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银杏叶提取物治疗急性脑缺血的双盲安慰剂对照试验。

A double blind placebo controlled trial of ginkgo biloba extract in acute cerebral ischaemia.

作者信息

Garg R K, Nag D, Agrawal A

机构信息

Dept of Neurology, K G's Medical College, Lucknow.

出版信息

J Assoc Physicians India. 1995 Nov;43(11):760-3.

PMID:8773035
Abstract

A double blind placebo controlled trial was conducted in 55 patients of acute ischaemic stroke. Twenty one and twenty six patients were randomly allotted in group A and group B respectively. In group A, the patients received 40 mg Ginkgo biloba extract at 6 hourly intervals along with routine management. The placebo tablets were dispensed in the tablet form of same size, shape and colour and were given in the same way. After the patients were subjected to computerized tomographic (CT) scan to confirm acute ischaemic infarction, they were assessed on Mathew's scale and reassessed, at 2 weeks and 4 weeks of drug/placebo administration. Both groups showed significant improvement in Mathew's scale score after 2 weeks and 4 weeks. The difference in degree of change was negligible (p > 0.05) in either group. Estimation of relative changes of neurological deficit based on baseline values also showed negligible (p > 0.05) difference. A trial of Ginkgo biloba extract within 6 hours of stroke in a larger dose and in larger sample could be beneficial clinically in patients of cerebral ischaemic infarct, and needs further study. The usefulness of the plant extract has been demonstrated clinically and experimentally in more than 40 trials of chronic cerebral ischaemia, done elsewhere. This was not evident in our study as our study group was different (more than 48 hours after stroke). There appears to be no contraindication or adverse effect of this medication (Ginkgo biloba) in acute ischaemic stroke.

摘要

对55例急性缺血性中风患者进行了一项双盲安慰剂对照试验。分别将21例和26例患者随机分配到A组和B组。A组患者在接受常规治疗的同时,每隔6小时服用40毫克银杏叶提取物。安慰剂片剂的大小、形状和颜色与药物片剂相同,并以相同方式给药。在患者接受计算机断层扫描(CT)以确认急性缺血性梗死之后,根据马修量表进行评估,并在给药/服用安慰剂2周和4周后重新评估。两组在2周和4周后马修量表评分均有显著改善。两组变化程度的差异可忽略不计(p>0.05)。基于基线值对神经功能缺损相对变化的评估也显示差异可忽略不计(p>0.05)。对更大剂量和更大样本的中风患者在6小时内使用银杏叶提取物进行试验,可能对脑缺血性梗死患者具有临床益处,需要进一步研究。在其他地方进行的40多项慢性脑缺血试验中,已在临床和实验上证明了这种植物提取物的有效性。在我们的研究中这并不明显,因为我们的研究组不同(中风后超过48小时)。这种药物(银杏叶)在急性缺血性中风中似乎没有禁忌证或不良反应。

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