CSA&TISC 2022:再看CAPITAL研究,中医药为抗动脉粥样硬化增添新证据

2022-08-10 MedSci原创 MedSci原创

2020年1月10日,由通心络胶囊、参松养心胶囊、芪苈强心胶囊系列循证医学研究为主的“中医脉络学说构建及其指导微血管病变防治”项目更是荣获了2019年度生命科学领域唯一一项国家科技进步一等奖。

      脑卒中是全世界面临的健康问题,是全球致残的主要原因,也是全球第二大死因。近年来,中国脑血管病事业发展迅速,在新时代下,进一步提升中国卒中防治质量,探索适合中国国情的脑血管病管理模式势在必行。

      2022年8月5日-7日,由中国卒中学会、国家神经系统疾病医疗质量控制中心、美国心脏学会/美国卒中学会等组织联合主办的中国卒中学会第八届学术年会暨天坛国际脑血管病会议2022(CSA & TISC 2022)采用线下+线上的会议形式隆重召开。国内外脑血管病专家相聚,共同为脑血管病防治事业的发展献计献策。

      与会专家分享交流脑血管领域多项热点亮点内容,分享交流行业新技术、新理念、新研究,推动医疗技术进步。8月6日,在大会的主会场,中国工程院院士、山东大学齐鲁医院张运教授系统回顾了CAPITAL研究,解读了通心络胶囊干预动脉粥样硬化、防治心脑血管病的疗效和优势。

山东大学齐鲁医院张运院士

      

       抗动脉粥样硬化疗效受阻,临床亟需创新药物破解困局

      他汀类药物对于动脉粥样硬化(AS)心血管事件的一级和二级预防具有良好疗效,是抗AS治疗的基石。然而即使采用高强度的他汀类药物治疗,仍有部分动脉粥样硬化性心血管疾病(ASCVD)高危患者,存在心血管事件的残余风险。

      张运院士介绍,有研究显示,他汀类药物剂量加倍后低密度脂蛋白胆固醇(LDL-C)水平仅降低6%,且长期大剂量他汀治疗可导致新发糖尿病、肝功能损伤等不良反应。除他汀以外,肠道胆固醇吸收抑制剂依折麦布降低LDL-C的幅度有限,只能作为他汀类药物的辅助治疗,而PCSK9的单克隆抗体费用较高,仅适用于少数他汀类药物疗效不佳或难以耐受的患者。考虑到我国国情,进一步寻找和验证可安全、有效治疗AS的药物具有重要临床意义。

 

      CAPITAL研究“应运而生”,通心络干预动脉斑块研究取得突破性进展

     早在1996年,通心络胶囊就被当时的卫生部批准用于治疗心绞痛和缺血性卒中。前期基础研究证实,通心络胶囊可通过降脂、抗氧化和抗炎作用缩小和稳定AS斑块。此后,中国医学科学院阜外医院杨跃进教授完成的“通心络胶囊防治急性心肌梗死介入治疗后心肌无复流的多中心、随机、双盲、安慰剂平行对照的临床研究”——ENLEAT研究显示,在常规西药治疗基础上加用通心络胶囊,显著降低了心梗术后心肌无复流发生率,缩小心肌梗死面积。但当时仍缺乏通心络胶囊抗AS的大规模、多中心、随机、双盲的临床研究证据,直到后来CAPITAL研究的问世,为通心络胶囊治疗AS提供了坚实有力的循证依据。

      这项由山东大学齐鲁医院牵头、国内35家中心参与开展的“应用通心络干预颈动脉斑块的随机、双盲、安慰剂对照、多中心临床研究(CAPITAL研究)”,旨在明确通心络胶囊治疗能否通过减小颈动脉内中膜厚度(IMT)和斑块面积延缓亚临床AS患者颈动脉斑块的进展。研究的主要观察终点为用药24个月后双侧颈动脉12个测量部位平均IMT的年平均变化率的组间差值,次要观察终点为用药24个月后颈动脉斑块最大面积、血管重构指数、血脂水平、高敏C反应蛋白以及首发主要心血管事件复合终点的组间差值。

      对于项目名称中“CAPITAL”的由来,张运院士也讲出了他的初衷,“放眼世界,中国是中医药的‘首都’。因此,对于这项由中国团队完成的中药通心络临床研究,自然就是中医药的‘CAPITAL’研究”。

      CAPITAL研究共纳入1212例受试者,按照意向治疗(ITT)原则进行统计学分析。结果显示,通心络组和对照组平均IMT的年变化率分别为-0.00095 mm和0.01312 mm,差值为-0.01407 [95%可信区间(CI):-0.01740~-0.01073,P<0.001]。在次要终点方面,与基线比较,通心络组治疗24个月时颈动脉长轴和短轴最大斑块面积分别减小0.513 mm2和0.234 mm2,而对照组分别增加1.671 mm2P=0.003)和3.301 mm2P<0.001)。同时,与对照组相比,通心络组在12个月和24个月时血管重构指数均明显降低P<0.001,交互P值<0.001)。在首发主要心血管事件方面,通心络组的主要心血管事件首发时间显著晚于对照组,发生率也显著降低,分别为7.7%和13.2%P=0.002),尤其通心络组的不稳定型心绞痛发生率明显少于安慰剂组(P=0.005)。在安全性方面,两组的不良反应发生率相似,提示了通心络胶囊应用的安全性。

     CAPITAL研究的结果证实,在亚临床AS患者中,基于现代常规抗AS治疗,通心络胶囊可延缓颈动脉IMT、斑块面积和血管重构的进展。期待未来开展更深入的研究,进一步明确通心络胶囊对于AS患者长期心血管事件的影响。

 

      CAPITAL研究获国际认可,络病理论成果赢得国奖殊荣

      2019年,CAPITAL研究的研究结果正式发表于国际权威科技期刊《自然》(Nature)子刊《科学报告》(Scientific Reports),引发国内外专家学者的高度关注和热议。

      据了解,早在2009年,张运院士团队开展的“中药通心络剂量依赖性增强易损斑块稳定性:与大剂量辛伐他汀治疗比较研究”的论文在国际权威医学杂志《美国生理学杂志》全文发表,其结果表明,通心络胶囊能够有效缩小斑块体积、降低斑块破裂风险,从而降低心梗、脑梗的发生风险。《美国生理学杂志》编辑部评价通心络“为未来可能发展成冠心病事件的高危患者点燃了希望之灯!”。

      2020年1月10日,由通心络胶囊、参松养心胶囊、芪苈强心胶囊系列循证医学研究为主的“中医脉络学说构建及其指导微血管病变防治”项目更是荣获了2019年度生命科学领域唯一一项国家科技进步一等奖。该奖项的获得验证了三种通络药物在心脑血管疾病的临床疗效,相关系列循证医学研究为解决国际心脑血管领域临床难题提供了新思路。

 

结语

      本届天坛国际脑血管病会议在与会专家的热烈探讨氛围中落幕,会议全程就卒中救治、颈动脉斑块治疗、脑血管病外科治疗等多方面问题开展了学术演讲与探讨。

      20年前,中国脑血管病领域很多方面与发达国家相比还有很大差距,转眼今日,我国脑血管病领域在诸多方面已与发达国家并驾齐驱,为中国脑血管病事业发展谱写新的篇章,创造中国脑血管病防治新格局,让世界神经科医师也见证了"中国力量"。在健康中国行动的引领下,期待中国脑血管病防治工作再上新台阶,创建脑心同治新学科,全方位、全周期保障人民健康。

 

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  3. [GetPortalCommentsPageByObjectIdResponse(id=1984782, encodeId=8f521984e821c, content=<a href='/topic/show?id=ddc11e48295' target=_blank style='color:#2F92EE;'>#TISC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17482, encryptionId=ddc11e48295, topicName=TISC)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTI5PdY90y5Jib8FnPhCXTR2d9v3K17epNSwB2eb0vmXUldNJl2e72S4unZTAHLAojicdVSialTDFHAxA/132, createdBy=78d82500042, createdName=ms7514935887898259, createdTime=Fri Jul 07 12:02:07 CST 2023, time=2023-07-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1944761, encodeId=c1101944e6172, content=<a href='/topic/show?id=411de6300ad' target=_blank style='color:#2F92EE;'>#粥样硬化#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=46, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=76300, encryptionId=411de6300ad, topicName=粥样硬化)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b30d401, createdName=huangshifeng, createdTime=Fri Dec 09 21:02:07 CST 2022, time=2022-12-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1240379, encodeId=2ee912403e9bc, content=点赞, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=1c7a5687904, createdName=ms8000001588433380, createdTime=Mon Aug 22 22:37:09 CST 2022, time=2022-08-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1898079, encodeId=d71a18980e9cc, content=<a href='/topic/show?id=832c404308' target=_blank style='color:#2F92EE;'>#CAP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=59, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4043, encryptionId=832c404308, topicName=CAP)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c39f145, createdName=smlt2008, createdTime=Mon Mar 27 19:02:07 CST 2023, time=2023-03-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1410238, encodeId=ddd214102387a, content=<a href='/topic/show?id=2c1c35262a9' target=_blank style='color:#2F92EE;'>#医药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=35262, encryptionId=2c1c35262a9, topicName=医药)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=36f62754598, createdName=cathymary, createdTime=Fri Aug 12 09:02:07 CST 2022, time=2022-08-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1587953, encodeId=d49b158e95357, content=<a href='/topic/show?id=cb1e1006ebd' target=_blank style='color:#2F92EE;'>#ISC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10067, encryptionId=cb1e1006ebd, topicName=ISC)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=173417575755, createdName=yankaienglish, createdTime=Fri Aug 12 09:02:07 CST 2022, time=2022-08-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1237933, encodeId=9053123e93316, content=。, beContent=null, objectType=article, channel=null, level=null, likeNumber=56, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7a6c5324601, createdName=148b6f0em37暂无昵称, createdTime=Wed Aug 10 21:41:46 CST 2022, time=2022-08-10, status=1, ipAttribution=)]
    2022-08-22 ms8000001588433380

    点赞

    0

  4. [GetPortalCommentsPageByObjectIdResponse(id=1984782, encodeId=8f521984e821c, content=<a href='/topic/show?id=ddc11e48295' target=_blank style='color:#2F92EE;'>#TISC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=44, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17482, encryptionId=ddc11e48295, topicName=TISC)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/Q0j4TwGTfTI5PdY90y5Jib8FnPhCXTR2d9v3K17epNSwB2eb0vmXUldNJl2e72S4unZTAHLAojicdVSialTDFHAxA/132, createdBy=78d82500042, createdName=ms7514935887898259, createdTime=Fri Jul 07 12:02:07 CST 2023, time=2023-07-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1944761, encodeId=c1101944e6172, content=<a href='/topic/show?id=411de6300ad' target=_blank style='color:#2F92EE;'>#粥样硬化#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=46, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=76300, encryptionId=411de6300ad, topicName=粥样硬化)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b30d401, createdName=huangshifeng, createdTime=Fri Dec 09 21:02:07 CST 2022, time=2022-12-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1240379, encodeId=2ee912403e9bc, content=点赞, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=1c7a5687904, createdName=ms8000001588433380, createdTime=Mon Aug 22 22:37:09 CST 2022, time=2022-08-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1898079, encodeId=d71a18980e9cc, content=<a href='/topic/show?id=832c404308' target=_blank style='color:#2F92EE;'>#CAP#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=59, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4043, encryptionId=832c404308, topicName=CAP)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c39f145, createdName=smlt2008, createdTime=Mon Mar 27 19:02:07 CST 2023, time=2023-03-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1410238, encodeId=ddd214102387a, content=<a href='/topic/show?id=2c1c35262a9' target=_blank style='color:#2F92EE;'>#医药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=35262, encryptionId=2c1c35262a9, topicName=医药)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=36f62754598, createdName=cathymary, createdTime=Fri Aug 12 09:02:07 CST 2022, time=2022-08-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1587953, encodeId=d49b158e95357, content=<a href='/topic/show?id=cb1e1006ebd' target=_blank style='color:#2F92EE;'>#ISC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10067, encryptionId=cb1e1006ebd, topicName=ISC)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=173417575755, createdName=yankaienglish, createdTime=Fri Aug 12 09:02:07 CST 2022, time=2022-08-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1237933, encodeId=9053123e93316, content=。, beContent=null, objectType=article, channel=null, level=null, likeNumber=56, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7a6c5324601, createdName=148b6f0em37暂无昵称, createdTime=Wed Aug 10 21:41:46 CST 2022, time=2022-08-10, status=1, ipAttribution=)]
    2023-03-27 smlt2008
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    2022-08-12 cathymary
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    2022-08-12 yankaienglish
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    2022-08-10 148b6f0em37暂无昵称

    0