三焦阳化胶囊干预轻度认知障碍临床研究

Clinical Study of Sanjiao Yanghua Capsule on Mild Cognitive Impairment

[目的]观察三焦阳化胶囊(益肺温阳化浊方)干预轻度认知障碍(MCI)患者的临床疗效。[方法]选择60例MCI患者随机分为对照组和治疗组,每组30例,另纳入30例健康老年人作为健康老年组。对照组予重新包装的盐酸多奈哌齐胶囊口服,5粒/次,3次/天,每日服药总量相当于盐酸多奈哌齐片5 mg。治疗组予三焦阳化胶囊口服,5粒/次,3次/天。两组治疗3个月,采用简易精神状态检查表(MMSE)、蒙特利尔认知评估量表(MoCA)、长谷川痴呆量表(HDS)、多维记忆评估量表(MMAS)、韦氏记忆量表(WMS)、血浆Aβ1-42、磷酸化Tau蛋白(p-Tau)、载脂蛋白E等位基因(APOE-4)、AD相关基因变异位点(SNP)、尿AD7c-NTP、头颅磁共振内侧颞叶萎缩(MTA)评分及脑电图(EEG)等多维指标进行疗效评价。[结果]治疗组总有效率为90.00%,对照组为86.67%,两组比较无显著性差异(P>0.05)。对照组与治疗组MMSE、MoCA、HDS、MMAS、WMS评分均较治疗前提高(P<0.05);与对照组治疗后比较,治疗组MMSE、MoCA、HDS、MMAS、WMS评分较高,但无显著性差异(P>0.05)。治疗后,两组Aβ1-42、p-Tau、尿AD7c-NTP含量及APOE-4表达水平均显著下降(P<0.05),且治疗组Aβ1-42、p-Tau、尿AD7c-NTP含量及APOE-4表达水平较对照组下降,但无显著性差异(P>0.05)。对照组和治疗组MTA评分异常率分别为93.33%和96.67%,治疗后,两组MTA评分与治疗前比较均无显著性差异(P>0.05)。治疗组、对照组EEGθ波脑电功率显著高于健康老年组(P<0.05),治疗组与对照组治疗后与治疗前比较,EEG各波段无显著性改变(P>0.05),组间比较也无显著性差异(P>0.05)。[结论]三焦阳化胶囊可改善MCI患者记忆功能,降低血浆Aβ1-42、p-Tau、尿AD7c-NTP含量及APOE-4表达,具有较好的临床疗效和安全性。

[Objective]To observe the clinical effect of Sanjiao Yanghua Capsule(Yifei Wenyang Huazhuo Decoction)on patients with mild cognitive impairment(MCI).[Methods]60 patients with MCI were randomly divided into control group and treatment group,with 30 cases in each group.In addition,30 healthy elderly people were added as healthy elderly group.The patients in the control group were taken with repackaged Donepezil Hydrochloride Capsules,5 capsules each time,3 times per day.The total amount of daily medication was equivalent to 5 mg of Donepezil Hydrochloride Tablets.The treatment group was given Sanjiao Yanghua Capsule orally,5 capsules each time,3 times per day.The two groups were treated for 3 months.Mini-mental state examination(MMSE),Montreal cognitive assessment(MoCA),Hasegawa dementia scale(HDS),multidimensional memory assessment scale(MMAS),Wechsler memory scale(WMS),plasma Aβ1-42,phosphorylated Tau protein(p-Tau),apolipoprotein E allele(APOE-4),AD-related gene mutation site(SNP),urinary AD7c-NTP,cranial magnetic resonance medial temporal lobe atrophy(MTA)score and electroencephalogram(EEG)were used to evaluate the efficacy.[Results]The total effective rate was 90.00%in the treatment group and 86.67%in the control group.There was no significant difference between the two groups(P>0.05).The scores of MMSE,MoCA,HDS,MMAS and WMS in the control group and the treatment group were higher than those before treatment(P<0.05).Compared with the control group after treatment,the scores of MMSE,MoCA,HDS,MMAS and WMS in the treatment group were higher,but there was no significant difference(P>0.05).After treatment,the levels of Aβ1-42,p-Tau,urinary AD7c-NTP and APOE-4 in the two groups were significantly decreased(P<0.05).The levels of Aβ1-42,p-Tau,urinary AD7c-NTP and APOE-4 in the treatment group were lower than those in the control group,but there was no significant difference(P>0.05).The abnormal rates of MTA scores in the control group and the treatment group were 93.33% and 96.67%,respectively.After treatment,there was no significant difference in MTA score between the two groups(P>0.05).The average power of EEG wave in the treatment group and the control group was significantly higher than that in the healthy elderly group(P<0.05).There was no significant difference in EEG bands between the treatment group and the control group before and after treatment(P>0.05),and there was no significant difference between the two groups(P>0.05)[.Conclusion]Sanjiao Yanghua Capsule can improve the memory function of MCI patients,reduce the expressions of plasma Aβ1-42,p-Tau,urine AD7c-NTP content and APOE-4,and has good clinical efficacy and safety.