【作者】 邓镜明；

【导师】 王升旭；

【作者基本信息】 南方医科大学 ， 中西医结合临床， 2014， 博士

【摘要】 背景膝关节骨关节炎(knee osteoarthritis,KOA)是OA中常见的一种,以关节软骨退变、破坏及伴有相邻软骨下骨板、关节边缘骨质增生、骨赘形成为特点的一种退行性疾病。属于中医“骨痹”的范畴。在临床上,主要表现为关节疼痛、肿胀及四肢僵硬。这些症状使得患者的活动能力大大受限,当疾病发展到后期则可导致关节功能的完全丧失,使患者失去行动能力,不仅影响了日常的工作和生活,也严重威害着人类的健康。随着当今世界快速步入老龄化社会,KOA的发病率也呈逐年上升的趋势。根据国内流行病学调查结果显示KOA的患病率不等,总体女性患病率高于男性,农村及郊区高于城市,60岁以上老年人患病率为5%-40%,而X线检查的结果则患病率更高。KOA是引起老年人下肢疼痛、活动障碍的主要原因。它虽不像肿瘤一样威胁病人生命,致残率也不如风湿性或类风湿性关节炎、强直性脊柱炎高,但因患病率较高,其所致关节不适以致功能障碍对病人生活质量和社会公共卫生事业的影响不可忽视,已经引起了国际社会的广泛关注。早在1998年4月,欧洲骨科研究会主席Lars indgren教授首先发起并倡议将2000-2010年定为国际“骨与关节十年”,而我国将成为世界KOA患病人数最多的国家。中医认为KOA属于“骨痹”的范畴,对其认识最早见于《内经》。中医认为本病为本虚标实之症,肝肾亏虚、气血虚弱是发病的病理基础；风寒湿阻、痰瘀留滞是邪实的主要表达形式。肝藏血主筋,筋为人体关节之所系,若血虚,血不养筋,则筋枯生痰,血虚生热,致筋脉拘急而挛痛。肾气亏虚冲任受损,则气血失和,脉络癖滞。而素体虚弱,气血不足兼受到风寒等外邪侵袭,留滞经络则发病。总体治则上,采用标本兼治,补虚祛邪的方法,主要是补肾为主,并结合辨证分型和经络辨证。主要有内治和外治两种。内治法是通过补肝益肾、强筋壮骨、活血止痛、温经通络、祛寒除湿等中药汤剂及成药制剂对机体的整体调节,标本兼治,以缓解临床症状。外治法主要有中药外敷、熏洗、针刺针刀、推拿手法、艾灸、关节内注射等治疗方法,近年来外治临床研究进展较快。笔者根据KOA的病因病机,考虑患者的接受程度,经过长期的临床发现,膝关节隔盐灸可以有效的治疗KOA,且患者更易于接受治疗。隔盐灸最早载于《肘后备急方》,主张用食盐填平脐窝,上置大艾炷施灸,用以治疗霍乱等急症。后世的医籍《备急千金要方》、《千金翼方》及元·危亦林的《世医得效方》等都有介绍。如《本草纲目》卷十一“霍乱转筋,欲死气绝,腹有暖气者,以盐填脐中,灸盐上七壮,即苏”；“小儿不尿,安盐于脐中,以艾灸之”。隔盐灸神阙穴,能温阳补气,培肾固本,肾中真阳得旺,火能生土,使脾阳充盛,增强体质,抗御外邪。有研究显示,神阙穴隔盐灸可产生部分钠离子渗透到病灶部位组织,有消炎、镇痛的作用。并且研究者认为隔盐灸会使脐部皮肤上的各种神经末梢进入活动状态,能促进人体的神经、体液调节,提高免疫功能,激发抗病能力,从而改善各组织器官的功能活动,达到治病目的。查阅相关文献发现,而膝关节局部进行隔盐灸治疗的文献尚未见报道,多数隔盐灸的临床报道为神阙穴隔盐灸,而大部分研究中缺乏严格的诊断标准及疗效标准,疗效评价缺少各项指标的量化,缺乏足够说服力,且关于隔盐灸治疗的作用机制研究十分缺乏,有待进一步挖掘。因此,本研究针对膝关节隔盐灸和温针灸治疗KOA的临床疗效进行对比研究,并对患者的生存质量进行观察分析,以验证膝关节隔盐灸治疗KOA的疗效。并从临床角度阐述其作用机理,以探讨膝关节隔盐灸治疗KOA的客观依据,从而最大限度地发挥隔盐灸的优势,以利于隔盐灸临床进一步的推广与应用。目的采用随机对照方法,以温针灸作为对照,WOMAC量表、VAS评分、SF-36量表进行评价,观察隔盐灸对KOA患者疼痛、关节功能的改善程度并对患者进行生活质量评估,为隔盐灸治疗KOA提供临床依据。方法1研究对象1.1病例来源2012年3月--2013年12月到南方医院针灸门诊及中西医结合医院针灸推拿门诊和病房就诊病人,符合膝关节骨关节炎诊断标准者90人,签署患者知情同意书,同意参加本研究。2研究方法2.1随机方法依据EXCEL表产生序列号为1-90所对应的随机化方案,以序列编号的不透光密封信封隐藏,志愿者签署知情同意书后按照被纳入研究的顺序编号将研究对象随机分入温针组和隔盐灸组。2.4治疗方法2.4.1隔盐灸组灸具：包胶铜管,20mm(内径)x30mm(高度),一端约45°,一端水平。灸材：怀安HAJ牌温灸纯艾炷,12mm(直径)×15mm(高度)、菊花牌餐桌幼盐取穴：患侧取穴,轮流取穴,每次不超过4个穴位。主穴：内外膝眼、曲泉、鹤顶、膝阳关、阿是穴；配穴：肾髓亏虚：配太溪、阳陵泉、绝骨；阳虚寒凝：配足三里、梁丘；血瘀阻滞：配血海。操作：患者平躺床上,膝下垫枕头,屈膝保持舒服位,常规皮肤消毒后,术者将灸具倾斜面贴于施灸穴位使上端尽量保持水平位,用胶纸固定于皮肤上,内置幼盐八分满,预留3mm空位装载燃烧后的灸灰,盐上放艾炷一壮完全燃烧,再换上一壮燃烧后,让余温散去后,将灸具脱下,清理皮肤,上搽烫火膏保护。隔日一次,每周3次,连续4周,共治疗12次。2.4.2温针组取穴：与治疗组相同操作：患者平躺床上,膝下垫枕头,屈膝保持舒服位。常规皮肤消毒后用采用1.5寸针灸针直刺,得气后将2cm长艾炷套在针柄上点燃施行温针灸,每次每穴2壮为宜,约40分钟。隔日一次,每周3次,连续4周,共治疗12次。3)意外情况处理：针刺在毛孔处时会发生疼痛,应重新调整进针方位,如针刺在血管上有出血者,起针时压迫出血部位即可2.5临床评价方法2.51主要指标膝关节骨关节炎自评量表(western ontario and macmaster university osteoarthritis index,WOMAC):为用24个问题来评价患有膝关节骨关节炎的病人,得分越高说明越严重。2.5.2次要指标1)中文版简明健康状况调查表SF-36:分为精神健康、身体健康评分两部分,得分越高表明生活质量越好。2)压痛评分。采用视觉模拟评分法(visual analogue scale,VAS)进行压痛评分。VAS法是采用绘有疼痛表情且又标有刻度1-10的尺子来表示疼痛程度,0为无痛,1-3为轻度疼痛,4-6为中度疼痛,7-9为重度疼痛,10为极度疼痛。在尺子上标出能代表疼痛强度的点,测量0到标出点的距离即为疼痛强度评分值。2.5.3疗效评定根据WOMAC积分,参照尼莫地平法,即：疗效指数=[(治疗前症状积分-治疗后症状积分)÷治疗前症状积分]×100%。临床痊愈为疗效指数≥80%；显效为50%(包含50%)-80%；有效为25%(包含25%)-50%；无效为<25%。2.5.4观察周期以12次为观察期限,于试验前、后分别观察记录有关的试验资料。若在2个疗程内达到临床痊愈者,停止观察。2.6不良事件处理方法(1)轻度：指针刺中或针刺后疼痛、出血,查体无阳性体征,患者愿继续参与研究。不做特殊处理。(2)严重：针刺中出现断针、严重晕针者视为严重不良事件,停止试验,予留院观察,出现断针者请外科给予诊治。(3)以上不良事件均由研究者详细记录发生时间、持续时间、严重程度及所待实验结束后统一分析。结果(1)总共90例患者,所有患者均按照疗程完成临床观察,研究过程中无脱落、剔除病例。(2)本研究共观察90例患者,其中男性患者42例(占46.67%),女性患者48例(53.33%),男女比例为1：1.14；年龄分布为40-75岁,平均年龄57.99±10.60岁；病程分布为4-10个月,平均病程为6.68±1.89月。(3)基线比较：两组患者治疗前WOMAC评分经两独立样本t检验比较,主观症状、临床体征、日常生活能力及JOA总分均无显著差异(P>0.05),两组组患者治疗前VAS、SF-36评分经两独立样本t检验比较,无显著差异(P>0.05),具有可比性。(4)温针灸治疗前后组内比较：治疗后,患者VAS评分、WOMAC总分及疼痛、关节僵硬度及日常活动评分均有显著下降,与治疗前相比较,差异具有统计学意义(P值均=0.001)。治疗后SF-36量表评分显著高于治疗前,两者有统计学差异(P值均=0.001)。提示：温针灸可有效的缓解KOA患者的疼痛症状,对其活动关节僵硬度及日常活动改善明显,可显著提高患者的生活质量。(5)隔盐灸组治疗前后组内比较：治疗后,患者VAS评分、WOMAC总分及疼痛、关节僵硬度及日常活动评分均有显著下降,与治疗前相比较,差异具有统计学意义(P值均=0.001)。治疗后SF-36量表评分显著高于治疗前,两者有统计学差异(P值均=0.001)。提示膝关节隔盐灸具有镇痛作用,可以有效的改善患者膝关节僵硬情况,缓解患者日常活动不利的情况,且膝关节隔盐灸可有效的改善患者的健康状态,可缓解患者因疾病而引起的生理、心理问题。(6)两组治疗后比较：结果发现,在观察的几个指标中,隔盐灸组对疼痛、日常活动及VAS评分的改善优于温针灸组(P值分别为0.014、0.034、0.001),而二者在治疗后对SF-36评分的改善程度方面无明显差异；总疗效的比较,隔盐灸组优于温针灸组(P=0.036)。表明隔盐灸可以有效的改善患者的生活质量,同时对患者的膝关节疼痛及日常生活的改善程度优于温针灸。结论(1)膝关节隔盐灸,可以有效的改善KOA患者膝关节僵硬情况,缓解患者日常活动不利的情况,具有镇痛作用,可显著提高患者的生活质量。(2)隔盐灸对KOA的治疗效果优于温针灸,且对患者的膝关节疼痛及日常生活的改善程度更显著更多还原

【Abstract】 BackgroundKnee Osteoarthritis (KOA) is a chronic, degenerative, joint disease that affects mostly middle-aged and older adults. As the most common form of arthritis, KOA is firstly characterized by a series of pathological changes in the whole joint such as cartilage,subchondral bone plate and synovium, including cartilage loss, subchondral bone sclerosis, cystic degeneration, inflammation in the synovium (synovitis), and compensatory osteophyte formation, which cause joint pain, stiffness, deformity and dysfunction.Evidences gathered have shown that osteoarthritis usually begins after middle age and is progressive. The incidence rises with age, and is higher in women than men. With the arrival of our aging society more and more people are suffering from knee osteoarthritis, which presents a sognificant obstacle in maintaining their health and quality of life. Although it is not as threatening as cancer that takes lives away, not as much disability incidence as rheumatic or rheumatoid arthritis, or ankylosing spondylitis, its incidence increases and never decreases. KOA still need to be taken seriously, for the severe effect onpatients’ quality of life and the public health service. So far, KOA has caused widespread concern in the international community.ObjectiveRandomized controlled method was used in the research, and WOMAC scale, VAS score, SF-36scale were included, while using warming needle moxibustion as control group. The evaluation on patients’ degree of improvement in joint function and quality of life was carried out through the observation of salt-partitioned moxibustion. All the data were provided as clinical basis for the treatment of KOA.Methods1Participants1.1Case SourceAll the patients were collected from the Acupuncture clinic of NanFang Hospital and the Acupuncture and massage clinic of Integrative Medicine Hospital between March2012to December2013.90cases were met the diagnostic criteria for osteoarthritis and Informed consents were signed when the patients participate in this study voluntarily.2Research Methods2.1Stochastic approachA patient number identified all patients included in the study after signing the informed consent form. Each patient was identified by a numerical code. Randomization scheme was based on serial numbers (1-90) of the EXCEL table.The correspondence between the number of patients and their treatment was performed by use of specific software for randomization, keeping that relation in a sealed envelope. This envelope was not opened until the moment before the treatment was applied. The response was assessed by researchers not involved in the application of treatment (blinded). Then the90patients were randomly divided into warming needle moxibustion and salt-partitioned moxibustion according to the order of inclusion criteria.2.4Intervention2.4.1Salt-partitioned moxibustionMoxibustion instrument:plasticcopper tubing,18cm (inside diameter) x18cm (height), one side is about45°, one side is horizontal.Moxibustion materials:Pure moxa cone moxibustion of Huai an (HUJ),12cm (diameter)×15cm (height), table salt of Chrysanthemum brand.Acupoints selection:ipsilateral acupoints, acupoints in turn, no more than four acupoints each time.Main acupoints:Neiwaixiyan(EX-LE5), Ququan(LR8), Heding(EX-LE2), Xiyangguan(GB33), Ashi;Adjunct points:kidney marrow deficiency:Taixi(KI3), Yanglingquan(GB34), Juegu(GB39); Yang deficiency and cold coagulation:Zusanli(ST36), Liangqiu(ST34); Blood stasis block:Xuehai(SP10).Operation:The patients were asked to lie in bed, and their knees were in comfort position padded with pillows. After routine skin disinfection, the doctor put the45°ide of moxibustion instrument on the acupoints and made sure the other side as horizontal as possible. Then moxibustion instrument should be fixed on the skin with adhesive tape. And plasticcopper tubing should be80%filled by the table salt, whose3mm vacancy left for the moxibustion ash after burning.Everytime there was one moxa cone burning on the salt. After its complete combustion and dispersion of Sweltering, doctor should take the moxibustion instrument away, clean the surface and skin of patients, and apply the cream to the areas gently.Two days one time, three times a week, for4weeks.12times in all.2.4.2warming needle moxibustion Acupoints selection:same as the group of salt-partitioned moxibustion.Operation:The patients were asked to lie in bed, and their knees were in comfort position padded with pillows.After routine skin disinfection,1.5-inch acupuncture needles were impelled in the acupoints.In addition the moxa cone about2cm was ignited and set on the handle of the acupuncture needle.2Zhuang(unit of moxa cone) each acupoint each time, about40minutes. Two days one time, three times a week, for4weeks.12timesinall.3) Accident treatment:pain occurs when the needle is impelled in pores, doctor should readjust the direction of the needle.If the needles are impelled in blood vessels, press the bleeding site when the needles are withdrawn.2.5Clinical evaluation method2.51main outcome measureswestern ontario and macmaster university osteoarthritis index (WOMAC):to evaluate patients with knee osteoarthritis by24questions, the higher score means the worse degree of the disease, including5assessed dimensions such as the pain, joint stiffness, physical function, social function and emotion.In details like there is5questions in pain,2questions in stiffness,17questions in physical function,6questions in social function,10questions in emotion.Every question will be given4points,3points,2points,1point, O pointsdepending on the different individual circumstances.Besides, some researchers only use3dimensions(pain, joint stiffness, and physiological functions)of the WOMAC.Also, the higher the score, the more severe the disease.2.5.2Secondary Indicator1) short-form-36health survey SF-36(Chinese):assessment is divided into mental health, physical health. Higher scores indicate better quality of life.2) tenderness score. Using a visual analogue scale (visual analogue scale, VAS) to evaluate tenderness score. VAS is designed to show the degree of pain by pain expression and the ruler which is marked the scale of1-10,0means painless, while1-3means mild pain,4-6moderate pain,7-9severe pain,10extreme pain. Mark on the ruler using the most representative point of pain intensity, and measure the distance from0to the mark.Finally the scores we got from VAS would bethe pain intensity scores.2.5.3Quality AssessmentAccording to the WOMAC and nimodipine therapy, namely:efficacy index=[(symptom score before treatment-symptom score after treatment)÷symptom score before treatment]×100%. Clinical recovery correspond to efficacy index≥80%; while markedly effectiveto50%(including50%)-80%; effective to25%(including25%)-50%; ineffective to<25%.2.5.4observation cycleObservation cycle is12times. The relevant data were observed and recorded before and after the trail. If the patient reaches clinical recovery within two courses, the ovservation can be stopped.2.6Accident treatment(1) Mild:refers to pain, or bleeding during the needling or after the needling.The physical examination shows no positive signs.The patient is still willing to participate in the study. Not need special treatment.(2) severe:accidents such as broken needle and faintng during acupuncture treatment.All these need to pause the trail immediately and make the patients stay in hospital for observation.Invite the surgery to give corresponding diagnosis and treatment.(3) All theaccidents occurred will be documentedby the researchers including the happening, duration and severity, and these records will be analyzed in the end of the experiment.Results(1)90patients in all, all patients completed treatment and clinical observations.In the research there was no loss or excluding cases.(2) This study contained90patients observed,42male patients (46.67%),48female patients (53.33%). The ratio of male to female was1:1.14.Age distribution was between40-75years old, mean age:57.99±10.60; duration distribution:4-10months, the average duration was6.68±1.89months.(3) baseline comparison:WOMAC score of the two groups of patients before treatmentby t test, there were no significant difference in subjective symptoms, clinical signs, activities of daily living and JOA scores (P>0.05). VAS, SF-36score were the same as WOMAC score and were comparable.(4) Statistical analysis before and after treatment in group2(warming needle moxibustion group):After the intervention, the VAS scores, WOMAC scores and pain, joint stiffness and daily activity scores of the patients were significantly reduced comparing with the situation before treatment. The difference was statistically significant.Meanwhile the SF-36scores after the intervention were significantly higher than the scores before treatment, and there was significant difference between them. All the data indicated that warming needle moxibustion can effectively relieve the pain of KOA patients and improve their joints stiffness and daily activities significantly, thus improve the quality of life of patients significantly.(5) Statistical analysis before and after treatment in group1(salt-partitioned moxibustion):After the intervention, the VAS scores, WOMAC scores and pain, joint stiffness and daily activity scores of the patients were significantly reduced comparing with the situation before the treatment. The difference was statistically significant. Meanwhile the SF-36scores after the intervention were significantly higher than the scores before treatment, and there was significant difference between them. All the data indicated that salt-partitioned moxibustion on the knee can be analgesic and improve the joints stiffness and daily activities significantly.Meanwhile it can improve the health status of patients and relieve physiological and psychological problems caused by the disease.(6) Statistical analysis between the two groups After treatment:It was found that several indicators observed such as WOMAC scores, pain, daily activities and VAS scores in salt-partitioned moxibustion group was lower than warming needle moxibustion group.But there was no significant difference between the two groups in terms of improving the level of SF-36scores. There was no significant difference between the groups after the treatment in the comparison of the total efficacy. All the data implied that salt-partitioned moxibustion can improve the quality of life of the patients and make better effect on improvement of pain and daily life than warming needle moxibustion.Conclusion(1) Salt-partitioned moxibustion of the knee, possibly analgesic when participating in the intervention, can effectively improve the situation of stiffness of KO A patients and their daily activities, thus improve the quality of life of patients.(2) The therapeutic effect of salt-partitioned moxibustion is better than warming needle moxibustion. Thus its impact in reducing pain and improving the quality of life is better than warming needle moxibustion.更多还原