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[北京某社区金思脑丸治疗轻度认知障碍老年人记忆障碍的随机单盲对照随访研究]

[A follow-up study on a randomized, single-blind control of King's Brain pills in treatment of memory disorder in elderly people with MCI in a Beijing community].

作者信息

Tian Jin-zhou, Zhu Ai-hua, Zhong Jian

机构信息

Dongzhimen Hospital Beijing University of Chinese Medicine, Beijing 100700, China.

出版信息

Zhongguo Zhong Yao Za Zhi. 2003 Oct;28(10):987-91.

PMID:15620194
Abstract

OBJECTIVE

To evaluate the effect of King's Brain pills (Compound Chinese ginseng extract from herbs) on the treatment and the delaying of memory decline in the elderly with mild cognitive impairment (MCI) in a community by a year follow-up of neuropsychology.

METHOD

75 patients with MCI were selected from Beixinqiao community of Beijing by a cutoff score of 0.0/0.5 on CDR and were randomly assigned into a treatment group (n = 30 cases), given 4 pills of a compound Chinese ginseng extract (King's Brain) with 2 placebo tablets, and a positive control group (n = 30 cases), given 2 tablets of Piracetam with 4 placebo tablets, as well as a placebo group (n = 15 cases), given a placebo of 4 tablets and 2 pills. All subjects took this medication 3 times a day for 3 months. Single-blind and double-moulding control were used in this study. At a baseline and a middlepoint (after 3 months), and a follow-up end (one year later) following a three months of medication therapeutics, all subjects were assessed using a battery consisting of MMSE and 5 memory items on BNPT battery.

RESULT

In the treatment group, MMSE score 27.50 +/- 1.68 was increased to 28.27 +/- 1.70 after 3 months but decreased to 26.90 +/- 1.90 after one year of the treatment. However, the latter score was higher than that in a placebo group 26.33 +/- 1.03 (P < 0.05). Verbal Learning Test score was significantly increased from 68.73 +/- 28.74 at baseline to 87.33 +/- 29.78 at follow-up point in the treatment group, which was significantly higher than that in the placebo group (P < 0.01). The total score of memory items on BNPT battery was significantly increased from 78.23 +/- 28.98 at baseline to 93.53 +/- 35.56 at follow-up point in the treatment group, higher than that in Piracetam group (P < 0.05) and the placebo group (P < 0.01).

CONCLUSION

Both King's Brain spills and piracetam tablets have protective effect on cognitive and memory decline in elderly with MCI.

摘要

目的

通过对社区中轻度认知障碍(MCI)老年人进行为期一年的神经心理学随访,评估健脑丸(复方中药人参提取物)对其治疗及延缓记忆衰退的效果。

方法

从北京北新桥社区选取75例MCI患者,以CDR评分为0.0/0.5作为入选标准,将其随机分为治疗组(n = 30例),给予4粒复方中药人参提取物(健脑丸)加2片安慰剂;阳性对照组(n = 30例),给予2片吡拉西坦加4片安慰剂;安慰剂组(n = 15例),给予4片安慰剂加2粒药丸。所有受试者每日服药3次,共3个月。本研究采用单盲双模拟对照。在基线、中点(3个月后)以及3个月药物治疗后的随访终点(1年后),使用由MMSE和BNPT量表上的5个记忆项目组成的测评工具对所有受试者进行评估。

结果

治疗组MMSE评分在3个月后从27.50±1.68提高到28.27±1.70,但治疗1年后降至26.90±1.90。然而,后者的评分高于安慰剂组的26.33±1.03(P < 0.05)。治疗组言语学习测验评分从基线时的68.73±28.74显著提高到随访时的87.33±29.78,显著高于安慰剂组(P < 0.01)。治疗组BNPT量表记忆项目总分从基线时的78.23±28.98显著提高到随访时的93.53±35.56,高于吡拉西坦组(P < 0.05)和安慰剂组(P < 0.01)。

结论

健脑丸和吡拉西坦片对MCI老年人的认知和记忆衰退均有保护作用。

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