脑康Ⅱ号联合茴拉西坦胶囊治疗老年遗忘型轻度认知障碍临床研究

Clinical Study on Naokang Ⅱ Combined with Aniracetam Capsules for Treatment of Elderly Patients with Amnestic Mild Cognitive Impairment

目的观察脑康Ⅱ号联合茴拉西坦胶囊治疗肾虚髓亏、痰瘀阻窍型老年遗忘型轻度认知障碍(aMCI)临床疗效,探讨其可能的相关机制。方法选择肾虚髓亏、痰瘀阻窍型老年aMCI患者101例,采用随机数字表法分为观察组(49例)与对照组(52例)。2组均予茴拉西坦胶囊,0.2 g/次,3次/d,餐后30 min口服;观察组在此基础上予脑康Ⅱ号,1剂/d,150 mL/次,2次/d,餐后30 min口服。2组均连续治疗12周。观察2组中医疗效,比较2组治疗前后阿尔茨海默病评价量表-认知部分(ADAS-cog)评分、听觉词语学习测验(AVLT)评分、中医证候积分及外周血乙酰胆碱酯酶(AChE)、超氧化物歧化酶(SOD)、丙二醛(MDA)水平,采用不良反应量表(TESS)评价不良反应。结果观察组总有效率为73.47%(36/49),对照组为26.92%(14/52),观察组明显优于对照组(P<0.01)。与本组治疗前比较,观察组治疗后ADAS-cog评分明显下降(P<0.05),2组治疗后AVLT评分明显升高(P<0.05,P<0.01);2组治疗后比较,观察组AVLT评分明显高于对照组(P<0.05)。与本组治疗前比较,观察组治疗后中医证候积分明显降低(P<0.05);观察组治疗前后中医证候积分差值明显高于对照组(P<0.01)。与本组治疗前比较,2组治疗后外周血AChE、MDA水平明显降低(P<0.05,P<0.01),观察组治疗后外周血SOD水平明显升高(P<0.05)。2组TESS评分比较差异无统计学意义(P>0.05)。结论脑康Ⅱ号联合茴拉西坦可有效改善老年aMCI患者肾虚髓亏、痰瘀阻窍证候,改善患者的认知功能,较单纯应用茴拉西坦胶囊可起到增效作用,其机制可能与改善患者AChE水平及氧化应激状态有关。

Objective To observe the clinical efficacy of Naokang Ⅱ combined with Aniracetam Capsules for treatment of the elderly patients with amnestic mild cognitive impairment(aMCI)of kidney and marrow deficiency and intermingled phlegm and blood stasis,to explore its possible mechanism.Methods Totally 101 elderly patients with aMCI of kidney and marrow deficiency and intermingled phlegm and blood stasis were studied,and were divided into observation group(49 patients)and control group(52 patients)according to random number table method.Both groups were given Aniracetam Capsules,0.2 g/time,3 times/d,orally 30 minutes after a meal;the observation group was given NaokangⅡon this basis,1 dose/d,150 mL/time,twice/d,orally 30 minutes after a meal,and both groups were treated continuously for 12 weeks.The TCM efficacy of the 2 groups was observed.The Alzheimer's disease assessment scale-cognitive subscale(ADAS-cog),auditory verbal learning test(AVLT)score,TCM syndrome score,peripheral blood acetylcholinesterase(AChE),superoxide dismutase(SOD),and malondialdehyde(MDA)levels in both groups were compared.Treatment emergent symptoms scale(TESS)was used to evaluate adverse reactions.Results The total effective rate of the observation group was 73.47%(36/49)and that of the control group was 26.92%(14/52).The observation group was significantly better than the control group(P<0.01).Compared with before treatment,the ADAS-cog score of the observation group decreased significantly after treatment(P<0.05),and the AVLT score of the two groups increased significantly after treatment(P<0.05,P<0.01).After treatment,the AVLT score of the observation group was significantly higher than that of the control group(P<0.05).Compared with before treatment,the TCM syndrome score of the observation group decreased significantly after treatment(P<0.05),the difference of TCM syndrome scores in the observation group before and after treatment was significantly higher than that in the control group(P<0.01).Compared with before treatment,the levels of AChE and MDA in peripheral blood of the two groups were significantly reduced after treatment(P<0.05,P<0.01),and the peripheral blood SOD level of the observation group increased significantly after treatment(P<0.05).There was no statistical significance in TESS scores between the two groups(P>0.05).Conclusion Naokang Ⅱ combined with Aniracetam Capsules can effectively improve the pathological state of kidney and marrow deficiency and intermingled phlegm and blood stasis,and improve the cognitive function of elderly patients with aMCI.Compared with taking only Aniracetam Capsules,which has a synergistic effect,the mechanism may be related to improving AChE levels and oxidative stress in patients.