卡巴拉汀治疗阿尔茨海默病患者的临床研究

The treatment by using rivastigmine for patients with Alzheimer disease: results of a multicenter,randomized,open-labeled,controlled clinical trial

目的 评价卡巴拉汀治疗中国轻中度阿尔茨海默病 (AD)患者的有效性和安全性。方法 多中心、随机、开放、对照试验。共有 12 4例 5 0岁以上轻中度AD患者 ,简易精神状态检查表(MMSE)得分在 10～ 2 6分之间 ,并随机分为两组 (卡巴拉汀组和多奈哌齐组各 62例 )。治疗时间 16周。疗效评价使用MMSE量表、Blessed Roth量表和总体衰退量表 (GDS) ,在筛查和 16周末进行。用Hachinski缺血积分量表鉴别AD和血管性痴呆 (VD)。安全性检查包括生命体征、实验室及心电图检查 ,每 4周 1次。结果 两组的人口统计学有可比性 (P >0 0 5 )。两组MMSE、GDS和Blessed Roth评分均有显著改善 (P <0 0 1)。Blessed Roth分值自身对比发现卡巴拉汀组显著改善日常生活能力 (P <0 0 1) ;治疗前后的差值比较也发现卡巴拉汀组在社会活动能力方面稍优于多奈哌齐组 (P =0 0 5 92 )。其他量表指标两组间差异无显著意义 (P >0 0 5 )。总的不良反应率在 12 9%～ 2 8 8%之间 ,两组间无显著差异。药物对病人生命体征及实验室指标无影响。结论 卡巴拉汀可显著改善AD患者的临床症状、且安全性和耐受性良好 ,是AD治疗的理想药物之一。

Objective To evaluate the efficacy and safety of rivastigmine in treating Chinese patients with mild to moderate Alzheimer's disease. Methods A multicenter,randomized,open labeled,controlled clinical trial was conducted In this trial,124 patients with mild to moderate Alzheimer's disease,aged 50 years or more,scored 10 to 26 on MMSE were enrolled They were assigned to two groups randomly,62 in rivastigmine group and 62 in donepezil group Efficacy was assessed on basis of scores on MMSE,Blessed Roth scale and GDS,at the baseline and at the end of week 16 AD was set to be differentiated from VD by using Hachinski Ischemic Scale Safety was assessed according to vital signs,laboratory test and ECG,once per four weeks. Results Two groups were comparable on demography ( P >0 05) After treatment the scores of the two groups on MMSE,GDS and Blessed Roth Scale were all improved significantly ( P <0 01) By self contrast of the subitems scores on Blessed Roth Scale it revealed rivastigmine could improve the activity of daily life ( P <0 01),but Donepezil couldn't ( P >0 05) With the variances between pre and post treatment comparison,it revealed that rivastigmine had a little better than Donepezil in improving social activity ( P =0 0592) There was no significant difference between the two groups in other indexes of the scales ( P >0 05) The overall incidence of adverse effects was between 12 9% and 28 8% There were no significant differences between these two groups Rivastigmine had no influence on vital signs and laboratory indexes Conclusion Rivastigmine may significantly improve the symptoms of the patient with AD and have a good safety and tolerability,being an ideal choice in treating AD