【作者】 陈妙霞；

【导师】 庄礼兴；

【作者基本信息】 广州中医药大学 ， 针灸推拿学， 2011， 博士

【摘要】 研究背景围绝经期综合征是妇女在绝经前后由于雌激素水平波动或下降所致的以植物神经系统功能紊乱为主,伴有神经心理症状的一组症候群。临床表现为烘热汗出、心烦易怒、心慌心跳、手足心热、头痛头晕、耳鸣、失眠、精神抑郁、焦虑不安等。这些症状为众多围绝经期妇女带来了困扰,严重影响地她们的生活质量。2009年香港年龄介乎4055岁女性人口已高达一百万人口,随着人口老化香港会有越来越多踏进围绝经期妇女人口,也意味着有更多围绝经期妇女受到该病的困扰,对相关医疗服务需求增加。随着社会健康水平知识的提高,新一代的香港围绝经期妇女更注重健康,追求更卓越的生活质量。由于围绝经期综合征临床症状繁多,病情反复,患病时间长,对广大患者做成严重的身心压力,同时也削弱她们的生产工作能力,令到她们的家庭关系及社交生活受到不良的影响。围绝经期妇女健康是一个不容忽视的大课题,有需要研究关注。由于治疗女性围绝经期综合征所用的西药存在一定的副作用,再加上医学模式的转变、健康概念有了新的内涵,人们不仅追求生命的量更注重生命的质,因此,寻找一种安全,有效的方法对防治本病具有重要的意义。中医是具有数千年实践的医学,中医治疗妇科疾病具有一定的疗效与特色,针灸和中药疗法治疗本病不仅具有较好的临床效果,且毒副作用少、简便易行。如何应用中医优势为围绝经期妇女提供符合需要的中医顾护调治保健措施,加强中医在本港医疗体系中为围绝期妇女健康做出贡献,突出中医防治疾病的优势,以提高广大香港围绝经期妇女的健康质素和生活质量,助她们轻松跨越围绝经期是很值得研究的课题目的本课题通过观察针刺结合补肾疏肝中药疗法治疗围绝经期综合征的临床疗效,并比较针刺加中药和纯中药两组不同治疗方法的效果,以及对围绝经期综合征患者生存质量的影响,来探讨针灸治疗围绝经期综合征的可能作用机理。期望通过本次研究,能为日后临床治疗该病提供一项安全有效又具中医特色的疗法,继而为提高众多香港围绝经期综合征患者生存质量做出贡献,并为推动香港中医专科化发展及弘扬中医文化做出贡献。方法收集博爱医院中医门诊2010年4月-2010年12月期间就诊,年龄在45-55岁之间的妇女,确诊为围绝经期综合征及符合中医肾虚肝郁证型的诊断的患者共63例为研究对象,按随机化原则,根据随机数字表将符合纳入标准的63例围绝经期综合征患者分为治疗组(针刺加中药组)31例,对照组(单纯中药组)32例。各组具体研究方法分别为：一、治疗组：采用针刺加补肾疏肝中药治疗。针刺取两组穴位：①：百会、关元、气海、三阴交(双)、太冲(双)；②：肝俞(双)、肾俞(双)、阳陵泉(双)、内关(双)、太溪(双)。操作方法：每次选一组穴位,两组穴位交替使用,下针后每10分钟行针1次,留针30分钟。两组穴位交替使用,隔天一次,月经期间停针灸治疗,连续治疗两个月。中药：对患者予以浓缩中药颗粒六味地黄丸合丹栀逍遥散(每10克六味地黄丸浓缩中药颗粒含生草药：熟地24g、淮山12g、山萸肉12g、茯苓9g、泽泻9g、牡丹皮9g；每10克丹栀逍遥散浓缩中药颗粒含生草药：柴胡12g、白术12g、当归12g、白芍12g、茯苓12g、牡丹皮10g、栀子10g、炙甘草6g。比例：六味地黄丸：丹栀逍遥散1：1,每天口服2次,每次10克(5克六味地黄丸合5克丹栀逍遥散),连续服用两个月。二、对照组：采用单纯补肾疏肝中药治疗,对患者予以浓缩中药颗粒六味地黄丸合丹栀逍遥散。比例：六味地黄丸：丹栀逍遥散1：1,每天口服2次,每次10克(5克六味地黄丸合5克丹栀逍遥散),连续服用两个月。两组治疗前后均从以下几个方面进行临床观察：(1)临床症状评分采用改良Kupperman评分量表,该量表自发表至今是目前国内外应用最广泛的围绝经综合征疗效评价指标,量表里的13个症状可反映与围绝经综合征相关的不同系统的表现,具有一定的代表性。(2)围绝经期综合征主要症状改变测定：对围绝经期综合征常见的主要症状潮热出汗、感觉异常、失眠、易激动、抑郁、眩晕、疲乏、骨关节痛,骨肉痛、头痛、心悸、皮肤蚂蚁走感、性交痛、泌尿系等13项症状,采用改良Kupperman评分表,在治疗前,中(治后1个月),治疗后(治后2个月)各评估1次,并计算其改善值,KI改善值。(3)SF-36健康调查简表(中文版),该量表广泛使用于临床,有较好的信度、效度和代表性,作为生存质量的主要结局指标。其中共有躯体健康(PF)、体角色功能(RP)、躯体疼痛(BP)、总体健康(GH)、活力(VT)、社会功能(SF)、情绪角色功能(RE)、心理健康(MH)等8个维度,每个维度包含若干问题,共36个项目。(4)安全性检测,治疗前后检查血、尿常规、肝肾功能、心电图等,并于治疗期间记录不良反应观察表,疗程结束后填写安全性评价表。两组患者治疗前,治疗1月后及治疗2月后进行均进行问卷评分。将全部数据输入SPSS13.0统计软件,对数据资料进行统计学处理及分析,得出结论。结果在实验过程中治疗组和对照均无失访或退出病例,具体治疗结果如下：一、治疗前两组患者在年龄、病程、中医证型方面等各项基本资料组间比较,经独立样本T检验后(P>0.05)无统计学差异,提示两组样本均来自于同一总体,彼此间具有可比性。二、围绝经期综合征临床症状疗效评价(1)改良Kupperman(KI)评分治疗前两组间总体症状总评分KI指数比较无差异(P>0.05),表明两组间基本资料具有可比性。①治疗后1个月及2个月治疗组KI指数自身前后比较有显著性差异(P<0.01),治疗后1个月及2个月对照组KI指数自身前后比较有显著性差异(P<0.01),提示两组治疗方法都有效,证明两组治疗方法都能大幅度降低了KI评分,有效治疗围绝经期综合征症状如潮热出汗、感觉异常、失眠、易激动、抑郁、眩晕、疲乏、骨关节痛、骨肉痛、头痛、心悸、皮肤蚂蚁走感、性交痛、泌尿系等症状,而且治疗两个月的效果明显比治疗一个月的效果好。②治后两组间KI指数改善值比较有差异(P<0.05),说明治疗组针刺加中药整体的效果比对照组单纯中药好。③治疗前两组的KI评分均值都接近25分,在治疗后1个月,治疗组KI指数均值由治疗前的25.90±6.91下降至治疗后的15.52±5.09；对照组KI指数均值由治疗前的24.25±6.21下降至治疗后的15.69±4.41；结果显示两组的KI指数都大幅度下降,证明两种治疗方法都可以有效改善患者肾虚肝郁体质所导致的围绝经期综合征症状。连续治疗2个月后,两组的KI指数持续下降,提示连续治疗两个月有加强疗效的作用。治疗组的KI改善值与对照组比较有显著差异,证明针药结合治疗比单纯中药疗效好。提示治疗组针药结合疗效明显优于对照纯中药组,针刺结合中药方对治疗围绝经期综合征疗效确切。(2)两组间各项围绝经期综合征症状组间疗效比较评价围绝经期综合征各症状疗效分析得出以下结论：①治疗组、对照组两组内比较：治疗1个月和治疗2个月在改善各个症状上两组均有效(P<0.05)。②治疗组、对照组两组组间比较：两组在治疗1个月和治疗2个月后KI改善值均比较无差异的症状为：潮热汗出、疲乏和性交痛症状；两组在治疗1个月和治疗2个月后KI改善值均比较有差异的症状为：失眠、易激动、抑郁、眩晕、骨关节、骨肉痛、头痛、心悸、皮肤蚂蚁样走感和泌尿系症状,说明治疗组的针刺加中药比对照组的纯中药治疗在神经系统,心理及疼痛症状上效果好；治疗1个月后,KI改善值均比较有差异的为：感觉异常(P=0.016),说明两组组间比较在改善感觉异常治疗组见效较快,但是治疗2个月后效果相若,提示中药的疗效起效较慢。三、治疗前后两组生存质量比较治疗前两组间相比,SF—36健康调查简表评分在8个维度上均无明显差异(P>0.05),说明两组之间具有可比性。①治疗组经治疗后在8个维度上均有明显改善(P<0.01),且在综合积分方面也有明显提高(P<0.01),说明针刺加中药治疗能有效改善其生存质量；②对照组经治疗后在8个维度上均有明显改善(P<0.01),且在综合积分方面也有明显提高(P<0.01),说明补肾疏肝法的中药治疗能有效改善其生存质量。③治疗后治两组间比较,除了在躯体健康(PF)、体角色功能(RP)、心理健康(MH)三方面治疗组与对照组无明显差异(P>0.05)外,在躯体疼痛(BP)、总体健康(GH)、生命活力(VT)、情绪角色功能(RE)及综合积分等方面,两组间比较,结果在统计学上均有显著性差异(P<0.01)。社会功能(SF)两组间比较,结果在统计学上有差异(P<0.05)。④表18结果显示运用针刺结加中药疗法的治疗组,在改善患者生存质量,如躯体疼痛(BP)、总体健康(GH)、生命活力(VT)、情绪角色功能(RE)、社会功能(SF)等五方面的作用,其疗效更优于采用单纯中药组；但两组在改善两躯体健康(PF)、体角色功能(RP)、心理健康(MH)三方面,组间的程度并无明显差异,说明两组在改善这三方面的疗效相若。四、治疗后两组疗效比较两组患者疗效构成比组间比较,经Ridit分析后两组间疗效比较有差异(P<0.05)。说明运用针刺结合中药治疗围绝经期综合征患者,其疗效明显优于采用单纯中药治疗方法。治疗组总有效率为90.3%,而对照组总有效率为75.0%,两组间总疗效比较,统计结果显示,两组间比较无差异(P>0.05),说明运用针刺结合中药治疗围绝经期综合征患者,其总体疗效与采用单纯中药治疗效果相若。五、治疗后两组不良反应比较整个研究过程中,治疗期间,治疗组与对照组中的患者均未发现明显不良反应,故两组安全级别均属于1级。结论临床证实针刺能刺激输穴通过经络的传导调节脏腑功能,使得全身各大系统的功能得到调整,改善神经功能,镇静、镇痛等使临床症状得到有效的控制和改善,患者躯体疼痛症状减轻、生活和工作能力、情绪稳定、社会功能增强、总体健康水平显著提高。补肾疏肝中药治疗本病切中病机,六味地黄丸及丹桅逍遥散合方对机体的作用是多方面、多系统、多靶点的,从而对肾虚肝郁型围绝经期综合征所导致的一系列烦躁易怒、头晕耳鸣、口干目涩、潮热汗出、口干口苦、心烦失眠等症状起良好的治疗效果。因此针药结合治疗围绝经期综合征疗效优于单纯中药治疗,值得在临床中推广使用。更多还原

【Abstract】 BackgroundClimacteric syndrome in premenopausal and postmenopausal women, estrogen level fluctuates or falls dramatically lead to autonomic nervous system dysfunction, neuropsychological symptoms associated with a group of syndromes. Clinical manifestations are hot flashes and sweating, upset, irritability, heart palpitation, dyshoria heat, headache, dizziness, tinnitus, insomnia, depression, anxiety and so on. These symptoms bring serious impact to their quality of life affect their health.2009 Hong Kong female population aged 40-55 years has been as high as one million, as the population group grows there will be more and more women suffering from the disease and increase demand for related medical services. With the improvement of community health knowledge, the new generation of Hong Kong perimenopausal women pay more attention to health and to pursuit superior quality of life. Because the vast clinical symptoms of climacteric syndrome, repeated illness, illness for a long time, the majority of patients caused serious physical and mental pressure, but also undermine the work of their productivities so that their family relationships and social lives have been adversely affected. Perimenopausal women’s health is a major issue can not be ignored, it is a beam subject worth to study. Because the treatment of female climacteric syndrome by western medicine cause certain side effects, coupled with the medical model of change, the new concept of health, the amount of people not only pay more attention to the pursuit of life, but also the quality of life. Therefore, to find a safe and effective method for the prevention and treatment of this disease has important practical significance. Chinese medicine had been practiced for thousands of years, Chinese medicine treatment of gynecological diseases has unique characteristics and good clinical effects, acupuncture and Chinese medicine therapies to treat the disease not only has better clinical effect, but also with fewer side effects, and in a easier way. How to take the advantages of Chinese medicine for the application on the treatment for perimenopausal syndromes, to strengthen the role of Chinese medicine in Hong Kong health care system to contribute to women’s health, to highlight the advantages of Chinese medicine on disease controlling for the improvement of the perimenopausal women’s heath in the quality and quality of life, to help them easily across the perimenopause is a very interesting topic.ObjectiveTo observe acupuncture combined with Chinese medicine treatment for the type of kidney deficiency and stagnation in liver Qi perimenopausal syndrome clinical efficacy, and to compare of acupuncture combined with Chinese medicine treatment with pure Chinese medicine treatment, and the effects of two different treatment modalities, and perimenopausal syndrome patients on quality of life, to further explore the acupuncture treatment mechanism on perimenopausal syndrome. Hope that through this study, to find a safe and effective clinical treatment measures for curing the disease in the future, but also with Chinese characteristics therapies, and then to improve the patients’quality of life with perimenopausal syndrome in Hong Kong, to contribute and to promote traditional Chinese medicine development in Hong Kong and promote Chinese medical specialty to contribute to traditional Chinese medical industry.MethodsCollection of Pok Oi Hospital Chinese Medicine Clinic patients during the period of April -December 2010, whose ages between 45-55 years old, diagnosed as perimenopausal syndrome and kidney deficiency and stagnation in liver Qi type consistent with traditional Chinese medicine diagnosis, with a total of 63 cases studied, according to the principle of randomization, according to random number table to meet the inclusion criteria of the 63 cases of perimenopausal syndrome were divided into treatment group (acupuncture combined with traditional Chinese medicine group) 31 patients, in the control group (treated with traditional Chinese medicine) were 32 patients. Specific research methods of each group are:1.The treatment group(Acupuncture combined with Chinese medicine treatment):Acupuncture:Take two sets of acupuncture points:①:Baihui, Guanyuan, Qihai, Sanyinjiao (double), Taichong (double);②:Ganshu (double), Shen shu (double), Yanglingquan (double), Neiguan (double), Taixi (double). Methods of operation:each time take a group of selected points, two groups are used interchangeably. Needling every 10 minutes, let the needles stay for 30 minutes. Alternate use of two sets of points, every other day, stops acupuncture treatment during menstruation period, continuous treatment for two months.Chinese medicine:Gives the patients concentrated Chinese medicine powder which is made up of Liu Wei Di Huang Wan and Dan Zhi Xiao Yao San (10 grams of concentrated Liu Wei Di Huang Wan powder containing Chinese medicinal herbs: Rehmannia 24g, Chinese yam 12g, Cornus 12g, Poria 9g, Alisma 9g, Cortex Moutan 9g; 10 grams of concentrated Dan Zhi Xiao Yao San powder containing Chinese medicinal herbs:Radix Bupleuri 12g, Atractylodes 12g, Angelica 12g, White Peony Root 12g, Poria 12g, Cortex Moutan 10g, Gardenia 10g, Baked Licorice 6g. Ratio:Liu Wei Di Huang Wan:Danzhi Xiao Yao San 1:1,2 times a day orally, each time 10 grams (5 grams Liu Wei Di Huang mixed with 5 grams Dan Xiao Yao San), Continuous taking for two months.2. The control group (Chinese medicine treament):Gives the patients concentrated Chinese medicine powder which is made up of Liu Wei Di Huang Wan and Dan Zhi Xiao Yao San. Ratio:Liu Wei Di Huang Wan:Dan Zhi Xiao Yao San 1:1,2 times a day orally, each timelO grams (5 grams Liu Wei Di Huang mixed with 5 grams Dan Xiao Yao San), Continuous taking for two months.Before and after treatment in both groups from the clinical observation of the following aspects:(1) clinical symptom score using the modified Kupperman score scale, the scale is most extensive used for the evaluation of perimenopausal syndrome, the scale reflects the 13 symptoms associated with menopause syndrome, the performance of different systems, with a certain representation. (2) Determination of the main symptoms of perimenopausal syndrome changes:hot flushes and sweating, paresthesia, insomnia, irritability, depression, dizziness, fatigue, bone and joint pain, muscle pain, headache, heart palpitation, feeling of ants crawling skin, the sense of painful intercourse, urinary symptoms, take assessments by using the modified Kupperman score scale, in the treatment before, during (1 month after treatment)and after treatment (2 months after treatment), and calculate the value of its improvements, calculate the KI improvement value. (3) MOS SF-36 Health Survey (Chinese version), which are widely used in clinical scale has good reliability, validity and representativeness of the main outcomes as quality of life indicators. Among them, physical health (PF), physical role function (RP), bodily pain (BP), general health (GH), vitality (VT), social function (SF), emotional role functioning (RE), mental health (MH),8 dimensions, each dimension contains a number of issues, a total of 36 items. (4) Safety testing:before and after the treatment examine blood, urine, liver and kidney function, ECG, etc., and the adverse reactions observed during the treatment will be recorded, safety course evaluation form will be completed after treatment. Two groups of patients before treatment,1 month and 2 months after treatment were carried out a questionnaire rating. All data entry into computer and the SPSS13.0 the statistical software is used for data processing and analysis of statistical data, draw conclusions.ResultsDuring the experiment, there has no lost or out of the control cases, specific treatment results were as follows:1. Before treatment two groups of patients in age, duration and other aspects of syndromes between the two groups of basic information, after examination by Riddit-test (P> 0.05) no significant difference, suggesting that two sets of samples from the same population, had a good comparability between.2.The clinical symptoms of perimenopausal syndrome efficacy evaluation(1) modified Kupperman (KI) scoreBefore treatment, the overall total score clinical symptoms between the two groups showed no difference between KI index (P>0.05), shows that basic information between the two groups were comparable.①After 1 month and 2 months treatment, the comparison of treatment group KI index of its own before and after, there was significant difference (P<0.01), after 1 month and 2 months treatment, the comparison of control group KI index of its own before and after, there was significant difference (P<0.01), suggesting that two treatment methods are effective, proven both methods can substantially reduce the KI score, effective relieving the symptoms of menopausal syndrome such as hot flashed and sweating, paresthesia, insomnia, irritability, depression, dizziness, Fatigue, bone and joint pain, muscle pain, headache, heart palpitation, feeling of ants crawling skin, the sense of painful intercourse, urinary symptoms, and treatment effects of two months was significantly better than the effect of one month treatment.②Comparison between the two groups after treatment, the improvement value of KI index were significantly different (P<0.05), proofing that the treatment group effect of acupuncture combined with Chinese medicine as a whole better than the control group with pure Chinese medicine.③Before treatment, the mean KI score in both groups are closed to 25 points,1 month after treatment, the treatment group mean KI index score dropped from 25.90±6.91 to 15.52±5.09; the control group mean KI index score dropped from 24.25±6.21 to 15.69±4.41; The results shown that the KI index of the two groups are significant decline in two treatment methods can prove effective in improving physical fitness in patients with the type of kidney deficiency and liver Qi stagnation perimenopausal syndrome symptoms. Treatment for 2 consecutive months, the two groups KI index continued to decline, suggesting that there is continuous treatment effect for two months to strengthen the role of efficacy.The comparison of KI to improvement value between two groups shown significant differences, proving that acupuncture combined with Chinese medicine treatment is effective than pure Chinese medicine treatment. Acupuncture combined with prompt treatment group were significantly better than pure Chinese medicine, acupuncture combined with Chinese medicine to treat perimenopausal syndrome is more effective.(2) Symptoms Comparative evaluation of efficacy between the two groups Clinical analysis of the symptoms come to the following summary:①treatment group and control group compared within groups:1 month treatment and 2 months treatment of various symptoms in both groups shown effective improvement (P <0.05).②treatment group and control group comparison between two groups: 1 month treatment and 2 months treatment the value of KI improvement were no difference in symptoms:hot flashes and sweating, fatigue, the sense of painful intercourse; the value of KI improvement comparison between groups shown significant difference in those symptoms:insomnia, irritability, depression, dizziness, bone and joint pain, muscle pain, headache, heart palpitation, feeling of ants crawling skin, urinary symptoms, indicating that the treatment group has a better curing effect than the control group in the nervous system, psychological and pain symptoms.1 month after treatment, KI improvement values comparison shown difference in two groups in paresthesia symptom (P=0.016), proving that the treated group had a more rapid and effective effect in relieving that symptom, but the treatment effect is almost the same after 2 months treatment in both groups, suggesting a slower onset of efficacy of traditional Chinese medicine.1. The comparison of the quality of life before and after treatment between two groupsBefore treatments, comparison between the two groups, SF-36 Health Survey score in 8 dimensions were no significant differences (P> 0.05), shown that they were comparable between groups.①After treatments,8 dimensions were significantly improved (P<0.01), and in terms of comprehensive integration also significantly increased (P<0.01), the curing effect in treatment group(acupuncture combined with Chinese medicine) that can improve their quality of life;②After treatment, in the control group,8 dimensions were significantly improved (P<0.01), and in terms of comprehensive integration also significantly increased (P<0.01), proving that Chinese medicine treatment of nourishing kidney and dredging liver Qi method can effectively improve their quality of life.③governance between two groups after treatment, in addition to physical health (PF), physical role function (RP), mental health (MH) had no significant difference (P>0.05), but in bodily pain (BP), general health (GH), vitality (VT), emotional role functioning (RE) and other aspects of comprehensive integration between two groups, the results were statistically significant differences (P<0.01). Social function (SF) between two groups, resulting in a statistically different (P<0.05).④Table 18 results shown that the use of acupuncture combined with Chinese medicine treatment group, improving patients quality of life in the role of five aspects, such as bodily pain (BP), general health (GH), vitality (VT), emotional role functioning (RE), social function (SF), and its efficacy is better than using pure traditional Chinese medicine group; but two groups in improving physical health (PF), physical role function (RP), mental health (MH), the degree of effectiveness had no significant difference, indicating that two groups in terms of improving those aspects were of similar efficacy.2. Comparison of effectiveness in two groups after treatmentThe constituent ratio of efficacy between the two groups were compared by ridit test after the treatments, shown significant differences (P<0.05), indicating the use of acupuncture combined with Chinese medicine treatment, significantly better than treatment with medicine alone in healing menopausal syndrome patients. The total effective rate was 90.3% in treatment group, while the control group, the total effective rate was 75.0%, total effective comparison between two groups, statistical results showed no significant difference between the two groups (P> 0.05), that confining the use of acupuncture combined with Chinese medicine treatment on menopausal syndrome, its overall efficacy were similar to the effect with pure Chinese medicine treatment group.5. The comparison of adverse reactions between two groups after treatmentThroughout the study, no significant adverse reactions found in both treatment group and control groups, so the two groups belong to a safety level.ConclusionClinically proven to stimulate acupuncture points through the meridians to regulate organs function, making the body function in a better way, adjusting to improve neurological function, sedation, analgesia, etc. so that effective control of clinical symptoms and improvement in pain and symptom relief in patients with physical, life and working ability, emotional stability, social enhancements, the overall health improved significantly. Chinese medicine treatment, the use of Liu Wei Di Huang Wan with Dan Zhi Xiao Yao San together regulating the body, in multi-system, multi-target way. This Chinese medical formula had good therapeutic effect on the type of kidney deficiency and liver Qi stagnation perimenopausal syndrome which caused a series of irritability, dizziness, tinnitus, dry eyes, hot flashes, and sweating, dry mouth, bittery mouth, upset, insomnia and other symptoms. The clinical results proven the effect of acupuncture combined with Chinese medicine on perimenopausal syndrome was better than that of Chinese medicine alone, it is worth promoting in clinical use.更多还原