摘要
目的评价美金刚对正在接受石杉碱甲治疗的中重度阿尔茨海默病（AD）患者的疗效与安全性。方法随机、开放标签、空白对照研究。共纳入正在接受固定剂量石杉碱甲治疗中重度AD患者85例，年龄60～85岁，平均（74．9±7．7）岁，随机分入联合治疗组（n=43）和单药治疗组（n=42），分别加用美金刚联合治疗或继续石杉碱甲单药治疗，随访24W，每4W随访一次，在基线和试验终点进行评估，主要疗效指标为严重障碍量表（S1B），次要疗效指标为印象变化量表（CIBIC—plus）、AD合作研究一日常生活能力量表（ADCS—ADL19）和神经精神症状问卷（NPI），疗效评估以评分相对于基线的变化为指标。安全性评价包括体格检查、实验室检查、心电图和不良事件。结果74例患者完成试验。联合治疗组与单药治疗组比较，量表评分变化分别为：SIB评分：3．2±5．7、0．2±4．4（P=0．012）；ADCS—ADL19评分：0．7＋3．9、-1．2±3．9沪=O．045）；NPI评分：06．9±8．1、02．7±7．0（P=0．018）；CIBIC—plus评分总有效率：52．6％、22．2％（P=0．035），差异均有统计学意义。不良事件发生率差异无统计学意义（P=0．757）。结论美金刚能显著改善同时接受石杉碱甲治疗的中重度AD患者的认知障碍、日常生活能力和精神行为症状，具有较好的安全性。
Objective To evaluate the efficacy and safety of memantine in patients with moderate to severe Alzheimer＇s disease （AD） already receiving stable treatment with huperzine A. Methods 85 patients with moderate to severe AD who received stable doses of huperzine A （ 60- 85 years, mean age of 74.9 ± 7.7 years ） underwent a randomized, open-label, blank-controlled trial. Patients were randomly divided into combination therapy group （n = 43） and monotherapy group （n=42） to receive memantine or not for 24 weeks. Follow-up observation was conducted every 4 weeks. The primary efficacy was evaluated by the Severe Impairment Battery （SIB）. The secondary efficacy was evaluated by using the Clinician＇ s Interview Based Impression of Change Plus （CIBIC-Plus）, AD Cooperative Study-Activities of Daily Living Inventory （ADCS-ADL19） and the Neuropsychiatric Inventory （NPI）. Changes of scores from baseline were outcome measures. Safety was assessed by physical examination, lab assays, ECG and adverse events. Results 74 patients completed the study and were evaluated. Combination therapy group showed a statistically significant improvement compared to the mono- therapy group in the SIB （3.2±5.7 vs 0.2±4.4, P=0.012）, ADCS-ADL19 （0.7±3.9 vs -1.2±3.9, P=0.045）, NPI （-6.9±8.1 vs -2.7±7.0, P=0.018） and total effective rates with CIBIC （52.6% vs 22.2%, P=0.035）. The incidence of adverse events was no significant difference （P=0.757）. Conclusions Memantine significantly improves the cognitive impairment, activities of daily living and behavioral and psychological symptoms of the moderate to severe AD patients while receiving Huperzine A.
出处
《老年医学与保健》
CAS
2011年第3期179-182,共4页
Geriatrics & Health Care
