温针灸治疗心脾两虚型慢性疲劳综合征的疗效及免疫机理研究
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摘要
研究背景：
慢性疲劳综合征(CFS),是一组以原因不明的持续或反复发作的慢性疲劳为主要特征的症候群。由于慢性疲劳综合征的发病率呈逐年上升趋势,尤其是发达国家发病率高达14%-29%。此病症日益受到医学界的高度重视。目前,有关慢性疲劳综合征问题的研究已成为国际上医学、心理学和社会学等领域的热点课题之一。
现代医学对其无特殊针对性治疗,主要是对症处理,未能从根本上解决患者的痛苦,而中医却可根据慢性疲劳综合征的各个阶段的不同临床表现,从整体观念出发,辨证分型,随症施治,获得较好疗效。针灸治疗慢性疲劳综合征以其安全、简便、价廉、疗效显著等特点,在临床上得到广泛迅速的开展,从而成为目前治疗慢性疲劳综合征的重要方法之一。本课题在总结慢性疲劳综合征的中西医文献研究的基础上,采用随机对照的研究方法,以电针、中药治疗作为对照组,通过观察不同疗法对心脾两虚型慢性疲劳综合征的临床疗效,探讨温针灸、电针、中药治疗这三种不同疗法的临床疗效、治可行性及其存在的问题,对于今后临床中推广温针灸治疗慢性疲劳综合征具有重要意义。
目的：
本研究目的主要探讨温针灸治疗心脾两虚型慢性疲劳综合征的临床疗效及相关免疫机理研究。本研究以温针灸治疗与电针治疗、中药治疗进行对照,旨在探讨温针灸、电针治疗、中药治疗心脾两虚型慢性疲劳综合征的临床疗效的差异,观察慢性疲劳综合征患者的免疫机能,如体液免疫水平测(血清IgG, IgA, IgM, C3和C4)、细胞免疫水平测定(CD3+、 CD4+、 CD8+的含量),以揭示其作用机理,而从为慢性疲劳综合征的临床治疗提供更有效的疗法。
方法：
本临床研究病例来自在台湾中医诊所治疗的慢性疲劳综合征患者,收集时间为2011年10月至2013年2月,所有病例均符合筛选标准,中医证型上符合心脾两虚证。共收集99例,其中温针灸组为33例,电针组为33例,中药组为33例。西医诊断标准参照1994年11月美国疾病控制中心(Centers for Diseases Control and Prevention, CDC)修订的CFS诊断标准。中医诊断标准参照2002年《中药新药临床指导原则》(试行)制定的关于“虚劳”的诊断标准。中医证型参照卫生部颁布《中药新药临床研究指导原则》制定心脾两虚证标准。疗效观察具体项目包括：中医证型的临床疗效评分、疲劳量表(FS—14)、焦虑自评量表(SAS)、生存质量测定量表(WHOQOL-BREF)、体液免疫水平测定(血清IgG, IgA, IgM, C3和C4)、细胞免疫水平测定(外周血CD3+、CD4+、 CD8+)。总体疗效判定标准参照《国外医学·中医中药分册》“中医诊治慢性疲劳综合征的疗效标准探讨”拟定。
结果：
治疗前温针灸组、中药组、电针组的性别、年龄、病程、心脾两虚型中医证型临床疗效评分、疲劳量表(FS—14)、焦虑自评量表(SAS)、生存质量测定量表(WHOQOL-BREF)、体液免疫水平测定(血清IgG, IgA, IgM, C3和C4)、细胞免疫水平测定(外周血CD3+、CD4+、 CD8+)经分析均无统计学意义,说明三组间的一般资料及临床基线资料具有可比性。
①在心脾两虚中医证型临床疗效评分比较方面
三疗程后：中药组、温针灸组心脾两虚中医证型临床疗效评分与治疗前相比明显减少,差异有显著统计学意义(P<0.01),电针组方面,中医证型临床疗效得分比治疗前减少有统计学差异(P<0.05)。组间比较方面,中药组比电针组得分有所减少(P<0.05)。提示：在一疗程治疗后,三种疗法对心脾两虚型慢性疲劳综合征的中医症状,如体倦乏力、神疲懒言、心悸、失眠多梦、胃纳减少或食欲差等均无明显改善作用；经过三个疗程治疗后,温针灸组、电针组、中药组对于减轻心脾两虚型慢性疲劳综合征的症状有不同程度的疗效,以中药组最为明显,并与电针组疗效有一定的差异。
②在疲劳量表(FS—-14)比较方面
三疗程后三组疲劳量表(FS—14)评分均比治疗前减少,差异有统计学意义(P<0.05),以温针灸组下降最为明显(P<0.05)。组间比较方面,温针灸组比电针组得分有所减少(P<0.05)。提示：在一疗程治疗后,温针灸治疗对心脾两虚型慢性疲劳综合征的疲劳症状,即具有一定改善作用,但电针、中药的对疲劳症状的短期疗效不明显；而经过三个疗程治疗后,温针灸组、电针组、中药组对于减轻心脾两虚型慢性疲劳综合征患者的疲劳症状有不同程度的疗效,温针灸的临床疗效最为突出。
③在焦虑自评量表(SAS)方面
三疗程后温针灸组焦虑自评量表(SAS)评分比治疗前分数明显减少,差异有显著统计学意义(P<0.01)；电针组、中药组与治疗前比较差异有统计学意义(P<0.05)；组间比较方面,三组进行两两比较,焦虑自评量表(SAS)评分方面均无统计学差异(P>0.05)。提示：在一疗程治疗后,三种疗法对于改善心脾两虚型慢性疲劳综合征的焦虑症状均无明显疗效,两个疗程后,电针组和温针灸组可减少慢性疲劳综合征的焦虑评分；经过三个疗程治疗后,温针灸组、电针组、中药组对于改善心脾两虚型慢性疲劳综合征患者的焦虑症状有一定促进作用,但三种疗法对于减轻焦虑症状作用相仿。
④在生存质量测定量表(WHOQOL-BREF)方面
三疗程后温针灸组、中药组生存质量测定量表(WHOQOL-BREF)评分比治疗前分数明显提高,差异有显著统计学意义(P<0.01)；电针组与治疗前比较差异有统计学意义(P<0.05)；组间比较方面,温针灸组、中药组与电针组相比,生存质量测定量表(WHOQOL-BREF)评分提高有统计学意义(P<0.05)。提示：三种疗法对于改善心脾两虚型慢性疲劳综合征的生存质量测定量表(WHOQOL-BREF)评分方面短期疗效上均无明显效果；经过三个疗程治疗后,温针灸组、电针组、中药组对于改善心脾两虚型慢性疲劳综合征患者的生存质量均有一定促进作用,以温针灸及中药治疗更为显著。
⑤在体液免疫水平测定比较方面
经过三个疗程的治疗后,温针灸组的血清C3、C4与中药组、电针组相比,差异有统计学意义(P<0.05)。提示：三个疗程治疗后,温针灸组、中药组治疗后的lgG. IgM含量均有升高趋势,IgA含量有下降趋势,但差别无统计意义(P>0.05)。温针灸治疗可以明显减少心脾两虚型慢性疲劳综合征患者的血清C3、C4,且比电针治疗、中药治疗更明显。说明温针灸对心脾两虚型慢性疲劳综合征患者疲劳状态异常的补体水平有纠正作用,且明显优于电针组和中药组。
⑥在细胞免疫水平测定比较方面
经过三个疗程的治疗后,温针灸组的外周血CD3+.CD8+与电针组相比,差异有统计学意义(P<0.05)；与中药组相比,温针灸组的外周血CD8+升高有统计学差异(P<0.05)。提示：三个疗程治疗后,温针灸组CD3+.CD8+含量较电针组明显增高,组间比较有统计学差异(P<0.01),与中药组相比,温针灸组的外周血CD8+升高也有统计学差异(P<0.05),表明温针灸疗法对细胞免疫含量的改善作用明显优于对照组。
⑦三组治疗后总体疗效比较
温针灸组、电针组、中药组治疗后经Kruskal Wallis H秩和检验,H=3.28,P=0.046,三组总体疗效差异有统计学意义(P<0.05),其中,温针灸组总有效人数29人,总有效率为87.9%；电针组总有效人数19人,总有效率为57.6%；中药组总有效人数21人,总有效率为63.3%。提示：温针灸贴治疗心脾两虚型慢性疲劳综合征患者与电针、中药治疗相比较,临床疗效较显著。
结论：
本课题研究结果初步提示,温针灸、电针、中药疗法对治疗心脾两虚型慢性疲劳综合征均取得一定的临床疗效,但温针灸背俞穴对心脾两虚型慢性疲劳综合征患者的临床症状改善疗效显著,明显优于电针组及中药组,疲劳量表-14积分及焦虑量表(SAS)量表积分均显著下降；患者的单项症状得到明显的改善,其中尤以体倦乏力、记忆力或注意力下降、劳累后持续不适、肌肉痛此四项单项症状的改善更为突出。并能够纠正心脾两虚型慢性疲劳综合征患者疲劳状态异常的补体水平,改善细胞免疫含量。温针灸对治疗心脾两虚型慢性疲劳综合征,减轻疲劳,减少患者家庭和社会的精神负担和经济负担具有十分重要的意义,使患者的工作能力、社会能力、日常生活得到恢复,显著提高了患者的生活质量。
Background of research
Chronic fatigue syndrome (CFS) is a set of unexplained persistent or recurrent chronic fatigue syndrome as the main feature. As the incidence of chronic fatigue syndrome showed an increasing trend, especially in developed countries, the incidence of up to14%-29%. This disease increasingly attach great importance to the medical profession. At present, research on chronic fatigue syndrome has become one of the hot topics in the field of medicine, psychology and sociology.
Modern medicine, no special targeted therapies, symptomatic treatment, not a fundamental solution to the suffering of patients, while the Chinese medicine according to the various stages of the chronic fatigue syndrome clinical manifestations, from the overall concept syndrome typewith the disease and treatment, access to good effect. Acupuncture treatment of chronic fatigue syndrome with its safe, simple, inexpensive, and significant effect in clinical widely and quickly carried out, thus becoming an important method for the treatment of chronic fatigue syndrome. The subject on the basis of the summary of chronic fatigue syndrome in the Western literature, randomized controlled study, electro-acupuncture, Chinese medicine treatment as a control group, by observing the different treatments for heart and spleen chronic fatigue syndrome clinical efficacy explore the warm acupuncture, electro-acupuncture, Chinese medicine treatment of the clinical efficacy of three different therapies, cure feasibility and its problems, for the promotion of warm acupuncture treatment of chronic fatigue syndrome in future clinical significance.
Object ive
The purpose of this study focuses on warm acupuncture in the treatment of heart and spleen of chronic fatigue syndrome clinical efficacy and immune mechanism. Temperature in this study acupuncture and electro-acupuncture, Chinese medicine treatment were compared to investigate the warm acupuncture, electro-acupuncture treatment, the difference of the clinical efficacy of traditional Chinese medicine treatment of heart and spleen of chronic fatigue syndrome, chronic fatigue syndrome patients immune function, such as the humoral immune level measured (serum IgG, IgA, IgM, C3and C4), cell immunity level of determination (CD3+, CD4+, CD8+content), in order to reveal its mechanism of action, while from chronic fatigue syndrome for the clinical treatment to provide a more effective therapy.
Methods
This clinical study cases from acupuncture clinics in Taiwan benevolence treatment of chronic fatigue syndrome patients, collection time from October2011to February2013, all cases are in line with the screening criteria, in line with the heart and spleen deficiency of both TCM syndromespatients signed an informed consent form agreeing to participate in this study. Collected a total of99cases, which warm acupuncture group of33cases, electro-acupuncture group of33cases, traditional Chinese medicine group of33cases. Western diagnostic criteria with reference to the November1994U. S. Centers for Disease Control (Centers for Diseases Control and Prevention, CDC) revised diagnostic criteria for CFS. The TCM syndromes reference Chinese medicine clinical research guidelines issued by the Ministry of Health to develop heart and spleen deficiency of both standards. The efficacy of specific projects include:the clinical efficacy of TCM syndromes score, fatigue scale (FS-14), self-rating anxiety scale (SAS), the Quality of Life Scale (WHOQOL-BREF), determination of the level of humoral immunity (serum IgG, IgA, IgM, C3, and C4), the determination of cellular immunity (peripheral blood CD3+, CD4+, CD8+). Overall efficacy criteria with reference to the "American Journal·Chinese medicine Volume Chinese medicine diagnosis and treatment of chronic fatigue syndrome Standard of" intended.
Results
Pre-treatment the warm acupuncture group, the Chinese Medicines, the EA group sex, age, duration of disease, heart and spleen TCM clinical efficacy score, fatigue scale (FS-14), self-rating anxiety scale (SAS), survivalMeasurement Scale of Quality (WHOQOL-BREF), determination of the level of humoral immunity (serum IgG, IgA, IgM, C3and C4), determination of cellular immunity (peripheral blood CD3+, CD4+, CD8+) analysis were not statistically significant, IIIgroup general information and clinical baseline data were comparable.
①he comparison of deficiency of heart and spleen syndrome
After three courses:traditional Chinese medicine group, heart and spleen TCM clinical efficacy score and pre-treatment of the warm acupuncture group compared to the significantly reduced, the difference was statistically significant (P<0.01), EA group, the TCM clinical eff icacyscore lower than before treatment were significantly different (P<0.05). Between the two groups regard, the Chinese Medicines score than the EA group decreased (P <0.05). Tip:after a course of treatment, the the three therapy for the heart and spleen chronic fatigue syndrome clinical symptoms, such as body tired fatigue, Shenpi lazy words, palpitations, insomnia and more dreams, reduce appetite or poor appetite, there was no significant improvement in function; after three courses of treatment, warm acupuncture, electro-acupuncture group, Chinese group to alleviate the symptoms of heart and spleen of chronic fatigue syndrome have varying degrees of efficacy, to CMB most obvious, and EA group there are some differences in efficacy.
②The comparison of fatigue scale (FS-14)
Three groups after three courses fatigue scale (FS-14) score than before treatment, the difference was statistically significant (P<0.05), in order to warm acupuncture decreased significantly in group (P<0.05). Group comparisons, warm acupuncture group than the EA group score decreased (P<0.05). Tip:after a course of treatment, the temperature acupuncture treatment on the heart and spleen fatigue symptoms of chronic fatigue syndrome, which has a certain improvement, but the electro-acupuncture, Chinese medicine treatment was stopped short-term symptoms of fatigue; through three course of treatment, warm acupuncture, electro-acupuncture group, Chinese group to alleviate the heart and spleen chronic fatigue syndrome in patients with symptoms of fatigue different degrees of efficacy, the temperature the clinical efficacy of acupuncture is the most prominent.
㏕he comparison of Self-Rating Anxiety Scale (SAS)
Warm acupuncture group after three courses anxiety self-rating scale (SAS) score than the scores before treatment significantly reduced, the difference was statistically significant (P<0.01); EA group, the Chinese Medicines and pre-treatment difference was statistically significant (P<0.05); between the two groups, the three sets of pairwise comparisons, anxiety Rating Scale (SAS) score were not statistically different (P>0.05). Tip:After a course of treatment, there was no significant effect of three therapies for improving heart and spleen anxiety symptoms of chronic fatigue syndrome, after two courses, the EA group and warm acupuncture group can reduce the anxiety of chronic fatigue syndrome Rating; after three courses of treatment, warm acupuncture group, EA group, the Chinese Medicines for improving heart and spleen chronic fatigue syndrome in patients with symptoms of anxiety a certain role, but three kinds of therapy to reduce the role of anxiety symptoms similar.
④The comparison of Quality of Life Scale (WHOQOL-BREF)
Three treatment after warm acupuncture group, the Chinese Medicines Quality of Life Scale (WHOQOL-BREF) rating than the pre-treatment scores improved significantly, the difference was statistically significant (P <0.01); electro-acupuncture group compared with before treatment difference was statisticallysignificant (P<0.05); between the two groups, the to warm acupuncture group, Chinese medicine group and EA group compared to the quality of Life scale (WHOQOL-BREF) score improved statistically significant (P<0.05). Tip:Three therapies for improving the quality of life of the heart and spleen of chronic fatigue syndrome Determination Scale (WHOQOL-BREF) had no significant effect in the short-term efficacy of the rating; After three courses of treatment, warm acupuncture group, EA group, the Chinese Medicines for improving heart and spleen chronic fatigue syndrome patient quality of life have a certain role to warm acupuncture and traditional Chinese medicine treatment more significant.
⑤omparison of Determination of the level of humoral immunity
After three courses of treatment, warm acupuncture Serum C3, C4and traditional Chinese medicine group, EA group compared to the difference was statistically significant (P<0.05). Tip:After three courses of treatment, warm acupuncture group, Chinese medicine treatment lgG, IgM content have tended to increase, IgA content on a downward trend, but the difference was not statistically significant (P>0.05). Warm acupuncture treatment can significantly reduce heart and spleen chronic fatigue syndrome patients with serum C3, C4, more obvious than the electro-acupuncture, Chinese medicine treatment. Warm acupuncture abnormal state of fatigue in patients with chronic fatigue syndrome, heart and spleen complement levels corrective action, and significantly better than the EA and the Chinese Medicines. After three courses of treatment, warm acupuncture Serum C3, C4and traditional Chinese medicine group, EA group compared to the difference was statistically significant (P <0.05). Tip:After three courses of treatment, warm acupuncture group, Chinese medicine treatment lgG, IgM content have tended to increase, IgA content on a downward trend, but the difference was not statistically significant (P>0.05). Warm acupuncture treatment can significantly reduce heart and spleen chronic fatigue syndrome patients with serum C3, C4, more obvious than the electro-acupuncture, Chinese medicine treatment. Warm acupuncture abnormal state of fatigue in patients with chronic fatigue syndrome, heart and spleen complement levels corrective action, and significantly better than the EA and the Chinese Medicines.
⑥Comparison of Determination of cellular immunity
After three courses of treatment, the temperature in the acupuncture group peripheral blood CD3+, CD8+compared with the EA group, the difference was statistically significant (P<0.05); of warm acupuncture group compared with the traditional Chinese medicine group, peripheral blood CD8+increasedthere is a statistically significant difference (P<0.05). Tip:After three courses of treatment, warm acupuncture group CD3+, CD8+content than the EA group was significantly higher, between the two groups statistically significant difference (P<0.01), compared with the traditional Chinese medicine group, warm acupuncture group peripheral blood CD8+increased significant difference (P<0.05), indicating that warm acupuncture therapy for the improvement of the content of the cell-mediated immunity than the control group.
⑦Comparison of the overall effect of the three groups after treatment
Warm acupuncture group, EA group, Chinese medicine treatment by Kruskal Wallis H rank test, H=3.28, P=0.046the three overall efficacy difference was statistically significant (P<0.05), in which warm acupuncture groupThe number of29people, the total effective rate was87.9%; the EA group total effective number of19, the total effective rate was57.6%; Chinese medicine group, the total effective number of21, the total effective rate was63.3%. Tip:warm acupuncture paste the treatment of heart and spleen chronic fatigue syndrome compared with electro-acupuncture, Chinese medicine treatment, significant clinical efficacy. Warm acupuncture group, EA group, Chinese medicine treatment by Kruskal Wallis H rank test, H=3.28, P=0.046the three overall efficacy difference was statistically significant (P<0.05), in which warm acupuncture groupThe number of29people, the total effective rate was87.9%; the EA group total effective number of19, the total effective rate was57.6%; Chinese medicine group, the total effective number of21, the total effective rate was63.3%. Tip:warm acupuncture paste the treatment of heart and spleen chronic fatigue syndrome compared with electro-acupuncture, Chinese medicine treatment, significant clinical efficacy.
Conclusion
The research preliminary results suggest that the clinical efficacy of warm acupuncture, electro-acupuncture, herbal therapy for the treatment of heart and spleen chronic fatigue syndrome have achieved, but warm acupuncture back-shu points on the heart and spleen chronic fatigue syndromeimprovement of clinical symptoms significant effect, significantly better than the EA group and Chinese medicine group, fatigue scale-14points and anxiety Scale (SAS) scale score decreased significantly; patient's individual symptoms have been significantly improved, especially in the bodytired fatigue, memory or decreased attention, tired after continuous discomfort, muscle pain improvement of the four individual symptoms are more prominent. And be able to correct abnormal heart and spleen in patients with chronic fatigue syndrome fatigue complement levels, to improve the content of cell-mediated immunity. Warm acupuncture treatment of heart and spleen chronic fatigue syndrome, reduce fatigue, reducing the patient's family and social emotional burden and financial burden of great significance, the patient's ability to work, social skills, daily life is restored, significantly improve the the patient's quality of life.
慢性疲劳综合征(CFS),是一组以原因不明的持续或反复发作的慢性疲劳为主要特征的症候群。由于慢性疲劳综合征的发病率呈逐年上升趋势,尤其是发达国家发病率高达14%-29%。此病症日益受到医学界的高度重视。目前,有关慢性疲劳综合征问题的研究已成为国际上医学、心理学和社会学等领域的热点课题之一。
现代医学对其无特殊针对性治疗,主要是对症处理,未能从根本上解决患者的痛苦,而中医却可根据慢性疲劳综合征的各个阶段的不同临床表现,从整体观念出发,辨证分型,随症施治,获得较好疗效。针灸治疗慢性疲劳综合征以其安全、简便、价廉、疗效显著等特点,在临床上得到广泛迅速的开展,从而成为目前治疗慢性疲劳综合征的重要方法之一。本课题在总结慢性疲劳综合征的中西医文献研究的基础上,采用随机对照的研究方法,以电针、中药治疗作为对照组,通过观察不同疗法对心脾两虚型慢性疲劳综合征的临床疗效,探讨温针灸、电针、中药治疗这三种不同疗法的临床疗效、治可行性及其存在的问题,对于今后临床中推广温针灸治疗慢性疲劳综合征具有重要意义。
目的：
本研究目的主要探讨温针灸治疗心脾两虚型慢性疲劳综合征的临床疗效及相关免疫机理研究。本研究以温针灸治疗与电针治疗、中药治疗进行对照,旨在探讨温针灸、电针治疗、中药治疗心脾两虚型慢性疲劳综合征的临床疗效的差异,观察慢性疲劳综合征患者的免疫机能,如体液免疫水平测(血清IgG, IgA, IgM, C3和C4)、细胞免疫水平测定(CD3+、 CD4+、 CD8+的含量),以揭示其作用机理,而从为慢性疲劳综合征的临床治疗提供更有效的疗法。
方法：
本临床研究病例来自在台湾中医诊所治疗的慢性疲劳综合征患者,收集时间为2011年10月至2013年2月,所有病例均符合筛选标准,中医证型上符合心脾两虚证。共收集99例,其中温针灸组为33例,电针组为33例,中药组为33例。西医诊断标准参照1994年11月美国疾病控制中心(Centers for Diseases Control and Prevention, CDC)修订的CFS诊断标准。中医诊断标准参照2002年《中药新药临床指导原则》(试行)制定的关于“虚劳”的诊断标准。中医证型参照卫生部颁布《中药新药临床研究指导原则》制定心脾两虚证标准。疗效观察具体项目包括：中医证型的临床疗效评分、疲劳量表(FS—14)、焦虑自评量表(SAS)、生存质量测定量表(WHOQOL-BREF)、体液免疫水平测定(血清IgG, IgA, IgM, C3和C4)、细胞免疫水平测定(外周血CD3+、CD4+、 CD8+)。总体疗效判定标准参照《国外医学·中医中药分册》“中医诊治慢性疲劳综合征的疗效标准探讨”拟定。
结果：
治疗前温针灸组、中药组、电针组的性别、年龄、病程、心脾两虚型中医证型临床疗效评分、疲劳量表(FS—14)、焦虑自评量表(SAS)、生存质量测定量表(WHOQOL-BREF)、体液免疫水平测定(血清IgG, IgA, IgM, C3和C4)、细胞免疫水平测定(外周血CD3+、CD4+、 CD8+)经分析均无统计学意义,说明三组间的一般资料及临床基线资料具有可比性。
①在心脾两虚中医证型临床疗效评分比较方面
三疗程后：中药组、温针灸组心脾两虚中医证型临床疗效评分与治疗前相比明显减少,差异有显著统计学意义(P<0.01),电针组方面,中医证型临床疗效得分比治疗前减少有统计学差异(P<0.05)。组间比较方面,中药组比电针组得分有所减少(P<0.05)。提示：在一疗程治疗后,三种疗法对心脾两虚型慢性疲劳综合征的中医症状,如体倦乏力、神疲懒言、心悸、失眠多梦、胃纳减少或食欲差等均无明显改善作用；经过三个疗程治疗后,温针灸组、电针组、中药组对于减轻心脾两虚型慢性疲劳综合征的症状有不同程度的疗效,以中药组最为明显,并与电针组疗效有一定的差异。
②在疲劳量表(FS—-14)比较方面
三疗程后三组疲劳量表(FS—14)评分均比治疗前减少,差异有统计学意义(P<0.05),以温针灸组下降最为明显(P<0.05)。组间比较方面,温针灸组比电针组得分有所减少(P<0.05)。提示：在一疗程治疗后,温针灸治疗对心脾两虚型慢性疲劳综合征的疲劳症状,即具有一定改善作用,但电针、中药的对疲劳症状的短期疗效不明显；而经过三个疗程治疗后,温针灸组、电针组、中药组对于减轻心脾两虚型慢性疲劳综合征患者的疲劳症状有不同程度的疗效,温针灸的临床疗效最为突出。
③在焦虑自评量表(SAS)方面
三疗程后温针灸组焦虑自评量表(SAS)评分比治疗前分数明显减少,差异有显著统计学意义(P<0.01)；电针组、中药组与治疗前比较差异有统计学意义(P<0.05)；组间比较方面,三组进行两两比较,焦虑自评量表(SAS)评分方面均无统计学差异(P>0.05)。提示：在一疗程治疗后,三种疗法对于改善心脾两虚型慢性疲劳综合征的焦虑症状均无明显疗效,两个疗程后,电针组和温针灸组可减少慢性疲劳综合征的焦虑评分；经过三个疗程治疗后,温针灸组、电针组、中药组对于改善心脾两虚型慢性疲劳综合征患者的焦虑症状有一定促进作用,但三种疗法对于减轻焦虑症状作用相仿。
④在生存质量测定量表(WHOQOL-BREF)方面
三疗程后温针灸组、中药组生存质量测定量表(WHOQOL-BREF)评分比治疗前分数明显提高,差异有显著统计学意义(P<0.01)；电针组与治疗前比较差异有统计学意义(P<0.05)；组间比较方面,温针灸组、中药组与电针组相比,生存质量测定量表(WHOQOL-BREF)评分提高有统计学意义(P<0.05)。提示：三种疗法对于改善心脾两虚型慢性疲劳综合征的生存质量测定量表(WHOQOL-BREF)评分方面短期疗效上均无明显效果；经过三个疗程治疗后,温针灸组、电针组、中药组对于改善心脾两虚型慢性疲劳综合征患者的生存质量均有一定促进作用,以温针灸及中药治疗更为显著。
⑤在体液免疫水平测定比较方面
经过三个疗程的治疗后,温针灸组的血清C3、C4与中药组、电针组相比,差异有统计学意义(P<0.05)。提示：三个疗程治疗后,温针灸组、中药组治疗后的lgG. IgM含量均有升高趋势,IgA含量有下降趋势,但差别无统计意义(P>0.05)。温针灸治疗可以明显减少心脾两虚型慢性疲劳综合征患者的血清C3、C4,且比电针治疗、中药治疗更明显。说明温针灸对心脾两虚型慢性疲劳综合征患者疲劳状态异常的补体水平有纠正作用,且明显优于电针组和中药组。
⑥在细胞免疫水平测定比较方面
经过三个疗程的治疗后,温针灸组的外周血CD3+.CD8+与电针组相比,差异有统计学意义(P<0.05)；与中药组相比,温针灸组的外周血CD8+升高有统计学差异(P<0.05)。提示：三个疗程治疗后,温针灸组CD3+.CD8+含量较电针组明显增高,组间比较有统计学差异(P<0.01),与中药组相比,温针灸组的外周血CD8+升高也有统计学差异(P<0.05),表明温针灸疗法对细胞免疫含量的改善作用明显优于对照组。
⑦三组治疗后总体疗效比较
温针灸组、电针组、中药组治疗后经Kruskal Wallis H秩和检验,H=3.28,P=0.046,三组总体疗效差异有统计学意义(P<0.05),其中,温针灸组总有效人数29人,总有效率为87.9%；电针组总有效人数19人,总有效率为57.6%；中药组总有效人数21人,总有效率为63.3%。提示：温针灸贴治疗心脾两虚型慢性疲劳综合征患者与电针、中药治疗相比较,临床疗效较显著。
结论：
本课题研究结果初步提示,温针灸、电针、中药疗法对治疗心脾两虚型慢性疲劳综合征均取得一定的临床疗效,但温针灸背俞穴对心脾两虚型慢性疲劳综合征患者的临床症状改善疗效显著,明显优于电针组及中药组,疲劳量表-14积分及焦虑量表(SAS)量表积分均显著下降；患者的单项症状得到明显的改善,其中尤以体倦乏力、记忆力或注意力下降、劳累后持续不适、肌肉痛此四项单项症状的改善更为突出。并能够纠正心脾两虚型慢性疲劳综合征患者疲劳状态异常的补体水平,改善细胞免疫含量。温针灸对治疗心脾两虚型慢性疲劳综合征,减轻疲劳,减少患者家庭和社会的精神负担和经济负担具有十分重要的意义,使患者的工作能力、社会能力、日常生活得到恢复,显著提高了患者的生活质量。
Background of research
Chronic fatigue syndrome (CFS) is a set of unexplained persistent or recurrent chronic fatigue syndrome as the main feature. As the incidence of chronic fatigue syndrome showed an increasing trend, especially in developed countries, the incidence of up to14%-29%. This disease increasingly attach great importance to the medical profession. At present, research on chronic fatigue syndrome has become one of the hot topics in the field of medicine, psychology and sociology.
Modern medicine, no special targeted therapies, symptomatic treatment, not a fundamental solution to the suffering of patients, while the Chinese medicine according to the various stages of the chronic fatigue syndrome clinical manifestations, from the overall concept syndrome typewith the disease and treatment, access to good effect. Acupuncture treatment of chronic fatigue syndrome with its safe, simple, inexpensive, and significant effect in clinical widely and quickly carried out, thus becoming an important method for the treatment of chronic fatigue syndrome. The subject on the basis of the summary of chronic fatigue syndrome in the Western literature, randomized controlled study, electro-acupuncture, Chinese medicine treatment as a control group, by observing the different treatments for heart and spleen chronic fatigue syndrome clinical efficacy explore the warm acupuncture, electro-acupuncture, Chinese medicine treatment of the clinical efficacy of three different therapies, cure feasibility and its problems, for the promotion of warm acupuncture treatment of chronic fatigue syndrome in future clinical significance.
Object ive
The purpose of this study focuses on warm acupuncture in the treatment of heart and spleen of chronic fatigue syndrome clinical efficacy and immune mechanism. Temperature in this study acupuncture and electro-acupuncture, Chinese medicine treatment were compared to investigate the warm acupuncture, electro-acupuncture treatment, the difference of the clinical efficacy of traditional Chinese medicine treatment of heart and spleen of chronic fatigue syndrome, chronic fatigue syndrome patients immune function, such as the humoral immune level measured (serum IgG, IgA, IgM, C3and C4), cell immunity level of determination (CD3+, CD4+, CD8+content), in order to reveal its mechanism of action, while from chronic fatigue syndrome for the clinical treatment to provide a more effective therapy.
Methods
This clinical study cases from acupuncture clinics in Taiwan benevolence treatment of chronic fatigue syndrome patients, collection time from October2011to February2013, all cases are in line with the screening criteria, in line with the heart and spleen deficiency of both TCM syndromespatients signed an informed consent form agreeing to participate in this study. Collected a total of99cases, which warm acupuncture group of33cases, electro-acupuncture group of33cases, traditional Chinese medicine group of33cases. Western diagnostic criteria with reference to the November1994U. S. Centers for Disease Control (Centers for Diseases Control and Prevention, CDC) revised diagnostic criteria for CFS. The TCM syndromes reference Chinese medicine clinical research guidelines issued by the Ministry of Health to develop heart and spleen deficiency of both standards. The efficacy of specific projects include:the clinical efficacy of TCM syndromes score, fatigue scale (FS-14), self-rating anxiety scale (SAS), the Quality of Life Scale (WHOQOL-BREF), determination of the level of humoral immunity (serum IgG, IgA, IgM, C3, and C4), the determination of cellular immunity (peripheral blood CD3+, CD4+, CD8+). Overall efficacy criteria with reference to the "American Journal·Chinese medicine Volume Chinese medicine diagnosis and treatment of chronic fatigue syndrome Standard of" intended.
Results
Pre-treatment the warm acupuncture group, the Chinese Medicines, the EA group sex, age, duration of disease, heart and spleen TCM clinical efficacy score, fatigue scale (FS-14), self-rating anxiety scale (SAS), survivalMeasurement Scale of Quality (WHOQOL-BREF), determination of the level of humoral immunity (serum IgG, IgA, IgM, C3and C4), determination of cellular immunity (peripheral blood CD3+, CD4+, CD8+) analysis were not statistically significant, IIIgroup general information and clinical baseline data were comparable.
①he comparison of deficiency of heart and spleen syndrome
After three courses:traditional Chinese medicine group, heart and spleen TCM clinical efficacy score and pre-treatment of the warm acupuncture group compared to the significantly reduced, the difference was statistically significant (P<0.01), EA group, the TCM clinical eff icacyscore lower than before treatment were significantly different (P<0.05). Between the two groups regard, the Chinese Medicines score than the EA group decreased (P <0.05). Tip:after a course of treatment, the the three therapy for the heart and spleen chronic fatigue syndrome clinical symptoms, such as body tired fatigue, Shenpi lazy words, palpitations, insomnia and more dreams, reduce appetite or poor appetite, there was no significant improvement in function; after three courses of treatment, warm acupuncture, electro-acupuncture group, Chinese group to alleviate the symptoms of heart and spleen of chronic fatigue syndrome have varying degrees of efficacy, to CMB most obvious, and EA group there are some differences in efficacy.
②The comparison of fatigue scale (FS-14)
Three groups after three courses fatigue scale (FS-14) score than before treatment, the difference was statistically significant (P<0.05), in order to warm acupuncture decreased significantly in group (P<0.05). Group comparisons, warm acupuncture group than the EA group score decreased (P<0.05). Tip:after a course of treatment, the temperature acupuncture treatment on the heart and spleen fatigue symptoms of chronic fatigue syndrome, which has a certain improvement, but the electro-acupuncture, Chinese medicine treatment was stopped short-term symptoms of fatigue; through three course of treatment, warm acupuncture, electro-acupuncture group, Chinese group to alleviate the heart and spleen chronic fatigue syndrome in patients with symptoms of fatigue different degrees of efficacy, the temperature the clinical efficacy of acupuncture is the most prominent.
㏕he comparison of Self-Rating Anxiety Scale (SAS)
Warm acupuncture group after three courses anxiety self-rating scale (SAS) score than the scores before treatment significantly reduced, the difference was statistically significant (P<0.01); EA group, the Chinese Medicines and pre-treatment difference was statistically significant (P<0.05); between the two groups, the three sets of pairwise comparisons, anxiety Rating Scale (SAS) score were not statistically different (P>0.05). Tip:After a course of treatment, there was no significant effect of three therapies for improving heart and spleen anxiety symptoms of chronic fatigue syndrome, after two courses, the EA group and warm acupuncture group can reduce the anxiety of chronic fatigue syndrome Rating; after three courses of treatment, warm acupuncture group, EA group, the Chinese Medicines for improving heart and spleen chronic fatigue syndrome in patients with symptoms of anxiety a certain role, but three kinds of therapy to reduce the role of anxiety symptoms similar.
④The comparison of Quality of Life Scale (WHOQOL-BREF)
Three treatment after warm acupuncture group, the Chinese Medicines Quality of Life Scale (WHOQOL-BREF) rating than the pre-treatment scores improved significantly, the difference was statistically significant (P <0.01); electro-acupuncture group compared with before treatment difference was statisticallysignificant (P<0.05); between the two groups, the to warm acupuncture group, Chinese medicine group and EA group compared to the quality of Life scale (WHOQOL-BREF) score improved statistically significant (P<0.05). Tip:Three therapies for improving the quality of life of the heart and spleen of chronic fatigue syndrome Determination Scale (WHOQOL-BREF) had no significant effect in the short-term efficacy of the rating; After three courses of treatment, warm acupuncture group, EA group, the Chinese Medicines for improving heart and spleen chronic fatigue syndrome patient quality of life have a certain role to warm acupuncture and traditional Chinese medicine treatment more significant.
⑤omparison of Determination of the level of humoral immunity
After three courses of treatment, warm acupuncture Serum C3, C4and traditional Chinese medicine group, EA group compared to the difference was statistically significant (P<0.05). Tip:After three courses of treatment, warm acupuncture group, Chinese medicine treatment lgG, IgM content have tended to increase, IgA content on a downward trend, but the difference was not statistically significant (P>0.05). Warm acupuncture treatment can significantly reduce heart and spleen chronic fatigue syndrome patients with serum C3, C4, more obvious than the electro-acupuncture, Chinese medicine treatment. Warm acupuncture abnormal state of fatigue in patients with chronic fatigue syndrome, heart and spleen complement levels corrective action, and significantly better than the EA and the Chinese Medicines. After three courses of treatment, warm acupuncture Serum C3, C4and traditional Chinese medicine group, EA group compared to the difference was statistically significant (P <0.05). Tip:After three courses of treatment, warm acupuncture group, Chinese medicine treatment lgG, IgM content have tended to increase, IgA content on a downward trend, but the difference was not statistically significant (P>0.05). Warm acupuncture treatment can significantly reduce heart and spleen chronic fatigue syndrome patients with serum C3, C4, more obvious than the electro-acupuncture, Chinese medicine treatment. Warm acupuncture abnormal state of fatigue in patients with chronic fatigue syndrome, heart and spleen complement levels corrective action, and significantly better than the EA and the Chinese Medicines.
⑥Comparison of Determination of cellular immunity
After three courses of treatment, the temperature in the acupuncture group peripheral blood CD3+, CD8+compared with the EA group, the difference was statistically significant (P<0.05); of warm acupuncture group compared with the traditional Chinese medicine group, peripheral blood CD8+increasedthere is a statistically significant difference (P<0.05). Tip:After three courses of treatment, warm acupuncture group CD3+, CD8+content than the EA group was significantly higher, between the two groups statistically significant difference (P<0.01), compared with the traditional Chinese medicine group, warm acupuncture group peripheral blood CD8+increased significant difference (P<0.05), indicating that warm acupuncture therapy for the improvement of the content of the cell-mediated immunity than the control group.
⑦Comparison of the overall effect of the three groups after treatment
Warm acupuncture group, EA group, Chinese medicine treatment by Kruskal Wallis H rank test, H=3.28, P=0.046the three overall efficacy difference was statistically significant (P<0.05), in which warm acupuncture groupThe number of29people, the total effective rate was87.9%; the EA group total effective number of19, the total effective rate was57.6%; Chinese medicine group, the total effective number of21, the total effective rate was63.3%. Tip:warm acupuncture paste the treatment of heart and spleen chronic fatigue syndrome compared with electro-acupuncture, Chinese medicine treatment, significant clinical efficacy. Warm acupuncture group, EA group, Chinese medicine treatment by Kruskal Wallis H rank test, H=3.28, P=0.046the three overall efficacy difference was statistically significant (P<0.05), in which warm acupuncture groupThe number of29people, the total effective rate was87.9%; the EA group total effective number of19, the total effective rate was57.6%; Chinese medicine group, the total effective number of21, the total effective rate was63.3%. Tip:warm acupuncture paste the treatment of heart and spleen chronic fatigue syndrome compared with electro-acupuncture, Chinese medicine treatment, significant clinical efficacy.
Conclusion
The research preliminary results suggest that the clinical efficacy of warm acupuncture, electro-acupuncture, herbal therapy for the treatment of heart and spleen chronic fatigue syndrome have achieved, but warm acupuncture back-shu points on the heart and spleen chronic fatigue syndromeimprovement of clinical symptoms significant effect, significantly better than the EA group and Chinese medicine group, fatigue scale-14points and anxiety Scale (SAS) scale score decreased significantly; patient's individual symptoms have been significantly improved, especially in the bodytired fatigue, memory or decreased attention, tired after continuous discomfort, muscle pain improvement of the four individual symptoms are more prominent. And be able to correct abnormal heart and spleen in patients with chronic fatigue syndrome fatigue complement levels, to improve the content of cell-mediated immunity. Warm acupuncture treatment of heart and spleen chronic fatigue syndrome, reduce fatigue, reducing the patient's family and social emotional burden and financial burden of great significance, the patient's ability to work, social skills, daily life is restored, significantly improve the the patient's quality of life.
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