血瘀证和活血化瘀治疗临床研究课件

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 manife

2、stations 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 diseases and

3、/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断：血瘀证Chinese Medicine Fe

4、atures 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）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

5、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-stasis with arthralgia 瘀血痹证Syncope due to blood-stasis 瘀血厥证Carbuncle due to

6、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） “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,

7、16671746 A.D.) （选引自叶天士临证指南医案）慢性疾病血瘀证 “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

8、病之要决在于明气血，气有虚实，血有亏瘀”） Adopted from 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(

9、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，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

10、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 肢体麻木或偏瘫Mania with emotional excitement or amnesia (forgetfulness) 情志记忆失常 Periodical mental dysfunction

11、 周期性精神失常 Ascites 腹水临床研究用定量血瘀证诊断标准记分方法The BSS scores for clinical diagnosis舌质紫暗少腹部抵抗压痛脉涩黑便病理性肿块舌下脉曲张脉结代无脉腹壁静脉曲张皮下瘀血斑月经色黑有块持续心绞痛一般固定性疼痛口唇齿龈暗红细络手足麻木（轻）8（重）10（轻）8（重）10101010（轻）8（重）1081010（轻）8（重）10（轻）8（重）10108655手术史腭粘膜征阳性肢体偏瘫精神异常皮肤粗糙全血粘度升高血浆粘度升高体外血栓干重增加体外血栓湿重增加血小板聚集性增高血栓弹力图异常微循环障碍血液动力学障碍纤溶活性降低血小板释放功能亢进病理

12、切片示血瘀新技术显示血管阻塞5（轻）4（重）5（轻）5（重）7（烦躁）4（狂躁）8（轻）4（重）5105108108101010101010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 Danggui ( Angelica sinensis ) 当归 Danpi (Paeonia suffruticosa Andr.) 丹皮 Danshen ( Salvia miltiorrhiza Bge. ) 丹参 Shengdihuan

13、g (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Liujinu ( Artemisia anomala S. Moore ) 刘寄奴Wulingzhi (Trogopterus xanthipes ) 五灵脂Yujin ( Curcuma aromatica Salisb. ) 郁金Sanqi ( P

14、anax 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. ) 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 herbsSumu (Caesalpinia sappan L. ) 苏木Ha

15、ifengteng (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Yanhusuo ( 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 Kin

16、ds 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Sanleng ( Sparganium stoloniferum Buch.-Ham. ) 三棱Erzhu (Curcuma zedoaria ) 莪术Ruxiang (Boswellia carterii Birdw. ) 乳香Moyao ( Commiphora myrrha Engl.

17、) 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兼治痰瘀药物举隅Examples of relieving BSS and phlegm accumulations herbs药名药物归类大黄南星菖蒲郁金香附川芎蒲黄水蛭益母草泽兰毛冬青薤白旋复花海风藤王不留行羌活陈皮通腑药化痰药芳香化

18、湿药活血化瘀药行气药活血化瘀药止血药活血化瘀药活血化瘀药活血化瘀药活血化瘀药行气药止咳平喘药祛风湿药活血化瘀药祛风湿药行气药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Nourishing blood and promoting blood circulation 养血活血 （Tao Hong Si Wu Tang Formula桃红四物汤）Purgatives with removing blood-stasis 通腑祛瘀（Tao He Cheng Qi Tang Formula桃核承气汤）Tonifying Y

19、ang 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通窍活血汤）Dispersing lumps and removing blood-stasis 散结化瘀 （Gui Zhi Fu

20、 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序号方剂名称出典药物组成1桃核承气汤伤太阳病桃仁、桂枝、芒硝、大黄、甘草2抵当汤金太阳病，阳明病金瘀血病，妇人杂病桃仁、水蛭、虻虫、大黄3大黄蛰虫丸金血痹虚劳病大黄、黄芩、桃仁、杏仁、甘草、芍药、地黄、干漆、虻虫、蛴螬、水蛭、蛰虫4大黄牡丹皮汤金血疮痈肠痈浸淫病桃仁、牡丹皮、芒硝、大黄、冬瓜子5桂枝茯苓丸金妇人妊娠病桂芝、茯苓、牡丹皮、桃仁、芍药6芎归胶艾汤金妇人妊娠病阿胶、川芎、甘草、艾叶、当归、芍药、地黄7

21、当归芍药散金妇人妊娠病当归、川芎、芍药、茯苓、白术、泽泻8下瘀血汤金妇人产后病大黄、桃仁、蛰虫9温经汤金妇人杂病吴茱萸、当归、川芎、芍药、人参、桂枝、阿胶、牡丹皮、甘草、生姜、半夏、麦门冬注：（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）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

22、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，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

23、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方剂名称心脑血管作用抗 清 抗 减 减缺 抗 抗 抗血 除 急 少 轻血 血 血浆 离 在小 氧 性 心 心样 栓 6-K-PGF1 体 体板 自 脑 肌 肌损 形 /TXB2 心 心聚 由 缺 细 细伤 成 比值升高 肌 肌集 基 血 胞 胞 缺 缺 耗 血 血 氧四物汤桃红四物汤补阳还五汤血府逐瘀汤少腹逐瘀汤膈下逐瘀汤身痛逐瘀汤通窍活血

24、汤 + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + +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 i

25、n 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 Dalbergia odorifera病 种心绞痛脑梗塞治疗例数5316695显 效 率21.9245.32平均有效率88.2690.63冠心号类活血药的临床应用冠心病不同治法的疗效比较治 法 疗 效宣痹通阳法 治标为主，有效率 6070%活血化瘀法 标本兼治， 有效率

26、88.26 % 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。药物组别疗程例数总有效率(%）显效（%）改善（%）无效（%）加重（%）精制冠心片甲组第一6177.026.250.821.41.6乙组第二5184.333.351.015.70共 计11280.429.550.918.70.9安慰剂组甲组第一618.21.66.690.21.6乙组第二5125.5025.570.63.9共 计11216.10.915.281.22.7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1

27、12例疗效分析精制冠心片精制冠心颗粒冠心病（心绞痛、心肌梗死）中医辨证试行标准（1980）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 Ligustrazine for Ischemic StrokeTetramethylpyrazine川芎嗪毒性与代谢Toxicity and metabolism of LigustrazineLD50: 239mg/kg(rat)half-life: 29.26min(blood)(r

28、abbit)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 antiplatelet drugLigustrazine was also demonstrated to lower platelet intracellular calcium and inhibit secretion of platelet -granules. Due to ex

29、act antiplatelet effect, Ligustrazine has been a common drug in treating cerebral ischemia and ischemic stroke in urban and rural area in China at present. 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 LigustrazineCompared with papaverine clinical curative rate：43与40 remar

30、kable 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Antiplatelet effect of Chinese MedicineChi Shao, Radix Paeoniae rubra 赤芍Dan Shen, Radix Salviae Miltiorrhizae 丹参Chuan Xiong, Rhizoma Ligusticum Wallich

31、ii 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 effective components isolated from herbal medicines for antiplateletFerulio 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)

32、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)Ginsenosides(人参总皂甙)Gypenosides(绞股蓝总皂甙)黄山药总皂甙蒺藜总皂甙组 别剂量/mgkg-1血小板最大凝集率/%NSTMPzFATM303040.825.5128.364.73 a16.544.89 ab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

33、TMPz组比较：b:P0.01 药 名其它制剂主要成分规格用 法丹参注射液丹参粉针剂丹参10ml/支1020ml/d, 入液静点复方丹参注射液香丹注射液丹参、降香等10ml/支1020ml/d, 入液静点血栓通注射液血塞通注射液三七总皂甙5ml/支10ml/d, 入液静点灯盏花细辛注射液灯盏花细辛总黄酮45mg/支180225mg/d, 入液静点川芎嗪注射液兴诺； 川 信川芎嗪40mg/支80120mg/d, 入液静点葛根素注射液戈荣葛根素100mg/支400500mg/d,入液静点初步认为具有抗血小板作用的常用活血化瘀注射剂药名组成规格用法精制冠心片(颗粒)降香、丹参、川芎、赤芍、红花0.5

34、g/片68片，tid复方丹参滴丸丹参、三七、冰片25mg/粒10粒， tid地奥心血康黄山药甾体总皂苷100mg/粒12粒， tid心血宁片葛根提取物、山楂提取物0.2g/片4片， tid丹七片丹参、三七0.3g/片35片， tid黄杨宁片小叶黄杨及其同属植物提取物12片， tid乐脉颗粒丹参、川芎、赤芍、红花、山楂等3g/包12包， tid冠脉宁片丹参、没药、鸡血藤、血竭、延胡索、当归、郁金、制何首乌、桃仁、黄精、红花、葛根、乳香、冰片0.5g/片3片， tid血府逐瘀胶囊当归、川芎、生地黄、赤芍、桃仁、红花、牛膝、柴胡、枳壳、桔梗、甘草0.4g/粒6粒， bid通心络胶囊人参、水蛭、土鳖虫

35、、全蝎、蜈蚣、蝉蜕、赤芍、冰片等0.38g/粒24粒， tid舒心口服液黄芪、党参、红花、当归、川芎、三棱20ml/支20ml， tid山海丹胶囊三七、人参、黄芪、红花、山羊血粉、决明子、葛根、佛手、海藻、何首乌、丹参、川芎等0.5g/粒5粒， tid麝香保心丸麝香、人参、苏合香、蟾酥等22.5mg/丸12丸， tid诺迪康胶囊圣地红景天0.28g/粒12粒， tid冠心苏合丸苏合香、冰片、乳香、檀香、青木香0.35g/粒1丸，qd tid心通口服液黄芪、麦冬、丹参、海藻、昆布、党参、葛根、川芎等10ml/支2支， tid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 indi

36、cations of antithrombotic drugsAcute coronary syndrome (ACS)，急性冠脉综合征Myocardial infarction (MI)，心肌梗死Ischemic stroke，缺血性中风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 drugsPolycythemia vera，真性红细胞增多症Vasuliti

37、s，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

38、 Hospital 中日友好医院 Guangdong Provincial Hospital of TCM 广东省中医院 Beijing International Institute of Biologic Products 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 Andreas R. Gruentzig (1939-1985)PTCAPCIHospitals carrying out PCI By 1993 30 hospitals By 1999 200 hospit

39、alsPatients treated with PCI By 1993 1000 cases (total) 1998 5000 cases/year 1999 8000 cases/year 2000 20000 cases/year 2004 70000 cases/yearThe 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

40、/年 2004年 70000 例/年Progress of RS StudyRestenosis (RS) is still the major limitation of the long-term success of coronary intervention treatmentNo ideal prophylactic measure so far although numerous clinical trials have been done Stents have certain effect with RS rate still between 20% and 30%Coatin

41、g stents showed wonderful prospect, but the reported results were inconsistent, and the expensive price limited its application 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

42、Yu TangWang Qing-Ren(1768-1831AD) of Qing Dynasty 清. 王清任The Typical Recipe of Activating Blood Circulation and Removing Stasis 活血化瘀代表方Medicinal RolesSovereign (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)，Ra

43、dix Rhemanniae (生地)；Assistant (佐) Radix Achyranthis Bidentatae (牛膝)，Radix Bupleuri (柴胡), Fructus Aurantii (枳壳)，Radix 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ModifiedXFZYT精制血府胶囊Concentrated XFZYT芎芍胶囊XS CapsuleEffective compon

44、entsABCDEFA：Model B：ProbucolC：Xue Fu Zhu Yu PreparationD：Low-dose XSE：Large-dose XSF：NormalOur previous 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”SyndromeXue Fu Zhu

45、Yu PreparationSimplify and Optimize PrescriptionXiongshao CapsuleSMC proliferationPLT aggregationThrombosisVascular remodelingThe Course of Our StudyEffectiveActive parts from Rhizoma chuanxiong and Radix Paeoniae rubra EBM?RCT?Pilot study showed its effectiveness临床研究进程再狭窄中医“血瘀证”经典活血化瘀方血府逐瘀制剂有 效精简优化

46、方药芎芍胶囊SMC增殖血小板聚集血栓形成血管重构川芎、赤芍有效部位 循证医学原则?随机对照试验?小规模临床试验 显示其有效性ObjectivesTo evaluate the therapeutic effect of ABC herbal medicine in interventing RS after PCI with multi-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

47、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 MethodControl GroupRoutine treatment + placebo Cap. Treatment GroupRoutine treatment + Xiongshao Cap.分组方法对照组：西药常规治疗 +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 correspon

48、dent 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，制备工艺考察证明了工艺可靠、质量稳定。Double-blind MethodBlind toPatients;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 CriteriaThe

49、 diagnostic criteria of CHD Related criteria on ischemic heart disease of WHO. Angiographic restenosis A residual stenosis of 50% after angioplasty that became 50% at follow-upCriterion for successful PCIThe diameter stenosis of target artery immediately after PCI decrease more than 20% with less th

50、an 50% residual stenosisCriterion of coronary lesion classificationRelated criteria established by ACC/AHA in 1988诊断标准冠心病诊断标准 参照WHO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 Criteria35 to 70 years oldAngi

51、na and/or objective evidence of myocardial ischemiaA significant (50%) stenosis was documented on a recent coronary angiogramSuccessfully performed PTCA and/or stentingOr AMI with successful emergency interventional treatmentThe 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

52、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 CriteriaRestenosis lesion or graft vessel lesionChronic completely obstructive lesion (3mons)；Severe left main artery lesion;Severe heart failure (EF3个月)；严重左主干病变；严重心功能不全(EF0.05Age (年龄)(MeanSD)(yr)58.5210.3058.749.910.05Heigh

53、t (身高) (MeanSD)(cm)167.387.21167.666.940.05Weight (体重) (MeanSD)(kg)72.4410.7871.0710.090.05Hypertension (高血压)85(54.1)84(53.5)0.05Diabetes (糖尿病)28(17.8)32(20.4)0.05Hyperlipidemia (高脂血症)45(28.7)38(24.2)0.05Diagnosis (诊断) Stable angina (稳定性心绞痛)4(2.5)6(3.8)0.05 Unstable angina(不稳定性心绞痛)94(59.9)87(55.4)0.

54、05 AMI (急性心肌梗死)59(37.6)64(40.8)0.05基线临床资料比较 Baseline Clinical Characteristics治疗组对照组P值基线冠脉造影资料比较Baseline Angiographic CharacteristicsComparison of clinical end-point event 两组临床终点事件的比较 Note: There was significant difference between the two groups(p0.05). Death 死亡0 0.00 00.00 Nonfatal MI 非致命性心梗1 0.64 10.64 Repeat PCI 重复介入治疗15 1.91 314.46 Event终点事件Treatment 治疗组Control 对照组 N (%) N (%) CABG 冠脉搭桥 00.00 30.00 两组临床结果比较 Clinical Outcome Treatment PlaceboGroup分组Repeat Angiography重复冠脉造影(N)RS (再狭窄)New Lesion (新病变)N(