银杏叶提取物改善急性缺血性脑卒中的认知和神经功能：一项随机对照试验。

Ginkgo biloba extract improved cognitive and neurological functions of acute ischaemic stroke: a randomised controlled trial.

机构信息

Department of Neurology, Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, China.

The State Key Laboratory of Pharmaceutical Biotechnology, Nanjing University, Nanjing, China.

出版信息

Stroke Vasc Neurol. 2017 Dec 18;2(4):189-197. doi: 10.1136/svn-2017-000104. eCollection 2017 Dec.

PURPOSE

To evaluate the efficacy and safety of Ginkgo biloba extract (GBE) in acute ischaemic stroke and its impact on the recurrence of vascular events.

METHODS

We conducted a multicentre, prospective, randomised, open label, blinded, controlled clinical trial enrollingpatients with an onset of acute stroke within 7 days from five hospitals in China Jiangsu Province. Participants were assigned to the GBE group (450 mg GBE with 100 mg aspirin daily) or the control group (100 mg aspirin daily) for 6 months. The primary outcome was the decline in the Montreal Cognitive Assessment score at 6 months. Secondary outcomes were other neuropsychological tests of cognitive and neurological function, the the incidence of adverse events and vascular events.

RESULTS

348 patients were enrolled: 179 in the GBE group and 169 in the control group. With 18 patients lost to follow-up, the dropout rate was 5.17%. Admission data between two groups were similar, but in the GBE group there was a marked slow down in the decline in the Montreal Cognitive Assessment scores (-2.77±0.21 vs -1.99±0.23, P=0.0116 (30 days); -3.34±0.24 vs -2.48±0.26, P=0.0165 (90 days); -4.00±0.26 vs -2.71±0.26, P=0.0004 (180 days)) compared with controls. The National Institutes of Health Stroke Scale scores at 12 and 30 days, the modified Rankin Scale scores for independent rate at 30, 90 and 180 days, and the Barthel Index scores at 30, 90 and 180 days in the GBE group were significantly improved compared with controls. Improvements were also observedin GBE groups for Mini-Metal State Examination scores of 30, 90 and 180 days, Webster's digit symbol test scores at 30 days and Executive Dysfunction Index scores at 30 and 180 days. No significant differences were seen in the incidence of adverse events or vascular events.

CONCLUSIONS

We conclude that GBE in combination with aspirin treatment alleviated cognitive and neurological deficits after acute ischaemic stroke without increasing the incidence of vascular events.

TRIAL REGISTRATION NUMBER

ChiCTR-TRC-12002688.

目的

评估银杏叶提取物（GBE）在急性缺血性脑卒中中的疗效和安全性及其对血管事件复发的影响。

方法

我们在中国江苏省的五家医院进行了一项多中心、前瞻性、随机、开放标签、盲法、对照临床试验，招募了发病 7 天内的急性脑卒中患者。将患者分配至 GBE 组（每天给予 450mg GBE 和 100mg 阿司匹林）或对照组（每天给予 100mg 阿司匹林），疗程为 6 个月。主要结局是 6 个月时蒙特利尔认知评估评分的下降。次要结局是认知和神经功能的其他神经心理学测试、不良事件和血管事件的发生率。

结果

共纳入 348 例患者：GBE 组 179 例，对照组 169 例。18 例患者失访，失访率为 5.17%。两组入院数据相似，但 GBE 组蒙特利尔认知评估评分的下降速度明显较慢（-2.77±0.21 比-1.99±0.23，P=0.0116（30 天）；-3.34±0.24 比-2.48±0.26，P=0.0165（90 天）；-4.00±0.26 比-2.71±0.26，P=0.0004（180 天））。与对照组相比，GBE 组 12 天和 30 天的美国国立卫生研究院卒中量表评分、30、90 和 180 天的改良 Rankin 量表评分独立率、30、90 和 180 天的巴氏指数评分均明显改善。GBE 组 30、90 和 180 天的简易精神状态检查评分、30 天的韦伯斯特数字符号测试评分和 30 和 180 天的执行功能指数评分也有改善。不良事件或血管事件的发生率无显著差异。