聚焦临床研究,引领神经科学新风向——2013天坛同际脑血管病会议(TISC2013)现场撷英
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由首都医科大学附属北京天坛医院王拥军教授主持进行的氯吡格雷联合阿司匹林与阿司匹林单独治疗急性非致残性脑血管事件高危人群研究(colopidogrel in high-risk patients with acute non-disabling cerebrovascular events,简称CHANCE研究)该研究已被世界权威医学期刊《新英格兰医学杂志》(NEJM)接受,将于今天在新英格兰杂志发表。
此项研究在今年2月份美国夏威夷举行的2013年国际卒中大会(ISC)上公布后,引起广泛反响,在今天的天坛会正式发布。
这是目前为止,全球最大多中心、随机、双盲、双模拟、平行对照小卒中和TIA临床研究。
CHANCE研究结果显示,在短暂性脑缺血发作(TIA)或小卒中后相对短期应用阿司匹林及氯吡格雷联合治疗在降低卒中复发风险方面优于阿司匹林单独治疗,且并不伴有严重出血并发症风险的显著增加。
这项仅在中国进行的CHANCE研究领先于另一项在美国招募和进行的类似研究,即TIA和卒中血小板定向抑制(POINT)研究。
该研究纳入了5170例患者40岁及以上的TIA或小卒中的患者。
其发病时间在24小时内,被随机分配到两组:阿司匹林(首日负荷剂量为75-300mg,随后75mg/天)加安慰剂治疗组,或相同的阿司匹林剂量加氯吡格雷(首日负荷剂量为300mg,随后75mg/天)治疗组。
双抗治疗组的患者还需要经过21天之后停用阿司匹林,因为与其他亚组人群类似,中国的患者具有相对较高的出血风险。
研究结果表明,同时接受阿司匹林和氯吡格雷双抗治疗的患者卒中复发率更低。
90天随访时,双抗治疗组患者无卒中(包括缺血性和出血性卒中)生存的风险比(HR)为0.68(95%CI,0.57 - 0.81,P <0.001)。
对于联合次要终点事件(卒中,心肌梗死,血管性死亡),HR为0.69(95%CI,0.58 - 0.82,P <0.001)。
聚焦临床研究,引领神经科学新风向盛夏之际,天坛国际脑血管病会议(下简称“天坛会”)于2013年 6月28日至30日在京举行。
全球卒中领军人物汇聚一堂,分享交流难得的经验体会。
记者看到,今年的天坛会再次亮点纷呈:首次正式发布具有国际影响力的大型临床研究成果;首设“天坛卒中研究奖”大奖;学术覆盖面“全而深”,囊括流行病学、神经介入、卒中预防、影像学、比较效果学、医疗质量改进等多领域热点、开设缺血预适应论坛等多个新论坛,深入剖析解读特种性疾病研究硕果。
【chance发布或引发临床研究潮】“预防早期卒中复发的研究始终是一个全球难点。
选择何种药物,适用什么治疗方法,一直未能得到很好的解决。
”2013年6月30日,天坛会创始人、执行主席王拥军教授在会上报告chance(氯吡格雷用于急性非致残性脑血管事件高危人群的疗效研究)及几项亚组研究成果时表示。
据了解,由王拥军教授率领团队牵头的chance项目研究,在国家科技重大专项“脑血管病创新药物临床评价技术平台建立”项目的支持下,共纳入国内114家中心,取得了5170例轻型卒中和短暂性脑缺血发作(tia)患者的有效数据,是迄今为止全球最大的多中心、随机、双盲、双模拟、平行对照轻型卒中和tia的临床研究。
该研究报告已于今年6月26日发表于《新英格兰医学杂志》(nejm)。
该研究结论有:轻型卒中和tia是可以治疗的医学急症;首次证明了使用chance治疗方案(阿司匹林+氯吡格雷,氯吡格雷首剂300mg)可使3个月内卒中再发风险降低32%;chance用药方案是安全的,不增加任何程度的出血时间;有理由推测对轻型卒中和tia存在更积极的治疗方案,但仍需进一步临床研究。
chance研究结果得到了国际主流医学界的认可,树立了中国临床研究在世界医学界的典范形象和信心,突破了我国重大新药创制临床评价的瓶颈,并有可能改写国际医学治疗指南并引领世界卒中治疗方向。
王拥军教授指出,评价一项研究要看效力。
天坛国际脑血管病会议(汇编)目录目录专题讲座你有诊治脑血管病的资格吗?.......................................................................................... 王拥军(1)How are you and your Hospital Qualified for Stroke Care? .................................. Yongjun Wnag(7)脑出血的临床研究热点.................................................................................................... 赵性泉(13)Stroke, CE Group ....................................................................................................... Qinyi Zhang(22)卒中后抑郁诊断及治疗.................................................................................................... 李舜伟(45)Post Stroke Depression---Diagnosis and Treatment ..................................................... L i Shunwei(49)Advances in the Medical Management of Intracerebral Hemorrhage ............... Stephan A. Mayer(53)Cerebrovascular Disease, Carotid Endarterecomy, and Stroke Centers ........... Douglas J Wirthlin(60)Stroke Team ............................................................................................................. James Roberts(70)Treatment for Aphasia ........................................................................................Melody OuYoung(75)卵圆孔未闭(PFO)与脑中风............................................................................. Naidong Wang(83)卵圆孔未闭动物模型的建立........................................................................................ 姜卫剑等(93)Establishment of an animal model of patient foramen ovale in porcine ..... J IANG Weijian,et al.(93)Study on the Secondary Ischemic Injury to ............................................................................... Perihematoma Region in Cerebral Hemorrhage rats .................................... X ing quan Zhao,et al.(94)如何进行脑卒中后的降压管理...................................................................................... 孙宁玲(100)脑卒中与急救.................................................................................................................. 王少石(101)Quantitative evaluation for secondary injury to perihematoma of hypertensive .......................... cerebral hemorrhage by functional MR and correlation analysis .............................................with ischemic factors ............................................................................ X ing quan Zhao,et al.(103)椎动脉开口部动脉粥样硬化性狭窄的血管内支架成形术及近期复查 ...................... 杜彬等(109)Stent-assisted angioplasty and short-term results in atherosclerotic ........................................... vertebral artery ostial stensis ............................................................................... DU Bin,et al.(110)血管性抑郁的概念和应用.............................................................................................. 李焰生(110)阿尔茨海默病的病因及危险因素................................................................................... 王荫华(111)TCD在临床试验中的应用............................................................................................. 黄家星(112)利用卵圆孔未闭动物模型研究Valsalva动作与矛盾性栓塞的关系....................... 姜卫剑等(112)The association of Valsalva maneuvers and paradoxical embolism in animal model ...................with artificial PFO ................................................................................. JIANG Weijian et al.(113)大脑中动脉粥样硬化性狭窄及脑梗塞发病机制.............................................................. 高山(113)干细胞治疗急性脑血管病的最新进展.............................................................................. 徐运(115)The newest progress in treatment of stem cells on stroke ................................................ Xu Yun(116)脑血管病综合防治模式探讨和存在的问题...................................................................... 凌锋(116)颅内静脉和静脉窦血栓形成的治疗.............................................................................. 张婧等(118)脑静脉(窦)血栓的影像学特点与血管内治疗...................................................... 李宝民等(119)实验性脑梗死后内源性神经干细胞活化与神经可塑性 .............................................. 曾进胜(121)颈动脉狭窄成形术中的支架选择.................................................................................. 李宝民(122)Angioplasty with Stent for Symptomatic Intracranial .................................................................. Stenosis Trial (ASSIST-I) .............................................................................. JIANG Weijian(123)高龄颈动脉狭窄的血管内支架成形治疗.................................................................. 李宝民等(124)颅外颈动脉狭窄支架成形术的常见并发症与对策 .................................................. 刘建民等(125)脑卒中应重视一级预防.................................................................................................. 王文志(126)Pay more attention to primary prevention of stroke ............................................... 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短期双联抗血小板可降低卒中风险日期:2013-02-27来源:医师报作者:我要分享 | 0Goldstein表示,短期双联抗血小板未增加出血事件风险“着实令人鼓舞”,因为出血是亚洲人群主要担忧的问题。
我国首都医科大学附属北京天坛医院王拥军教授在2013年国际卒中大会(ISC)报告的CHANCE研究显示,对于短暂性脑缺血发作(TIA)或急性轻症卒中(minor stroke)高危患者,与阿司匹林单用相比,症状发作24 h内联用阿司匹林与氯吡格雷3个月可显著降低新发卒中风险,而大出血风险并未增加。
(ISC 2013,摘要号LB11)CHANCE研究为一项双盲、安慰剂对照、多中心研究,纳入我国5170例症状发作24 h内的轻症卒中(入组时NIHSS评分≤3分)或高危TIA(ABCD2评分≥4分)患者,随机分入阿司匹林(75 mg/d,共应用21 d)+氯吡格雷(负荷剂量300 mg,此后75 mg/d)双联抗血小板治疗组或阿司匹林(负荷剂量75~300 mg,此后75 mg/d)+安慰剂治疗组,共治疗3个月。
结果显示,与对照组相比,双联抗血小板治疗组90 d无卒中生存率明显升高(HR=0.68,P<0.001,图1),无次要终点事件(卒中、心肌梗死和心血管死亡)生存率也较高(HR=0.69,P<0.001)。
两组中出血性卒中发生率相似,均为0.3%,严重出血事件发生率均为0.2%;尽管双联抗血小板治疗组的轻微出血事件发生率相对较高(1.2% 与 0.7%),但多为鼻出血。
评论主要研究者之一、美国加州大学S. Claiborne Johnston教授表示,中国的卒中发生率很高,因此CHANCE研究具有非常重要的意义,对全球的公共卫生将产生较大的影响。
美国杜克大学Larry B. Goldstein在对该研究进行评论时指出,该研究结果非常有用,可能会改变目前的临床实践。
他认为,该研究的关键点在于短期联用阿司匹林和氯吡格雷,因为SPS3研究和MATCH研究均发现,长期双联抗血小板治疗可致大出血风险增加。