201011 Distinguished Scholar Lecture Series 201011 The System

2010/11年度「傑出學人系列」講座 Distinguished Scholar Lecture Series 2010/11 針藥結合治療缺血性中風病的 系統研究 The System Research of Acupuncture and Herbs to Treat Ischemic Stroke 石學敏 SHI Xuemin 中國 程院院士 天津中醫藥大學第一附屬醫院榮譽院長 Academician, Chinese Academy of Engineering Honorary President, The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

中風病的治療難點 The problem of treating apoplexy 如何減輕血管神經單元的損害、促進重構神經組 織、重建腦組織迴圈是神經功能恢復的根本。中風病 治療的難點及突破點，聚焦在神經與血管的新生。 How to reduce the damage of neurovascular unit, promote reconstruction nerve tissue and reconstruction brain circulation is neurological recovery. The treatment of stroke, focus on problems and breakthrough of new blood vessels and nerves.

目前，治療中風病最有效的方法是卒中單元，但是現代 醫學意義上的卒中單元需要較高的軟硬體配備，無法於現有 醫療資源基礎上推廣應用。所以，如何利用有效的中醫手段 構建符合中國特色的“中風單元”是今後重要的研究方向。 Currently, the treatment of stroke are the most effective ways to stroke, but modern medical unit on the significance of the software and hardware unit needs higher stroke with existing medical resources, not in based on application. Therefore, how to effectively use the traditional method to set up Chinese characteristic "stroke unit" is an important research direction in future.

針刺和有效中藥製劑是我國治療中風病的重要手段，也 是構建“中風單元”的主要因素。由“醒腦開竅針刺法”、“丹 芪偏癱膠囊”相結合為關鍵內核的“石氏中風單元”，在臨床 上取得了顯著療效，並被國家列為重大科技推廣專案。 Acupuncture and herbs are effective treatment in China and an important factor of "stroke unit". “Shi’s stroke unit” which be made of “XNKQ” acupuncture therapy and Danqi hemiplegia capsule, get great clinical effect, and has achieved remarkable listed by the state science and technology major promotion projects.

在選穴上以陰經和督脈穴為主，並強調針刺 手法量學規範，有別於傳統的取穴和針刺方法。 The points on Yin meridians and Du meridian are mainly selected and standard quantitative manipulations are applied emphatically, which are quite different from traditional point selection and acupuncture manipulations in treatment of apoplexy.

治 療 方 法 Treatment

1. 處 方 主穴：內關(手厥陰心包經) 人中(督脈) 三陰交(足太陰脾經) 1. Point Prescription Mainpoints: Neiguan(PC 6, the Pericardium Meridian of Hand-Juejin) Renzhong(DU 26, the DU Meridian) Sanjinjiao(SP 6, the Spleen Meridian of Foot-Taiyin)

輔穴：極泉(手少陰心經) 委中(足太陽膀胱經) 尺澤(手太陰肺經) Supplementary points： Jiquan(HT 1, the Heart Meridian of Hand-shaoyin) Weizhong(BL 40, the Bladder Meridian of Foot-Taiyang) Chize(LU 5, the Lung Meridian of Hand-Taiyin))

配穴：吞咽障礙加風池、翳風、完骨；手指 握固加合穀；語言不利加上廉泉，金津、玉 液放血；足內翻加丘墟透照海。 Point Modification: For difficulty of swallowing, Fengchi(GB 20), Yifeng(SJ 17) and Wangu(GB 12) are added. For failing to extend fingers with stiffness, Hegu (LI 4) is added. For slurred speech, Shanglianquan(EX-HN) is added, and Jinjin(EX-HN 12) and Yuye(EX-HN 13) are used with blood-letting method. For strephenopodia, penetrating method from Qiuxu(GB 40) to Zhaohai(KI 6) is used.

2. 操作方法 Manipulation 内 關 Neiguan (PC 6) 直刺 0. 5 -1寸，採用撚轉提插結合瀉法，施手法 1分鐘； First puncture bilateral Neiguan(PC 6) perpendicularly for 0. 5 -1 cun, using combinative reducing method of lifting-thrusting and twirlingrotating the needle for 1 minute;

人 中 Renzhong (DU 26) 向鼻中隔方向斜刺 0. 3 -0. 5寸，用重雀啄法， 至眼球濕潤或流淚為度； Secondly puncture Renzhong(DU 26) obliquely upwards to the nasal septum for 0. 3 -0. 5 cun with heavy bird-pecking method until the patient’s eyeballs are moistened or tears flow down.

三 陰 交 Sanyinjiao (SP 6) 沿脛骨內側緣與皮膚呈45度角斜刺，進針 1~1. 5，用提 插補法，使患側下肢抽動 3次為度 Thirdly puncture Sanyinjiao(SP 6) obliquely for 1 -1. 5 cun, at the angle of 45 degrees with the skin surface along the posterior border of the medial aspect of the tibia, with reinforcing method of lifting and thrusting the needle to make the affected low limb have tic for three times.

三 陰 交 Sanyinjiao (SP 6) 沿脛骨內側緣與皮膚呈45度角斜刺，進針 1~1. 5，用提 插補法，使患側下肢抽動 3次為度 Thirdly puncture Sanyinjiao(SP 6) obliquely for 1 -1. 5 cun, at the angle of 45 degrees with the skin surface along the posterior border of the medial aspect of the tibia, with reinforcing method of lifting and thrusting the needle to make the affected low limb have tic for three times.

極 泉 Jiquan (HT 1) 原穴沿經下移 1寸，避開腋毛，直刺 1 -1. 5寸， 用提插瀉法，以患側上肢抽動 3次為度。 Select Jiquan(HT 1) point at 1 cun below the original location along the heart meridian to keep away from the armpit hair, puncture perpendicularly for 1 -1. 5 cun with reducing method of lifting and thrusting the needle to make the affected upper limb have tic for three times.

尺 澤 Chize (LU 5) 屈肘成 120度角，直刺 1寸，用提插瀉法， 使患者前臂、手指抽動 3次為度。 Perpendicularly puncture Chize(LU 5) for 1 cun depth while the forearm bends to form an angle of 120 degrees with reducing manipulation of lifting and thrusting the needle until the affected arm and fingers have tic for three times.

委 中 Weizhong (BL 40) 仰臥直腿抬高取穴， 直刺 0. 5 -1寸，施提 插瀉法，使患側下 肢抽動 3次為度。 Select Weizhong(BL 40) point with the supine position and the lower limb lifted, puncture perpendicularly for 0. 5 -1 cun, with reducing method of lifting and thrusting to make the lower limb have tic for 3 times.

風池、完骨、翳風 Fengchi(GB 20) Wangu(GB 12) Yifeng(SJ 17) 針向結喉，進針 2 -2. 5寸採用小幅度高頻率撚轉補法， 每穴施手法 1分鐘； Puncture Fengchi(GB 20), Wangu(GB 12) and Yifeng(SJ 17) in the direction of the laryngeal protuberance for 2 -2. 5 cun, with reinforcing manipulation of twirling and rotating the needle in high frequency and small amplitude for 1 minute to each acupoint.

合谷針向三間穴 Hegu(LI 4) to Sanjian(LI 3) 進針 1 -1. 5寸，採用提插瀉法，使患者第二手指 抽動或五指自然伸展為度； Puncture Hegu(LI 4) 1 -1. 5 cun in depth with the needle tip toward Sanjian(LI 3), with reducing method of lifting and thrusting to make the patient’s second finger or five fingers extended freely.

上廉泉 Shanglianquan (EX-HN) 針向舌根 1. 5 -2寸，用提插瀉法； Puncture Shanglianquan(EX-HN) for 1. 5 -2 cun, with the needle tip towards the root of the tongue and reducing method of lifting and thrusting the needle.

金津、玉液 Jinjin(EX-HN 12) Yuye(EX-HN 13) 用三棱針點刺放血，出血1 -2毫升； Prick Jinjin(EX-HN 12) and Yuye(EX-HN 13) with the three-edged needle to cause bleeding for 1 -2 ml.

丘墟透向照海穴 Qiuxu(GB 40) to Zhaohai(KI 6) 約1. 5 -2寸，局部酸脹為度。 Puncture Qiuxu (GB 40) 1. 5 -2 cun in depth with the needle tip toward Zhaohai(KI 6), until soreness and distension occurred locally.

中風病其他併發症的治療 Treatment of Complications

(1)便秘：針外水道、外歸來、豐隆 Constipation: Puncture Waishuidao(EX-CA), Waiguilai(EX-CA) and Fenglong(ST 40)

(2)呼衰：針刺雙側氣舍 Respiratory Failure: Puncture bilateral Qishe(ST 11)

(3)尿失禁、尿潴留：針中極、曲骨、 關元、局部施灸、按摩或熱敷 Incontinence of Urine, Retention of Urine: Puncture Zhongji(RN 3), Qugu(RN 4), Sanyinjiao (SP 6), Yinlingquan(SP 9). Moxibustion is applied on the local area, while massage and hot compress are applicable too.

(4)共濟失調：針風府、啞門、頸椎夾脊穴 Ataxia: Puncture Fengfu(DU 16), Yamen(DU 15) and cervical Jiaji points(EX-B 2).

頸 椎 夾 脊 穴 Cervical Jiaji Points(EX-B 2)

(5)複視：針天柱、晴明、球後 Double Vision: Puncture Fengchi(GB 20), Tianzhu(BL 10), Jingming(BL 1) and Qiuhou(EX-HN 7)

(6)癲癇：針大陵、鳩尾 Epilepsy: Puncture Daling(PC 7), Jiuwei(RN 15)

(7)肩周炎：針肩髃、肩髎、肩內陵、 肩貞、肩中俞、肩外俞，痛點刺絡拔罐 Periarthritis of Shoulder: Puncture Jianneiling(EX-UE), Jianliao(SJ 14), Jianzhen(SI 9), Jianzhongshu(SI 15), Jianwaishu (SI 14). Apply blood letting and cupping method to the local pain point.

(8)血管性痴呆：針百會、四神聰、 四白、太沖 Vascular Dementia: Puncture Baihui (DU 20), Sishencong(EX-HN 1), Sibai(ST 2) and Taichong(LR 3).

太 沖 Taichong(LR 3)

(9)睡眠倒錯：針上星、神門 Paradoxic Sleep: Puncture Shangxing (DU 23), Shenmen(HT 7).

在 30餘年的臨床實踐中，逐步形成了針刺治療缺血性中 風病及其併發症的診療規範和評價體系。近年來更是引入先進 的研究方法和手段，對其療效進行了綜合系統的評價，獲得了 高級別的臨床證據，並結合現代科學技術，系統地闡明了針刺 治療缺血性中風病的科學內涵及療效機理。 In more than 30 years of clinical practice, gradually formed the acupuncture treatment of ischemic apoplexy and the treatment of complication norms and evaluation system. In recent years is introduced advanced research methods and its effect on the comprehensive evaluation system, advanced clinical evidence, and combined with the modern science and technology, systematically expounds the acupuncture treatment of ischemic stroke mechanism of scientific connotation and curative effect.

臨床研究嚴格按照循證醫學原則進行RCT試驗證明： Clinical studies in strict accordance with the principle of evidencebased medicine RCT experiments prove： 針刺可明顯改善各期中風患者神經功能缺損程度 Acupuncture can obviously improve the neurologic deficits in stroke patients NIHSS CSS SSS 39

針刺可改善各期中風患者日常生活能力，急性期的改善尤其明顯 Acupuncture may improve the stroke patients in daily life, especially in the acute phase of improvement BI BI改变量

6個月隨訪證實，針刺可改善各期中風患者神經功能缺損及日常生 活能力的作用 6 months follow-up, acupuncture can improve the stroke patients neurologic deficits and daily life 神經功能缺損（SSS） 日常生活能力（SS-QOL） 41

針刺可降低各期中風患者殘障程度 Acupuncture may reduce the degree of disability in stroke patients 牛津殘障評分（OHS） 牛津殘障評分 66% 63% 76% 33% 40% 急性期 恢复期 后遗症期

終點指標： End index： 針刺可降低缺血性中風病患者的復發率和死亡率 Acupuncture may reduce the recurrence of patients with ischemic stroke mortality 復 發 率 死 亡 率 6. 7% 15. 9% 28. 8% 3. 3% 4. 3% 2. 2% 1. 1% 1. 7% 2. 2% 1. 1% 0. 86% 0 急性期 恢復期 後遺症期

安全性評價： Safety evaluation: Ø 不良反應：未出現嚴重不良反應 Adverse reaction: did not appear serious adverse reactions Ø 極少數出現輕微不良反應，主要有皮下出血，血 腫，疼痛。 A mild adverse reactions, subcutaneous bleeding, hematoma, pain

本研究獲得了天津市科技進步一等獎 The research of the Tianjin science and technology progress prize

針刺治療缺血性中風病的機理研究 The mechanism research of Acupuncture treatment ischemic stroke 機理研究緊扣中風病的治療難點及突破點，聚焦在神經與血 管的再生。研究針刺手段促進損傷後腦迴圈重建及神經細胞再生 的作用，從形態學、生物化學、中樞神經機制、分子生物學等方 面開展了二十餘項基礎實驗。 Defines the mechanism research and treatment of apoplexy, focusing on nerve and breakthrough of blood vessels. Research methods to promote the head injury acupuncture and nerve cells regeneration cycle, from the morphology, biochemistry, molecular biology, central nervous mechanism for more than twenty experiments.

醒腦開竅針刺法對缺血區腦組織的改善 47 “XNKQ” can improve the brain ischemia area 形態學研究，證明針刺可促進側枝迴圈建立 Morphology research that acupuncture can promote collateral circulation 阻斷大腦中動脈後，大腦表面缺血區所見： Block after middle cerebral artery surface area, the brain ischemia 梗塞半球 腦表面缺血區 缺血後 自身代償情況 針刺干預情況 Cerebral infarction hemisphere surface ischemia After compensatory. Their ischemia Acupuncture intervention

醒腦開竅針法對腦梗死患者腦葡萄糖代謝的影響 Acupuncture in patients with cerebral infarction of the brain glucose metabolism 醒腦開竅針刺法可以： • 促進病灶周圍功能重組 Promote surrounding function restructuring • 啟動運動功能區域 Activation function area • 促使正常腦區的代償 To decompensation the normal brain areas • 改善與記憶、認知、語言功能和情緒等相關區域的代謝 Improve memory, cognition, emotion and language functions related areas of metabolism 49

l 治療中風病恢復期的國家新藥，純中藥製劑 Treatment of national drug stroke recovery, traditional Chinese medicine preparation l 具有補氣活血、豁痰熄風的功效 Fill with blood, and the efficacy of wind tax-exempt phlegm off l 2001年獲國家新藥證書（國藥准字z 20010105） 2001 was approved by the state drug certificate (z 20010105) l 2002年獲得國家GMP認證並投產上市 2002 obtains the national GMP authentication and production

丹芪偏癱膠囊的藥物組成及功效 The capsule and partial drug efficacy 處方：黃芪、丹參、川芎、水蛭、人 牛黃、全蠍、石菖蒲等 Prescription: astragalus, danshen, artificial bezoar and leeches, chuanxiong rhizoma, whole xie, etc. 功能：益氣活血，豁痰熄風 Function: qi, sputum extinguish wind. Tax-exempt

藥物作用及特點 Drug and characteristics 1. 減少腦梗死面積：藥理實驗表明，該藥可以有效降低腦梗塞組 織百分比，改善實驗動物行為障礙。 1. Reduce cerebral infarction area: the pharmacological experiments show that can effectively reduce cerebral infarction, the improvement of experimental animals percentage organization behavior. 2. 保護及修復受損腦細胞：藥理實驗表明，該藥增加腦供血，有 效恢復受損腦細胞功能。 2. Protection and repair damaged brain cells: that the drug increases pharmacological experiments, recover damaged brain cells cerebral blood.

3. 有效恢復肢體功能：臨床實驗結果顯示，該藥對改善肢體功 能效果明顯。 3. Effectively restore limb function: clinical experiment results show that the drug to improve functional effect is obvious. 4. 降低血粘度：藥理實驗及臨床實驗表明，該藥改善血液流 變學指標，降低血粘度。 4. Reduced blood viscosity, pharmacological experimental and clinical experiments showed that the drug improving hemorheology indices, reduce blood viscosity.

5. 重病重劑，起效迅速：腦卒中病情較重，不用重劑難以起 效，故每日每次用量較大，經過臨床觀察，該藥對恢復早期 腦卒中患者，起效迅速。 5. Illness weight, agent quickly: stroke disease is heavier, not heavy agent to effect, so every large dosage, daily clinical observation, the drug for early stroke patients, quickly. 6. 全成分提取生產 藝先進：採用韓國技術製造的動態提取 設備，充分提取有效成份。 6. All components extraction advanced production technology, USES the south Korean technology of manufacturing equipment, fully dynamic extracting effective components extraction.

丹芪偏癱膠囊，已獲得國際認可 Hemiplegia capsule, has gained international recognition 题目：Dianqi Piantang Jiaonang(DJ), a traditional Chinese Medicine in post-stroke recovery 中藥丹芪偏癱膠囊在中風後的康復作用 雜誌：Stroke 卒中（美国） 影響因子： 6. 499 作者：Christopher Chen, MD (新加坡國立大學藥理學博士) 結論：經過對605例患者進行隨機對照研究證明，與對照中成藥相比丹芪偏 癱膠囊可顯著改善患者神經功能缺損，提高生活品質，且具有較好的 安全性。 After patients required for 605 randomized study compared with controls, proprietary hemiplegia capsules can significantly improve patient neurologic deficits, and improve the quality of life, and has good safety.

题目：Neuroprotective and neuroproliferative activities of Neuro. Aid (MLC 601, MLC 901), a Chinese medicine, in vitro and in vivo 中藥丹芪偏癱膠囊(MLC 601, MLC 901)在體內、體外的神經保護及再生作用 雜誌：Neuropharmacology 神經藥理學雜誌（英國） 影響因數： 3. 383 作者：C. Heurteaux （法國瓦勒堡尼斯大學） 摘要：丹芪偏癱膠囊可以防止神經元死亡，促進神經再生，促進細胞增殖、神經突起生長， 促進密集性的軸突、樹突網路的發展。中風超早期應用本品可以降低死亡率，對於中風 不同時期的治療有著重要的意義。 Hemiplegia capsules can prevent neurons, promote nerve regeneration death, promote cell proliferation, nerve growth and promote protuberant coarctation of axons, dendritic network development. Use this product super early stroke reduces mortality, different period of treatment for stroke has important significance.

题目：Danqi Piantan Jiaonang Does Not Modify Hemostasis, Hematology, and Biochemistry in Normal subjects and Stroke Patients 丹芪偏癱膠囊對正常受試者和中風病人凝血、生化指標的影響 雜誌：Cerebrovascular diseases腦血管病雜誌 瑞士 影響因子： 3. 041 作者：Robert Gan 新加坡國立腦神經醫學院 結論：丹芪偏癱膠囊不會明顯改變正常受試者和中風病人的血液、止血和生化參數。 具有很好的安全性。 Hemiplegia capsules won't change significantly normal subjects and stroke patients, bleeding and biochemical parameters of blood. Good safety.

题目：A double-blind, placebo-controlled, randomized phase II pilot study to investigate the potential efficacy of the traditional chinese medicine Neuroaid (MLC 601) in enhancing recovery after stroke (TIERS). 丹芪偏癱膠囊治療中風後恢復期的二期臨床研究：隨機、對照、雙盲試驗 雜誌：cerebrovascular diseases 腦血管病雜誌 瑞士 影响因子： 3. 041 作者：Keng He Kong, 新加坡，宏茂橋醫院 結論：丹芪偏癱膠囊可以顯著改善中風患者神經功能和生活能力，而且對後迴圈梗 死和嚴重的中風患者也有良好的治療效應 Hemiplegia capsules can significantly improve neural function and stroke patients, but also for life cycle and serious infarction after stroke patients also has a good effect.

以“醒腦開竅”針法、丹芪偏癱膠囊為組合的針藥結合治療缺血性中風 病取得了巨大的成果 60 “XNKQ” acupuncture therapy and Danqi hemiplegia capsule, treatment of ischemic apoplexy made great achievements • 國家科技部、中醫藥管理局科技成果推廣專案 National science and technology department, administration of traditional Chinese medicine science promotion project • 已推廣到全國和世界60多個國家和地區，形成了輻射全球的技術平台 Has extended to the world in more than 60 countries and regions of the world, formed the radiation technology platform