加兰他敏片治疗阿尔采末病的多中心、随机双盲评价

Evaluation of galantamine in treatme nt of Alzheimer's disease: a multicenter,randomized,double-blind study

目的 :验证加兰他敏治疗轻、中度阿尔采末病 (AD)的疗效和不良反应。方法 :轻中度AD病人97例 ,其中 4 7例 [男性 2 1例 ,女性 2 6例 ,年龄 (72±s 6 )a],用加兰他敏 1片 ,po ,tid。另外 5 0例 [男性 2 7例 ,女性 2 3例 ,年龄 (71± 6 )a],用安慰剂 ,开始 1片 ,po ,tid。 2组治疗 1wk后 ,分别加至 2片 ,po ,tid。疗程为 8wk。以精神状态判断量表作疗效判断。结果 :加兰他敏组总有效率 5 3% ,安慰剂组为 18% ,加兰他敏组不良反应主要为胃肠道反应 ,多为恶心 ,呕吐等。结论 :加兰他敏组在认知功能、总体疗效等方面改善率均显著高于安慰剂组 ,对轻。

AIM: To evaluate the clinical effects and adverse reactions of galantamine in treating mild to moderate Alzheimer's disease (AD). METHODS: ninety seven patients with mild to modrate AD were divid into two groups. Forty seven(M 21, F 26; age (72± s 6) a) were treated with galantamine, initiate one tablet (5 mg), po , tid. while fifty patients (F 27,M 23; age(71±6) a) were treated with placebo initiate one tablet, po , tid. After 1 wk treatment. The doses of both groups were augmented to two tablets, po , bid, for 8 wk. Before and after treatment, data on the various psychiatric rating scales were examined for all patients. RESULTS: The overall clinical effective rate was 53 % in galantamine group, and 18 % in placebo group respectively. There was a significant difference between the two groups ( P <0.01). Adverse reactions of glanatamine group involved mainly the gastric intestinal system, including nause,vomiting,etc. CONCLUSION: Galantamine group has a much higher rate of improvement in cognitive function and total clinical effect than the placebo group, and without serious adverse reactions. Hence, galantamine can be considered effective and safe in treating mild to moderate AD patients.