银丹心脑通软胶囊联合茴拉西坦治疗老年轻度认知障碍痰瘀交阻证的研究

目的:研究和探讨银丹心脑通软胶囊联合茴拉西坦治疗老年轻度认知障碍(MCI)痰瘀交阻证的临床疗效、安全性及预后。方法:将149例MCI痰瘀交阻证患者随机分为两组,均给予茴拉西坦口服;治疗组75例在此基础上给予银丹心脑通软胶囊口服。两组均用药3个月,判定两组中、西医疗效,西医疗效指数,认知能力简易精神状态量表(MMSE)],日常生活能力(ADL),中医证候评分,阿尔茨海默病(AD)转化率及相关安全性。结果:西医临床疗效比较,总有效率对照组为66.3%,治疗组为82.7%,两组相比较,差异有统计学意义(P0.05);对照组疗效指数为(4.07±1.34),治疗组为(12.08±2.65),两组相比较,差异有统计学意义(P0.01);中医证候疗效比较,总有效率对照组为62.2%,治疗组为88.0%,两组相比较,差异有统计学意义(P0.01);MMSE,治疗后治疗组除时间定向能力和实物命名能力外,其余各项指标均较对照组变化显著(P0.05或P0.01);ADL,治疗后治疗组各项指标均较对照组变化显著(P0.05);中医证候评分,治疗后治疗组各项评分及总积分均较对照组相应指标变化显著(P0.05或P0.01)。AD转化率,随访6个月,治疗组3例(4.0%)进展为AD,对照组11例(14.9%)进展为AD,差异有统计学意义(P0.05);两组不良反应相比较,差异有统计学意义(P0.05)。结论:银丹心脑通软胶囊联合茴拉西坦治疗MCI痰瘀交阻证疗效肯定,安全性好,预后良好。

Clinical Study of Yindanxinnaotong Soft Capsule Combined with Aniracetam on Elder Mild Cognitive Impairment with Phlegm and Blood Stasis into Resistance Syndrome

Objective： To study and investigate clinical curative effect, safety and prognosis of Yindanxinnaotong soft capsule combined with aniracetam on treating elder mild cognitive impairment （MCI） with phlegm and blood stasis into resistance syndrome. Methods： The 149 cases of MCI with phlegm and blood stasis into resistance syndrome were randomly divided into two groups; all the patients were given aniracetam orally; The treatment group （n=75） was given Yindanxinnaotong soft capsule orally. Both groups were treated for 3 months; TCM and western medicine curative effect, western medicine curative effect index, cognitive abilitymini-mental state examination （MMSE）], activitis of daily living （ADL）, TCM symptoms score, alzheimer＇s disease （AD） conversion and related security were observed and compared. Results： The total effectiveness rate of clinical effect of western medicine was 66.3% in the control group and 82.7% in treatment group, and the difference was statistically significant （P〈0.05）; The effect index was （4.07±1.34） in control group and （12.08±2.65） in treatment group, and the difference was statistically significant （P〈0.01）; the total effectiveness rate of TCM curative effect was 62.2% in control group and 85.0% in treatment group, and the difference was statistically significant（P〈0.01）; In MMSE, except time directional ability and material object named ability, the rest of all the indexes in the treatment group changed more significantly than those of the control group （P〈0.05 or P〈0.01）; In ADL, all indices of the treatment group changed more significantly than those of control group （P〈 0.05）; the total TCM symptoms score of the treatment group changed more significantly than those of the control group （P〈0.05 or P〈0.01）. AD conversion rate was observed by following up for 6 months; there were 3 cases （4.0%） progressed to AD in the treatment group, and 11 patients （14.9%） in control group, and the difference was stati