Liu X, Xia J, Wang L, Song Y, Yang J, Yan Y, Ren H, Zhao G
Department of Neurology, Xijing Hospital, Fourth Millitary Medical University, Xi'an, Shaanxi, China.
Eur J Neurol. 2009 May;16(5):569-75. doi: 10.1111/j.1468-1331.2009.02534.x. Epub 2009 Feb 19.
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.
人参皂苷-Rd是一种选择性竞争性Ca2+受体拮抗剂。开展了一项II期随机、双盲、安慰剂对照、多中心研究，以检验人参皂苷-Rd治疗急性缺血性脑卒中患者的疗效和安全性。
总共199例患者被等比例随机分组，分别接受为期14天的安慰剂输注（B组）、10 mg人参皂苷-Rd（A组）或20 mg人参皂苷-Rd（C组）。主要终点为15天时的美国国立卫生研究院卒中量表（NIHSS）评分。次要终点为8天时的NIHSS评分和巴氏指数、15天及90天时的巴氏指数和改良Rankin量表。安全性终点包括严重和非严重不良事件、实验室检查值和生命体征。分析采用意向性治疗。
对于主要研究结果，三组在15天时的NIHSS评分存在显著差异（P = 0.0003）。比较A组与B组以及B组与C组，NIHSS平均值的差异具有统计学意义（分别为P = 0.0004，P = 0.0009）。A组与C组之间无显著差异（P = 0.9640）。对于次要研究结果，人参皂苷-Rd未改善神经功能。三组中严重和非严重不良事件的发生率相似。
人参皂苷-Rd可能对急性缺血性脑卒中具有一定益处。
Zotero 插件