| Ginsenoside-Rd improves outcome of acute ischaemic stroke - a randomized, double-blind, placebo-controlled, multicenter trial. | |
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MedLine Citation:
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PMID: 22233205 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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Background and purpose: Ginsenoside-Rd is a receptor-operated calcium channel antagonist and has shown promise as a neuroprotectant in our phase II study. As an extended work, we sought to confirm its efficacy and safety of Ginsenoside-Rd in patients with acute ischaemic stroke. Methods: We conducted a randomized, double-blind, placebo-controlled trial involving 390 patients with acute ischaemic stroke in a 3:1 ratio to receive a 14-day intravenous infusion of Ginsenoside-Rd or placebo within 72 h after the onset of stroke. Our primary end-point was the distribution of disability scores on the modified Rankin scale (mRs) at 90 days. Results: The efficacy analysis was based on 386 patients (Ginsenoside-Rd group: 290; placebo group: 96). Ginsenoside-Rd significantly improved the overall distribution of scores on the mRs, as compared with the placebo (P = 0.02; odds ratios [OR], 1.74; 95% confidence interval [CI], 1.08-2.78). There were significant differences between the two groups when we categorized the scores into 0-1 vs. 2-5 (P = 0.01; OR, 2.32; 95% CI, 1.23-4.38; 66.8% vs. 53.1%). It also improved the National Institutes of Health Stroke Scale (NIHSS) at 15 days [P < 0.01; least squares mean (LSM), -0.77; 95% CI, -1.31 to -0.24]. Mortality and rates of adverse events were similar in the two groups. Conclusions: Ginsenoside-Rd improved the primary outcome of acute ischaemic stroke and had an acceptable adverse-event profile. |
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Authors:
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X Liu; L Wang; A Wen; J Yang; Y Yan; Y Song; X Liu; H Ren; Y Wu; Z Li; W Chen; Y Xu; L Li; J Xia; G Zhao |
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Publication Detail:
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Type: JOURNAL ARTICLE Date: 2012-1-10 |
Journal Detail:
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Title: European journal of neurology : the official journal of the European Federation of Neurological Societies Volume: - ISSN: 1468-1331 ISO Abbreviation: - Publication Date: 2012 Jan |
Date Detail:
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Created Date: 2012-1-11 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 9506311 Medline TA: Eur J Neurol Country: - |
Other Details:
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Languages: ENG Pagination: - Citation Subset: - |
Copyright Information:
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© 2012 The Author(s). European Journal of Neurology © 2012 EFNS. |
Affiliation:
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Department of Neurology, Xijing Hospital, Xi'an Department of Statistics, Fourth Military Medical University, Xi'an Department of Pharmacy, Xijing Hospital, Xi'an Department of Neurology, Lanzhou Military Command General Hospital, Lanzhou Department of Neurology, The First Affiliated Hospital of Chongqing University of Medical Sciences, Chongqing Department of Neurology, The First Hospital of Shaanxi province, Xi'an Department of Neurology, Nanjing Military Command General Hospital, Nanjing Department of Neurology, The First Affiliated Hospital of Kunming Medical College, Kunming Department of Neurology, The First Affiliated Hospital of Nanchang University, Nanchang Department of Neurology, School of Medicine of Xi'an Jiaotong University, Xi'an Department of Neurology, Wuhan General Hospital of Guangzhou Military Command, Wuhan Department of Neurology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China. |
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