血瘀证和活血化瘀治疗临床研究.ppt

1、血瘀证和活血化瘀治疗临床研究Clinical Research on Blood-stasis Syndrome (BSS) and Activating-blood- circulation (ABC) Treatment 2005-05-26，北京,血瘀证,BSS, Xue Yu Zheng Oketsu Syndrome Eohyul (血流不畅，血液淤滞的一种证候）,具有中国传统医学特色的一种综合征诊断 国际传统医学界认同 涉及病种多,临床实践指导意义大,多种病可归入血瘀证范畴(1)Many kinds of modern diseases and/or their clinical

2、manifestations could be diagnosed within BSS category,心血管系统：冠心病心绞痛，急性心肌梗死，风湿性心脏病，心力衰竭，各类脉管炎等 神经精神系统：脑中风，脑外伤，慢性头痛，震颤麻痹，周围神经疾病，精神分裂症 血液系统疾病：真性红细胞增多症，紫癜，再障，弥漫性血管内凝血，高粘血症等 消化系统：溃疡病，胃炎，消化道出血，慢性肝炎，肝纤维化 呼吸系统：慢性阻塞性肺疾病，高原反应等 泌尿系统：急慢性肾炎，血尿等 免疫系统：硬皮病，红斑狼疮，类风湿性关节炎，荨麻疹，血管神经性水肿等,多种病可归入血瘀证范畴(2)Many kinds of modern

3、 diseases and/or their clinical manifestations could be diagnosed within BSS category,代谢系统：高脂血症，糖尿病神经血管并发症等 结缔组织系统：灼伤及外伤性皮肤瘢痕，角膜瘢痕等 妇产科：功能性子宫出血，痛经，子宫内膜异位症，宫外孕，盆腔炎，子宫肌瘤等 儿科：新生儿硬肿症，肝炎及紫癜等 皮肤科：红斑结节类病，色素沉着性病，酒糟鼻 眼科：视网膜血管阻塞病，眼部免疫病及退行性病 口腔及耳鼻喉科：三叉神经痛，突发性聋等 骨科：骨折等 外科：部分急腹症等 肿瘤科：血管瘤，肝癌等 器官移植：排异反应等,中国传统医学特色诊

4、断：血瘀证Chinese Medicine Features Diagnosis-BSS,久病多瘀（慢瘀） 温热病重症必瘀（热瘀） 创伤外症多瘀（伤瘀） 急症多瘀（急瘀） 老年多瘀（老瘀） 寒凝致瘀（寒瘀） 紫舌无症状（潜瘀,前瘀）,主要依据,生物流变学特点（血管流变学及血液流变学所见） 宏观生物流变学（血液粘度，血浆粘度，血管壁应力，微血管应力） 微观生物流变学（红细胞聚集性及变形能力，红细胞血小板表面电荷水平；血细胞性状、粘附性及变形性；血浆蛋白含量，凝血因子，细胞膜功能，神经介质，免疫因子，血栓素等水平）,真性红细胞增多症、肺心病、心衰、高原反应、脑梗塞、心肌梗塞、周围血管阻塞、休克、高

5、脂血症、高血压、原发性骨髓瘤、多数肿瘤、烧伤、创伤、脱水、增龄改变、DIC、甲亢、经期妇女、妊娠、红斑狼疮、视网膜静脉阻塞、ARDS、部分感染等,失血、贫血、晚期肿瘤、尿毒症、肝硬变腹水、酒精中毒、部分白血病、部分月经病、红细胞膜损伤等,血瘀证的现代分类 BSS modern classification,Blood and vessels stasis 血脉凝泣Evil blood 恶血Retained blood 留血Vascular obstruction 脉不通Injured blood stasis 损伤瘀血Blood-stasis due to accumulated cold 寒

6、凝瘀血Blood-stasis due to anger 大怒瘀血,血瘀证的经典概念(1) Classical Concepts of BSS,Quoted from “Inner Classic of the Yellow Emperor” (West Han Dynasty, 100 B.C.) （选引自黄帝内经）,血瘀证的经典概念(2) Classical Concepts of BSS,Blood-stasis due to chronic disorders 病久入深瘀血Blood-stasis with sudden pain of organs 瘀血“五藏卒痛”Blood-sta

7、sis with arthralgia 瘀血痹证Syncope due to blood-stasis 瘀血厥证Carbuncle due to blood-stasis 瘀血成痈Blood-stasis with blood exhaustion 瘀血血枯,Quoted from “Inner Classic of the Yellow Emperor” (West Han Dynasty, 100 B.C.) （选引自黄帝内经）,“Stagnation blood accumulated in certain channel or organ”, Extracted from Dr. Zh

8、ang Zhong-jings “Golden Chamber” and “On Febrile” (East Han Dynasty, 142220A.D.) （选引自张仲景伤寒论、金匮要略)）,“瘀血病脉证治”专论,“Many chronic diseases could have blood-collateral disturbances” (“久病入络”),Quoted from Dr. Ye Tian-shis “Clinical Guidance with Case Studies” (Qing Dynasty, 16671746 A.D.) （选引自叶天士临证指南医案）,慢性疾病

9、血瘀证,“Although there were many causes of diseases, they fell mainly into two groups: disturbances Qi and Xue (blood). There were strong and weak Qi, and there were the anemic and congealed blood (stasis)”. Dr. Wang listed fifty more diseases due to BSS in his book.（“治病之要决在于明气血，气有虚实，血有亏瘀”）,Adopted fro

10、m Dr. Wang Ching-rens “Corrections in Chinese Medicine” (Qing Dynasty, 17681831A.D.) （引自王清任医林改错）,临床重视血瘀证的治疗,十纲辨证(Diferentiation with ten principle syndromes),+ 气血辨证 气虚、气陷、气滞、气逆 血虚、血瘀、血热 气滞血瘀、气虚血瘀、气血两虚 气虚失血、气随血脱、痰瘀互结,阴阳、寒热、表里、虚实,Principle Syndromesfrom eight to ten,血瘀证基本诊断条件(1) Fundamental conditions

11、 for BSS diagnosis, Purple of the tongue, or purple dots or scars on the tongue 舌质紫黯或有瘀斑、瘀点 Hesitant pulse, or slow and uneven pulse, and intermittent pulse, or lack of pulse 涩脉、间歇脉、或无脉 Constant prickly pain or colic pain with resistance of pressing 痛有定处，不喜按 Pathological mass including organic enlar

12、gement, newly mass, inflammatory mass, histological hyperplasia or degeneration 瘀积肿块,血瘀证基本诊断条件(2)Fundamental conditions for BSS diagnosis,Abnormal blood vessels including varicosity of undertongue or other parts, capillary dilation, spasm, cyanosis of lips or extremeties, obstruction 舌下或他处瘀阻，唇或四肢青紫，

13、梗阻 Bleeding and its consequence as blood-stool, subcutaneous purple scars 出血及其后遗证如黑便及皮下瘀斑,血瘀证其他诊断条件Other conditions (manifestation due to blood-stasis) for BSS diagnosis, Rough skin, skin hypertrophy or alligator skin-crumps 肌肤甲错 Menstruation disorder 月经失调 Numbness of extremeties or hemiplegia 肢体麻木或

14、偏瘫 Mania with emotional excitement or amnesia (forgetfulness) 情志记忆失常 Periodical mental dysfunction 周期性精神失常 Ascites 腹水,血瘀证实验室所见Laboratory findings for BSS diagnosis, Microcirculation disturbance 微循环失调 Abnormal hemorheology 血流变学异常 Hemodynamic changes 血流动力学异常 Platelet hyperaggregation 血小板聚集性增高 Cerebro-

15、vascular thrombosis or embolism 脑血管梗塞 Ultrastructural blood-stasis by Echo, angiography or CT/MRI examination 超声、血管造影或CT/MRI所见超微结构血瘀征象,临床研究用定量血瘀证诊断标准记分方法The BSS scores for clinical diagnosis,注:判断标准以19分以下为非血瘀证;2049分为轻度血瘀证;50分以上为重度血瘀证,三类活血化瘀药物Three Kinds of ABC Herbs,1. 和血类药物 Blood-harmonizing herbs D

16、anggui ( Angelica sinensis ) 当归 Danpi (Paeonia suffruticosa Andr.) 丹皮 Danshen ( Salvia miltiorrhiza Bge. ) 丹参 Shengdihuang (glutinosa) 生地黄 Chishao (paeonia) 赤芍 Jixueteng (spatholobus suberectus) 鸡血藤,Chuanxiong ( Ligusticum ) 川芎 Puhuang ( Typha angustifolia ) 蒲黄 Honghua (Carthamus tinctorius ) 红花 Liu

17、jinu ( Artemisia anomala S. Moore ) 刘寄奴 Wulingzhi (Trogopterus xanthipes ) 五灵脂 Yujin ( Curcuma aromatica Salisb. ) 郁金 Sanqi ( Panax notoginseng ) 三七 Chuanshanjia (Manis pentadactyla ) 穿山甲 Jianghuang ( Curcuma longa L. ) 姜黄 Yimucao ( Leonurus heterophyllus Sweet ) 益母草 Zelan (Lycopus lucidus Turcz. )

18、泽兰,2. 活血类药物Blood-activating herbs,三类活血化瘀药物Three Kinds of ABC Herbs,2. 活血类药物 Blood-activating herbs Sumu (Caesalpinia sappan L. ) 苏木 Haifengteng (Piper futokadsura Sieb.) 海风藤 Yizhihao ( Paris polyphylla Smith ) 一枝蒿 Niuxi ( Achyranthes bidentata Blume ) 牛膝 Mabiancao ( Verbena officinalis L. ) 马鞭草 Yanh

19、usuo ( Corydalis turtschaninovii Bess.f. ) 延胡索 Guijianyu ( Bidens bipinnata L. ) 鬼见羽 Ziwei ( Campsis grandiflora ) 紫葳 Wine 酒,三类活血化瘀药物Three Kinds of ABC Herbs,3.破血类药物Blood-stasis-removing herbs Dahuang ( Rheum palmatum L. ) 大黄 Shuizhi (Whitmania pigra ) 水蛭 Mengchong ( Tabanus bivittatus Mats.) 虻虫 San

20、leng ( Sparganium stoloniferum Buch.-Ham. ) 三棱 Erzhu (Curcuma zedoaria ) 莪术 Ruxiang (Boswellia carterii Birdw. ) 乳香 Moyao ( Commiphora myrrha Engl. ) 没药 Xuejie ( Daemonorops draco Bl. ) 血竭 Taoren ( Prunus persica ) 桃仁,三类活血化瘀药物Three Kinds of ABC Herbs,神农本草经确载活血化瘀药分析,41/365种 丹参、 牡丹皮、 牛膝、 芍药、 桃仁、 虻虫、 蛰

21、虫、川芎、 鳖甲、 蛴螬、 乌贼骨等 大黄、 柴胡之推陈致新作用,活血化瘀药,即美国医药学界习称之ABC药 Activating Blood Circulation Herbs Promoting Blood Circulation to Remove Blood-stasis,活血化瘀兼治痰瘀药物举隅Examples of relieving BSS and phlegm accumulations herbs,34种活血化瘀药的比较研究,观察指标(26项)： 血液粘滞 血小板功能 红细胞变形性 血栓形成试验 冠脉流量 心肌收缩力 心肌细胞耗氧量 其他,血瘀证治疗原则和方剂(1)Therap

22、eutic principles and formulas for BSS,Tonifying Qi and activating blood circulation 益气活血 （Bu Yang Huan Wu Tang Formula 补阳还五汤） Modulating Qi and activating blood circulation 理气活血 （Xue Fu Zhu Yu Tang Formula血府逐瘀汤，Dan Shen Yin Formula丹参饮） Warming Channel and activating blood circulation 温经活血 （Wen Jing

23、Tang Formula温经汤） Antitoxic and promoting blood circulation 解毒活血 （Xian Fang Huo Ming Yin Formula仙方活命饮） Cooling blood and removing blood-stasis 凉血祛瘀 （Xi Jiao Di Huang Tang Formula犀角地黄汤）,Nourishing blood and promoting blood circulation 养血活血 （Tao Hong Si Wu Tang Formula桃红四物汤） Purgatives with removing bl

24、ood-stasis 通腑祛瘀（Tao He Cheng Qi Tang Formula桃核承气汤） Tonifying Yang and promoting blood circulation 补阳活血 （Sheng Hua Tang Formula生化汤） Eliminating Wind and removing blood-stasis 祛风化瘀 （Shen Tong Zhu Yu Tang Formula身痛逐瘀汤） Opening orifice and promoting blood circulation 开窍活血（Tong Qiao Huo Xue Tang Formula通

25、窍活血汤） Dispersing lumps and removing blood-stasis 散结化瘀 （Gui Zhi Fu Ling Wan Formula桂枝茯苓丸）,血瘀证治疗原则和方剂(2)Therapeutic principles and formulas for BSS,日本常用活血化瘀方剂及其组成,注：（1）伤：指伤寒论，金：指金匱要略; （2）重者，用偏寒性及虫类药,张仲景活血化瘀古方新用,当归芍药散 （痴呆，记忆功能障碍） 大黄牡丹皮汤（阑尾炎） 温经汤 （闭经、带证） 鳖甲煎丸 （肝脾肿大） 大黄蛰虫丸 （风心病） 桃仁承气汤 （精神神经疾患） 下瘀血汤 （产后腹痛

26、） 抵当汤 （月经不利） 红蓝花酒 （妇女病、心痛） 王不留行散 （外伤性出血）,黄帝内经 的活血化瘀方剂,四乌贼骨一芦茹丸 组成:茜草,乌贼骨,鲍鱼,雀卵 功效:活血化瘀,温经补肾,医学衷中参西录 (张锡纯) 治白带恶臭医方,理带汤 乌贼骨、茜草、生龙牡、山药,抗心梗合剂(AMI Mixture),组成：黄芪30g、党参15g、黄精15g、 丹参30g、赤芍15g、郁金15g 功效：益气活血 Planta Medica,1983;48(1):63-64,愈梗通瘀汤(自拟,1990),组成：生晒参1015g，生黄芪15g，紫丹参15g，全当归10g，延胡索10g，川芎10g，广藿香1218g，

27、佩兰1015g，陈皮10g，半夏10g，生大黄610g 功效：益气活血，祛瘀抗栓，利湿化浊 适应症：用于心肌梗死急性期及恢复期患者，能够促进梗塞组织愈合，保护心功能，改善生存质量，延长寿命 处理好通与补的关系,人参三七元胡粉(郭士魁经验方,1985)人参三七琥珀粉(岳美中经验方,1964),人参三七元胡粉（1.5:1.5:3）:益气活血，理气定痛 人参三七琥珀粉（1.5:1.5:0.5）:益气，活血，安神,活血化瘀八个古方主要药效学作用比较,八个经典古方的比较研究,活血化瘀方临床治疗应用Clinical trial of ABC formulas for certain diseases,抗心

28、绞痛和抗血小板治疗 Treatment of anti-angina pectoris and anti-platelet 预防冠心病PTCA/支架治疗后再狭窄 Prevention of restenosis after PTCA/stenting in CHD 血府逐瘀汤及其有效部位的应用 By the application of Xue Fu Zhu Yu Tang Formula,冠心号复方组成,川芎 Ligusticum wallichii 赤芍 Paeonia obovata 丹参 Salvia miltiorrhiza 红花 Carthamus tinctorius 降香 Da

29、lbergia odorifera,冠心号类活血药的临床应用,冠心病不同治法的疗效比较,编者按：本文是一篇水平较高的工作总结，其突出的优点是研究的设计和方法使临床资料具有较好的对比性，因而，它的结论就具有较强的说服力。,中华心血管病杂志1982年第10卷第2期 临床论著 精制冠心片双盲法治疗冠心病心绞痛 112例疗效分析,精制冠心片,精制冠心颗粒,扩大活血化瘀治疗范围达 54种疾病，充分发挥中医药优势，特别是心脑血管病疗效明显提高 个体化、合理应用、方证相应,是取得疗效的前提,活血化瘀治法的推广应用 -活血化瘀现象,川芎嗪对缺血性中风的效果The efficacy of Ligustrazin

30、e for Ischemic Stroke,Tetramethylpyrazine,川芎嗪毒性与代谢Toxicity and metabolism of Ligustrazine,LD50: 239mg/kg(rat) half-life: 29.26min(blood)(rabbit) Passing through BBB (Brain stem:cerebrum = 4:1),川芎嗪抗血栓素(thromboxane)生成作用,Inhibitory effect of ABC-herbs on TXB2 production,抗血小板中药示例An example of herbal ant

31、iplatelet drug,Ligustrazine was also demonstrated to lower platelet intracellular calcium and inhibit secretion of platelet -granules. Due to exact antiplatelet effect, Ligustrazine has been a common drug in treating cerebral ischemia and ischemic stroke in urban and rural area in China at present.,

32、川芎嗪静脉应用对缺血性中风临床疗效The clinical efficacy on ischemic stroke by IV use with Ligustrazine,Compared with papaverine clinical curative rate：43与40 remarkable effective rate：23与22 effective rate ：23与10 none effective rate：11与22 total effective rate： 88.6与78.0% (administrations：ivgtt, 80mg/d10),中药抗血小板作用Antip

33、latelet effect of Chinese Medicine,Chi Shao, Radix Paeoniae rubra 赤芍 Dan Shen, Radix Salviae Miltiorrhizae 丹参 Chuan Xiong, Rhizoma Ligusticum Wallichii 川芎 Pu Huang, Pollen Typhae 蒲黄 Yi Mu Cao, Herba Leonuri 益母草 Wang Bu Liu Xing, Semen Vaccariae 王不留行 Hong Hua, Flos Carthami 红花,其他抗血小板中药有效成分Other effec

34、tive components isolated from herbal medicines for antiplatelet,Ferulio acid(阿魏酸) Tanshin Phenolic Acids A (丹参素) Propyl Gallate(赤芍801, 没食子酸丙酯) Berberine (小檗碱) Saponin of notoginseng (三七皂甙) 芍药酚 52021(银杏内酯) Tetrandrine (粉防己碱) Quercetin(槲皮素) Kadsurenone(海风藤酮) (新灯盏花素) 甲基莲心碱() Rhynchophylline (钩藤碱) Ginse

35、nosides(人参总皂甙) Gypenosides(绞股蓝总皂甙) 黄山药总皂甙 蒺藜总皂甙,阿魏酸和川芎嗪(FATM)组合对ADP诱导的血小板体内凝集的抑制作用(n=7),与NS组比较：a:P0.01;与TMPz组比较：b:P0.01,初步认为具有抗血小板作用 的常用活血化瘀注射剂,初认具有抗血小板作用常用活血化瘀口服中成药,抗血栓药适应症The indications of antithrombotic drugs,Acute coronary syndrome (ACS)，急性冠脉综合征 Myocardial infarction (MI)，心肌梗死 Ischemic stroke，缺

36、血性中风 Venous thrombembolism (VTE)，静脉血栓栓塞 Peripheral arterial occlusion (PAO)，周围动脉阻塞 Atrial fibrillation，心房颤动,抗血栓药适应症The indications of antithrombotic drugs,Polycythemia vera，真性红细胞增多症 Vasulitis，血管炎 Cor-pulmonale，肺心病 Chronic heart failure，慢性心力衰竭,Study on Restenosis after PCI Intervened by TCM Therapy冠心

37、病介入治疗后再狭窄的中医干预治疗研究, Charged by：Xiyuan Hospital, China Academy of TCM 承担单位：中国中医研究院西苑医院 Coordinated by：Beijing An-zhen Hospital 北京安贞医院 合作单位： Beijing Tong-ren Hospital 北京同仁医院 China-Japan Friendship Hospital 中日友好医院 Guangdong Provincial Hospital of TCM 广东省中医院 Beijing International Institute of Biologic P

38、roducts 北京国际生物制品研究所,The National Tenth “Five-year” Project “十五”国家科技攻关计划课题,No. 2001BA701A20,PTCA,PCI,Hospitals carrying out PCI By 1993 30 hospitals By 1999 200 hospitals Patients treated with PCI By 1993 1000 cases (total) 1998 5000 cases/year 1999 8000 cases/year 2000 20000 cases/year 2004 70000 ca

39、ses/year,The Development of PCI in China,我国 PCI 开展现状,开展 PCI 手术的医院 到 1993年 30家医院 到 1999年 200家医院 接收 PCI 治疗的患者 到 1993年 1000 例 (累计) 1998年 5000 例/年 1999年 8000 例/年 2000年 20000 例/年 2004年 70000 例/年,Progress of RS Study,Restenosis (RS) is still the major limitation of the long-term success of coronary interv

40、ention treatment No ideal prophylactic measure so far although numerous clinical trials have been done Stents have certain effect with RS rate still between 20% and 30% Coating stents showed wonderful prospect, but the reported results were inconsistent, and the expensive price limited its applicati

41、on in China,再狭窄(RS)研究进展,再狭窄仍然是限制冠状动脉介入治疗远期疗效的主要因素 虽然国际上进行了大量干预再狭窄的临床试验，但目前还没有找到理想的治疗手段 支架植入术具有一定的效果，但再狭窄发生率仍然在20%30%之间。 药物涂层支架显是有良好的前景，但研究结果报道不一，其昂贵的价格也限制了其在国内的推广应用,血府逐瘀汤Xue Fu Zhu Yu Tang,Wang Qing-Ren(1768-1831AD) of Qing Dynasty 清. 王清任 The Typical Recipe of Activating Blood Circulation and Removi

42、ng Stasis 活血化瘀代表方,Medicinal Roles Sovereign (君) Semen Persicae (桃仁)，Flos Carthami (红花) , Radix Angelicae (当归)； Minister (臣) Padix Raeoniae Rubra (赤芍)，Rhizoma Ligustici Chuanxiong (川芎)，Radix Rhemanniae (生地)； Assistant (佐) Radix Achyranthis Bidentatae (牛膝)，Radix Bupleuri (柴胡), Fructus Aurantii (枳壳)，Ra

43、dix Platycodi (桔梗)； Envoy (使) Radix Glycyrrhizae (甘草).,介入治疗后再狭窄 Restenosis Post PTCA/Stent,中医“血瘀证” BSS,经典活血化瘀方 血府逐瘀制剂 XFZYT,简化方药 Modified XFZYT,精制血府胶囊 Concentrated XFZYT,芎芍胶囊 XS Capsule Effective components,A：Model B：Probucol C：Xue Fu Zhu Yu Preparation D：Low-dose XS E：Large-dose XS F：Normal,Our pre

44、vious Experimental Study (China Minipig, VG50) 4 weeks after balloon injury of coronary artery,我们既往 实验研究 (中国小型猪, VG50) 冠状动脉球囊损伤后4周,A：对照组 B：普罗布考组 C：血管通组 D：芎芍小组 E：芎芍大组 F：正常对照,RS,“Blood Stasis” Syndrome,Xue Fu Zhu Yu Preparation,Simplify and Optimize Prescription,Xiongshao Capsule,SMC proliferation,PLT

45、 aggregation,Thrombosis,Vascular remodeling,The Course of Our Study,Effective,Active parts from Rhizoma chuanxiong and Radix Paeoniae rubra,EBM? RCT?,Pilot study showed its effectiveness,临床研究进程,Objectives,To evaluate the therapeutic effect of ABC herbal medicine in interventing RS after PCI with mul

46、ti-center, randomized, double-blind and placebo-controlled method according to principles of EBM and GCP.,研究目标,按照EBM和GCP原则，采用多中心、随机双盲、安慰剂对照方法，客观评价活血化瘀中药制剂干预冠心病介入治疗后再狭窄的临床疗效,Grouping Method,Control Group Routine treatment + placebo Cap. Treatment Group Routine treatment + Xiongshao Cap.,分组方法,对照组： 西药常

47、规治疗 +安慰剂组 治疗组： 西药常规治疗 +芎芍胶囊组,Placebo Cap.安慰剂胶囊,Xiongshao Cap.芎芍胶囊,They have the same form of preparation, appearance and color. Both have correspondent quality examination record. 两者在剂型、颜色、外观上完全相同，均有相应质量检测报告。,Placebo-controlled,安慰剂对照,治疗药物药学研究,川芎总酚和赤芍总甙两味中药有效部位混匀制颗粒，装入胶囊。选择微晶纤维素作为胶囊剂辅料，经三批中试生产，制备工艺考察

48、证明了工艺可靠、质量稳定。,Double-blind Method,Blind to Patients; Physician; CAG data analyzer; Statistic analyzer.,双盲方法,盲法针对 患者; 临床医生; CAG 数据分析人员; 统计分析者.,Diagnostic Criteria,The diagnostic criteria of CHD Related criteria on ischemic heart disease of WHO. Angiographic restenosis A residual stenosis of 50% after

49、 angioplasty that became 50% at follow-up Criterion for successful PCI The diameter stenosis of target artery immediately after PCI decrease more than 20% with less than 50% residual stenosis Criterion of coronary lesion classification Related criteria established by ACC/AHA in 1988,诊断标准,冠心病诊断标准 参照W

50、HO缺血性心脏病诊断标准 冠脉造影再狭窄标准 血管成形术后残余狭窄50% PCI术成功的标准 靶血管PCI术后即刻管腔直径狭窄减少超过 20% ，且残余狭窄不超过 50% 冠状动脉病变分型标准 参照 1988年美国心脏病学会和美国心脏协会(ACC/AHA)制定的标准,Inclusion Criteria,35 to 70 years old Angina and/or objective evidence of myocardial ischemia A significant (50%) stenosis was documented on a recent coronary angiogr

51、am Successfully performed PTCA and/or stenting Or AMI with successful emergency interventional treatment The TCM syndrome type was not restricted,纳入标准,年龄在3570岁 有心绞痛症状和/或心肌缺血的客观证据 近期冠状动脉造影证实冠状动脉有显著狭窄(50%)； 行PTCA及冠脉内支架植入术成功的患者； 或AMI患者行急诊介入治疗成功的患者中医辨证分型不限,Exclusion Criteria,Restenosis lesion or graft v

52、essel lesion Chronic completely obstructive lesion (3mons)； Severe left main artery lesion; Severe heart failure (EF35%); Uncontrolled level III hypertension; Severe valvular heart disease; Complicated by severe hepatic or renal impairment, diseases of hemopoietic and neurologic systems, or psychopa

53、thy, or malignant tumor; Refused to subscribe written informed consent, or estimated poor compliance; Participation in another study; Pregnant or breast-feed women.,排除标准,再狭窄病变或移植血管病变； 慢性完全闭塞病变(3个月)； 严重左主干病变； 严重心功能不全(EF35%)； 未控制的级高血压患者； 严重瓣膜性心脏病; 合并严重肝、肾、造血系统、神经系统等原发性疾病及精神病、恶性肿瘤患者 患者拒绝签署知情同意书，或估计依从性较

54、差； 参加其他临床试验的患者； 妊娠期或哺乳期妇女。,Clinical and Angiographic End Points,Primary end point Angiographic restenosis Clinical end points Death Nonfatal target lesion myocardial infarction Coronary artery bypass graft surgery Repeat target-vessel angioplasty,临床及冠造终点,主要研究终点 冠脉造影所示再狭窄 临床研究终点 死亡 病变血管出现非致命性心肌梗死 重复血

55、管成形术 冠状动脉搭桥术,Follow-up of patients,The clinical follow-up visit was scheduled 1, 3 and 6 months after PCI for clinical and laboratory assessment. Patient compliance was assessed by returned empty bottles of the trial drug. Repeat CAG was required at 6 months after PCI to assess angiographic restenos

56、is.,患者随访,术后1个月、3个月及6个月门诊复查，通过患者服完药的药瓶监测其服药的依从性。 术后6个月行冠脉造影复查，以评估冠脉造影再狭窄的情况。临床终点事件随访至术后1年。,研究概况Study Outline,335 cases enrolled 335例入选,Control group对照组 169 cases,Treatment group治疗组 166 cases,308 cases completed with 145 repeat angiography 308例完成试验，145例重复冠脉造影,Randomize随机,3 cases lost脱落,12 cases exclude剔除,3 cases