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石杉碱甲治疗阿尔茨海默病的有效性和安全性的多中心双盲随机对照试验 被引量:66

Clinical efficacy and safety of huperzine A in treatment of mild to moderate Alzheimer disease, a placebo-controlled, double-blind, randomized trial
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摘要 目的 与安慰剂双盲对照评估石杉碱甲治疗轻、中度阿尔茨海默病 (AD)患者的临床疗效和安全性。方法 来自全国 15个中心 2 0 2例可能或很可能的AD患者随机接受石杉碱甲或安慰剂治疗 12周。石杉碱甲组 10 0例 ,4 0 0 μg d ,安慰剂组 10 2例 ,每 6周评估 1次。 结果  2 0 2例患者进入意向性治疗分析 ,其中 197例患者通过末次观察前推法 (LOCF)完成统计。比较石杉碱甲组和安慰剂组各种疗效评估量表的评分自基线水平至治疗 6周和 12周时评分变化的均值 ,以及治疗 12周时评分和基线相比有改善的患者的比例 :治疗 12周和基线相比 ,简易精神状态检查 (MMSE)平均改善 2 7分 ;AD评估量表的认知分量表 (ADAS Cog)得分平均改善 4 6分 ,改善至少 4分者 5 6 1% ;ADAS非认知副表 (ADAS non Cog)得分平均改善 1 5分 ,临床好转的患者为 5 9 2 % ;日常生活活动量表 (ADL)得分平均改善 2 4分 ,改善至少 10 %的患者 32 7% ;印象变化量表 (CIBICplus)获 1~ 3分的患者为 70 % ,1~ 2分者 2 7 8%。这些指标和安慰剂组比较 ,两组间的差异有显著意义。总的不良反应率石杉碱甲组为 3% ,均为轻度、一过性反应。结论 石杉碱甲可显著改善AD患者认知功能、行为和心境障碍、日常生活活动能力和总体功能 ,具有良好的安全性。 Objective To evaluate the clinical efficacy and safety of huperzine A in treatment of patients with mild to moderate Alzheimer disease (AD). Methods Two hundred and two patients with the diagnosis of possible or probable AD from 15 centers the nationwide were randomly divided into two groups: huperzine A group ( n =100, given huperzine A 400 μg/day for 12 weeks) and placebo group ( n =102). Different scales were used to evaluate the cognitive function, activity of daily life (ADL), non cognitive disorders, and overall clinical efficacy. Safety evaluation was conducted every 6 weeks. Results In comparison with the baseline data, there was an improvement of 4.6 points in cognition assessed by ADAS Cog ( P =0.000); an imprevement of 2.7 points by MMSE ( P =0.000), an improvement of 1.5 points in behavior and mood by ADAS non Cog ( P =0.008) with 59.2% of the patients being on the mend clinically; and an improvement of 2.4 points by ADL ( P =0.001) with the capacity of ADL improved by at least 10% among 32.75% of the patients. 70% of the patients in huperzine A group scored 1~3 points, and 27.8% of them scored 1~2 points by CIBIC plus. The proportions of patients with an improvement of ≥4 points by ADAS Cog were 56.1% and 12.5% in the huperzine A group and placebo group respectively ( P =0 000). The proportions of patients with an improvement of ≥4 points by MMSE were 37 8% and 10 1% in the huperzine A group and placebo group respectively ( P =0 000). The proportions of patients with an improvement of 1~3 points in global rating by CIBIC plus were 59 2% and 40 6% in the huperzine A group and placebo group respectively ( P =0 01). The proportions of patients with an improvement of ≥10% points by ADL were 32 7% and 17 2% in the huperzine A group and placebo group respectively ( P =0 01). The proportions of patients with an improvement of >0 points by ADS non C0g were 70 0% and 36 3% in the huperzine A group and placebo group respectively ( P =0 000). Mild and transient adverse events (edema of bilateral ankles and insomnia) were observed in 3% of huperzine A treated patients. Conclusion A safe and effective medicine, huperzine A remarkably improves the cognition, behavior, ADL,and mood of AD patients.
出处 《中华医学杂志》 CAS CSCD 北大核心 2002年第14期941-944,共4页 National Medical Journal of China
基金 CMB基金资助项目 (99 699)
关键词 阿尔茨海默病 石杉碱甲 对照临床试验 治疗 Alzheimer′s disease Huperzine A Controlled clinical trials,randomized
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