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1、血瘀證和活血化瘀治療臨床研究Clinical Research on Blood-stasis Syndrome (BSS) and Activating-blood- circulation (ABC) Treatment 2005-05-26,北京血瘀證 BSS, Xue Yu Zheng Oketsu Syndrome Eohyul(血流不暢,血液淤滯的一種證候)具有中國傳統(tǒng)醫(yī)學(xué)特色的一種綜合征診斷國際傳統(tǒng)醫(yī)學(xué)界認同涉及病種多,臨床實踐指導(dǎo)意義大多種病可歸入血瘀證范疇(1)Many kinds of modern diseases and/or their clinical manife

2、stations could be diagnosed within BSS category 心血管系統(tǒng):冠心病心絞痛,急性心肌梗死,風(fēng)濕性心臟病,心力衰竭,各類脈管炎等神經(jīng)精神系統(tǒng):腦中風(fēng),腦外傷,慢性頭痛,震顫麻痹,周圍神經(jīng)疾病,精神分裂癥血液系統(tǒng)疾?。赫嫘约t細胞增多癥,紫癜,再障,彌漫性血管內(nèi)凝血,高粘血癥等消化系統(tǒng):潰瘍病,胃炎,消化道出血,慢性肝炎,肝纖維化呼吸系統(tǒng):慢性阻塞性肺疾病,高原反應(yīng)等泌尿系統(tǒng):急慢性腎炎,血尿等免疫系統(tǒng):硬皮病,紅斑狼瘡,類風(fēng)濕性關(guān)節(jié)炎,蕁麻疹,血管神經(jīng)性水腫等多種病可歸入血瘀證范疇(2)Many kinds of modern diseases and

3、/or their clinical manifestations could be diagnosed within BSS category 代謝系統(tǒng):高脂血癥,糖尿病神經(jīng)血管并發(fā)癥等結(jié)締組織系統(tǒng):灼傷及外傷性皮膚瘢痕,角膜瘢痕等婦產(chǎn)科:功能性子宮出血,痛經(jīng),子宮內(nèi)膜異位癥,宮外孕,盆腔炎,子宮肌瘤等兒科:新生兒硬腫癥,肝炎及紫癜等皮膚科:紅斑結(jié)節(jié)類病,色素沉著性病,酒糟鼻眼科:視網(wǎng)膜血管阻塞病,眼部免疫病及退行性病口腔及耳鼻喉科:三叉神經(jīng)痛,突發(fā)性聾等骨科:骨折等外科:部分急腹癥等腫瘤科:血管瘤,肝癌等器官移植:排異反應(yīng)等中國傳統(tǒng)醫(yī)學(xué)特色診斷:血瘀證Chinese Medicine Fe

4、atures Diagnosis-BSS久病多瘀(慢瘀)溫?zé)岵≈匕Y必瘀(熱瘀)創(chuàng)傷外癥多瘀(傷瘀)急癥多瘀(急瘀)老年多瘀(老瘀)寒凝致瘀(寒瘀)紫舌無癥狀(潛瘀,前瘀)Blood and vessels stasis 血脈凝泣Evil blood 惡血Retained blood 留血Vascular obstruction 脈不通Injured blood stasis 損傷瘀血Blood-stasis due to accumulated cold 寒凝瘀血Blood-stasis due to anger 大怒瘀血血瘀證的經(jīng)典概念(1)Classical Concepts of BSS

5、Quoted from “Inner Classic of the Yellow Emperor” (West Han Dynasty, 100 B.C.) (選引自黃帝內(nèi)經(jīng))血瘀證的經(jīng)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 瘀血痹證Syncope due to blood-stasis 瘀血厥證Carbuncle due to

6、blood-stasis 瘀血成癰Blood-stasis with blood exhaustion 瘀血血枯Quoted from “Inner Classic of the Yellow Emperor” (West Han Dynasty, 100 B.C.) (選引自黃帝內(nèi)經(jīng)) “Many chronic diseases could have blood-collateral disturbances” (“久病入絡(luò)”)Quoted from Dr. Ye Tian-shis “Clinical Guidance with Case Studies” (Qing Dynasty,

7、16671746 A.D.) (選引自葉天士臨證指南醫(yī)案)慢性疾病血瘀證 “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、病之要決在于明氣血,氣有虛實,血有虧瘀”) Adopted from Dr. Wang Ching-rens “Corrections in Chinese Medicine” (Qing Dynasty, 17681831A.D.) (引自王清任醫(yī)林改錯)臨床重視血瘀證的治療十綱辨證(Diferentiation with ten principle syndromes) + 氣血辨證氣虛、氣陷、氣滯、氣逆血虛、血瘀、血熱氣滯血瘀、氣虛血瘀、氣血兩虛氣虛失血、氣隨血脫、痰瘀互結(jié)陰陽、寒熱、表里、虛實Principle Syndromesfrom eight to ten 血瘀證基本診斷條件(

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 舌下或他處瘀阻,唇或四肢青紫,梗阻 Bleeding and its consequence as blood-stool, subcutaneous purple scars 出血及其后遺證如黑便及皮下瘀斑血瘀證其他診

10、斷條件Other conditions (manifestation due to blood-stasis) for BSS diagnosis Rough skin, skin hypertrophy or alligator skin-crumps 肌膚甲錯 Menstruation disorder 月經(jīng)失調(diào) Numbness of extremeties or hemiplegia 肢體麻木或偏癱Mania with emotional excitement or amnesia (forgetfulness) 情志記憶失常 Periodical mental dysfunction

11、 周期性精神失常 Ascites 腹水臨床研究用定量血瘀證診斷標準記分方法The BSS scores for clinical diagnosis舌質(zhì)紫暗少腹部抵抗壓痛脈澀黑便病理性腫塊舌下脈曲張脈結(jié)代無脈腹壁靜脈曲張皮下瘀血斑月經(jīng)色黑有塊持續(xù)心絞痛一般固定性疼痛口唇齒齦暗紅細絡(luò)手足麻木(輕)8(重)10(輕)8(重)10101010(輕)8(重)1081010(輕)8(重)10(輕)8(重)10108655手術(shù)史腭粘膜征陽性肢體偏癱精神異常皮膚粗糙全血粘度升高血漿粘度升高體外血栓干重增加體外血栓濕重增加血小板聚集性增高血栓彈力圖異常微循環(huán)障礙血液動力學(xué)障礙纖溶活性降低血小板釋放功能亢進病理

12、切片示血瘀新技術(shù)顯示血管阻塞5(輕)4(重)5(輕)5(重)7(煩躁)4(狂躁)8(輕)4(重)5105108108101010101010注:判斷標準以19分以下為非血瘀證;2049分為輕度血瘀證;50分以上為重度血瘀證 三類活血化瘀藥物Three Kinds of ABC Herbs 1. 和血類藥物 Blood-harmonizing herbs Danggui ( Angelica sinensis ) 當(dāng)歸 Danpi (Paeonia suffruticosa Andr.) 丹皮 Danshen ( Salvia miltiorrhiza Bge. ) 丹參 Shengdihuan

13、g (glutinosa) 生地黃 Chishao (paeonia) 赤芍 Jixueteng (spatholobus suberectus) 雞血藤 Chuanxiong ( Ligusticum ) 川芎Puhuang ( Typha angustifolia ) 蒲黃Honghua (Carthamus tinctorius ) 紅花Liujinu ( Artemisia anomala S. Moore ) 劉寄奴Wulingzhi (Trogopterus xanthipes ) 五靈脂Yujin ( Curcuma aromatica Salisb. ) 郁金Sanqi ( P

14、anax notoginseng ) 三七Chuanshanjia (Manis pentadactyla ) 穿山甲Jianghuang ( Curcuma longa L. ) 姜黃Yimucao ( Leonurus heterophyllus Sweet ) 益母草Zelan (Lycopus lucidus Turcz. ) 澤蘭 2. 活血類藥物Blood-activating herbs三類活血化瘀藥物Three Kinds of ABC Herbs 2. 活血類藥物 Blood-activating herbsSumu (Caesalpinia sappan L. ) 蘇木Ha

15、ifengteng (Piper futokadsura Sieb.) 海風(fēng)藤Yizhihao ( Paris polyphylla Smith ) 一枝蒿Niuxi ( Achyranthes bidentata Blume ) 牛膝Mabiancao ( Verbena officinalis L. ) 馬鞭草Yanhusuo ( Corydalis turtschaninovii Bess.f. ) 延胡索Guijianyu ( Bidens bipinnata L. ) 鬼見羽Ziwei ( Campsis grandiflora ) 紫葳Wine 酒三類活血化瘀藥物Three Kin

16、ds of ABC Herbs 3.破血類藥物Blood-stasis-removing herbs Dahuang ( Rheum palmatum L. ) 大黃Shuizhi (Whitmania pigra ) 水蛭Mengchong ( Tabanus bivittatus Mats.) 虻蟲Sanleng ( Sparganium stoloniferum Buch.-Ham. ) 三棱Erzhu (Curcuma zedoaria ) 莪術(shù)Ruxiang (Boswellia carterii Birdw. ) 乳香Moyao ( Commiphora myrrha Engl.

17、) 沒藥Xuejie ( Daemonorops draco Bl. ) 血竭Taoren ( Prunus persica ) 桃仁三類活血化瘀藥物Three Kinds of ABC Herbs神農(nóng)本草經(jīng)確載活血化瘀藥分析41/365種丹參、 牡丹皮、 牛膝、 芍藥、 桃仁、 虻蟲、 蟄蟲、川芎、 鱉甲、 蠐螬、 烏賊骨等大黃、 柴胡之推陳致新作用活血化瘀兼治痰瘀藥物舉隅Examples of relieving BSS and phlegm accumulations herbs藥名藥物歸類大黃南星菖蒲郁金香附川芎蒲黃水蛭益母草澤蘭毛冬青薤白旋復(fù)花海風(fēng)藤王不留行羌活陳皮通腑藥化痰藥芳香化

18、濕藥活血化瘀藥行氣藥活血化瘀藥止血藥活血化瘀藥活血化瘀藥活血化瘀藥活血化瘀藥行氣藥止咳平喘藥祛風(fēng)濕藥活血化瘀藥祛風(fēng)濕藥行氣藥34種活血化瘀藥的比較研究觀察指標(26項):血液粘滯血小板功能紅細胞變形性血栓形成試驗冠脈流量心肌收縮力心肌細胞耗氧量其他Nourishing blood and promoting blood circulation 養(yǎng)血活血 (Tao Hong Si Wu Tang Formula桃紅四物湯)Purgatives with removing blood-stasis 通腑祛瘀(Tao He Cheng Qi Tang Formula桃核承氣湯)Tonifying Y

19、ang and promoting blood circulation 補陽活血 (Sheng Hua Tang Formula生化湯)Eliminating Wind and removing blood-stasis 祛風(fēng)化瘀 (Shen Tong Zhu Yu Tang Formula身痛逐瘀湯)Opening orifice and promoting blood circulation 開竅活血(Tong Qiao Huo Xue Tang Formula通竅活血湯)Dispersing lumps and removing blood-stasis 散結(jié)化瘀 (Gui Zhi Fu

20、 Ling Wan Formula桂枝茯苓丸)血瘀證治療原則和方劑(2)Therapeutic principles and formulas for BSS日本常用活血化瘀方劑及其組成序號方劑名稱出典藥物組成1桃核承氣湯傷太陽病桃仁、桂枝、芒硝、大黃、甘草2抵當(dāng)湯金太陽病,陽明病金瘀血病,婦人雜病桃仁、水蛭、虻蟲、大黃3大黃蟄蟲丸金血痹虛勞病大黃、黃芩、桃仁、杏仁、甘草、芍藥、地黃、干漆、虻蟲、蠐螬、水蛭、蟄蟲4大黃牡丹皮湯金血瘡癰腸癰浸淫病桃仁、牡丹皮、芒硝、大黃、冬瓜子5桂枝茯苓丸金婦人妊娠病桂芝、茯苓、牡丹皮、桃仁、芍藥6芎歸膠艾湯金婦人妊娠病阿膠、川芎、甘草、艾葉、當(dāng)歸、芍藥、地黃7

21、當(dāng)歸芍藥散金婦人妊娠病當(dāng)歸、川芎、芍藥、茯苓、白術(shù)、澤瀉8下瘀血湯金婦人產(chǎn)后病大黃、桃仁、蟄蟲9溫經(jīng)湯金婦人雜病吳茱萸、當(dāng)歸、川芎、芍藥、人參、桂枝、阿膠、牡丹皮、甘草、生姜、半夏、麥門冬注:(1)傷:指傷寒論,金:指金匱要略; (2)重者,用偏寒性及蟲類藥 張仲景活血化瘀古方新用當(dāng)歸芍藥散 (癡呆,記憶功能障礙)大黃牡丹皮湯(闌尾炎)溫經(jīng)湯 (閉經(jīng)、帶證)鱉甲煎丸 (肝脾腫大)大黃蟄蟲丸 (風(fēng)心?。┨胰食袣鉁?(精神神經(jīng)疾患)下瘀血湯 (產(chǎn)后腹痛)抵當(dāng)湯 (月經(jīng)不利)紅藍花酒 (婦女病、心痛)王不留行散 (外傷性出血)黃帝內(nèi)經(jīng) 的活血化瘀方劑四烏賊骨一蘆茹丸 組成:茜草,烏賊骨,鮑魚,雀卵

22、功效:活血化瘀,溫經(jīng)補腎醫(yī)學(xué)衷中參西錄 (張錫純) 治白帶惡臭醫(yī)方理帶湯 烏賊骨、茜草、生龍牡、山藥抗心梗合劑(AMI Mixture)組成:黃芪30g、黨參15g、黃精15g、 丹參30g、赤芍15g、郁金15g功效:益氣活血 Planta Medica,1983;48(1):63-64愈梗通瘀湯(自擬,1990)組成:生曬參1015g,生黃芪15g,紫丹參15g,全當(dāng)歸10g,延胡索10g,川芎10g,廣藿香1218g,佩蘭1015g,陳皮10g,半夏10g,生大黃610g功效:益氣活血,祛瘀抗栓,利濕化濁適應(yīng)癥:用于心肌梗死急性期及恢復(fù)期患者,能夠促進梗塞組織愈合,保護心功能,改善生存質(zhì)

23、量,延長壽命處理好通與補的關(guān)系人參三七元胡粉(郭士魁經(jīng)驗方,1985)人參三七琥珀粉(岳美中經(jīng)驗方,1964)人參三七元胡粉(1.5:1.5:3):益氣活血,理氣定痛人參三七琥珀粉(1.5:1.5:0.5):益氣,活血,安神活血化瘀八個古方主要藥效學(xué)作用比較方劑名稱心腦血管作用抗 清 抗 減 減缺 抗 抗 抗血 除 急 少 輕血 血 血漿 離 在小 氧 性 心 心樣 栓 6-K-PGF1 體 體板 自 腦 肌 肌損 形 /TXB2 心 心聚 由 缺 細 細傷 成 比值升高 肌 肌集 基 血 胞 胞 缺 缺 耗 血 血 氧四物湯桃紅四物湯補陽還五湯血府逐瘀湯少腹逐瘀湯膈下逐瘀湯身痛逐瘀湯通竅活血

24、湯 + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + +八個經(jīng)典古方的比較研究活血化瘀方臨床治療應(yīng)用Clinical trial of ABC formulas for certain diseases抗心絞痛和抗血小板治療 Treatment of anti-angina pectoris and anti-platelet預(yù)防冠心病PTCA/支架治療后再狹窄 Prevention of restenosis after PTCA/stenting i

25、n CHD血府逐瘀湯及其有效部位的應(yīng)用 By the application of Xue Fu Zhu Yu Tang Formula冠心號復(fù)方組成川芎 Ligusticum wallichii赤芍 Paeonia obovata丹參 Salvia miltiorrhiza紅花 Carthamus tinctorius降香 Dalbergia odorifera病 種心絞痛腦梗塞治療例數(shù)5316695顯 效 率21.9245.32平均有效率88.2690.63冠心號類活血藥的臨床應(yīng)用冠心病不同治法的療效比較治 法 療 效宣痹通陽法 治標為主,有效率 6070%活血化瘀法 標本兼治, 有效率

26、88.26 % 編者按:本文是一篇水平較高的工作總結(jié),其突出的優(yōu)點是研究的設(shè)計和方法使臨床資料具有較好的對比性,因而,它的結(jié)論就具有較強的說服力。藥物組別療程例數(shù)總有效率(%)顯效(%)改善(%)無效(%)加重(%)精制冠心片甲組第一6177.026.250.821.41.6乙組第二5184.333.351.015.70共 計11280.429.550.918.70.9安慰劑組甲組第一618.21.66.690.21.6乙組第二5125.5025.570.63.9共 計11216.10.915.281.22.7中華心血管病雜志1982年第10卷第2期 臨床論著精制冠心片雙盲法治療冠心病心絞痛1

27、12例療效分析精制冠心片精制冠心顆粒冠心?。ㄐ慕g痛、心肌梗死)中醫(yī)辨證試行標準(1980)擴大活血化瘀治療范圍達 54種疾病,充分發(fā)揮中醫(yī)藥優(yōu)勢,特別是心腦血管病療效明顯提高個體化、合理應(yīng)用、方證相應(yīng),是取得療效的前提活血化瘀治法的推廣應(yīng)用-活血化瘀現(xiàn)象川芎嗪對缺血性中風(fēng)的效果The efficacy of Ligustrazine for Ischemic StrokeTetramethylpyrazine川芎嗪毒性與代謝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抗血小板中藥示例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. 川芎嗪靜脈應(yīng)用對缺血性中風(fēng)臨床療效The clinical efficacy on ischemic stroke by IV use with LigustrazineCompared with papaverine clinical curative rate:43與40 remar

30、kable effective rate:23與22 effective rate :23與10 none effective rate:11與22 total effective rate: 88.6與78.0% (administrations:ivgtt, 80mg/d10)中藥抗血小板作用Antiplatelet effect of Chinese MedicineChi Shao, Radix Paeoniae rubra 赤芍Dan Shen, Radix Salviae Miltiorrhizae 丹參Chuan Xiong, Rhizoma Ligusticum Wallich

31、ii 川芎Pu Huang, Pollen Typhae 蒲黃Yi Mu Cao, Herba Leonuri 益母草Wang Bu Liu Xing, Semen Vaccariae 王不留行Hong Hua, Flos Carthami 紅花其他抗血小板中藥有效成分Other effective components isolated from herbal medicines for antiplateletFerulio acid(阿魏酸)Tanshin Phenolic Acids A (丹參素)Propyl Gallate(赤芍801, 沒食子酸丙酯)Berberine (小檗堿)

32、Saponin of notoginseng (三七皂甙)芍藥酚52021(銀杏內(nèi)酯)Tetrandrine (粉防己堿)Quercetin(槲皮素)Kadsurenone(海風(fēng)藤酮)(新燈盞花素)甲基蓮心堿()Rhynchophylline (鉤藤堿)Ginsenosides(人參總皂甙)Gypenosides(絞股藍總皂甙)黃山藥總皂甙蒺藜總皂甙組 別劑量/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)組合對ADP誘導(dǎo)的血小板體內(nèi)凝集的抑制作用(n=7) 與NS組比較:a:P0.01;與

33、TMPz組比較:b:P0.01 藥 名其它制劑主要成分規(guī)格用 法丹參注射液丹參粉針劑丹參10ml/支1020ml/d, 入液靜點復(fù)方丹參注射液香丹注射液丹參、降香等10ml/支1020ml/d, 入液靜點血栓通注射液血塞通注射液三七總皂甙5ml/支10ml/d, 入液靜點燈盞花細辛注射液燈盞花細辛總黃酮45mg/支180225mg/d, 入液靜點川芎嗪注射液興諾; 川 信川芎嗪40mg/支80120mg/d, 入液靜點葛根素注射液戈榮葛根素100mg/支400500mg/d,入液靜點初步認為具有抗血小板作用的常用活血化瘀注射劑藥名組成規(guī)格用法精制冠心片(顆粒)降香、丹參、川芎、赤芍、紅花0.5

34、g/片68片,tid復(fù)方丹參滴丸丹參、三七、冰片25mg/粒10粒, tid地奧心血康黃山藥甾體總皂苷100mg/粒12粒, tid心血寧片葛根提取物、山楂提取物0.2g/片4片, tid丹七片丹參、三七0.3g/片35片, tid黃楊寧片小葉黃楊及其同屬植物提取物12片, tid樂脈顆粒丹參、川芎、赤芍、紅花、山楂等3g/包12包, tid冠脈寧片丹參、沒藥、雞血藤、血竭、延胡索、當(dāng)歸、郁金、制何首烏、桃仁、黃精、紅花、葛根、乳香、冰片0.5g/片3片, tid血府逐瘀膠囊當(dāng)歸、川芎、生地黃、赤芍、桃仁、紅花、牛膝、柴胡、枳殼、桔梗、甘草0.4g/粒6粒, bid通心絡(luò)膠囊人參、水蛭、土鱉蟲

35、、全蝎、蜈蚣、蟬蛻、赤芍、冰片等0.38g/粒24粒, tid舒心口服液黃芪、黨參、紅花、當(dāng)歸、川芎、三棱20ml/支20ml, tid山海丹膠囊三七、人參、黃芪、紅花、山羊血粉、決明子、葛根、佛手、海藻、何首烏、丹參、川芎等0.5g/粒5粒, tid麝香保心丸麝香、人參、蘇合香、蟾酥等22.5mg/丸12丸, tid諾迪康膠囊圣地紅景天0.28g/粒12粒, tid冠心蘇合丸蘇合香、冰片、乳香、檀香、青木香0.35g/粒1丸,qd tid心通口服液黃芪、麥冬、丹參、海藻、昆布、黨參、葛根、川芎等10ml/支2支, tid初認具有抗血小板作用常用活血化瘀口服中成藥抗血栓藥適應(yīng)癥The indi

36、cations of antithrombotic drugsAcute coronary syndrome (ACS),急性冠脈綜合征Myocardial infarction (MI),心肌梗死Ischemic stroke,缺血性中風(fēng)Venous thrombembolism (VTE),靜脈血栓栓塞Peripheral arterial occlusion (PAO),周圍動脈阻塞Atrial fibrillation,心房顫動抗血栓藥適應(yīng)癥The indications of antithrombotic drugsPolycythemia vera,真性紅細胞增多癥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冠心病介入治療后再狹窄的中醫(yī)干預(yù)治療研究 Charged by:Xiyuan Hospital, China Academy of TCM 承擔(dān)單位:中國中醫(yī)研究院西苑醫(yī)院 Coordinated by:Beijing An-zhen Hospital 北京安貞醫(yī)院 合作單位: Beijing Tong-ren Hospital 北京同仁醫(yī)院 China-Japan Friendship

38、 Hospital 中日友好醫(yī)院 Guangdong Provincial Hospital of TCM 廣東省中醫(yī)院 Beijing International Institute of Biologic Products 北京國際生物制品研究所The National Tenth “Five-year” Project “十五”國家科技攻關(guān)計劃課題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我國 PCI 開展現(xiàn)狀開展 PCI 手術(shù)的醫(yī)院 到 1993年 30家醫(yī)院 到 1999年 200家醫(yī)院接收 PCI 治療的患者 到 1993年 1000 例 (累計) 1998年 5000 例/年 1999年 8000 例/年 2000年 20000 例

40、/年 2004年 70000 例/年P(guān)rogress 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再狹窄(RS)研究進展再狹窄仍然是限制冠狀動脈介入治療遠期療效的主要因素雖然國際上進行了大量干預(yù)再狹窄的臨床試驗,但目前還沒有找到理想的治療手段支架植入術(shù)具有一定的效果,但再狹窄發(fā)生率仍然在20%30%之間。藥物涂層支架顯是有良好的前景,但研究結(jié)果報道不一,其昂貴的價格也限制了其在國內(nèi)的推廣應(yīng)用血府逐瘀湯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),F(xiàn)los Carthami (紅花) , Radix Angelicae (當(dāng)歸);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 (枳殼),Radix Platycodi (桔梗);Envoy (使) Radix Glycyrrhizae (甘草).介入治療后再狹窄Restenosis Post PTCA/Stent 中醫(yī)“血瘀證”BSS經(jīng)典活血化瘀方血府逐瘀制劑XFZYT簡化方藥ModifiedXFZYT精制血府膠囊Concentrated XFZYT芎芍膠囊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 我們既往 實驗研究 (中國小型豬, VG50) 冠狀動脈球囊損傷后4周 A:對照組B:普羅布考組C:血管通組D:芎芍小組E:芎芍大組F:正常對照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臨床研究進程再狹窄中醫(yī)“血瘀證”經(jīng)典活血化瘀方血府逐瘀制劑有 效精簡優(yōu)化

46、方藥芎芍膠囊SMC增殖血小板聚集血栓形成血管重構(gòu)川芎、赤芍有效部位 循證醫(yī)學(xué)原則?隨機對照試驗?小規(guī)模臨床試驗 顯示其有效性O(shè)bjectivesTo 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.研究目標按照EBM和GCP原則,采用多中心、隨機雙盲、安

47、慰劑對照方法,客觀評價活血化瘀中藥制劑干預(yù)冠心病介入治療后再狹窄的臨床療效Grouping MethodControl GroupRoutine treatment + placebo Cap. Treatment GroupRoutine treatment + Xiongshao Cap.分組方法對照組:西藥常規(guī)治療 +安慰劑組治療組:西藥常規(guī)治療 +芎芍膠囊組Placebo Cap.安慰劑膠囊Xiongshao Cap.芎芍膠囊They have the same form of preparation, appearance and color. Both have correspon

48、dent quality examination record.兩者在劑型、顏色、外觀上完全相同,均有相應(yīng)質(zhì)量檢測報告。Placebo-controlled安慰劑對照治療藥物藥學(xué)研究川芎總酚和赤芍總甙兩味中藥有效部位混勻制顆粒,裝入膠囊。選擇微晶纖維素作為膠囊劑輔料,經(jīng)三批中試生產(chǎn),制備工藝考察證明了工藝可靠、質(zhì)量穩(wěn)定。Double-blind MethodBlind toPatients;Physician;CAG data analyzer;Statistic analyzer. 雙盲方法盲法針對患者;臨床醫(yī)生;CAG 數(shù)據(jù)分析人員;統(tǒng)計分析者.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診斷標準冠心病診斷標準 參照WHO缺血性心臟病診斷標準 冠脈造影再狹窄標準 血管成形術(shù)后殘余狹窄50% PCI術(shù)成功的標準 靶血管PCI術(shù)后即刻管腔直徑狹窄減少超過 20% ,且殘余狹窄不超過 50%冠狀動脈病變分型標準參照 1988年美國心臟病學(xué)會和美國心臟協(xié)會(ACC/AHA)制定的標準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納入標準年齡在3570歲有心絞痛癥狀和/或心肌缺血的客觀證據(jù)近期冠狀動

52、脈造影證實冠狀動脈有顯著狹窄(50%);行PTCA及冠脈內(nèi)支架植入術(shù)成功的患者;或AMI患者行急診介入治療成功的患者中醫(yī)辨證分型不限Exclusion CriteriaRestenosis lesion or graft vessel lesionChronic completely obstructive lesion (3mons);Severe left main artery lesion;Severe heart failure (EF3個月);嚴重左主干病變;嚴重心功能不全(EF0.05Age (年齡)(MeanSD)(yr)58.5210.3058.749.910.05Heigh

53、t (身高) (MeanSD)(cm)167.387.21167.666.940.05Weight (體重) (MeanSD)(kg)72.4410.7871.0710.090.05Hypertension (高血壓)85(54.1)84(53.5)0.05Diabetes (糖尿病)28(17.8)32(20.4)0.05Hyperlipidemia (高脂血癥)45(28.7)38(24.2)0.05Diagnosis (診斷) Stable angina (穩(wěn)定性心絞痛)4(2.5)6(3.8)0.05 Unstable angina(不穩(wěn)定性心絞痛)94(59.9)87(55.4)0.

54、05 AMI (急性心肌梗死)59(37.6)64(40.8)0.05基線臨床資料比較 Baseline Clinical Characteristics治療組對照組P值基線冠脈造影資料比較Baseline Angiographic CharacteristicsComparison of clinical end-point event 兩組臨床終點事件的比較 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 重復(fù)介入治療15 1.91 314.46 Event終點事件Treatment 治療組Control 對照組 N (%) N (%) CABG 冠脈搭橋 00.00 30.00 兩組臨床結(jié)果比較 Clinical Outcome Treatment PlaceboGroup分組Repeat Angiography重復(fù)冠脈造影(N)RS (再狹窄)New Lesion (新病變)N(

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