银杏叶治疗血管性认知障碍的疗效和安全性

The efficacy and safety of ginkgo biloba for the treatment of vascular cognitive impairment

目的探索银杏叶提取物治疗血管性认知障碍(VCI)的患者中的疗效和安全性。方法 VCI患者90例,平均年龄(67.1±8.0)岁,59例女性患者(1:1:1),在6个月的时间内分别接受120mg·d^(-1)和60mg·d^(-1)银杏叶或安慰剂。对功效指标进行评估,包括神经心理测试评分和经颅多普勒超声检查。安全性评估包括实验室检查,不良反应和临床检查。结果与安慰剂相比,120mg·d^(-1)和60mg·d^(-1)的银杏叶仅在临床总体印象评分中(2.6±0.8 vs 3.1±0.7 vs 2.8±0.7;P=0.038)差异有统计学意义。临床总体印象评分显示,与银杏叶组相比,安慰剂组(-0.3±0.5;P=0.021)基线值显着下降。经颅多普勒超声检查的结果无明显差异。安慰剂组(16例)的不良反应显著高于两个银杏叶提取物组(分别为8例和9例),实验室检查和临床检查显示接受银杏叶提取物组和安慰剂组之间无差异。结论银杏叶减缓了VCI患者的认知功能恶化,但其效果仅在四项神经(MDRS,CGI,SCAG和MMSE)心理测试中显示。然而,由于这种轻微的效果与一些不良反应的共同存在,本文不能证明它是无效的或不安全,仍然需要进一步的研究来提供银杏提取物的功效和安全性的明确证据。

Objective To determine the efficacy and safety of ginkgo biloba extract in patients diagnosed with vascular cognitive impairment （ VCI ） . Method A total of ninety patients （ aged 67.1 ±8.0 years and fifty- nine women ） were randomly assigned to receive 120mg · d-1 and 60mg · d-1 of ginkgo biloba or placebo in 6 months, respectively （ 1：1：1 ） . Evaluation of efficacy indicators, including neuropsychological test scores and transcranial Doppler uhrasound. Safety assessment includes laboratory tests, adverse reactions and clinical examinations. Results Compared with placebo, 120mg ~ d-1 and 60mg · d-1 of ginkgo biloba were statistically significant differences only in the clinical overall impression score （ 2.6±0.8 vs 3.1 ± 0.7 vs 2.8 ± 0.7; P=0.038 ） . The overall impression score showed a significant decrease in baseline values in the placebo group （ -0.3 ± 0.5; P=0.021 ） compared with the ginkgo biloba group. There was no significant difference in transcranial Doppler uhrasonography. The adverse effects of the placebo group （ 16 subjects ） were significantly higher than that of the two ginkgo biloba extract groups （ 8 and 9 subjects, respectively ） , laboratory tests and clinical examinations showed acceptance of Ginkgo biloba extract and comfort There was no difference between the groups. Conclusion Ginkgo biloba slows the deterioration of cognitive function in patients with VCI, but the effect is only shown in the psychological tests of the four neurons （ MDRS, CGI, SCAG and MMSE ） . However, due to the coexistence of this slight effect with some adverse reactions, we can not prove that it is ineffective or insecure and still needs further research to provide clear evidence of the efficacy and safety of ginkgo biloba extract.