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三七提取物(三七通舒)治疗缺血性脑卒中的随机对照研究。

Radix/rhizoma notoginseng extract (sanchitongtshu) for ischemic stroke: a randomized controlled study.

机构信息

Department of Neurology, West China Hospital of Sichuan University, PR China.

出版信息

Phytomedicine. 2011 Apr 15;18(6):437-42. doi: 10.1016/j.phymed.2010.10.004. Epub 2010 Nov 19.

DOI:10.1016/j.phymed.2010.10.004
PMID:21094030
Abstract

Agents of sanchi have been widely used as a complementary medicine for stroke in China. Sanchitongshu is a new Chinese patent medicine extracted from sanchi which has stronger anti-platelet activity than other agents of sanchi. Our aim was to investigate the synergistic action of low dose of aspirin combined with sanchitongshu capsule in the treatment of patients with light and moderate ischemic stroke in acute and subacute stages. This was a multi-center, double-blinded, randomized controlled clinical trial conducted in four hospitals in China from July 2004 to 2006. 140 patients of ischemic stroke in anterior cerebral circulation within 30 days of onset were enrolled. Participants were assigned either to receive aspirin (50mg per day) and sanchitongshu capsule (200mg three times a day) or aspirin (50mg per day) and placebo capsule. Low dose of aspirin combined with sanchitongshu capsule significantly ameliorated neurological deficit (increased score of ESS: t=-5.02, p<0.0001) and activities of daily living (increased score of BI: t=-2.4, p=0.0178) after treatment compared with aspirin alone. Adverse reaction which occurred equally in both arms, was light to moderate and disappeared without special treatment. Sanchitongshu capsule, as a complementary medicine to aspirin, was effective in improving outcomes after ischemic stroke. It was a safe drug in our trial.

摘要

在中国,三七制剂被广泛用作中风的辅助治疗药物。三芪通舒胶囊是从三七中提取的一种新的中药,其抗血小板活性强于其他三七制剂。我们的目的是研究小剂量阿司匹林与三芪通舒胶囊联合治疗急性和亚急性期轻中度缺血性脑卒中患者的协同作用。这是一项多中心、双盲、随机对照临床试验,于 2004 年 7 月至 2006 年在中国的 4 家医院进行。纳入发病后 30 天内的前循环缺血性脑卒中患者 140 例。参与者被分配接受阿司匹林(每天 50mg)和三芪通舒胶囊(每天 3 次,每次 200mg)或阿司匹林(每天 50mg)和安慰剂胶囊。与单独使用阿司匹林相比,小剂量阿司匹林联合三芪通舒胶囊治疗后明显改善了神经功能缺损(ESS 评分增加:t=-5.02,p<0.0001)和日常生活活动能力(BI 评分增加:t=-2.4,p=0.0178)。两种治疗方案都出现了不良反应,程度较轻且无需特殊治疗即可缓解。三芪通舒胶囊作为阿司匹林的辅助治疗药物,能有效改善缺血性脑卒中后的结局。在我们的试验中,它是一种安全的药物。

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