Objective: To observe the clinical efficacy of Alzheimer’s Diseaseof spleen deficiency and sputum resistance type with modified Kaixin San,to evaluate the clinical effectiveness and safety.Methods: 72 patients with AD of spleen deficiency and sputum resistance type were randomly divided into test group(36 cases)and control group(36 cases).The test group was treated with modified Kaixin San combined with Donepezil Hydrochloride Tablets,and the control group was treated with Donepezil Hydrochloride Tablets,and both groups were treated continuously for 24 weeks.The Minimum Mental State Examination(MM SE)assessment scale,Alzheimer’s disease assessment scale(ADAS-Cog)assess ment scale and Activity of Daily Living(ADL)assessment scale and TCM syndrome scores were recorded before and after treatment in both groups,and recording the safety indexes and the adverse reactions during the treatment,to evaluate its clinical efficacy and safety.Results:1.After treatment,the total effective rate of the test group was81.8%,and the total effective rate of the control group was 65.6%,and the efficacy of the test group was better than that of the control group(P<0.05).2.MMSE score in both groups were significantly higher than those before treatment(P<0.01),and ADAS-Cog score and ADL score were significantly lower than those before treatment(P<0.01).MMSE score of the test group were significantly higher than those of the control group(P<0.05),ADAS-Cog score and ADL score were significantly lower than those of the control group(P<0.05),indicating that both interventions were effective,the test group was better than the control group in improving mental status,cognitive ability,and ability of daily life of patients with AD.3.Both the test group and the control group significantly reduced the scores of TCM syndromes of AD patients(P<0.01),and the scores of TCM syndromes in the test group was lower than that in the control group(P<0.01).4.The safety indexes of patients in both groups did not change significantly compared with those before treatment,and the test group had fewer adverse reactions than the control group,with good safety.Conclusion:The clinical efficacy of modified Kaixin San in the treatment of AD with spleen deficiency and sputum resistance is definite,which can significantly improve the cognitive function and activities of daily living of AD patients and improve the Chinese medical evidence of patients,without significant side effects and adverse reactions,with good safety. |