发作期痰瘀型偏头痛针刺方案优选
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摘要
本研究以偏头痛患者为研究对象,以针刺为干预手段,以临床多见的痰瘀型为切入点,以症状最为明显的发作期为介入时期,以即刻镇痛效果为观察点,采用正交试验设计,应用L_9(3~4)正交表对效穴组合(A)、毫针及电针疗法(B)、耳穴疗法(C)、放血疗法(D)四个因素及它们各自不同的三个水平在治疗发作期痰瘀型偏头痛中所起的作用进行了分析;试验过程中同时应用了随机(分层随机、中心随机)和盲法(第三者评价盲),并最终从上述的四因素三水平中优选出针对发作期痰瘀型偏头痛的最佳针刺治疗方案。
偏头痛是一种高发的、顽固的慢性疼痛性疾病,给患者的日常生活带来极大的痛苦。根据国际疼痛协会对疼痛的定义,疼痛(偏头痛也不例外)是一种主观感觉,并同时涉及到躯体、精神、环境、认知、行为等多种因素,病因复杂,影响因素繁多。针对这种情况,西医学能给出的治疗方法主要是药物止痛,然而药物的依赖性和成瘾性问题已经越来越突出,故而向中医,尤其是针灸领域寻求更加切实可行的解决方案就成为众多学者新的研究动向。
然而,在参与世界卫生组织西太区(WHO—WPR)传统医学办公室及中国国家中医药管理局制定《针灸治疗偏头痛临床实践指南》的过程中发现,目前相关的针灸临床研究还存在一定的问题,主要是治疗方法的多样和混乱以及缺乏多种针刺方法之间的比较性研究。在这种情况下,进行偏头痛针刺治疗方案的优选研究是有其必要性的。而正交试验正是进行方案优选的最佳试验设计方式。
1研究目的
观察不同针刺方法对发作期痰瘀型偏头痛的疗效,对不同方法的疗效进行横向比较,从中优选出最佳治疗方案或方案组合,为临床应用提供一定的依据。
2研究方法
2.1病例来源
所有偏头痛患者均来自于2008年6月到2009年5月在中国中医科学院针灸医院门诊咨询和就诊的患者。
2.2实验设计方法
本试验采用分层随机和正交试验设计方法,应用L_9(3~4)正交表,进行四因素三水平的试验,每重复一次需要9例患者。患者就诊后按照性别、年龄、病情严重程度先进行分层,使得进入每一个重复试验组的9例患者条件均衡,然后将这9例患者随机分配到9种治疗方案进行试验。随机(分层随机、中心随机法)和盲法(第三者评价盲)同时应用。
四因素: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:A因素A1水平:局部取穴(一侧头痛取患侧,两侧头痛取双侧)
A2水平:A1+远端取穴(远端取穴均为双侧)
A3水平:A2+辨证取穴(辨证取穴均为双侧)
B因素B1水平:0(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
C因素C1水平:0(不采用耳穴治疗方法)
C2水平:耳穴针刺
C3水平:耳穴电针
D因素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)
2.3治疗方法
取穴:局部取丝竹空、率谷、太阳、风池;远端取合谷、列缺、太冲、足临泣;辨证取中脘、丰隆、阴陵泉、血海、膈俞。
毫针及电针疗法:丝竹空和率谷穴采用透刺法,其余腧穴使用常规刺法,针刺深度为1～1.3寸;电针疗法在毫针刺的基础上在头部腧穴加用电针,选用疏密波,强度以患者能耐受为度。
耳穴疗法:穴位选用神门、交感、皮质下、脑点、敏感点(在颞、枕、额部探测敏感点,如无敏感点则选取脑点)。针刺及电针的操作方法与体针相同。
放血疗法:穴位选用太阳紫脉或太阳、阿是穴(患处压痛点、敏感点、结节或显露的浅静脉)。用中号三棱针刺破皮肤后放出适量血液。
疗程:毫针刺和电针的留针时间均为30分钟,仅治疗1次。
2.4诊疗标准
本研究采用1988年国际头痛协会(IHS)颁布的偏头痛诊断标准;严重程度标准采用1988年IHS发布的疼痛程度分级法(0级～Ⅲ级);分期采用中国国家药品监督管理局发布的《中药新药临床研究指导原则》(2002试行版)中“中药新药治疗偏头痛的临床研究指导原则”的标准;而中医证型诊断标准采用国家中医药管理局制定的《中医病证诊断疗效标准》中“头风诊断依据”及1995年中华人民共和国卫生部制定发布的《中药新药临床研究指导原则》中“中药新药治疗偏头痛的临床研究指导原则”中痰瘀型的诊断标准。在此基础上制定了严格的纳入、排除、剔除、脱落、中止标准。疗效评价采用视觉模拟评分法(VisualAnalogue Scale,VAS)对治疗前及治疗后10分钟、20分钟、30分钟、1小时、2小时、3小时、4小时、5小时、6小时、12小时、24小时的12个时点四个因素的R值进行分析,并使用超声经颅多普勒血流分析(Transcranial Doppler,TCD)对患者患侧、健侧大脑血管的血流状况进行分析以进一步验证疗效。
2.5数据处理及统计分析
应用EpiData3.1建立数据库,分别由2人各自独立将CRF表中的内容录入数据库。然后用EpiData3.1对双录入形成的两个库进行核查,如有出入,参照CRF表中的原始数据进行修改,最后将修订后的数据库锁定,作为最终进行统计分析用库。使用CHISS软件对相关数据进行统计分析。针对正交试验,采用CHISS软件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以得出结论。
3研究结果
3.1 VAS结果
(1)治疗后10分钟,四因素对降低VAS评分的影响大小排序为RB＞RC＞RD＞RA,各因素不同水平对降低VAS评分的影响大小排序为:A3＞A1＞A2,B2＞B3＞B1,C2＞C3＞C1,D2＞D1＞D3。这一时点,缓解头痛最佳的针刺方案组合为A3B2C2D2(毫针刺局部+远端+辨证穴、耳穴针刺、太阳紫脉放血);
(2)治疗后20分钟,四因素对降低VAS评分的影响大小排序为RB＞RD＞RA＞RC,各因素不同水平对降低VAS评分的影响大小排序为:A1＞A2＞A3,B2＞B1＞B3,C3＞C2＞C1,D2＞D1＞D3。这一时点,缓解头痛最佳的针刺方案组合为A1B2C3D2(毫针刺局部穴、太阳紫脉放血、耳穴电针);
(3)治疗后30分钟,四因素对降低VAS评分的影响大小排序与上一时点(20分钟)相同,而各因素不同水平对降低VAS评分的影响大小排序除了B因素为B2＞B3＞B1外,其余也与上一时点相同。这一时点,缓解头痛最佳的针刺方案组合依然为A1B2C3D2(毫针刺局部穴、太阳紫脉放血、耳穴电针);
(4)治疗后1小时,四因素对降低VAS评分的影响大小排序为RD＞RB＞RC＞RA,各因素不同水平对降低VAS评分的影响大小排序为:A3＞A1＞A2,B2＞B3＞B1,C2＞C3＞C1,D2＞D1＞D3。这一时点,缓解头痛最佳的针刺方案组合为A3B2C2D2(太阳紫脉放血、毫针刺局部+远端+辨证穴、耳穴针刺);
(5)治疗后2小时,四因素对降低VAS评分的影响大小排序为RC＞RD＞RB＞RA,各因素不同水平对降低VAS评分的影响大小排序为:A3＞A1＞A2,B2＞B1＞B3,C2＞C3＞C1,D2＞D1＞D3。这一时点,缓解头痛最佳的针刺方案组合为A3B2C2D2(耳穴针刺、太阳紫脉放血、毫针刺局部+远端+辨证穴);
(6)治疗后3小时,四因素对降低VAS评分的影响大小排序为RD＞RB＞RC＞RA,各因素不同水平对降低VAS评分的影响大小排序为:A1＞A3＞A2,B2＞B1＞B3,C2＞C3＞C1,D2＞D1＞D3。这一时点,缓解头痛最佳的针刺方案组合为A1B2C2D2(太阳紫脉放血、毫针刺局部穴、耳穴针刺);
(7)治疗后4小时,四因素对降低VAS评分的影响大小排序为RD＞RA＞RC＞RB,各因素不同水平对降低VAS评分的影响大小排序为:A1＞A2＞A3,B1＞B2＞B3,C2＞C3＞C1,D2＞D1＞D3。这一时点,缓解头痛最佳的针刺方案组合为A1B1C2D2(太阳紫脉放血、耳穴针刺);
(8)治疗后5小时,四因素对降低VAS评分的影响大小排序为RB＞RD＞RC＞RA,各因素不同水平对降低VAS评分的影响大小排序为:A1＞A2＞A3,B2＞B1＞B3,C3＞C2＞C1,D2＞D1＞D3。这一时点,缓解头痛最佳的针刺方案组合为A1B2C2D2(毫针刺局部穴、太阳紫脉放血、耳穴针刺);
(9)治疗后6小时,四因素对降低VAS评分的影响大小排序为RC＞RD＞RA＞RB,各因素不同水平对降低VAS评分的影响大小排序为:A1＞A2＞A3,B2＞B1＞B3,C2＞C3＞C1,D2＞D1＞D3。这一时点,缓解头痛最佳的针刺方案组合为A1B2C3D2(耳穴电针、太阳紫脉放血、毫针刺局部穴);
(10)治疗后12小时,四因素对降低VAS评分的影响大小排序为RC＞RD＞RA＞RB,各因素不同水平对降低VAS评分的影响大小排序为:A2＞A1＞A3,B2＞B1＞B3,C2＞C3＞C1,D2＞D1＞D3。这一时点,缓解头痛最佳的针刺方案组合为:A2B2C2D2(耳穴针刺、太阳紫脉放血、毫针刺局部+远端穴);
(11)治疗后24小时,四因素对降低VAS评分的影响大小排序为RA＞RD＞RC＞RB,各因素不同水平对降低VAS评分的影响大小排序为:A2＞A1＞A3,B2＞B3＞B1,C2＞C3＞C1,D1＞D2＞D3。这一时点,缓解头痛最佳的针刺方案组合为A2B2C2D1(太阳紫脉加阿是穴放血、耳穴针刺、毫针刺局部+远端穴);
(12)对治疗后10分钟至24小时各个时点数据进行分析,四因素对缓解头痛的影响的大致趋势为:D最好,B与C基本持平(1小时之前RB明显大于RC,而5小时之后RB则明显小于RC,1～5小时两者基本持平,但C的稳定性好于B,且B持续走低,而C则持续走高),A始终处于一个较低的状态。提示,治疗后1小时之内放血和毫针或电针的疗效较好,而对1～24小时而言,放血和耳穴的疗效可靠;到了针刺后24小时,四个因素的影响度均明显下降,从这个角度看,对于发作期痰瘀型偏头痛患者来说,最佳的治疗频率至少为每天一次;
(13)A因素三水平的影响大小顺序为A1＞A2＞A3,即局部取穴＞局部+远端取穴＞局部+远端+辨证取穴;B因素三水平的影响大小顺序为B2＞B1＞B3,即毫针刺＞不针刺＞电针针刺;C因素三水平的影响大小顺序为C2＞C3＞C1,即耳穴针刺＞耳穴电针＞不用耳穴;D因素三水平的影响大小顺序为D2＞D1＞D3,即太阳紫脉放血＞太阳紫脉+阿是放血＞不放血。
综上,就1小时以内的疗效而言,最佳治疗方案为太阳紫脉放血加毫针刺局部腧穴;而对1～24小时的疗效而言,最佳治疗方案是太阳紫脉放血加耳穴针刺。
3.2 TCD结果
在同时接受针刺治疗的情况下,患侧大脑血管对不同的针刺方法做出明显不同的反应,而健侧大脑血管对不同针刺方法的反应几乎没有差异,这说明针刺主要针对患侧大脑动脉起作用。
4研究结论
1.就针刺治疗发作期痰瘀型偏头痛1小时以内的疗效而言,最佳治疗方案为太阳紫脉放血加毫针刺局部腧穴。
2.就针刺治疗发作期痰瘀型偏头痛1～24小时的疗效而言,最佳治疗方案为太阳紫脉放血加耳穴针刺。
3.针刺治疗发作期痰瘀型偏头痛的疗法中,放血疗法效果显著而稳定;毫针或电针疗法1小时以内的疗效可靠,1～24小时的疗效不理想;耳穴疗法1小时以内的疗效不理想,但1～24小时的疗效可靠。
4.对于发作期痰瘀型偏头痛患者来说,最佳的治疗频率至少为每日一次。
5.针刺治疗发作期痰瘀型偏头痛时,主要针对患侧大脑动脉起作用。
6.痰瘀型偏头痛的严重程度与日常劳倦程度关系不大。
7.影响痰瘀型偏头痛的日常生活因素主要为饮食、睡眠、锻炼、气候和空气污染,部分患者与遗传有关,女性患者与月经有关。
8.对痰瘀型偏头痛患者来说,青年人较中年人更能客观地对疼痛做出评价。
本研究对针刺治疗发作期痰瘀型偏头痛的即刻疗效最佳治疗方案、最佳治疗频率以及相关影响因素都做了相关的研究和讨论并最终得出结论,对临床应用有一定的指导意义,但由于最终入组的27例患者均为女性,所有的结果、讨论、结论均是建立在这基础之上的,因而此结论仅对女性偏头痛患者适用。
Objective
Observe and compare the effect of different acupuncture methods on migraine in phlegm and blood stasis type at attack stage to choose the best acupuncture treatment prescriptions for it and to provide some guide for clinical application.
Methods
Both the stratified random and the orthogonal design are applied in this study.The orthogonal design that uses the orthogonal table of L_9(3~4) is about 4 factors and 3 levels of each factor.The patients were classified first according to their gender,age and disease severity to make the 9 patients' condition isostatic in every repeated group and they are distributed to 9 treatment descriptions randomly after that.The blind method in evaluation is also used in this study.The study needs 27 cases. The 4 factors are combination of points(A),acupuncture or electro-acupuncture method(B),auricular acupuncture method(C) and bloodletting method(D). The 3 levels of factor A are local points(A1),local points together with distal points (A2) and local points,distal points together with points according to syndrome differentiation(A3).The 3 levels of factor B are no acupuncture(B1),acupuncture(B2) and acupuncture together with electro-acupuncture(B3).The 3 levels of factor C are no auricular acupuncture(C1),auricular acupuncture(C2) and auricular acupuncture together with electro-acupuncture(C3).The 3 levels of factor D are bloodletting at abnormal collateral around Taiyang(EX-H5) or Taiyang(EX-H5) together with Ashi(D1),bloodletting at abnormal collateral around Taiyang(EX-H5) or Taiyang(EX-H5)(D2) and no bloodletting(D3).
Points:Local points are Sizhukong(SJ23),Shuaigu(GB8) Taiyang(EX-H5) and Fengchi(GB20).Points in both sides are used when the migraine is in both sides while points in the sick side are used when the migraine is in one side.Distal points are Hegu(LI4),Lieque(LU7),Taichong(LR3) and Zulinqi(GB41) in both sides. Points according to syndrome differentiation are Zhongwan(RN14),Fenglong(ST40), Xuehai(SP10) and Geshu(UB17) in both sides.
Acupuncture and electro-acupuncture method:The penetration needle is used at Sizhukong(SJ23) and Shuaigu(GB8) and other points use conventional acupuncture method in depth of 1～1.3 cun.The electro-acupuncture in dilatational wave is used at points in the head on the base of acupuncture method and the strength should make the patient comfortable.
Auricular acupuncture method:Points used in this method are Shenmen, sympathetic,subcortex,brain point and Ashi which is near the temple,forehead and occiput.The operation methods are the same as that of acupuncture and electro-acupuncture method.
Bloodletting method:Points used in this method are abnormal collateral around Taiyang(EX-H5) or Taiyang(EX-H5) and Ashi.Pricking the points and expressing 10～15 drops of blood or some blood until the blood's color is normal.
The duration of each treatment is 30 minutes and the course is 1 time. The differentiation of VAS between it before treatment and it 10 minutes,20 minutes, 30 minutes,1 hour,2 hour,3 hour,4 hour,5hour,6 hour,12 hour and 24 hour after treatment is used to evaluate the treatment effect.The analysis on cerebral blood flow of the arteries both in sick side and in health side by TCD is also used to verify the treatment effect.
Results
The results of VAS:The general tendency of the 4 factors to relieve the migraine is as follows:factor D is the most important,factor B and C are almost the same,factor A is the least important.The function of B is obvious bigger than that of C in 1 hour while the function of C is obvious bigger than that of B during 5～24 hour.The function of them are almost the same during 1～5 hour except that C's stability is better than B.Above all,the best treatment method is bloodletting together with acupuncture or electro-acupuncture in 1 hour while during 1～24 hour,the best one is bloodletting together with auricular acupuncture.The functions of 4 factors are all very weak at the 24 hour,so the best treatment frequency for migraine at attack stage in phlegm and blood stasis type is once a day.The functions of 3 levels of factor A to relieve the migraine is A1＞A2＞A3.The function of 3 levels of factor B to relieve the migraine is B2＞B1＞B3.The function of 3 levels of factor C to relieve the migraine is C2＞C3＞C1.The function of 3 levels of factor D to relieve the migraine is D2＞D1＞D3. So the best acupuncture treatment prescription in 1 hour is bloodletting at abnormal collateral around Taiyang(EX-H5) together with acupuncture at local points.The best acupuncture treatment prescription during 1～24 hour is bloodletting at abnormal collateral around Taiyang(EX-H5) together with auricular acupuncture.
The results of TCD:The reactions of cerebral arteries in sick side is obvious different to different treatment methods while that in health side is almost the same which means the acupuncture therapy effects the cerebral arteries in sick side mainly.
Conclusions
1.The best acupuncture treatment prescription for migraine at attack stage in phlegm and blood stasis type in 1 hour is bloodletting at abnormal collateral around Taiyang (EX-H5) together with acupuncture at local points.
2.The best acupuncture treatment prescription for migraine at attack stage in phlegm and blood stasis type during 1～24 hour is bloodletting at abnormal collateral around Taiyang(EX-H5) together with auricular acupuncture.
3.In the acupuncture methods for migraine at attack stage in phlegm and blood stasis type,the bloodletting method is effective and stable,the acupuncture or electro-acupuncture method is effective in 1 hour while unstable after 1 hour,the auricular acupuncture is in contrary.
4.The best treatment frequency for migraine at attack stage in phlegm and blood stasis type is once a day.
5.The acupuncture treatment for migraine at attack stage in phlegm and blood stasis type effects the cerebral arteries in sick side mainly.
6.The severity of migraine isn't so related to degree of fatigue.
7.The routine influence factors of migraine are main diet,sleep,exercises,climate, and pollute air.Some cases are connected with heredity and women are related to menstruation.
8.Young people can evaluate pain more objectively than middle aged people.
Note:The conclusions above are suitable for women only.
偏头痛是一种高发的、顽固的慢性疼痛性疾病,给患者的日常生活带来极大的痛苦。根据国际疼痛协会对疼痛的定义,疼痛(偏头痛也不例外)是一种主观感觉,并同时涉及到躯体、精神、环境、认知、行为等多种因素,病因复杂,影响因素繁多。针对这种情况,西医学能给出的治疗方法主要是药物止痛,然而药物的依赖性和成瘾性问题已经越来越突出,故而向中医,尤其是针灸领域寻求更加切实可行的解决方案就成为众多学者新的研究动向。
然而,在参与世界卫生组织西太区(WHO—WPR)传统医学办公室及中国国家中医药管理局制定《针灸治疗偏头痛临床实践指南》的过程中发现,目前相关的针灸临床研究还存在一定的问题,主要是治疗方法的多样和混乱以及缺乏多种针刺方法之间的比较性研究。在这种情况下,进行偏头痛针刺治疗方案的优选研究是有其必要性的。而正交试验正是进行方案优选的最佳试验设计方式。
1研究目的
观察不同针刺方法对发作期痰瘀型偏头痛的疗效,对不同方法的疗效进行横向比较,从中优选出最佳治疗方案或方案组合,为临床应用提供一定的依据。
2研究方法
2.1病例来源
所有偏头痛患者均来自于2008年6月到2009年5月在中国中医科学院针灸医院门诊咨询和就诊的患者。
2.2实验设计方法
本试验采用分层随机和正交试验设计方法,应用L_9(3~4)正交表,进行四因素三水平的试验,每重复一次需要9例患者。患者就诊后按照性别、年龄、病情严重程度先进行分层,使得进入每一个重复试验组的9例患者条件均衡,然后将这9例患者随机分配到9种治疗方案进行试验。随机(分层随机、中心随机法)和盲法(第三者评价盲)同时应用。
四因素: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:A因素A1水平:局部取穴(一侧头痛取患侧,两侧头痛取双侧)
A2水平:A1+远端取穴(远端取穴均为双侧)
A3水平:A2+辨证取穴(辨证取穴均为双侧)
B因素B1水平:0(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
C因素C1水平:0(不采用耳穴治疗方法)
C2水平:耳穴针刺
C3水平:耳穴电针
D因素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)
2.3治疗方法
取穴:局部取丝竹空、率谷、太阳、风池;远端取合谷、列缺、太冲、足临泣;辨证取中脘、丰隆、阴陵泉、血海、膈俞。
毫针及电针疗法:丝竹空和率谷穴采用透刺法,其余腧穴使用常规刺法,针刺深度为1～1.3寸;电针疗法在毫针刺的基础上在头部腧穴加用电针,选用疏密波,强度以患者能耐受为度。
耳穴疗法:穴位选用神门、交感、皮质下、脑点、敏感点(在颞、枕、额部探测敏感点,如无敏感点则选取脑点)。针刺及电针的操作方法与体针相同。
放血疗法:穴位选用太阳紫脉或太阳、阿是穴(患处压痛点、敏感点、结节或显露的浅静脉)。用中号三棱针刺破皮肤后放出适量血液。
疗程:毫针刺和电针的留针时间均为30分钟,仅治疗1次。
2.4诊疗标准
本研究采用1988年国际头痛协会(IHS)颁布的偏头痛诊断标准;严重程度标准采用1988年IHS发布的疼痛程度分级法(0级～Ⅲ级);分期采用中国国家药品监督管理局发布的《中药新药临床研究指导原则》(2002试行版)中“中药新药治疗偏头痛的临床研究指导原则”的标准;而中医证型诊断标准采用国家中医药管理局制定的《中医病证诊断疗效标准》中“头风诊断依据”及1995年中华人民共和国卫生部制定发布的《中药新药临床研究指导原则》中“中药新药治疗偏头痛的临床研究指导原则”中痰瘀型的诊断标准。在此基础上制定了严格的纳入、排除、剔除、脱落、中止标准。疗效评价采用视觉模拟评分法(VisualAnalogue Scale,VAS)对治疗前及治疗后10分钟、20分钟、30分钟、1小时、2小时、3小时、4小时、5小时、6小时、12小时、24小时的12个时点四个因素的R值进行分析,并使用超声经颅多普勒血流分析(Transcranial Doppler,TCD)对患者患侧、健侧大脑血管的血流状况进行分析以进一步验证疗效。
2.5数据处理及统计分析
应用EpiData3.1建立数据库,分别由2人各自独立将CRF表中的内容录入数据库。然后用EpiData3.1对双录入形成的两个库进行核查,如有出入,参照CRF表中的原始数据进行修改,最后将修订后的数据库锁定,作为最终进行统计分析用库。使用CHISS软件对相关数据进行统计分析。针对正交试验,采用CHISS软件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以得出结论。
3研究结果
3.1 VAS结果
(1)治疗后10分钟,四因素对降低VAS评分的影响大小排序为RB＞RC＞RD＞RA,各因素不同水平对降低VAS评分的影响大小排序为:A3＞A1＞A2,B2＞B3＞B1,C2＞C3＞C1,D2＞D1＞D3。这一时点,缓解头痛最佳的针刺方案组合为A3B2C2D2(毫针刺局部+远端+辨证穴、耳穴针刺、太阳紫脉放血);
(2)治疗后20分钟,四因素对降低VAS评分的影响大小排序为RB＞RD＞RA＞RC,各因素不同水平对降低VAS评分的影响大小排序为:A1＞A2＞A3,B2＞B1＞B3,C3＞C2＞C1,D2＞D1＞D3。这一时点,缓解头痛最佳的针刺方案组合为A1B2C3D2(毫针刺局部穴、太阳紫脉放血、耳穴电针);
(3)治疗后30分钟,四因素对降低VAS评分的影响大小排序与上一时点(20分钟)相同,而各因素不同水平对降低VAS评分的影响大小排序除了B因素为B2＞B3＞B1外,其余也与上一时点相同。这一时点,缓解头痛最佳的针刺方案组合依然为A1B2C3D2(毫针刺局部穴、太阳紫脉放血、耳穴电针);
(4)治疗后1小时,四因素对降低VAS评分的影响大小排序为RD＞RB＞RC＞RA,各因素不同水平对降低VAS评分的影响大小排序为:A3＞A1＞A2,B2＞B3＞B1,C2＞C3＞C1,D2＞D1＞D3。这一时点,缓解头痛最佳的针刺方案组合为A3B2C2D2(太阳紫脉放血、毫针刺局部+远端+辨证穴、耳穴针刺);
(5)治疗后2小时,四因素对降低VAS评分的影响大小排序为RC＞RD＞RB＞RA,各因素不同水平对降低VAS评分的影响大小排序为:A3＞A1＞A2,B2＞B1＞B3,C2＞C3＞C1,D2＞D1＞D3。这一时点,缓解头痛最佳的针刺方案组合为A3B2C2D2(耳穴针刺、太阳紫脉放血、毫针刺局部+远端+辨证穴);
(6)治疗后3小时,四因素对降低VAS评分的影响大小排序为RD＞RB＞RC＞RA,各因素不同水平对降低VAS评分的影响大小排序为:A1＞A3＞A2,B2＞B1＞B3,C2＞C3＞C1,D2＞D1＞D3。这一时点,缓解头痛最佳的针刺方案组合为A1B2C2D2(太阳紫脉放血、毫针刺局部穴、耳穴针刺);
(7)治疗后4小时,四因素对降低VAS评分的影响大小排序为RD＞RA＞RC＞RB,各因素不同水平对降低VAS评分的影响大小排序为:A1＞A2＞A3,B1＞B2＞B3,C2＞C3＞C1,D2＞D1＞D3。这一时点,缓解头痛最佳的针刺方案组合为A1B1C2D2(太阳紫脉放血、耳穴针刺);
(8)治疗后5小时,四因素对降低VAS评分的影响大小排序为RB＞RD＞RC＞RA,各因素不同水平对降低VAS评分的影响大小排序为:A1＞A2＞A3,B2＞B1＞B3,C3＞C2＞C1,D2＞D1＞D3。这一时点,缓解头痛最佳的针刺方案组合为A1B2C2D2(毫针刺局部穴、太阳紫脉放血、耳穴针刺);
(9)治疗后6小时,四因素对降低VAS评分的影响大小排序为RC＞RD＞RA＞RB,各因素不同水平对降低VAS评分的影响大小排序为:A1＞A2＞A3,B2＞B1＞B3,C2＞C3＞C1,D2＞D1＞D3。这一时点,缓解头痛最佳的针刺方案组合为A1B2C3D2(耳穴电针、太阳紫脉放血、毫针刺局部穴);
(10)治疗后12小时,四因素对降低VAS评分的影响大小排序为RC＞RD＞RA＞RB,各因素不同水平对降低VAS评分的影响大小排序为:A2＞A1＞A3,B2＞B1＞B3,C2＞C3＞C1,D2＞D1＞D3。这一时点,缓解头痛最佳的针刺方案组合为:A2B2C2D2(耳穴针刺、太阳紫脉放血、毫针刺局部+远端穴);
(11)治疗后24小时,四因素对降低VAS评分的影响大小排序为RA＞RD＞RC＞RB,各因素不同水平对降低VAS评分的影响大小排序为:A2＞A1＞A3,B2＞B3＞B1,C2＞C3＞C1,D1＞D2＞D3。这一时点,缓解头痛最佳的针刺方案组合为A2B2C2D1(太阳紫脉加阿是穴放血、耳穴针刺、毫针刺局部+远端穴);
(12)对治疗后10分钟至24小时各个时点数据进行分析,四因素对缓解头痛的影响的大致趋势为:D最好,B与C基本持平(1小时之前RB明显大于RC,而5小时之后RB则明显小于RC,1～5小时两者基本持平,但C的稳定性好于B,且B持续走低,而C则持续走高),A始终处于一个较低的状态。提示,治疗后1小时之内放血和毫针或电针的疗效较好,而对1～24小时而言,放血和耳穴的疗效可靠;到了针刺后24小时,四个因素的影响度均明显下降,从这个角度看,对于发作期痰瘀型偏头痛患者来说,最佳的治疗频率至少为每天一次;
(13)A因素三水平的影响大小顺序为A1＞A2＞A3,即局部取穴＞局部+远端取穴＞局部+远端+辨证取穴;B因素三水平的影响大小顺序为B2＞B1＞B3,即毫针刺＞不针刺＞电针针刺;C因素三水平的影响大小顺序为C2＞C3＞C1,即耳穴针刺＞耳穴电针＞不用耳穴;D因素三水平的影响大小顺序为D2＞D1＞D3,即太阳紫脉放血＞太阳紫脉+阿是放血＞不放血。
综上,就1小时以内的疗效而言,最佳治疗方案为太阳紫脉放血加毫针刺局部腧穴;而对1～24小时的疗效而言,最佳治疗方案是太阳紫脉放血加耳穴针刺。
3.2 TCD结果
在同时接受针刺治疗的情况下,患侧大脑血管对不同的针刺方法做出明显不同的反应,而健侧大脑血管对不同针刺方法的反应几乎没有差异,这说明针刺主要针对患侧大脑动脉起作用。
4研究结论
1.就针刺治疗发作期痰瘀型偏头痛1小时以内的疗效而言,最佳治疗方案为太阳紫脉放血加毫针刺局部腧穴。
2.就针刺治疗发作期痰瘀型偏头痛1～24小时的疗效而言,最佳治疗方案为太阳紫脉放血加耳穴针刺。
3.针刺治疗发作期痰瘀型偏头痛的疗法中,放血疗法效果显著而稳定;毫针或电针疗法1小时以内的疗效可靠,1～24小时的疗效不理想;耳穴疗法1小时以内的疗效不理想,但1～24小时的疗效可靠。
4.对于发作期痰瘀型偏头痛患者来说,最佳的治疗频率至少为每日一次。
5.针刺治疗发作期痰瘀型偏头痛时,主要针对患侧大脑动脉起作用。
6.痰瘀型偏头痛的严重程度与日常劳倦程度关系不大。
7.影响痰瘀型偏头痛的日常生活因素主要为饮食、睡眠、锻炼、气候和空气污染,部分患者与遗传有关,女性患者与月经有关。
8.对痰瘀型偏头痛患者来说,青年人较中年人更能客观地对疼痛做出评价。
本研究对针刺治疗发作期痰瘀型偏头痛的即刻疗效最佳治疗方案、最佳治疗频率以及相关影响因素都做了相关的研究和讨论并最终得出结论,对临床应用有一定的指导意义,但由于最终入组的27例患者均为女性,所有的结果、讨论、结论均是建立在这基础之上的,因而此结论仅对女性偏头痛患者适用。
Objective
Observe and compare the effect of different acupuncture methods on migraine in phlegm and blood stasis type at attack stage to choose the best acupuncture treatment prescriptions for it and to provide some guide for clinical application.
Methods
Both the stratified random and the orthogonal design are applied in this study.The orthogonal design that uses the orthogonal table of L_9(3~4) is about 4 factors and 3 levels of each factor.The patients were classified first according to their gender,age and disease severity to make the 9 patients' condition isostatic in every repeated group and they are distributed to 9 treatment descriptions randomly after that.The blind method in evaluation is also used in this study.The study needs 27 cases. The 4 factors are combination of points(A),acupuncture or electro-acupuncture method(B),auricular acupuncture method(C) and bloodletting method(D). The 3 levels of factor A are local points(A1),local points together with distal points (A2) and local points,distal points together with points according to syndrome differentiation(A3).The 3 levels of factor B are no acupuncture(B1),acupuncture(B2) and acupuncture together with electro-acupuncture(B3).The 3 levels of factor C are no auricular acupuncture(C1),auricular acupuncture(C2) and auricular acupuncture together with electro-acupuncture(C3).The 3 levels of factor D are bloodletting at abnormal collateral around Taiyang(EX-H5) or Taiyang(EX-H5) together with Ashi(D1),bloodletting at abnormal collateral around Taiyang(EX-H5) or Taiyang(EX-H5)(D2) and no bloodletting(D3).
Points:Local points are Sizhukong(SJ23),Shuaigu(GB8) Taiyang(EX-H5) and Fengchi(GB20).Points in both sides are used when the migraine is in both sides while points in the sick side are used when the migraine is in one side.Distal points are Hegu(LI4),Lieque(LU7),Taichong(LR3) and Zulinqi(GB41) in both sides. Points according to syndrome differentiation are Zhongwan(RN14),Fenglong(ST40), Xuehai(SP10) and Geshu(UB17) in both sides.
Acupuncture and electro-acupuncture method:The penetration needle is used at Sizhukong(SJ23) and Shuaigu(GB8) and other points use conventional acupuncture method in depth of 1～1.3 cun.The electro-acupuncture in dilatational wave is used at points in the head on the base of acupuncture method and the strength should make the patient comfortable.
Auricular acupuncture method:Points used in this method are Shenmen, sympathetic,subcortex,brain point and Ashi which is near the temple,forehead and occiput.The operation methods are the same as that of acupuncture and electro-acupuncture method.
Bloodletting method:Points used in this method are abnormal collateral around Taiyang(EX-H5) or Taiyang(EX-H5) and Ashi.Pricking the points and expressing 10～15 drops of blood or some blood until the blood's color is normal.
The duration of each treatment is 30 minutes and the course is 1 time. The differentiation of VAS between it before treatment and it 10 minutes,20 minutes, 30 minutes,1 hour,2 hour,3 hour,4 hour,5hour,6 hour,12 hour and 24 hour after treatment is used to evaluate the treatment effect.The analysis on cerebral blood flow of the arteries both in sick side and in health side by TCD is also used to verify the treatment effect.
Results
The results of VAS:The general tendency of the 4 factors to relieve the migraine is as follows:factor D is the most important,factor B and C are almost the same,factor A is the least important.The function of B is obvious bigger than that of C in 1 hour while the function of C is obvious bigger than that of B during 5～24 hour.The function of them are almost the same during 1～5 hour except that C's stability is better than B.Above all,the best treatment method is bloodletting together with acupuncture or electro-acupuncture in 1 hour while during 1～24 hour,the best one is bloodletting together with auricular acupuncture.The functions of 4 factors are all very weak at the 24 hour,so the best treatment frequency for migraine at attack stage in phlegm and blood stasis type is once a day.The functions of 3 levels of factor A to relieve the migraine is A1＞A2＞A3.The function of 3 levels of factor B to relieve the migraine is B2＞B1＞B3.The function of 3 levels of factor C to relieve the migraine is C2＞C3＞C1.The function of 3 levels of factor D to relieve the migraine is D2＞D1＞D3. So the best acupuncture treatment prescription in 1 hour is bloodletting at abnormal collateral around Taiyang(EX-H5) together with acupuncture at local points.The best acupuncture treatment prescription during 1～24 hour is bloodletting at abnormal collateral around Taiyang(EX-H5) together with auricular acupuncture.
The results of TCD:The reactions of cerebral arteries in sick side is obvious different to different treatment methods while that in health side is almost the same which means the acupuncture therapy effects the cerebral arteries in sick side mainly.
Conclusions
1.The best acupuncture treatment prescription for migraine at attack stage in phlegm and blood stasis type in 1 hour is bloodletting at abnormal collateral around Taiyang (EX-H5) together with acupuncture at local points.
2.The best acupuncture treatment prescription for migraine at attack stage in phlegm and blood stasis type during 1～24 hour is bloodletting at abnormal collateral around Taiyang(EX-H5) together with auricular acupuncture.
3.In the acupuncture methods for migraine at attack stage in phlegm and blood stasis type,the bloodletting method is effective and stable,the acupuncture or electro-acupuncture method is effective in 1 hour while unstable after 1 hour,the auricular acupuncture is in contrary.
4.The best treatment frequency for migraine at attack stage in phlegm and blood stasis type is once a day.
5.The acupuncture treatment for migraine at attack stage in phlegm and blood stasis type effects the cerebral arteries in sick side mainly.
6.The severity of migraine isn't so related to degree of fatigue.
7.The routine influence factors of migraine are main diet,sleep,exercises,climate, and pollute air.Some cases are connected with heredity and women are related to menstruation.
8.Young people can evaluate pain more objectively than middle aged people.
Note:The conclusions above are suitable for women only.
引文
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