【作者】 李斌；

【导师】 赖新生；

【作者基本信息】 广州中医药大学 ， 针灸推拿学， 2012， 博士

【摘要】 颈性眩晕(CerivealVertigo, CV),又称“颈源性眩晕”,是由于颈部椎间盘变形、骨质增生、髓核突出、神经刺激、慢性劳损、外伤和炎症等多种因素刺激和压迫周围的神经和血管,引起大脑供血不足而出现以头晕、恶心、呕吐及颈部不适为主症的一类病症。临床症状一般有头晕,恶心,呕吐,耳鸣,视物不清等,最突出的特点为体位性眩晕即当改变体位尤以扭转头部时眩晕加重,严重者可发生碎倒,但一般不伴有意识障碍。可见,该病症并不是一个特定的疾病名称,而是泛指由于颈椎病而引起椎-基底动脉供血不足而导致眩晕的一类中枢性眩晕名称。随着社会现代化的进程,人们的生活习惯、工作发生了极大的变化,不少新生的“现代病“也日趋增多,颈椎病就是其中的一种。原本为老年性的颈椎病现已向中青年扩展,甚至一些中学生也常有头痛头晕,颈项酸痛不适的现象。如不及早地进行防治,将严重影响人们的正常工作、健康和生活。严重者可因脊髓压迫而瘫痪,也可因长期脑供血不足而导致脑细胞失养,记忆力衰退,引发老年性痴呆。根据近几年研究报告显示,眩晕病在40～60岁的中老年人群中多发,而且总数的40%是由颈性眩晕引起。现代社会的逐步发展逐渐增加的工作效率和劳动强度,并且随着广泛使用电脑和生活节奏的加快,大大增加了年轻人的颈性眩晕的发病率,并且长期保持低头状态工作会与本病有密切关系。此病会对工作效率和生活质量造成一定影响。颈性眩晕的病因及发病机制目前尚无统一的观点,诸多学者阐论不一。国内学者主要将颈性眩晕归入椎动脉型和交感型颈椎病的范畴。尽管国内外有理疗、药物治疗、手术等治疗方法。但是针灸疗法凭借着简洁、方便、经济、绿色的优势受到越来越多患者的欢迎。随着国内针灸治疗颈性眩晕的临床随机对照试验日益增多,有必要系统全面了解该领域的针灸临床的科研现状和文献计量情况。因此,本研究采用循证医学和文献计量学的方法,全面评价针灸治疗颈性眩晕的临床随机对照试验的研究现状,以期为同道提供参考。另外,临床随机对照试验是验证干预措施疗效的标准设计方案,其研究和报告质量直接影响对干预措施疗效的判断。因此,本研究还采用国际公认的试验报告统一标准(CONSORT声明)和报告针刺临床试验中干预措施的国际标准(STRICTA)来评价针灸治疗颈性眩晕的临床随机对照试验的报告质量,以期为今后进行高质量研究提供改进依据。目的：依据既定检索策略,CNKI298篇、CBM107篇、WF45篇、VIP46篇。文献语言均为中文。经过浏览题目、文摘、全文后,确定180篇随机对照试验进行研究。通过筛选,排除不符合纳入标准的253篇文献,包括：重复检出的文献210篇；综述、评论、探讨类文献30篇；动物实验类文献12篇；重复发表的文献6篇；非随机对照临床试验文献21篇；个案经验文献6篇；其他不符合纳入文献51篇。详细的文献筛选流程见图1。所有文献发表的时间为1997-2011年。依据临床流行病学和循证医学原则和方法,本研究制定了《针灸治疗颈性眩晕试验质量评价信息采集表》(简称评价表)。内容涉及基本情况,诊断、纳入和排除标准,估算样本含量,基线资料可比性,随机方法,随机方案隐藏,观察指标和疗效标准,盲法使用,病例随访,不良反应,统计学处理以及结论推导等。方法：文献系统分析与评价是依据临床流行病学和循证医学原则和方法,本研究制定了《针灸治疗颈性眩晕试验质量评价信息采集表》(简称评价表)。内容涉及基本情况,诊断、纳入和排除标准,估算样本含量,基线资料可比性,随机方法,随机方案隐藏,观察指标和疗效标准,盲法使用,病例随访,不良反应,统计学处理以及结论推导等。而Meta分析是按照Cochrane Review Handbook5.0推荐使用的质量评价标准：偏倚风险评估工具,包括7个方面：①随机分配方法；②分配方案隐藏；③对研究对象、治疗方案实施者、结果测量者采用盲法；④结果数据的完整性；⑤选择性报告研究结果；⑥其它偏倚来源。针对每一项研究结果,对上述7条作出“是”(低度偏倚)、“否”(高度偏倚)和“不清楚”(缺乏相关信息或偏倚情况不确定)的判断。两位评价者交叉核对纳入试验的质量评价结果,对有分歧而难以确定则通过讨论或由第三位评价者协助解决。结果：按检索策略和资料收集方法,在第一部分检索180篇文献中继续筛选合格文献,最终纳入11篇随机对照试验。均为单个随机平行对照试验。除4没有交代纳入病例来源,其余研究对象均为门诊和／或住院病例。颈性眩晕有2项试验采用1994年国家中医药管理局颁布的《中医病症诊断疗效标准》、7项研究采用同第二届全国颈椎病专题座谈会制定的标准,有1项试验采用中药新药临床研究指导原则的标准。仅有3项研究交代纳入标准,6项研究叙述排除标准。在疗效标准方面,7项研究采用国家中医药管理局颁布的《中医病症诊断疗效标准》,另有两项研究采用眩晕症状与功能评估量表,其余均为自拟标准。所有研究均采用临床有效率,有3项研究观测椎基底动脉血流的情况,2项研究采用颈性眩晕症状与功能评估量表。截止2011年底,针灸治疗颈性眩晕的随机对照试验逐年增加,研究机构的层次不断提高,特别是几年来注重随机序列方法的使用,但是仍然存在如下方面的不足：①随机序列的产生未能交代。随机序列是临床试验减少偏倚,提高试验结果真实性的首要措施。如果随机序列没有交代,那么证据的使用者无法判断该文献是否是真正的随机对照试验。②缺乏盲法的使用。③组间资料缺乏足够论述。真正意义上双盲也许很难实施,但是评价者盲法和分配隐藏是可以实施的。以上几点是今后我们在设计针灸治疗颈性眩晕的干预试验时应该注意的。针灸之所以能长期存在并经久不衰,关键在于其防治病症的广泛性和有效性。而随机对照试验是评价针灸临床防治效果的最有力的工具之一。开展针灸随机对照试验研究可对病症认识,针灸防治病症的有效性、安全性和社会-经济效益等方面做出较为客观的评估,为针灸相关决策提供可靠的最高级别证据,也为进一步开展高质量的针灸临床研究在方法学上提出建设性意见。国内针灸或相关领域的研究人员在接受了循证医学和临床流行病学的基本训练后,从事此类型研究的逐年增多。1997就有针灸治疗颈性眩晕的随机对照试验出现,继而大量试验研究不断涌现,说明针灸关注颈性眩晕的临床研究起步还是比较早的,传播也日益广泛。本研究评价了从1997-2011年12月间国内期刊发表的180篇有关针灸的治疗颈性眩晕的随机对照试验。总体来看,这些文献比以往的临床观察有了很大的进步,体现在提出的临床问题比较具体,多角度评价针灸的临床疗效,逐步向国际标准靠拢,研究结论较为客观,但是仍存在一些不足。更多还原

【Abstract】 Cervical vertigo (CerivealVertigo CV), also known as "cervical vertigo", is due to neck disc deformation, bone hyperplasia, and herniated nucleus, nerve stimulation, chronic fatigue, trauma and inflammation and other factors that stimulate and oppression around the nerves and blood vessels, causing insufficient blood supply to the brain and main symptoms of dizziness, nausea, vomiting, and neck discomfort of a class of diseases. Clinical symptoms are dizziness, nausea, vomiting, ringing in the ears, as the material is unclear, the most prominent features of positional vertigo that is, when a change of position especially when you turn the head, dizziness increased, severe cases can be broken down, but generally do not accompanied by disturbance of consciousness. Visible, the disease is not a specific disease name, but refers to cervical spondylosis of vertebral-basilar artery insufficiency caused by the vertigo of a class of central vertigo name.With the process of social modernization, people’s living habits, work has undergone great changes, many nascent "modern disease" is also increasing, cervical spondylosis is one of them. Originally for age-related cervical disease is now to expand middle-aged, and even some middle school students often have headaches and dizziness, neck pain discomfort phenomenon. If we do not control, will seriously affect people’s normal work, health and life. Severe cases may be due to spinal cord compression and paralysis, can also be due to the insufficiency of long-term brain and cause brain cell dystrophy, memory loss caused by Alzheimer’s disease.According to the research report shows that in recent years, vertigo in40to60years in the elderly population in the hair, and40%of the total number of cervical vertigo. The gradual development of modern society, gradually increase the work efficiency and labor intensity, and with the acceleration of widespread use of computers and the pace of life, greatly increased the incidence of cervical vertigo of young people, and long bow to state with the disease close relationship. Work efficiency and quality of life of the disease will have some impact.The etiology and pathogenesis of cervical vertigo is no unified point of view, many scholars explain on the different Domestic scholars cervical vertigo in the vertebral artery type and scope of the sympathetic cervical spondylosis. Although the domestic and foreign physical therapy, medication, surgery and other treatments. Acupuncture by virtue of simplicity, convenience, economy, green advantage more and more welcomed by patients. With the increasing number of domestic acupuncture treatment of cervical vertigo clinical randomized controlled trials, the necessary systematic and comprehensive understanding in the field of acupuncture clinical research status and bibliometric situation. In this study, evidence-based medicine and bibliometrics, a comprehensive evaluation of randomized controlled trials of acupuncture treatment of cervical vertigo Clinical Research, in order to provide a reference for fellow.In addition, randomized controlled trials to verify the efficacy of interventions to standard design, studies and reports a direct impact on the quality of the judgment of the efficacy of interventions. Therefore, this study also uses an internationally recognized test Consolidated Standards of Reporting (CONSORT statement) and international standards (The STRICTA) report on acupuncture clinical trials of interventions to evaluate the clinical acupuncture treatment of cervical vertigo to the quality of reporting randomized controlled trials of future high-quality research to provide improved basis.Objective:Based on the established search strategy, CNKI298CBM107articles, WF45, VIP46. Literature languages are Chinese. Browse topics, abstracts and full text to determine the180randomized controlled trials to study. Exclude through the screening,253articles met the inclusion criteria, including: duplicate detection literature210; Review, review, investigate the class of30; of animal experiments12;6repeat the published literature; non-randomized controlled21; of the clinical trials of six cases in the empirical literature; other does not meet the51included studies. Detailed literature screening process shown in Figure1. All literature published from1997to2011. In accordance with the principles and methods of clinical epidemiology and evidence-based medicine, this study developed the acupuncture treatment of cervical vertigo test quality evaluation information collection form (referred to as the evaluation form). Covering basic, diagnostic, inclusion and exclusion criteria, to estimate the sample size, comparability of baseline data, the random method, random program, hide, observe the indicators and efficacy standards, blinding, use the follow-up of cases, adverse reactions, statistical analysis, and conclusions deduced and so on.Results:The search strategy and data collection methods, retrieved in the first part180in the literature continue screening qualified literature, and ultimately included in the11randomized controlled trials. Are the single randomized controlled trials. In addition to four, no mention into the source of cases, the rest of the study are outpatient and/or hospitalized patients. Cervical vertigo two trials using the "Chinese disease diagnosis and efficacy standards promulgated by the State Administration of Traditional Chinese Medicine in1994, seven studies using the standards set by the Second National symposium of cervical spondylosis, a test of new herbal drugs clinical research standards of the guiding principles. Only three studies account for the inclusion criteria and six studies described in the exclusion criteria. Promulgated by the State Administration of Traditional Chinese medicine disease diagnosis and efficacy standards in terms of efficacy standards, seven studies, two other studies with vertigo symptoms and functional assessment scale, the rest are self. All studies using clinical efficiency, there are three observations of vertebral basilar artery blood flow, two cervical vertigo symptoms and functional assessment scales. By the end of2011, the randomized controlled trials of acupuncture treatment of cervical vertigo increased year by year, and continuously improve the level of research institutions, especially a few years to focus on the use of random sequence method, but there are still the following deficiencies:①The random sequence generation failed to be accountable. Random sequence of clinical trials to reduce bias, the primary measures to improve the authenticity of the test results. If the random sequence is not accountable, then the users of the evidence can not determine whether it is truly randomized controlled trials of the literature.②Group baseline information on the lack of adequate description. Although most trials are accountable to the baseline data were comparable, but the detailed data and statistical value is not well represented. Such clinical trials Qi comparability will be greatly reduced.(3) blinded use missing. Blinded use and random adaptation, the main purpose is to make the observation execution and subjects are not subject to the subjective will have impact in order to reduce test bias. Although the true sense of the double-blind may be difficult to implement, but the evaluator blinding and allocation concealment can be implemented. The above points are the future, we should pay attention to the design of acupuncture treatment of cervical vertigo Intervention Trial.Acupuncture has been able to exist for a long and enduring, the extensiveness and effectiveness of the key to its prevention and control disease. Randomized controlled trial is one of the most powerful tool in the evaluation of prevention and treatment of acupuncture effect. To carry out acupuncture randomized controlled Experimental Study on understanding of the disease, the effectiveness of acupuncture control the disease, security and social economic benefits to make a more objective assessment, to provide the highest level of evidence for acupuncture-related decision-making, but also for further quality acupuncture clinical research on the methodology put forward constructive ideas. Domestic acupuncture or related fields, researchers in evidence-based medicine and clinical epidemiology training, engaged in this type of research is increasing year by year. There are randomized controlled trials of acupuncture treatment of cervical vertigo1997, then a lot of tests continue to emerge, indicating that the clinical research of acupuncture concern of cervical vertigo started earlier, the spread of increasingly widespread. This study evaluated the randomized controlled trial of180domestic journals published from1997to December2011, the acupuncture treatment of cervical vertigo. Overall, the literature than the previous clinical observation have made great progress, reflecting the specific clinical issues in the proposed multi-angle to evaluate the clinical efficacy of acupuncture, and gradually move closer to international standards, a more objective conclusions, but there are still some inadequate.更多还原