有统计学意义（χ^2=3．83，P〈0．05）。24个月末，治疗组MMSE评分（25．52±1．07）分较基线无显著下降，对照组评分（24．75±1．49）显著下降，且低于治疗组（χ^2=2．85，P〈0．05）；治疗组MoCA评分至研究终点时（19．39±2．01）分才出现显著性下降，对照组12个月末即开始出现显著下降，24个月末时，评分显著低于治疗组（t=2．41，P〈0．05）。治疗组ADAS-Cog评分至研究终点时（7．62±1．06）分仍无显著性增高，对照组评分无论是12个月末（7．70±0．75）分，还是24个月末（8．18±0．80）分均较基线有显著性增高，24个月末两组评分有显著性差异（t=2．6，P〈0．05）。结论复方海蛇胶囊能有效降低aMCI向AD的转化，且能显著维持记忆和认知功能水平。

Objective To evaluate the preventive effects of Haishe capsules on the conversion of amnestic mild cognitive impairment （aMCI） to Alzheimer＇s disease（AD）. Methods Patients （n= 120） wilh aMCI from our department were recruited and randomly divided into the treatment group and the control group （n=60 in each group）. The treatment group was given 0.9 gram of Haishe capsules three times a day while the control group received no drug treatment. Data on the conversion ratio, memory and cognitive function were comparedbetween the groups in a 24-months follow-up. Results By the end of the study, 12 patients in the treatment group and 15 in the control group dropped out. Valid data for 93 patients were available for statistical analysis （48 in the treatment group and 45 in the control group）. The number of aMCI patients who converted to AD was 6, with a conversion ratio of 12.5% （6/48）; and the number of patients who went through conversion in the control group was 13, with a conversion ratio of 28.8% （13/45）. The difference in conversion between the two groups was statistically significant （χ^2=3.83, P〈0.05）. After 24 months, MMSE scores for the treatment group （25.52±1.07） had no significant change compared with baseline levels, while MMSE scores for the control group decreased significantly（24.75±1. 49） and were markedly lower than thosefor the treatment group （t=2.85, P〈0.05）. MoCA scores for the treatment group （19.39 ±2.01） did not show decline until the end of the study, while those for the control group started to decrease about half way through the study and were lower than scores for the treatment group （t 2.41, P〈0.05）. Compared with baseline levels, ADAS-Cogscores for the treatment group （7.62 ± 1.06） did not increase significantly during the course of the study. ADAS Cogscores forthe control group were higher at both half way （7.70±0.75） and the end of the study （8.18±0.80）than base line levels, and there was a statistically significant difference in end of-study ADAS-Cog scores between the two groups（t=-2.6, P〈0.05）. Conclusions Haishe capsules not only effectively maintain memory and cognitive function, but also delay the conversion from aMCI to AD.