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耳穴额—颞—枕透穴埋针刺法治疗偏头痛的随机对照研究

A Randomized Controlled Study of Auricular Point Forehead-Temporal-Pillow Aperture Point Through Point Needle-Embedding Therapy in Treating Migraine

【作者】 郑丽娅

【导师】 贾春生;

【作者基本信息】 河北医科大学 , 针灸推拿学, 2009, 硕士

【摘要】 目的:偏头痛是临床上的一种常见病、多发病,以反复发作的单侧或双侧搏动性头痛为主要症状,可伴有恶心、呕吐、畏光或怕声等伴随症状。随着社会的发展,人们生活节奏加快,社会竞争日益激烈,偏头痛的发病率呈现明显上升趋势。WHO提出,偏头痛与四肢瘫痪、精神障碍和痴呆均已成为最严重的慢性功能障碍性疾病。目前西药治疗本病虽有疗效,但副作用较多,而针灸疗法具有良好的镇痛特性,与西药相比,具有疗效确切、费用低廉、副作用少等特点,故在本病的治疗上应用十分广泛。耳穴疗法是诸多针灸疗法中镇痛效果较为突出的一种疗法,近年来应用耳穴治疗偏头痛的临床报道很多,其治疗方法亦多种多样,有耳穴贴压法、耳穴针刺法、穴位注射法、耳背静脉放血法、耳穴埋针法等。吾师在多年的临床实践中发现了耳针沿皮透刺刺法——这一比传统耳穴针刺的点状刺法操作更方便、疗效更佳的刺法。为了进一步探讨耳穴透穴埋针法对偏头痛患者的治疗效果,导师承担了河北省中医药管理局科研项目《耳穴额-颞-枕透穴埋针刺法治疗偏头痛的临床观察》的研究工作,本课题为其中的一部分,旨在通过与治疗偏头痛的有效药物尼莫地平做对照,观察耳穴额-颞-枕透穴埋针刺法对偏头痛的治疗效果,以期为耳穴治疗偏头痛提供一种更好的刺法技术,同时为临床提供一种疗效显著、无毒副作用且更便于患者就诊的治疗方法。方法:根据国际头痛协会(IHS)2004年所修订的偏头痛的诊断标准,参照国家药品监督管理局颁布的《中药新药治疗偏头痛的临床研究指导原则》的头痛分期标准、纳入标准、排除标准选择了92例偏头痛患者。本课题采用完全随机设计,按患者就诊的先后顺序编号,利用随机数字表将受试对象随机分为试验组与对照组,每组46例。以耳穴额-颞-枕透穴埋针刺法作为试验组,以口服尼莫地平作为对照组,试验组先于患侧耳郭埋针,留针5天,5天为一疗程,疗程间隔2天,再于健侧耳郭埋针,两耳交替进行,共治疗4个疗程;对照组口服尼莫地平,40mg/次,3次/日,连续服用四周。治疗前记录病人的基本情况,如姓名、性别、年龄、职业、病史、家族史、工作单位、联系电话等。同时记录病人视力、眼底检查结果、月经情况、头痛与月经的关系、头痛与精神紧张、劳累及情绪因素的关系等。在治疗过程中,请病人详细记录头痛发作时的情况,以头痛程度、疼痛持续时间、头痛发作次数、伴随症状作为镇痛效应观察指标,采用孙氏标准进行评分。治疗期间与病人保持联系,随时记录所出现的意外情况或不良反应。治疗结束后1个月和6个月对病人进行两次随访。分别记录两组患者治疗前、治疗期间(自开始治疗至治疗结束)、治疗结束后1个月和6个月的各项镇痛效应指标评分情况,将所得数据,以α=0.05作为假设检验的水准,采用双侧检验,进行χ2检验、t检验与Wilcoxon秩和检验,用SPSS11.5统计软件进行统计学处理与分析。结果:对两组患者的性别、年龄做假设检验,均为P>差别无显著性。两组患者治疗前镇痛效应指标综合评分比较,P>0.05,差别无显著性,两组间具有可比性。两组患者治疗期间、治疗结束后1个月和治疗结束后6个月镇痛效应指标综合评分与治疗前相比,差异均有显著性意义(P<0.01),治疗后不同时间镇痛效应指标综合评分较治疗前均下降,两种治疗措施均能减轻患者疼痛程度,缩短疼痛持续时间,减少头痛发作次数和伴随症状,改善患者的临床症状。治疗期间两组患者综合评分比较,差异无显著性意义(P>0.05),两组患者临床症状改善无差别,说明治疗期间耳穴额-颞-枕透穴埋针法治疗偏头痛的疗效与尼莫地平近似。治疗结束后1个月两组患者综合评分比较,差异有显著性意义(P<0.05),试验组综合评分低于对照组,治疗结束后1个月试验组对偏头痛患者临床症状的改善优于对照组。治疗结束后6个月两组患者综合评分比较,差异有显著性意义(P<0.01),试验组综合评分低于对照组,治疗结束后6个月试验组对偏头痛患者临床症状的改善优于对照组。两组患者近期疗效比较,差异有显著性意义(P<0.01),试验组疗效优于对照组。两组患者远期疗效比较,差异有显著性意义(P<0.01),试验组疗效优于对照组,说明耳穴额-颞-枕透穴埋针刺法治疗偏头痛在近期疗效和远期疗效方面均优于对照药尼莫地平。两组患者不良反应率比较,P<0.05,有统计学意义,试验组不良反应率低于对照组。结论:1耳穴额-颞-枕透穴埋针刺法与口服尼莫地平均能减轻患者疼痛程度,缩短疼痛持续时间,减少头痛发作次数和伴随症状,两种治疗方法对偏头痛患者均有疗效。2治疗期间两组患者临床症状改善无明显差别,治疗期间耳穴额-颞-枕透穴埋针刺法治疗偏头痛的疗效与尼莫地平近似。3耳穴额-颞-枕透穴埋针刺法治疗偏头痛在近期疗效和远期疗效方面均优于对照药尼莫地平。4耳穴额-颞-枕透穴埋针法无不良反应,可以避免尼莫地平的恶心、头晕等副作用,是一种安全的疗法。综上所述,耳穴额-颞-枕透穴埋针刺法是治疗偏头痛的一种安全、有效的方法,且其具有操作简便、疗效显著、痛苦较小、无副作用等特点,值得在临床中推广使用。

【Abstract】 Objective: Migraine is commonly and frequently encountered disease in clinical setting. The main symptom is recurrent pulsatile headache which attacks one side or both sides of brain, accompanied with nausea, vomiting, photophobia or fearing of sound and so on. With the development of the society, pace of life becomes faster, and the social competition becomes more fiercely, the incidence of migraine is on an obvious rise. WHO puts forwards that migraine, quadriplegia and dementia have been listed among the most severe chronic diseases due to dysfunction. At present, although western medicine have some curative effects, but lots of side effects. While acupuncture and moxibustion therapy has a good analgesic characteristic property, and compared with western medicine, this method has the effect of exact, low-cost, less side effects, etc. Therefore, it has a wide range of applications in the treatment of Migraine. Auricular therapy is a lot more prominent analgesic effect of a therapy. There are lots of clinical reports on treating migraine using diverse auricular therapies such as: auricular point flattening therapy, auricular acupuncture therapy, point-injection therapy, bloodletting therapy on the ear vein, auricular point Needle-Embedding therapy and so on. My tutor has discovered the method of point acupuncture by needling auricular point along the skin, which is more convenient to operation and effective in curing than traditional globular Auricular point. In order to further explore the curative effects of auricular point through point Needle-Embedding therapy for migraine patients, my tutor is taking over the research subject of《The Clinical Observation of Auricular Point Forehead-Temporal-Pillow Aperture Point Through Point Needle-Embedding Therapy in Treating Migraine》which belongs to TCM Administration of Hebei Province. This thesis is involved in the subject, with the purpose of comparing it with the efficacious migraine medicine—nimodipine. The curative effects of Auricular Point Forehead-Temporal-Pillow Aperture Point Through Point Needle-Embedding Therapy in the migraine treating process is observed, aiming to get a better acupuncture therapy and provide an effective and innocuous therapy that can be convenient to cure the migraine patient.Method: According to 2004 IHS revised migraine diagnosis standard,referring to the headache stage principal, the enrolled principal and the exclusion principal in the《Clinical study guide principal on new herb curing migraine》which are put forward by national medicine administration, we have chosen 92 migraine patients. The research project chooses the test examples at random. The test patient has been numbered according to their sequences to the clinics. Then we use random number table to make two group of respective 46 cases—the test group, that is Auricular Point Forehead-Temporal-Pillow Aperture Point Through Point Needle-Embedding group and compare group, that is taken nimodipine orally. The patients in the test group had been embedded needles in their auricular points in the sick sides for 5 days as one part of the whole treatment. Then after 2 days, the patients had been embedded needles in their auricular points in the healthy sides for 5 days. The two sides had been alternately treated for 4 periods of treatment in total. While the comparing group had took nimodipine 40mg each time,3 times a day for 4 weeks orally. Before treatment, we had recorded the general information of the patients, such as name, gender, age, profession, medical record, family history, work unit and their telephone number. At the same time, we also had recorded the relationship among headache, the vision, eye ground test result and menses situation, menses and the relationship among headache and strain, exhaustion and emotion. During treating process, the patient would be asked to record the attack of the headache. Collecting the index of the degree of the ache, the lasting time, the headache frequency of attack and accompanied symptoms as observing index, we had scored them according to Sun’s criteria. Keeping contract with the patients during treating period, then we could record unexpected situation and the untoward effect momentarily. One month and six months after the treatment, we had respectively followed up a case by regular visits to the patient for two times, recorded the general score of each analgesic items during pre-treating period, treating period and post-treating period of one month and six months. Then we put all data together, supposingα=0.05 as test standard, adopted two sides of brain tests, carried onχ2 Test, t Test and Wilcoxon rank-sum test,used SPSS11.5 statistical software to treat and analyze.Results: The hypothesis test result in gender and age of two test groups is P>0.05, there is no obvious difference. Through the analysis of pre-treating condition, we had got that P>0.05, there is no obvious difference. The analysis result of the two groups’patients’course of disease before curing is P>0.05, there is no obvious difference. After compared the general score of analgesic effect index between two test groups, P>0.05, there is no obvious difference. So the two groups have comparability.Comparing the general score of analgesic effect index between the pre-treating condition and post-treating period of one and six months, there appeared an obvious difference (P<0.01),the general score of analgesic effect index decreased. Both of the two therapies can relieve the degree of headache, shorten headache duration, reduce headache frequency of attack and accompanied symptoms. Thereby improve the clinical state of the patients. During the treatment, comparing the general score of two groups, there is no obvious difference (P>0.05), the improvement condition of their clinical symptoms has no difference, which showed that the efficacy of Auricular Point Forehead-Temporal-Pillow Aperture Point Through Point Needle-Embedding Therapy in the migraine approximates to nimodipine. After one month treatment, there have an obvious difference in the general score (P<0.05), the score of the test group is obvious lower than that of compared group. All of this indicates that the improvement effect to clinical symptom in the test group is better than that in compare group after a month treatment. After six months treatment, there have a significance difference in the general score (P<0.01), the score of the test group is obvious lower than that of compare group. All of this indicates that the improvement effect to clinical symptoms in the test group is better than that in compare group after six months treatment. Through comparisons of the curing effect in two groups recently, there have a significance difference (P<0.01),the curing effect in test group is better than that in compare group in short term. Comparing the curing effect in two groups in long term, the difference have a remarkable significance (P< 0.01), the test group also have a more significance curing effect than that of compare group in long term. This showed that both short-term and long-term efficacy of Auricular Point Aperture Point Through Point Needle-Embedding therapy in Treating Migraine were superior to the control drug nimodipine. The comparison of untoward rate is P<0.05, there have statistical significance and indicate the untoward rate in test group is lower than that of compare group.Conclusions:1 Both the Auricular point Forehead-Temporal-Pillow aperture point through point needle-embedding therapy and taken nimodipine orally can relieve the degree of headache, shorten headache duration, reduce headache frequency of attack and accompanied symptoms, so both therapies have efficacy in patients with migraine.2 During treating period, the improvement condition of the two group’s clinical symptoms has no difference, which showed that the efficacy of Auricular point Forehead-Temporal-Pillow aperture point through point needle-embedding therapy in treating migraine approximates to nimodipine.3 Both short-term and long-term efficacy of Auricular point aperture point through point needle-embedding therapy in treating migraine were superior to the control drug nimodipine.4 The therapy of Auricular point aperture point through point needle-embedding has no adverse reactions, and can avoid the side effects of nimodipine, such as nausea, vomiting etc. So it is a safe therapy.In a word, the Auricular Point Forehead-Temporal-Pillow Aperture Point Through Point Needle-Embedding therapy is a safe and effective therapy in migraine treating. And with the characteristics of simple, effective, less pain and no side effects, etc. So it is worth to promote in the use of clinical setting.

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