盐酸美金刚联合复方海蛇胶囊治疗阿尔茨海默病的临床研究

目的探究盐酸美金刚联合复方海蛇胶囊治疗阿尔茨海默病（AD）的临床疗效及安全性。方法纳入2015年10月至2016年6月就诊的AD患者共54例，随机分为美金刚组（对照组）和关金刚联合复方海蛇胶囊治疗组（观察组），观察6个月。采用简易智力状态检查量表（MMSE）、日常生活量表（ADL）、神经精神科问卷（NPI）评估患者认知状态、日常生活能力及精神行为症状（BPSD），采用不良反应量表（TESS）评估不良反应及耐受性，分别于基线和6个月末进行评估。通过Pearsonx。检验、凇验及协方差分析对结果进行统计学分析。结果6个月末，观察组患者在MMSE、ADL及NPl分数上均较基线水平有明显改善（P〈0．05）。对照组患者在MMSEY2．ADL分数上较基线水平有明显改善（P〈0．05）。观察组患者的MMSE评分明显高于对照组，ADL及NPI评分明显低于对照组（P〈0．05）。两组不良反应无统计学差异，均耐受良好。结论美金刚联合复方海蛇胶囊治疗对AD患者的认知症状、日常生活能力及BPSD均有改善，疗效显著优于美金刚单药治疗。联用未进一步加重不良反应发生率，耐受性好。

Objective To explore the clinical efficacy and safety of memantine monotherapy versus combination with R_einhartdt and Sea Cucumber Capsule for Alzheimer disease. Methods In October 2015 to June 2016, a total of 54 AD patients were randomly divided into memantine group （ control group ） and memantine combined with compound tkeinhartdt and Sea Cucumber Capsule treatment group （ observation group ） , 6 months of observation.Then Mini Mental Sate Examination （ MMSE ） , activities of daily living （ ADL ） , neuropsychiatric inventory （ NPI ） were used to assess the cognitive conditions, ability of daily life and behavioral and psychological symptoms of dementia （ BPSD ） , The treatment emergent symptom scale （ TESS ） was used to evaluate adverse reactions and tolerance at baseline and the end of 6 months. The results were analyzed by Pearson X 2test, t test and covariance analysis. Results In the end of 6 months, the patients in the combination group showed significant improvement in MMSE, ADL and NPI scores （P〈0.05） .In the control group, only MMSE and ADL score were significantly improved compared with baseline （ P〈0.05 ） .The MMSE score of patients in the combined treatment group was significantly higher than that in the control group, and the scores of ADL and NPI were significantly lower than those in the control group （ P〈0.001 ） .The two groups had good tolerance for adverse reactions. Conclusion The clinical efficacy with AD is improved by combination of Memantine and Reinhartdt and Sea Cucumber Capsule , and the efficacy is better than that of the monotherapy. The combined use can not further aggravate the incidence of adverse reactions.