Objective: To explore the efficacy and tolerance of Memantine combined Reinhartdt And Sea Cucumber Capsule (R.S.C) on treating agitation in patients with moderate-severe Alzheimer disease (AD). Methods: One hundred and fifty-eight moderate-sever AD patients from Sep.2013 to Sep.2014 in Zhejiang Provincial People's Hospital were randomly divided into two groups: group of Memantine combined R. S.C and group of single Memantine. Then Mini-Mental Sate Examination (MMSE) and Neuropsychiatric Inventory (NPI) were used to evaluate cognition symptom, behavioral and psychological symptoms of dementia (BPSD) and agitation symptom at the baseline and the end of 24 weeks.The Treatment Emergent Symptom Scale (TESS) was used to assess adverse reaction and tolerance.At last, the data was analyzed by chi-square test, t-test and covariance test. Result: At the terminal of experience, the total NPI scores and agitation factor decreased markedly in both of the two groups (P<0.05). Among the patients who had agitation symptom at the baseline, the total NPI scores and agitation factor (18±5, 3.7±2.6) in group of Memantine combined R. S.C were notably lower than those in the group of single Memantine (21±6, 5.3±2.5) (P<0.05). The incidence of adverse reaction between the two groups had no significant difference (combined treatment group was 27.7%, single treatment group was 23.2%). One patient dropped out because of skin allergy, and most adverse reactions were tolerant. Conclusions: Both two groups are effective in agitation and BPSD, and Memantine combined R. S.C is better than single treatment.R.S.C dose not aggravate adverse reaction and can be well tolerated.
目的： 探讨美金刚联合复方海蛇胶囊治疗中－重度阿尔茨海默病(AD)激越症状的疗效及耐受性。 方法： 纳入2013年9月1日至2014年9月在浙江省人民医院记忆门诊就诊的中－重度AD患者共158例，按随机表法随机分为美金刚联合复方海蛇胶囊治疗组(联合治疗组)和美金刚单药治疗组(对照组)，观察24周。采用简易智力状态检查量表(MMSE)、神经精神科问卷(NPI)评估患者智力状态、精神行为症状(BPSD)及激越症状，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24周末进行评估。通过Pearson χ(2)检验、t检验及协方差分析对研究结果进行统计分析。 结果： 治疗终点，两组的NPI总分及激越因子分均获得显著改善(P<0.05)。对基线有激越症状的患者，治疗终点时联合治疗组NPI总分及激越因子分[(18±5)分，(3.7±2.6)分]显著低于对照组[(21±6)分，(5.3±2.5)分](P<0.05)。两组的不良反应发生率差异无统计学意义(联合治疗组27.7%，对照组23.2%)，联合治疗组1例患者因皮肤过敏发生脱落，其他不良反应均能较好耐受。 结论： 美金刚联合复方海蛇胶囊治疗对BPSD及激越症状均有改善，美金刚和复方海蛇胶囊联合治疗组的疗效显著优于美金刚单药治疗。复方海蛇胶囊未进一步加重不良反应发生率，且都能较好耐受。.
Keywords: Agitation; Alzheimer disease; Behavioral and psychological symptoms of dementia; Case-control study.