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Efficacy and safety of ginsenoside-Rd for acute ischaemic stroke: a randomized, double-blind, placebo-controlled, phase II multicenter trial

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机构: [1]Department of Neurology, Xijing Hospital, China [2]Department of Statistics, Fourth Military Medical University, Xi'an, Shaanxi, China [3]Department of Neurology, First Hospital of Shaanxi province, Shaanxi, China [4]Department of Neurology, Lanzhou Military Command General Hospital, Gansu, China [5]Department of Neurology, First Affiliated Hospital of Chongqing University of Medical Sciences, Chongqing, China [6]Department of Neurology, First Affilliated Hospital of Kunming Medical College, Yunnan, China
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关键词: ginsenoside-Rd ischaemic stroke randomized trial

摘要:
Ginsenoside-Rd is a selective competitive Ca2+ receptor antagonist. A phase II randomized, double-blind, placebo-controlled, multicenter study was conducted to examine the efficacy and safety of ginsenoside-Rd in patients with acute ischaemic stroke. A total of 199 patients were randomized equally to receive a 14-day infusion of placebo (group B), ginsenoside-Rd 10 mg (group A) or ginsenoside-Rd 20 mg (group C). Primary end-points were National Institutes of Health Stroke Scale (NIHSS) scores at 15 days. Secondary end-points were NIHSS scores and the Barthel Index at 8 days, the Barthel Index and the modified Rankin scale at 15 days and 90 days. The safety end-points included serious and non-serious adverse events, laboratory values and vital signs. Analysis was by intention to treat. For the primary study outcome, there is significant difference amongst the three groups at 15 days in NIHSS scores (P = 0.0003). Comparing group A with B and group B with C, the difference in the mean for NIHSS was significant in statistics (P = 0.0004, P = 0.0009 respectively). This is no significant difference between group A and C (P = 0.9640). For the secondary study outcome, ginsenoside-Rd did not improve neurological functioning. Incidence of serious and non-serious adverse events was similar amongst the three groups. Ginsenoside-Rd may be of some benefit in acute ischaemic stroke.

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出版当年[2010]版:
大类 | 3 区 医学
小类 | 3 区 临床神经病学 4 区 神经科学
最新[2023]版:
大类 | 2 区 医学
小类 | 2 区 神经科学 3 区 临床神经病学
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出版当年[2009]版:
Q2 CLINICAL NEUROLOGY Q3 NEUROSCIENCES
最新[2023]版:
Q1 CLINICAL NEUROLOGY Q1 NEUROSCIENCES

影响因子: 最新[2023版] 最新五年平均 出版当年[2009版] 出版当年五年平均 出版前一年[2008版] 出版后一年[2010版]

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第一作者机构: [1]Department of Neurology, Xijing Hospital, China
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通讯机构: [*1]Department of Neurology, Xijing Hospital, Fourth Military Medical University, No.17, Chang Le Road, Shaanxi Province, Xian 710032, China
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