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 ability[mini-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 88.0% in treatment group, and the difference was statistically significant(P0.01);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(P0.05 or P0.01); 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(P0.05 or P0.01). 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 statistically significant(P0.05); the difference on adverse reactions between the two groups was statistically significant(P 0.05). Conclusion: Yindanxinnaotong soft capsule combined with aniracetam can provide sure effect for elder mild cognitive impairment(MCI) with phlegm and blood stasis into resistance syndrome, with good safety and good prognosis.