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电针夹脊穴结合康复治疗治疗腰椎间盘突出症的临床研究
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摘要
背景:
     腰椎间盘突出症(Lumbar Disc Herniation,LDH)是因为慢性劳损、外伤、年龄的增长,引起腰椎的椎间盘发生变性、纤维环破裂、髓核突出,刺激或压迫相应的神经根、血管、马尾神经所表现出来的一系列临床病症。腰椎间盘突出症是临床引起腰腿疼的最主要原因,严重影响患者的日常生活、学习与工作。流行病学调查表示,中国人群发病率约为0.95%,腰椎间盘突出症中以腰4-5,腰5-骶1间隙发病率最高,约占90%-96%。本病在发病因素上,受多种因素的影响,如长期坐位姿势、职业区别、体育锻炼减少等,男性的发病率普遍高于女性,随着社会的发展,脑力劳动人数的增加,本病发病率逐年上升及低龄化的趋势。
     关于腰椎间盘突出症的西医疗法方面,主要分为手术治疗和非手术治疗两大类,采用手术治疗易发生后遗症,有一部分患者遗留经常性腰腿痛或麻木等症状。西医非手术疗法中,药物治疗的治疗周期长,易于反复,副作用大,很多病人常常因不能坚持而导致治疗的失败。中医方面,对本病的治疗亦方法众多,或内服中药,或中药外敷,或推拿按摩,或施以针灸之法。如何更好地提高腰椎间盘突出症患者的疗效,减轻其病痛,对我们传统医学是一个挑战。其中针灸治疗腰椎间盘突出症的疗效近年来在国内外受到了肯定,成为目前治疗腰椎间盘突出症行之有效的治疗方法之一,并显示进一步优化各种有关针灸治疗腰椎间盘突出症的方案有重要的意义。多项临床研究和实验研究显示,电针夹脊穴能够减轻腰椎间盘突出症引起的疼痛,具有无痛、方便、安全、无明显毒副作用的特点,对于缓解患者疼痛,提高生活质量,具有深远的社会意义。最近国内医学界重新提出的整合医学理念为临床治疗本病提供了新的思路,本研究正是基于临床经验以及整合医学的理论而设立。
     目的:
     对比电针夹脊穴与康复治疗的整合疗法与单一疗法治疗腰椎间盘突出症的临床疗效差异及其对致炎因子的影响。
     方法:
     采用简单随机的方法,选取2010年11月至2012年11月期间在台湾信华中医诊所治疗的患者,符合纳入标准的腰椎间盘突出症患者,共收集病例92例,按1:1:1的比例随机分配至电针夹脊穴结合康复治疗的整合治疗组、电针夹脊组、康复治疗组,其中整合治疗组31例,电针夹脊组为31例,康复治疗组为30例。
     整合治疗组选用的主穴为病变椎体的夹脊穴及阿是穴,并参照王启才主编的《针灸治疗学》进行配穴,进行常规电针并按康复治疗组的方法治疗;电针夹脊组按整合治疗组的穴位,仅行电针治疗;康复治疗组采取包括中频理疗、牵引及功能锻炼在内的康复治疗方法。
     所有符合纳入标准病例按设计要求观察,一周治疗3次,共治疗1个月。疗效观察具体项目包括:JOA下腰痛评价量表、世界卫生组织生存质量量表简表(WHOQOL-BREF)、简化McGill疼痛量表、生化指标(白细胞介素-1β、肿瘤坏死因子α及血浆血栓素B2等致炎因子)。其中专用的JOA下腰痛评价量表作为主要疗效指标,而有效率的疗效评价则参考《中医病症诊断疗效标准》。
     应用SPSS17.0统计软件进行数据统计分析。计量资料用均数±标准差((?)±S)表示,计量资料组间比较采用F检验(方差不齐采用Kruskal-Wallis H秩和检验),组间两两比较用LSD检验法,自身前后比较用配对t检验,不符合正态分布用Wilcoxon配对秩和检验。分类资料组间比较采用卡方检验,等级资料组间比较采用Kruskal-Wallis H秩和检验。所有的统计检验均采用双侧检验,检测水平α=0.05。
     结果:
     1.基线比较情况:
     通过对三组的性别、年龄、病程、中医证型等人口学资料及基本资料进行组间比较分析,显示三组在人口学资料和基本资料上差异无显著差异(P>0.05),排除了三组因性别、年龄、病程、中医证型等组间基线水平不平衡造成的偏倚,提示三组具有可比性。
     2.疗效比较情况
     ①JOA下腰痛评分比较方面
     在改善腰椎间盘突出症患者临床症状方面,电针夹脊穴结合康复治疗、康复治疗具有良好疗效,且电针夹脊穴结合康复治疗的治疗效果治疗结束后治疗疗效尤佳。电针夹脊治疗对改善腰椎间盘突出症患者下腰痛方面,治疗结束后疗效较好(P<0.05),但治疗6次后疗效不明显(P>0.05)。经组间比较结果显示,三组对于改善腰椎间盘突出症患者临床症状方面均有一定疗效,且电针夹脊穴结合康复治疗疗效尤为显著,康复治疗次之,电针夹脊效果相对欠佳。
     ②生存质量量表评分比较方面
     不论是总生存质量及总健康状况比较,还是量表4个维度的比较,三种治疗方案均可以改善患者的生存质量,其中以电针夹脊穴结合康复治疗的方案效应最为显著。组间比较提示,在治疗6次后、治疗结束后及随访1个月3个时点的评分比较上,电针夹脊穴结合康复治疗组均优于电针夹脊穴组和康复治疗组(P<0.05),而电针夹脊穴组则只在治疗6次评分时点优于康复组(P<0.05),治疗结束后及随访1个月的评分中,均是康复治疗组优于电针夹脊穴组(P<0.05),说明电针夹脊穴的治疗方案在即时效应上优于康复治疗的方案,但在持续效应方面则是康复治疗方案占优。
     ③在McGill疼痛量表得分比较方面
     对于评价腰椎间盘突出症患者治疗前后简化McGill疼痛量表方面,三种治疗方法均有不同程度的疗效(P<0.05),其中电针夹脊穴结合康复治疗组、康复治疗组在治疗结束后较治疗6次后量表得分下降明显(P<0.01),说明治疗结束后疼痛改善效果尤为明显;而电针夹脊治疗腰椎间盘突出症患者在治疗结束后量表得分才有小幅度的下降,说明电针夹脊治疗对本病疼痛的改善需较长疗程,且改善情况不如电针夹脊穴结合康复治疗组及康复治疗组(P>0.05)。经组间比较,在缓解腰椎间盘突出症患者疼痛症状的程度上,电针夹脊穴结合康复治疗组、康复治疗组的量表评分下降较电针夹脊治疗组更为明显(P<0.05),说明电针夹脊穴结合康复治疗、康复治疗的临床疗效优于电针夹脊治疗。
     ④致炎因子的生化指标评价
     在降低腰椎间盘突出症患者血清白细胞介素-1β(IL-1β)方面,治疗6次后,三种疗法对于减少腰椎间盘突出症患者白细胞介素-1β的表达均无明显作用(P>0.05)。治疗结束后,三种疗法对于减少本病患者血清白细胞介素-1β(IL-1β)均有不同程度的改善(P<0.05)。组间比较显示:治疗结束后,在降低腰椎间盘突出症患者血清白细胞介素1β(IL-1β)表达水平方面,以电针夹脊穴结合康复治疗的效果最为显著(P<0.01),康复治疗次之(P<0.05),电针夹脊治疗改善情况不如前两者。
     在降低腰椎间盘突出症患者血清肿瘤坏死因子α(TNFα)方面,治疗6次的三种疗法对于减少TNFα的效果不明显(P>0.05),但治疗结束后TNFα均有一定幅度的减少,且电针夹脊穴结合康复治疗及康复治疗两种疗法的TNFα减少幅度更显著(P<0.01)。组间比较显示:治疗结束后,电针夹脊穴结合康复治疗对于减少腰椎间盘突出症患者肿瘤坏死因子α(TNFα)效果优于电针夹脊治疗和康复治疗(P<0.05)。
     在治疗6次后,电针夹脊穴结合康复治疗对于减少本病患者的血浆血栓素β2(TXB2)的含量有一定作用(P<0.05),但电针夹脊、康复治疗则无明显效果。治疗结束后,三种疗法对于减少本病患者的血浆血栓素B2(TXB2)的含量均有不同程度的作用,且以电针夹脊穴结合康复治疗疗法的作用最明显(P<0.05)。组间比较显示:治疗结束后,电针夹脊穴结合康复治疗对于改善腰椎间盘突出症患者的血浆血栓素B2(TXB2)的作用优于电针夹脊和康复治疗(P<0.05)。
     ⑤在临床疗效方面
     经秩和检验,三组临床疗效差异有统计学意义(P<0.05),其中,电针夹脊穴结合康复治疗组临床总有效率为87.1%;电针夹脊组临床总有效率为53.3%;康复治疗组总有效率为70.0%。提示:电针夹脊穴结合康复治疗腰椎间盘突出症患者与电针夹脊、康复治疗相比较,对于改善患者的腰腿痛症状、腰部活动功能、日常工作和生活等方面效果较显著,临床疗效较佳。
     结论:
     1.在以JOA下腰痛量表为主要疗效指标,McGill简式疼痛量表为次要疗效指标的临床疗效评价上,整合治疗方案的疗效优于单纯电针夹脊穴或康复治疗的疗法;
     2.三种方法均可降低腰椎间盘突出症患者的致炎因子水平,其中整合治疗方案所需要治疗时间最短;
     3.在改善患者生存质量方面,本研究的三种方法中,电针夹脊穴的方案的优势体现在其即时效应方面,而康复治疗方案的持续效应较优,二者的整合疗法包含它们的各自的优势,是提高患者生存质量的更好的方案。
Background
     Lumbar disc herniation is series of clinical symptoms due to the lumbar disc degeneration, annular disruption, nucleus pulpous herniated, and the prominence stimulated the nerve root and the cauda equine. It is the main reason which causes the lumbago and pain of legs. In severe cases, it can cause disability and loss of ability to work, seriously affect the patient's life and work. The epidemiological survey said that about0.95%of the Chinese population, the incidence of lumbar disc herniation, lumbar,4to5, L5~S1gap the highest incidence, accounting for about90%to96%, while the incidence of multiple intervertebral only5%to22%. Male patients than female, with the social development, mental increase in the number affected by the long-term sitting posture, occupational factors, physical exercise reduced the incidence of the disease has an upward trend and the trend of younger age.
     Western medicine treatment for lumbar disc herniation including surgical methods and non-surgical methods. The surgical treatment could be linked to some sequelae, such as chronic low back pain or numbness symptoms. The most common treatment of non-surgical methods is the use of NSAID (non-steroidal anti-inflammatory pain medication), but it needs to be administered in a long term, where the patients may be complicated in its possible toxicity side-effects. Numerous of Chinese medicine methods can be used for the disease, such as herbs, external application of herbs, massage, and acupuncture and moxibustion. The affirmation of acupuncture and moxibustion for lumbar disc herniation in recent years make it an effective treatment for the disease. And studies show that further optimizing the acupuncture and moxibustion therapy for the disease is significant meaningful. A number of clinical and experimental studies show that electro-acupuncture(EA) of Jiaji points can relieve the severe pain caused by lumbar disc herniation, which also show that electro-acupuncture is a painless, convenient, safe and non-obvious-toxicity therapy, and it is significant to society for the ease of the patient's pain and the improvement of life quality. The integrative medicine which was recalled by Chinese medicine recently gave me a new idea for this disease, and this study was established based on it and my clinical experience.
     Object i ve
     To study the differentiation of the clinical efficacy and the influence of pro-inflammatory cytokine for lumbar disc herniation in terms of the integrative treatment of electro-acupuncture therapy and rehabilitation therapy.
     Methods
     A simple random method was selected, and the patients were all from Taiwan Xin hua clinic of Chinese medicine in November2010to November2012. And there were92cases all collected which met the inclusion criteria. And according to the ratio of1:1:1, all cases were randomly assigned to integrative treatment group (electro-acupuncture combined with rehabilitation group)(31cases), EA Jiaji group (31cases), and rehabilitation group (30cases).
     Integrative treatment group has chosen Jiaji points of the abnormal vertebra and "Ashi" points as the main points for acupuncture treatment, and the priscribtion was referenced to the Acupuncture and Moxi bust ion Therapy, with the treatment of electro-acupuncture and rehabilitation; EA Jiaji group were using the aforementioned points, and only electro-acupuncture was used; rehabilitation group were taking rehabilitation treatment including intermediate frequency (IF) physiotherapy, traction and functional exercises.
     All included cases were observated according to designed requirements, therapeutic treatment were three times a week and the total treatment period was1month. The specific efficacy outcomes for observation include:JOA low back pain scale, the World Health Organization Quality of Life Scale Short Form (WHOQOL-BREF), simplified McGill Pain Questionnaire, biochemical indicators (that is proinflammatory cytokines include interleukin prime-1β, tumor necrosis factor a and plasma thromboxane prime B2). The JOA low back pain scale was used as the primary efficacy outcome, and efficient efficacy evaluation was reference to Chinese Disease Diagnosis and Effieacy Standards.
     Application SPSS17.0statistical software was used for statistical analysis. Measurement data are expressed as mean±standard deviation, F-test was used to compare measurement data groups (heterogeneity of variance using Kruskal-Wallis H rank sum test) between groups comparison, and LSD test for between group comparison, the paired t test was used for within group comparison, Wilcoxon rank sum test was for the non-normal distribution comparison. Grouped data between groups were compared using chi-square test, the ranked data were compared using Kruskal-Wallis H rank sum test. All statistical tests were two-sided test, the detection level is α=0.05.
     Results
     1. Baseline Comparison
     Comparative analysis between groups on three groups of gender, age, course of disease, syndrome of TCM and other demographic information showed there were no significant difference among three groups on demographic data and basic information (P>0.05), excluding the bias due to the demographic data and basic information, suggesting that three groups were comparable.
     2. Efficacy Comparison
     ①JOA low back pain scores
     For improving the clinical symptoms of lumbar disc herniation, integrative therapy and rehabilitation therapy have a good effect, and integrative method was better after the treatment. In releaving the low back pain, the electro-acupuncture therapy has better effect (P<0.05), but after midterm treatment was not that better (P>0.05). Analysis of group comparison showed that all three treatments for improving the clinical symptoms of lumbar disc herniation have a certain effect, and integrative therapy is particularly significant, followed by rehabilitation therapy, and EA Jiaji is relatively poor.
     ②Quality of life comparisons
     Whether total quality of life and total health, or scale comparison of the four dimensions, three treatments can improve the patient's quality of life, when the most significant treatment is integrative therapy. Within group comparison suggested that the integrative treatment were better than the electro-acupuncture treatment and rehabilitation treatment (P<0.05), and electro-acupuncture Jiaji treatment is only better than the rehabilitation group after midterm time-point (P<0.05). After treatment and1month follow-up time-point, the rehabilitation group is better than the EA Jiaji group (P<0.05), which indicated that the electro-acupuncture therapy is better than the rehabilitation therapy on the immediate effects, but the long-term efficacy is dominant rehabilitation therapy.
     ③McGill scores comparison:
     Evaluation of McGill Questionnaire before and after the treatment of patients with lumbar disc herniation, three methods have different levels of efficacy (P<0.05), while the scores of integrative group and rehabilitation group after treatment decreased significantly than scores after the6th treatment (P<0.01), which indicated that pain releave after treatment effect is particularly evident; but scores of the EA therapy after treatment has a minor decline, shows that the electro-acupuncture therapy for pain releave of the disease need a longer course of treatment. By between group comparison, at the aspect of the extent releaving patients'pain, the scale of integrative treatment group and the rehabilitation group score decreased more than the EA group (P<0.05), which showed that clinical efficacy of integrative therapy and the rehabilitation therapy is better than EA therapy.
     ④Proinflammatory cytokines of Biochemical indicators comparison
     In reducing the interleukin-1β (TL-1β) serum of patients with lumbar disc herniation, after6-times treatment (midterm), all three therapies cannot reduce interleukin prime-1β expression (P>0.05). After treatment, all three therapies for reducing the serum of patients'interleukin-1β (IL-1β) was significant (P<0.05) in varying degrees. Between groups comparison showed that after the treatment, of declining expression levels of serum interleukin-1β (IL-1β), the integrative therapy has the most significant efficacy (P<0.01), followed by rehabilitation therapy (P<0.05), and then electro-acupuncture treatment.
     In lower lumbar disc herniation in patients with tumor necrosis factor a (TNF-α), a course of three treatments to reduce the effect of TNF-α is not obvious (P>0.05), but after treatment TNF-α have a certain level of reduction, integrative and rehabilitation therapy TNF-reduce the magnitude significant (P<0.01). Group comparison:integrative therapy for reducing lumbar disc herniation in patients with tumor necrosis factor α (TNF-α) is better than of electro-acupuncture treatment and rehabilitation treatment (P<0.05) after two courses.
     After a course of integrative therapy for reducing the content of the patients plasma thromboxane B2(TXB2) have a certain effect (P<0.05), but the EA Jiaji, rehabilitation treatment had no significant effect. Two courses, the most significant effect of the content of the three therapy for reducing the patients plasma thromboxane B2(TXB2) have different levels of effect, and integrative therapy (P<0.05). Group comparison:integrative treatment for the improvement of the lumbar disc herniation plasma thromboxane B2(TXB2) better than the EA Jiaji and rehabilitation treatment (P<0.05) after two courses.
     ⑤linical Efficacy
     By rank sum test, three groups of clinical efficacy difference was statistically significant (P<0.05), and the total effective rate of integrative treatment group was87.1%, when EA group was53.3%and rehabilitation group was70.0%. Which indicated that compared with EA therapy and rehabilitation therapy, integrative therapy treatment of lumbar disc herniation patients has better better clinical efficacy in releaving the patient's back pain, improving waist activities, daily work and life.
     Conelusion
     1. The integrative treatment is more effective than electro-acupuncture therapy or rehabilitation therapy in the evaluation of JOA scale and McGill scale;
     2. All3therapies can reduced lumbar disc herniation patients' proinflammatory cytokines level, but integrative treatment treat the shortest times;
     3. For improving the patients'quality of life within three treatments, the advantages of electro-acupuncture therapy reflected in its immediate effects, when the continuing effect of the rehabilitation therapy is better. The integrative of the two therapies include both the advantage of them, and is a best solution to improve the patients'quality of life.
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