【作者】 焦玥；

【导师】 吴中朝；

【作者基本信息】 中国中医科学院 ， 针灸推拿学， 2009， 硕士

【摘要】 1研究目的从缓解头痛程度与改善颅内主要血管血流速度方面比较与优选适宜的针刺方案,为临床干预发作期中重度女性少阳经偏头痛在治疗思路与方法及疗效评价领域提供证据。2研究方法本研究将世界卫生组织课题《循证针灸临床实践指南》推荐的干预发作期偏头痛的影响针刺疗效的四因素（效穴组合、毫针和电针疗法、耳穴疗法、放血疗法）及各自的三种方法,应用于四因素三水平的正交试验中。通过观察18例发作期中重度女性少阳经偏头痛患者治疗后10分钟-24小时各时点较治疗前疼痛缓解强度及颅内主要血管血流速度的改善情况,纵向比较不同因素,同时横向比较各因素的不同水平之间的有效性,以优选适宜发作期中重度女性少阳经偏头痛的针刺治疗方案。2.1研究设计与治疗2.1.1正交试验设计依据研究目的,需采用四因素三水平正交设计方案。根据正交试验原理,应用L₉（3⁴）正交表,即一个组内要进行九组试验。四因素分别为:A效穴组合,B毫针及电针疗法,C耳穴疗法,D放血疗法。三水平分别为:（1）A因素:效穴组合A1水平:常规穴组A2水平:A1+远端穴组A3水平:A2+加强穴组常规穴组:丝竹空、率谷、太阳、风池;远端穴组:双侧合谷、太冲、足临泣、阳陵泉、丘墟;加强穴组:颔厌、悬颅。（2）B因素:毫针及电针疗法B1水平:0（即不进行毫针及电针治疗）B2水平:毫针刺法B3水平:B2基础上+电针（局部穴位）（3）C因素:耳穴疗法C1水平:0（即不采用耳穴治疗方法）C2水平:耳穴针刺C3水平:耳穴电针（4）D因素:放血疗法D1水平:太阳紫脉（或太阳）+阿是穴放血D2水平:太阳紫脉（或太阳）放血D3水平:0（即不进行放血治疗）表1 L₉（3⁴）正交试验设计表根据表1确定试验的治疗方案。如：第一组试验治疗方案位选A1（常规穴组）+B1（不进行毫针及电针治疗）+C1（即不采用耳穴治疗方法）+D1（太阳紫脉获太阳+阿是穴放血），也就是说，本组仅在太阳紫脉和阿是穴进行放血，不进行毫针、电针及耳穴治疗。其他试验号依此类推。2.12分组及治疗方法将18例女性患者首先根据年龄，然后根据病情严重程度进行分层，分至2个组内。之后各组内再进行随机，分配至9种不同的治疗方案（如下图）：治疗方法:（1）毫针刺法①丝竹空、率谷采用透刺法,丝竹空进针后朝率谷方向平刺1-1.5寸,行快速小幅度捻转;②太阳穴向后斜刺进针,施小幅度捻转手法,以局部酸胀为度;③风池进针后朝风府方向平刺1.5-2寸,采用快速小幅度捻转手法不提插,以局部酸胀为度,或向头顶、颞部、前额及眼眶扩散为宜;④颔厌、悬颅采用透刺法,颔厌穴进针后沿皮向悬颅平刺1-1.5寸,行快速小幅度捻转。上述穴位,单侧头痛取患侧,双侧头痛取两侧。⑤远端穴位均为双侧取穴,采用常规进针方法,得气后均用泻法。诸穴得气后均行针1分钟,留针30分钟,留针期间行针2次,每次以得气为度。（2）电针法进针方法均同毫针刺法,得气后在局部穴位针柄上接电针,电针仪波型选择疏密波,强度以病人耐受为度;留针30分钟。（3）耳穴疗法①毫针刺:在神门、交感、皮质下、脑点、胰胆、敏感点进行针刺,深度以穿入软骨但不透过对侧皮肤为度,中等量刺激。留针30分钟。间隔5-10分钟快速捻转行针1次。②电针刺:得气后在神门和敏感点的针柄上接电针,电针仪波型选择疏密波,强度以病人能够耐受为度,留针30分钟。（4）放血疗法用中号三棱针在太阳紫脉（或太阳穴）、阿是穴点刺放血,待出血自行停止即可。2.2诊疗标准本课题采用国际头痛协会偏头痛诊断标准（1988）、疼痛程度分级法及中国国家药品监督管理局发布的（2002试行版）“中药新药治疗偏头痛的临床研究指导原则”,依据《灵枢·经脉》篇归纳的偏头痛分经诊断标准,同时制定严格的纳入、排除、剔除、中止标准。采用视觉模拟评分法（VAS）对疼痛缓解的程度进行评估,应用超声经颅多普勒血流成像法,对颅内主要血管血液流速的改善情况进行分析,以比较并优选适宜的针刺治疗方案。另外也对安全性评价（生理指标及不良反应）等进行了观察。2.3数据处理及统计分析采用Epidata3.1软件建立数据库。应用CHISS软件进行统计分析。首先对数据进行描述性统计,然后按照正交表的要求,对试验结果进行分析。3研究结果研究结果包括18例入组患者人口学资料、一般情况、头痛严重程度的统计描述;治疗后10分钟-24小时各时点不同针刺影响因素及不同水平对头痛缓解程度的影响及趋势;治疗后30分钟不同针刺方案对改善脑血流速度的影响以及本研究的安全性评价。3.1人口学资料的统计描述主要从年龄方面进行描述。18例患者均为女性,按年龄可分为两组,分别是20-40岁组9例,41-60岁组9例,平均年龄为37.8±10.8（岁）。3.2疾病一般情况的统计描述（1）西医诊断:17例为无先兆偏头痛,1例为有先兆偏头痛,二者比例17:1。（2）病史:病史平均为15.8±9.1（年）。（3）头痛发作持续的时间:在不进行任何治疗情况下,头痛发作持续时间平均为37.5±19.5（小时）。（4）头痛性质:头痛呈搏动性的为12例（占66.7%）,非搏动性的为6例（占33.3%）。（5）患侧:左侧头痛的有7人,右侧头痛的有9人,两侧均头痛的有2人,其中1人以左侧为重,另1人以右侧为重。（6）头痛部位:少阳经颞前部头痛者（太阳、颔厌、悬颅穴附近）9人,少阳经颞耳部头痛者（率谷穴附近）3人,上述痛处并存或兼及颞后部痛者（天冲完骨线或风池穴附近）6人。可见入组的少阳经偏头痛病例是以颞前、颞耳部疼痛为主。总体疼痛均在少阳经穴位分布的颞部区域内,即大体分布于少阳经太阳、率谷:颔厌、悬颅穴的近似“+”型的连线范围内。3.3头痛严重程度的统计描述（1）积分法:头痛严重程度积分平均为16.1±1.4（分）。（2）基于积分法的头痛分级法:按照病情程度分2组,分别是9例中度（Ⅱ级）患者（占50.0%）,9例重度患者（占50.0%）。（3）患者自评头痛严重程度:自评为中度者有10例（占55.6%）,自评为重度者有8例（占44.4%）,二者基本各占一半。（4）不同方法之间的一致性比较:自评与依据积分法评级一致者有15例（占83.3%）,自评时高估者仅有1例（占5.6%）,自评时低估者有2例（占11.1%）。3.4治疗后各时点不同针刺影响因素对缓解头痛强度的影响3.4.1治疗后10分钟不同针刺影响因素对缓解头痛强度的影响在治疗后10分钟这一时点,缓解头痛强度最佳的针刺方案组合应为:电针刺常规穴组+太阳紫脉和阿是穴放血+耳穴电针或针刺。3.4.2治疗后20分钟不同针刺影响因素对缓解头痛强度的影响在治疗后20分钟这一时点,缓解头痛强度最佳的针刺方案组合为:毫针刺（常规穴+远端穴+加强穴）+太阳紫脉和阿是穴放血+耳穴针刺。3.4.3治疗后30分钟不同针刺影响因素对缓解头痛强度的影响在治疗后30分钟这一时点,缓解头痛强度最佳的针刺方案组合为:毫针刺（常规穴+远端穴+加强穴）+太阳紫脉和阿是穴放血+耳穴针刺。3.4.4治疗后1小时不同针刺影响因素对缓解头痛强度的影响在治疗后1小时这一时点,缓解头痛强度最佳的针刺方案组合为:毫针刺（常规穴+远端穴）+耳穴针刺+太阳紫脉放血。3.4.5治疗后2小时不同针刺影响因素对缓解头痛强度的影响在治疗后2小时这一时点,缓解头痛强度最佳的针刺方案组合为:耳穴针刺+太阳紫脉和阿是穴放血。3.4.6治疗后3小时不同针刺影响因素对缓解头痛强度的影响在治疗后3小时这一时点,缓解头痛强度最佳的针刺方案组合仍为:耳穴针刺+太阳紫脉和阿是穴放血。3.4.7治疗后4小时不同针刺影响因素对缓解头痛强度的影响在治疗后4小时这一时点,缓解头痛强度最佳的针刺方案组合仍为:耳穴电针+电针（透穴组+远端组）+太阳紫脉放血。3.4.8治疗后5小时不同针刺影响因素对缓解头痛强度的影响在治疗后5小时这一时点,缓解头痛强度最佳的针刺方案组合为:耳穴电针+太阳紫脉放血。3.4.9治疗后6小时不同针刺影响因素对缓解头痛强度的影响在治疗后6小时这一时点,缓解头痛强度最佳的针刺方案组合为:耳穴电针+太阳紫脉放血。3.4.10治疗后12小时不同针刺影响因素对缓解头痛强度的影响在治疗后12小时这一时点,缓解头痛强度最佳的针刺方案组合为:耳穴电针+太阳紫脉和阿是穴放血。3.4.11治疗后24小时不同针刺影响因素对缓解头痛强度的影响在治疗后24小时这一时点,缓解头痛强度最佳的针刺方案组合仍为:耳穴电针+太阳紫脉和阿是穴放血。3.5治疗后各时点不同针刺影响因素对缓解头痛强度的影响趋势（1）在治疗后30分钟内缓解头痛强度方面,太阳紫脉和阿是穴放血及耳穴毫针刺较体针效果好。（2）在治疗后30分钟-6小时缓解头痛强度方面,耳穴电针和电针常规穴组+远端穴组较放血疗法效果好。（3）在治疗后6小时-24小时缓解头痛强度方面,毫针和电针疗法大于效穴组合、耳穴疗法、放血疗法,但与耳穴疗法差距不明显。维持疗效的仍然是耳穴电针疗法。3.6治疗后各时点四因素各水平对缓解头痛强度的影响趋势3.6.1治疗后各时点各效穴组合对缓解头痛强度的影响趋势总的来说,常规穴组+远端穴组对于缓解头痛程度的影响趋势优于常规穴组及常规穴组+远端穴组+加强穴组。3.6.2治疗后各时点毫针及电针疗法各水平对缓解头痛强度的影响趋势总的来说,从对疗效的整体稳定性上看,毫针刺+电针效果对于缓解头痛程度的影响趋势优于不用毫针或电针及单纯毫针刺。3.6.3治疗后各时点耳穴疗法各水平对缓解头痛强度的影响趋势总的来说,耳穴电针对于缓解头痛程度的影响趋势优于不用耳穴疗法及耳穴毫针。3.6.4治疗后各时点放血疗法各水平对缓解头痛强度的影响趋势总的来说,太阳紫脉和阿是穴放血对于缓解头痛程度的影响优于不用放血疗法及只在太阳紫脉放血。3.7治疗后30分钟不同针刺影响因素对改善脑血流速度的影响在治疗后大概30分钟左右,对脑血流速度改善最佳的针刺方案组合为:太阳紫脉和阿是穴刺络放血+针刺常规穴组+耳穴电针。3.8安全性分析在整个临床观察中,四种针刺影响因素对于入组的18例患者各项生理指标未出现超出正常范围的干扰,也未出现晕针、滞针、断针、血肿等不良事件。4研究结论（1）四种针刺疗效影响因素都能够较长时间（24小时之内）保持止痛效果。（2）综合各针刺影响因素及其内部各水平对于缓解头痛强度的影响,发作期中重度女性少阳经偏头痛总的推荐治疗方案是首先进行太阳紫脉和阿是穴的放血疗法,然后进行耳穴电针疗法和常规穴组+远端穴组的电针疗法。（3）治疗后约30分钟左右改善颅内主要血管血液流速方面,最佳的针刺方案组合为:太阳紫脉和阿是穴刺络放血+针刺常规穴组+耳穴电针。与缓解疼痛效果最佳的方案有一定对应性。更多还原

【Abstract】 1 OBJECTIVEThe incidences of migraine have been growing steadily with the changing times. The aim of this study is to determine the most efficient therapeutic protocol in treating patients with moderate to severe acute attack of migraine of Shaoyang meridian origin. The aim of which is to alleviate pain and normalize cerebral blood flow in the shortest possible time.2 METHODSThe study was done in the Acupuncture Hospital of China Academy of Chinese Medical Sciences from July 2008 to April 2009. 18 patients who were diagnosed to have moderate to severe migraine of Shaoyang meridian origin were included in the study. They were divided into 2 groups （A and B）. Group A inclusion criteria were as follows: Gender: female, Age 20-40 y/o, Moderate migraine; Group B were as follows Gender: female, Age 41-60 y/o, Severe migraine.This research applied four factors and three sub-classes of acupuncture treatment. Data was gathered and an orthogonal test was used to interpret the data. Outcome was assessed using the Visual analogue scale （VAS） every 10, 20, 30 minutes and every hour thereafter to 6 hours, then 12 hours and 24 hours after treatments. And objective measurement of cerebral blood flow using a transcranial Doppler were employed before and 30 minutes after treatment. Data gathered were interpreted using the orthogonal test.2.1 Research Design and Treatment PlanThe best research design to interpret multi variant data is using the orthogonal test. So the L₉（3⁴） orthogonal table was referred to.Four Factors were:A: combination of acupoints B: needle and electro-needle therapyC: auricular acupunctureD: bloodletting therapyThree sub-classes were:A: Combination of acupointsLevel 1: normal group of acupoints （acupoints applied at the side where migraine attacked）Level 2: Level 1+distal group of acupoints （acupoints applied at both sides）Level 3: Level 2+effect-reinforcing group of acupoints （acupoints applied at the side where migraine attacked）POINTS:Local points: sizhukong（SJ23）, shuaigu（GB8）;temple, fengchi（GB20）Distal points: hegu（LI4）, taichong（LV3）, zulinqi（GB41）, yanglingquan-（GB34）, qiuxu（GB40）Effect-reinforcing group: hanyan（GB4）, xuanlu（GB5）B: Needle and electro-needle therapyLevel 1: 0 （neither usage of needle nor electro-needle）Level 2: needle therapyLevel 3: electro-needle therapy （applied at local acupoints）C: Auricular acupunctureLevel 1: 0 （without usage of auricular acupuncture）Level 2: auricular needleLevel 3: auricular electro-needleD: Bloodletting therapyLevel 1: bloodletting on superficial collaterals of blood stasis in temple area （or temple） +A shi acupointsLevel 2: bloodletting on superficial collaterals of blood stasis in temple area （or temple） Level 3: 0 （without usage of bloodletting therapy）18 patients were divided into 2 groups. Group A （Gender: female, Age: 20-40 y/o, Moderate severity）; Group B （Gender: female, Age: 41-60 y/o, Severe migraine）. Random distribution of patients to nine protocols was employed in both groups using single blinded study.A.Needle therapy（1）Horizontal insertion from SJ23 to GB8 or from GB4 to GB5 in depth of 1.5-3 cun. Quick twisting and twirling of needle was done to get Qi.（2）Oblique insertion of needle in both taiyang points, with twisting and twirling until a sensation of soreness and/or distention after was felt.（3）Perpendicular insertion of needle on GB20 was applied. Twisting and twirling manipulation after entry of needle. Perpendicular insertion of needle on fengfu（DU16） in depth of 1.5-2 cun was done and the needle was manipulated to make the sensation of Qi extend to the Vertex of the head, temporo-parietal, Orbital cavity, and frontal area.（4）Perpendicular insertion of needle on LI4, LV3, GB41, GB34, and GB40 with reducing technique applied on each point.All points were manipulated every 15 minutes with 1-minute duration per manipulation. Needles were retained for 30 minutes. B. Electro-needle therapyMethod for entry of needle is the same with needle therapy. After obtaining qi, electric stimulation was applied on the needles through wires attached to the needles. Dense-Dispersed wave was used and the intensity of the stimulation was regulated according to the subjective perception of each patient. All patients were subjected for 30 minutes.C. Auricular acupuncture（1）Auricular needle: Needles were applied on shenmen, sympathetic nerve, subcortex, brainstem, pancreas & gallbladder and a shi point in temporal region with moderate stimulation and without going through the cartilage. Quick twisting and twirling manipulation was employed every 5-10 minutes.（2） Auricular electro-needle:After obtaining qi, electric stimulation was applied on shenmen and a shi point in temporal region. Intensity of stimulation was regulated according to patients maximum tolerable comfort zone. Each lasted for 30 minutes.D. Bloodletting therapyBloodletting therapy was applied on superficial collaterals of blood stasis in the temporal area and a shi acupoints by using a three-edged needle gauge 20, the amount of blood expressed per patient ranged from 0.5 ml to 1.5 ml.2.2 Therapeutic EvaluationVisual Analogue Scale（VAS） was used to grade the degree of pain relief, and Changes in blood flow in cerebral vessels were analyzed using a transcranial Doppler（TCD）.2.3 Data Process and Statistical AnalysisEpidata3.1 was used to establish database, and CHISS software was used to analyze the results.3 RESULTSThe results included analytical description of demographic data, general conditions, severity of migraine, influential trend of different factors in different levels of design and different post-treatment times with regards to the degree of pain relief and Cerebral blood flow using transcranial Doppler. Lifestyle improvement, through subjective verbal analysis of patients. Evaluation of Safety of Different protocols applied to each patient.Women with an average age of 37±10.8 （year-old） are most commonly affected. Most of them have a history for 15.8±9 years, duration of the attacks if not treated is 37.5±19.5 hours. Among the 4 therapeutic factors, the auricular and blood letting therapy proved to be most effective to relieve symptoms during the 1st 30 minutes; while the Auricular and Acupoints from 30 minutes to 6 hours; and Needle and electric stimulation after 6 hours to 1 day. However, the data during the 6 hours to 1 day, between the Needle-electric stimulation factor VS the auricular factor have only a small difference between each other.4 CONCLUSIONSThe growing incidence of Acute attacks of Shaoyang migraine HA, debilitating healthy people are growing steadily. With the help of dietary modifications, lifestyle change coupled with immediate treatment with auricular or bloodletting therapy during the acute attack of headache will ensure pain relief during the 1st 30 min after initial treatment. Although, this is the most superior method in the study, nevertheless auricular/acupoints have shown to improve migraine from 30 minutes to 6 hours while Needle/electric stimulation from 7 hours to a day. We cannot totally rank the effectiveness of the treatment models after 24 hours.Visual Analogue pain scale is a subjective way of determining the severity as well as relief of symptoms. It is the best way to accurately determine the effectiveness of the treatment Protocols for pain relief. The results of Transcranial Doppler to determine the changes in Blood flow in the Cerebral vessels is affected by the trajectory of the probe towards the blood vessels which makes it a less accurate prognostic tool in determining effectiveness of treatment. With out dispute, the 4 factors are effective in the different time frames after initial treatment; however, continuous relief of pain after 24 hours can not be assured because the duration of the treatment only encompassed a day.更多还原