中医“情志疗法”治疗绝经综合征内在规则的数据挖掘研究
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摘要
研究目的
绝经综合征病有发病年龄提早、发病率成上升趋势。如何缓解妇女绝经综合征症状,提高生活质量,一直是世界医学研究的重点,其治疗已成为全球医药事业的重要组成部分。现代医学主张激素替代治疗(HRT)治疗绝经综合征,但HRT可导致各种副反应等缺点,影响了病人的依从性,因此努力寻找临床疗效显著且副作用小的治疗方法是当务之急。非药物疗法已成为国内外研究的热点,但又主要集中在单纯使用心理疗法,或作为辅助治疗,更多将其单纯归入到心理学范畴或应用精神类药物进行治疗,且目前缺少完整的心理治疗方案、没有行业中公认的治疗方法。
导师前期课题采用国际、国内公认的疗效评价指标评价情志疗法治疗绝经综合征的疗效,结果显示情志组与安慰剂组的初诊与第4周、第8周的KI总分差值比较,差异无统计学意义(P>0.05),初诊与第12周KI总分差值比较差异统计学意义(P<0.05)；且情志组、中药组、中药+情志组的组间比较差异无统计学意义(P>0.05)。本课题在前期课题2001年到2003年主持的国家科技十五攻关课题,及2004年到2006年的十一五滚动课题流调的收集数据基础上,探研绝经综合征的内在规律及情志疗法治疗绝经综合征的内在规律,为进一步完善情志疗法治疗绝经综合征的技术规范和诊疗标准提供理论依据。
研究方法
将符合绝经综合征的中西医诊断标准、纳入标准、排除标准的病例,进行数据整合、预处理、格式转换后,利用SPSS 13.0软件进行描述性分析,组间比较采用方差分析,组内比较采用配对t检验；weka 3.5.7软件进行聚类分析、关联规则分析。分析内容：(1)绝经综合征疾病的内在规则：绝经综合征患者不同情志的调查分析；抑郁、焦虑与中医证型的聚类分析；焦虑、抑郁与一般情况及kupperman index (KI)量表、Menopause-Specific Quality of Life(MENQOL)量表及中医证候记分表中症状进行关联规则分析；睡眠问题与躯体症状的关联规则分析。(2)情志治疗绝经综合征的内在规则：中药组、中药+情志组、情志组与安慰剂组的KI、MENQOL量表及中医证候记分表不同观察时点总分差值的比较；情志组KI、MENQOL量表及中医证候记分表不同观察时点总分的比较；各组KI、MENQOL量表及中医证候记分表各症状的有效率分析；中医证候记分表的症状与第12周疗效的关联规则分析。
研究结果
1绝经综合征疾病的内在规则
1.1绝经综合征患者不同情绪的调查分析
(1)绝经综合征患者17种不同情绪中以焦虑、抑郁的频率最高,分别为89.47%、77.03%。(2)KI、MENQOL量表量表及中医证候记分表中各症状的频率>80%,且重度症状频率>7%症状为失眠、骨关节肌肉痛、疲乏、潮热出汗。
1.2抑郁、焦虑与中医证型的聚类分析
(1)抑郁、焦虑的聚类分析：单纯焦虑症状、焦虑合并抑郁症状、其它情志、单纯抑郁症状频率分别为18%、63%、13%、6%。
(2)抑郁、焦虑与中医证型的聚类分析：绝经综合征患者肾阴虚证型中总焦虑频率为81%,总抑郁频率为71%；肾阳虚中总焦虑频率为81%,总抑郁频率为69%。1.3一般情况、焦虑及抑郁之间的关联规则
(1)体型瘦、重度病情、中度病情、大学及大学以上学历与焦虑成正相关规则。绝经、初中学历、高中学历、轻度病情与焦虑成负相关规则。焦虑与体型属于中等成双向负相关规则。
(2)重度病情、中度病情、初中学历、体型胖与抑郁成正相关规则。FSH>30U／L、已绝经与抑郁成双向正相关规则。高中学历、未绝经、大学及大学以上学历、FSH≤30U／L与抑郁成负相关规则。抑郁与体型属于中等成双向负相关规则。
(3)重度病情与FSH>30U／L成正相关规则；中度病情与FSH值>30U／L成不相关规则,轻度病情与FSH>30U／L成负相关规则。重度病情与肾阴虚证型成负相关规则,中、轻度病情与肾阴虚证型成正相关规则。
1.4焦虑、抑郁与MENQOL量表中血管舒缩、躯体、性生活症状的关联规则
(1)血管舒缩、性生活症状与焦虑、抑郁均成双向正相关规则。
(2)焦虑、抑郁与躯体症状中外表精神差、外貌、肤质或气色发生变化、皮肤干燥、缺乏精力、尿频、睡眠有问题、体力下降、疲劳或筋疲力尽、颈项疼痛或头痛、腰痛、肌肉和关节疼痛症状成双向正相关规则。感到肿胀不适、体重增加、当大笑或咳嗽时无法控制小便症状与焦虑、抑郁成正相关规则。
1.5焦虑、抑郁与KI量表、中医证候记分表条目的关联规则分析
(1)焦虑、抑郁与KI量表：焦虑、抑郁与心悸、易激动、感觉异常、性交痛症状成双向正相关规则。泌尿系症状与焦虑成双向正相关规则,与抑郁成不相关规则。皮肤蚁走感与焦虑、抑郁症状成正相关规则。
(2)焦虑、抑郁与与中医证候记分表：焦虑、抑郁与面色晦暗、耳鸣、肢冷、头目眩晕、便秘、膝软、手足心热、夜尿成双向正相关规则。腰酸、口干与抑郁成双向正相关规则。
1.6睡眠问题与躯体症状的关联规则分析：
MENQOL量表中当大笑或咳时无法控制小便、感到肿胀不适与睡眠有问题症状成正相关规则。体重增加与睡眠有问题成不相关规则。睡眠有问题与躯体症状中其他症状成双向正相关规则。
2情志疗法治疗绝经综合征的内在规则
2.1中医证候记分表、KI量表、MENQOL量表不同观察时点总分差值的组间比较：
(1)中医证候记分表：中药组初诊与第8周、第12周总分差值与安慰剂组比较,差异均有显著性意义。中+情组初诊与第4周、第8周、第12周总分差值与安慰剂组比较,差异均有显著性意义。情志组初诊与第8、12周总分差值与安慰剂组比较,差异均有显著性意义。
(2)KI量表：中药组的初诊与第8周总分差值与安慰剂组比较,差异有显著性意义。中+情组初诊与第4周、第8周、第12周总分差值与安慰剂组比较,差异均有显著性意义。情志组的初诊与第12周总分差值与安慰剂组比较,差异有显著性意义。
(3)生存质量量表：4组初诊与第12周4个维度总分差值比较,差异均无统计学意义。
2.2情志组中医证候记分表、KI量表、MENQOL量表不同观察时点的比较结果显示,均有统计学意义。
2.3中医证候记分表、KI量表、MENQOL量表各症状的有效率分析
(1)MENQOL量表中各症状的有效率分析：四组中有效率均≥50%的症状有烘热、白天汗自出、盗汗、睡眠有问题、感疲劳或筋疲力尽、体力下降、感到缺乏精力、腰痛、焦虑或紧张、颈项部疼痛或头痛、肌肉关节疼痛症状。另外,中药组有记忆减退、尿频。中+情志组有对自己生活不满意、做事不如以往得心应手、抑郁情绪低落或沮丧、外表精神差。情志组有抑郁情绪低落或沮丧、缺乏耐心、记忆减退。安慰剂组有做事不如以往得心应手。
(2)中医证候记分量表中各症状的有效率分析：四组中有效率均≥50%的症状有汗出、烦躁易怒、烘热、口干、夜寐不安、腰酸。另外,中药组有手足心热。中+情组有头目眩晕、郁郁寡欢、手足心热、面色晦暗。中情志组有手足心热、郁郁寡欢、面色晦暗、膝软症状。
(3)KI量表中各症状的有效率分析：四组中有效率≥50%的症状有潮热出汗、易激动、失眠、疲乏、感觉异常、骨关节肌肉痛。另外,中+情志组还有心悸、抑郁、眩晕。情志组有心悸、抑郁。
2.4中医证候记分表中症状与第12周疗效的关联规则结果：症状经治疗后对有效率的影响程度从高到低的依次为
(1)情志组：重度腰酸、重度汗出、中度面色晦暗、重度烘热、中度烦躁易怒、中度夜寐不安、中度手足心热、中度膝软。
(2)中+情志组：轻度烦躁易怒、中度夜寐不安、中度手足心热、重度烦躁易怒、重度汗出、烘热、重度郁郁寡欢、中度头目眩晕、轻度头目眩晕、中度膝软、中度烘热、中度口干、轻度口干、轻度手足心热、轻度郁郁寡欢、轻度烘热、中度汗出、轻度腰酸、中度腰酸、轻度汗出、中度面色晦暗、轻度面色晦暗、中度郁郁寡欢。
(3)中药组：重度烦躁易怒、中度手足心热、中度口干、中度夜寐不安、重度烘热、中度汗出、重度汗出、中度烘热、中度烦躁易怒、轻度腰酸。
研究结论
1绝经综合征症状中严重影响患者生活及工作的症状主要有潮热出汗、失眠、骨关节肌肉痛、疲乏症状。
2绝经综合征患者异常情志的出现受一般情况、血管舒缩症状、躯体症状、性生活症状等多方面因素影响。其情志的改变具有易怒、易悲、易焦虑特点,尤其具有复合情志的特点；且情志应分等级及表现方式不同。
3情志相胜疗法不能完全适应绝经综合征患者复合情志的治疗。情志疗法治疗绝经综合征患者可根据情志轻重等级不同及表现方式不同,进行治疗方案的调整。
Object ives:
The trend of menopausal syndrome is an upward and earlier age. It has been a focus of the world's medical research that is how to alleviate symptomsand improve life quality of women with menopausal syndrome. Modern medicine had advocated that menopausal syndrome was treated by Hormone replacement therapy (HRT), but HRT have a variety of side effects, and affected the patient's compliance. It is urgent to find a treatment that is significant effect and relatively few side-effects. Non-drug therapy is becoming a focus at home and abroad, but it was mainly concentrated in psychological therapy alone or as adjuvant therapy, moreover, there is lack of a complete psychological treatment programs, and a accepted treatment in industry.
The result showed that compared with placebo group, total score difference of first visit and the 4th week, first visit and the 8th week in emotional group were no significant difference (P>0.05), first visit and the 12th week in emotional group were significant difference (P<0.05); compared with TCM group, TCM and emotional group, total score difference of emotional group were no significant difference (P>0.05). On the basis of data that was collected by National Science and Technology 15 key from 2001 to 2003 and the Eleventh Five-year rolling from 2004 to 2006 in the previous issues. To research rules of menopausal syndrome, and emotional therapy for menopausal syndrome. To provide theory for the technical specifications and standards of diagnosis and treatment of emotional therapy for menopausal syndrome.
Methods:
Patients fulfilling the diagnostic criteria, inclusion criteria and exclusion criteria, then data integration, pre-processing, format conversion. Data were analyzed by descriptive analysis, groups were analyzed by analysis of variance, group comparison were analyzed by paired t test. To adopt cluster analysis and association rules methods for data mining. Analytical content: (1) The inherent rules of menopausal syndrome:Investigation and Analysis of emotions of Menopausal syndrom. Cluster analysis of depression, anxiety and TCM Syndrome. Association rules of emotion and the general situation, kupperman index (KI), Menopause-Specific Quality of Life (MENQOL) and traditon chinese medicine (TCM) scales. Association rules of sleep problems and somatic symptoms. (2) Internal rules of emotional therapy for menopausal syndrome: Different time points scores compared bewteen four groups of KI、MENQOL scales and TCM score table. Different time points scores compared in emotional group of KI、MENQOL scales and TCM score table before and after treatment. Efficiency Analysis of the various symptoms of each group. Association rules between efficacy and symptoms in the TCM sare table.
Results:
1 The inherent rules of menopausal syndrome
1.1 Investigation and Analysis emotions of menopausal syndrome:
(1) The frequency of anxiety and depression was respectively 89.47%、77.03%, which is he highest frequency in 17 emotions of women with menopausal syndrome.
(2) There were four symptoms that Frequency of symptoms in KI and MENQOL scale was more than 80%, and Frequency of Severe symptoms of women with menopausal syndrome was more than 7%, the symptoms were insomnia, Musculoskeletal pain, fatigue, hot flushes and sweating symptoms. 1.2 Cluster analysis of depression, anxiety and TCM Syndrome:
(1) Cluster analysis of depression and anxiety:Frequency of pure anxiety, anxiety and depressive symptoms, other emotions, pure depression was respectively 18%、63%、13%、6%。
(2) Cluster analysis of depression, anxiety and TCM Syndrome:The frequency of total anxiety and depression in Kidney Yin deficiency Syndrome was respectively 81%、71%. The frequency of total anxiety and depression in Kidney Yang deficiency Syndrome was respectively 81%、69%.
(1)lean body, Severe and moderate disease, university and college education were positively correlated with anxiety. Menopause, junior secondary education, high school education and mild disease were negatively correlated with anxiety. Appropriate body was two-way negatively correlated with anxiety.
(2) Severe and moderate disease, junior secondary education, menopause and fat body were positively correlated with depression. FSH>30U/L and Menopause were two-way positively correlated with depression. High school education, premenopausal, university and college education, FSH≤30U/L were negatively correlated with depression. appropriate body was two-way negative correlated with depression.
(3) Severe disease and FSH>30U/Lwas positive association rules, moderate disease and FSH>30U/L was no association rules, mild disease was positively correlated with FSH>30U/L. Severe disease and and Kidney-yin deficiency was negative association rules, moderate and mild disease were positively correlated with Kidney-yin deficiency. 1.4 Association rules of anxiety, depression and symdrome of MENQOL scale
(1) Asomotor, sexual domains, and anxiety, depression were the two-way positive correlation rules.
(2) Anxiety, depression and physical domains:poor spirit, changes of appearance of skin or complexion, dry skin, lack of energy, frequent urination, sleep problems, physical decline, fatigue or exhaustion, neck pain or headache, backache, muscle and joint pain, and anxiety, depression were two-way positive correlation rules. Swelling and discomfort feeling, weight gain, unable to control urination when cough or laugh, these symptoms and anxiety, depression were positive correlation rules.
1.5 Association rules of anxiety, depression and symptoms of KI scale, TCM sore table:
(1) There were two-way positive rules, btween palpitations, irritability, paresthesia, algopareunia symptoms of KI sale and anxiety, depression. Anxiety and urinary symptoms was two-way positive rules. Urinary symptoms and depression was not relevant rules. Crawing feeling of skin was positively correlated with anxiety and depression.
(2)Gloomy complexion, tinnitus, cold feel of limbs, dizziness, constipation, knees soft, hand and foot fever, nocturia symtoms of TCM sore table were positively correlated with anxiety and depression. Depression and dry mouth, sore waist was two-way positive correlation rules.
1.6 Association rules of Sleep problems and physical domains:Unable to control urination when cough or laugh, Swelling and discomfort feeling were positively correlated with sleep problems. Weight gain and sleep problems were not relevant rules. Other symptoms of MENQOL scale were positively correlated two-way rules with sleep problems.
2 Internal rules of emotional therapy for menopausal syndrome
2.1 Efficiency Analysis of the symptom
(1) TCM score table:Compared with placebo group, total score difference of first visit and the 8th week, first visit and the 12th week in TCM group were significant difference. Total score difference of first visit and the 4th week, first visit and the 8th week, first visit and the 12th week in TCM and emotion group were significant difference. Total score difference of first visit and the 8th week, first visit and the 12th week in emotion group were significant difference.
(2) KI scale:Compared with placebo group, total score difference of first visit and the 8th week in TCM group were significant difference. Total score difference of first visit and the 4th week, first visit and the 8th week, first visit and the 12th week in TCM and emotion group were significant difference. Total score difference of first visit and the 12th week in emotion group were significant difference.
(3) MENQOL scale:Total score difference of four dimensions between first visit and the 12th week in four groups were no significant difference. 2.2 Total score of TCM score table, KI and MENQOL scale in different time in emotion group were compared, there was statistically significant. 2.3 Efficiency Analysis of the symptom
(1) Efficiency Analysis of the symptom in MENQOL scale were more than 50% in four groups:hot flushes, spontaneous perspiration in daytime, night sweats, sleep problems, tired or exhausted, Physical decline, feel a lack of energy, lumbago, anxiety or tension, neck pain or headache, muscle and joint pain. There had also frequent urination, hypomnesia in tcm group, not satisfied with life, work smoothly in the past, depression or low mood and poor spritis in tcm and emotion group, depression or low mood, hypomnesia and a lack of patience in emotion group, work smoothly in the past in placebo group.
(2) Efficiency Analysis of the symptom in TCM score table were more than 50% in four groups:sweating、irritability、hot flushes、dry mouth、insomnia、sore waist. There was hand and foot fever in tcm group, TCM and emotion group had dizzines, depression, hand and foot fever, complexion dark and gloomy. Emotion group had hand and foot fever, depression, complexion dark and gloomy, soft-knee.
(3) The efficiency of each symptom in KI scale was more than 50%:there were hot flushes and sweating, excitability, insomnia, fatigue, paresthesia, muscle, bone and joint pain in four groups. There were palpitations, depression, dizziness in tcm and emotion group. There were palpitations, depression in emotion group.
2.4 Association rules between symptom in TCM score table and efficacy at 12th week:Effect of treatment on efficacy from high to low:
(1) Emotion Group:severe sore waist, severe sweating, moderate complexion dark and gloomy, severe hot flushes, moderate irritability, moderate insomnia, moderate hand and foot fever, moderate soft-knee.
(2) TCM and emotion group:mild irritability, moderat insomnia, moderate hand and foot fever, severe irritability, severe sweating, severe hot flushes, severe depression, moderate dizzines, mild dizzines, moderate soft-knee, moderate hot flushes, moderate dry mouth, mild dry mouth, mild hand and foot fever, mild depression, mild hot flushes, moderate severe sweating, mild sore waist, moderate sore waist, mild sweating, moderate complexion dark and gloomy, mild complexion dark and gloomy, moderate depression.
(3) TCM group:severe irritability, moderate hand and foot fever, moderate dry mouth, moderat insomnia, severe hot flushes, moderate sweating, severe sweating, moderate hot flushes, moderate irritability, mild sore waist.
Conlusion:
1 The symptoms that seriously impacted on life and work of menopausal women were hot flushes and sweating, insomnia, musculoskeletal pain, fatigue symptoms.
2 the Abnormal emotions of women with menopausal syndrome were affected by many factors, such as general situation, vasomotor symptoms, somatic symptoms, sexual symptoms. The emotions were irritability, easy to grief, and anxiety, especially complex emotions. Emotions should have different grade and performance.
3 The emotional therapy can not completely suitable for women with menopausal syndrome and complex emotions. According to the different grade and performance style of emotion, emotional therapy can be adjusted.
绝经综合征病有发病年龄提早、发病率成上升趋势。如何缓解妇女绝经综合征症状,提高生活质量,一直是世界医学研究的重点,其治疗已成为全球医药事业的重要组成部分。现代医学主张激素替代治疗(HRT)治疗绝经综合征,但HRT可导致各种副反应等缺点,影响了病人的依从性,因此努力寻找临床疗效显著且副作用小的治疗方法是当务之急。非药物疗法已成为国内外研究的热点,但又主要集中在单纯使用心理疗法,或作为辅助治疗,更多将其单纯归入到心理学范畴或应用精神类药物进行治疗,且目前缺少完整的心理治疗方案、没有行业中公认的治疗方法。
导师前期课题采用国际、国内公认的疗效评价指标评价情志疗法治疗绝经综合征的疗效,结果显示情志组与安慰剂组的初诊与第4周、第8周的KI总分差值比较,差异无统计学意义(P>0.05),初诊与第12周KI总分差值比较差异统计学意义(P<0.05)；且情志组、中药组、中药+情志组的组间比较差异无统计学意义(P>0.05)。本课题在前期课题2001年到2003年主持的国家科技十五攻关课题,及2004年到2006年的十一五滚动课题流调的收集数据基础上,探研绝经综合征的内在规律及情志疗法治疗绝经综合征的内在规律,为进一步完善情志疗法治疗绝经综合征的技术规范和诊疗标准提供理论依据。
研究方法
将符合绝经综合征的中西医诊断标准、纳入标准、排除标准的病例,进行数据整合、预处理、格式转换后,利用SPSS 13.0软件进行描述性分析,组间比较采用方差分析,组内比较采用配对t检验；weka 3.5.7软件进行聚类分析、关联规则分析。分析内容：(1)绝经综合征疾病的内在规则：绝经综合征患者不同情志的调查分析；抑郁、焦虑与中医证型的聚类分析；焦虑、抑郁与一般情况及kupperman index (KI)量表、Menopause-Specific Quality of Life(MENQOL)量表及中医证候记分表中症状进行关联规则分析；睡眠问题与躯体症状的关联规则分析。(2)情志治疗绝经综合征的内在规则：中药组、中药+情志组、情志组与安慰剂组的KI、MENQOL量表及中医证候记分表不同观察时点总分差值的比较；情志组KI、MENQOL量表及中医证候记分表不同观察时点总分的比较；各组KI、MENQOL量表及中医证候记分表各症状的有效率分析；中医证候记分表的症状与第12周疗效的关联规则分析。
研究结果
1绝经综合征疾病的内在规则
1.1绝经综合征患者不同情绪的调查分析
(1)绝经综合征患者17种不同情绪中以焦虑、抑郁的频率最高,分别为89.47%、77.03%。(2)KI、MENQOL量表量表及中医证候记分表中各症状的频率>80%,且重度症状频率>7%症状为失眠、骨关节肌肉痛、疲乏、潮热出汗。
1.2抑郁、焦虑与中医证型的聚类分析
(1)抑郁、焦虑的聚类分析：单纯焦虑症状、焦虑合并抑郁症状、其它情志、单纯抑郁症状频率分别为18%、63%、13%、6%。
(2)抑郁、焦虑与中医证型的聚类分析：绝经综合征患者肾阴虚证型中总焦虑频率为81%,总抑郁频率为71%；肾阳虚中总焦虑频率为81%,总抑郁频率为69%。1.3一般情况、焦虑及抑郁之间的关联规则
(1)体型瘦、重度病情、中度病情、大学及大学以上学历与焦虑成正相关规则。绝经、初中学历、高中学历、轻度病情与焦虑成负相关规则。焦虑与体型属于中等成双向负相关规则。
(2)重度病情、中度病情、初中学历、体型胖与抑郁成正相关规则。FSH>30U／L、已绝经与抑郁成双向正相关规则。高中学历、未绝经、大学及大学以上学历、FSH≤30U／L与抑郁成负相关规则。抑郁与体型属于中等成双向负相关规则。
(3)重度病情与FSH>30U／L成正相关规则；中度病情与FSH值>30U／L成不相关规则,轻度病情与FSH>30U／L成负相关规则。重度病情与肾阴虚证型成负相关规则,中、轻度病情与肾阴虚证型成正相关规则。
1.4焦虑、抑郁与MENQOL量表中血管舒缩、躯体、性生活症状的关联规则
(1)血管舒缩、性生活症状与焦虑、抑郁均成双向正相关规则。
(2)焦虑、抑郁与躯体症状中外表精神差、外貌、肤质或气色发生变化、皮肤干燥、缺乏精力、尿频、睡眠有问题、体力下降、疲劳或筋疲力尽、颈项疼痛或头痛、腰痛、肌肉和关节疼痛症状成双向正相关规则。感到肿胀不适、体重增加、当大笑或咳嗽时无法控制小便症状与焦虑、抑郁成正相关规则。
1.5焦虑、抑郁与KI量表、中医证候记分表条目的关联规则分析
(1)焦虑、抑郁与KI量表：焦虑、抑郁与心悸、易激动、感觉异常、性交痛症状成双向正相关规则。泌尿系症状与焦虑成双向正相关规则,与抑郁成不相关规则。皮肤蚁走感与焦虑、抑郁症状成正相关规则。
(2)焦虑、抑郁与与中医证候记分表：焦虑、抑郁与面色晦暗、耳鸣、肢冷、头目眩晕、便秘、膝软、手足心热、夜尿成双向正相关规则。腰酸、口干与抑郁成双向正相关规则。
1.6睡眠问题与躯体症状的关联规则分析：
MENQOL量表中当大笑或咳时无法控制小便、感到肿胀不适与睡眠有问题症状成正相关规则。体重增加与睡眠有问题成不相关规则。睡眠有问题与躯体症状中其他症状成双向正相关规则。
2情志疗法治疗绝经综合征的内在规则
2.1中医证候记分表、KI量表、MENQOL量表不同观察时点总分差值的组间比较：
(1)中医证候记分表：中药组初诊与第8周、第12周总分差值与安慰剂组比较,差异均有显著性意义。中+情组初诊与第4周、第8周、第12周总分差值与安慰剂组比较,差异均有显著性意义。情志组初诊与第8、12周总分差值与安慰剂组比较,差异均有显著性意义。
(2)KI量表：中药组的初诊与第8周总分差值与安慰剂组比较,差异有显著性意义。中+情组初诊与第4周、第8周、第12周总分差值与安慰剂组比较,差异均有显著性意义。情志组的初诊与第12周总分差值与安慰剂组比较,差异有显著性意义。
(3)生存质量量表：4组初诊与第12周4个维度总分差值比较,差异均无统计学意义。
2.2情志组中医证候记分表、KI量表、MENQOL量表不同观察时点的比较结果显示,均有统计学意义。
2.3中医证候记分表、KI量表、MENQOL量表各症状的有效率分析
(1)MENQOL量表中各症状的有效率分析：四组中有效率均≥50%的症状有烘热、白天汗自出、盗汗、睡眠有问题、感疲劳或筋疲力尽、体力下降、感到缺乏精力、腰痛、焦虑或紧张、颈项部疼痛或头痛、肌肉关节疼痛症状。另外,中药组有记忆减退、尿频。中+情志组有对自己生活不满意、做事不如以往得心应手、抑郁情绪低落或沮丧、外表精神差。情志组有抑郁情绪低落或沮丧、缺乏耐心、记忆减退。安慰剂组有做事不如以往得心应手。
(2)中医证候记分量表中各症状的有效率分析：四组中有效率均≥50%的症状有汗出、烦躁易怒、烘热、口干、夜寐不安、腰酸。另外,中药组有手足心热。中+情组有头目眩晕、郁郁寡欢、手足心热、面色晦暗。中情志组有手足心热、郁郁寡欢、面色晦暗、膝软症状。
(3)KI量表中各症状的有效率分析：四组中有效率≥50%的症状有潮热出汗、易激动、失眠、疲乏、感觉异常、骨关节肌肉痛。另外,中+情志组还有心悸、抑郁、眩晕。情志组有心悸、抑郁。
2.4中医证候记分表中症状与第12周疗效的关联规则结果：症状经治疗后对有效率的影响程度从高到低的依次为
(1)情志组：重度腰酸、重度汗出、中度面色晦暗、重度烘热、中度烦躁易怒、中度夜寐不安、中度手足心热、中度膝软。
(2)中+情志组：轻度烦躁易怒、中度夜寐不安、中度手足心热、重度烦躁易怒、重度汗出、烘热、重度郁郁寡欢、中度头目眩晕、轻度头目眩晕、中度膝软、中度烘热、中度口干、轻度口干、轻度手足心热、轻度郁郁寡欢、轻度烘热、中度汗出、轻度腰酸、中度腰酸、轻度汗出、中度面色晦暗、轻度面色晦暗、中度郁郁寡欢。
(3)中药组：重度烦躁易怒、中度手足心热、中度口干、中度夜寐不安、重度烘热、中度汗出、重度汗出、中度烘热、中度烦躁易怒、轻度腰酸。
研究结论
1绝经综合征症状中严重影响患者生活及工作的症状主要有潮热出汗、失眠、骨关节肌肉痛、疲乏症状。
2绝经综合征患者异常情志的出现受一般情况、血管舒缩症状、躯体症状、性生活症状等多方面因素影响。其情志的改变具有易怒、易悲、易焦虑特点,尤其具有复合情志的特点；且情志应分等级及表现方式不同。
3情志相胜疗法不能完全适应绝经综合征患者复合情志的治疗。情志疗法治疗绝经综合征患者可根据情志轻重等级不同及表现方式不同,进行治疗方案的调整。
Object ives:
The trend of menopausal syndrome is an upward and earlier age. It has been a focus of the world's medical research that is how to alleviate symptomsand improve life quality of women with menopausal syndrome. Modern medicine had advocated that menopausal syndrome was treated by Hormone replacement therapy (HRT), but HRT have a variety of side effects, and affected the patient's compliance. It is urgent to find a treatment that is significant effect and relatively few side-effects. Non-drug therapy is becoming a focus at home and abroad, but it was mainly concentrated in psychological therapy alone or as adjuvant therapy, moreover, there is lack of a complete psychological treatment programs, and a accepted treatment in industry.
The result showed that compared with placebo group, total score difference of first visit and the 4th week, first visit and the 8th week in emotional group were no significant difference (P>0.05), first visit and the 12th week in emotional group were significant difference (P<0.05); compared with TCM group, TCM and emotional group, total score difference of emotional group were no significant difference (P>0.05). On the basis of data that was collected by National Science and Technology 15 key from 2001 to 2003 and the Eleventh Five-year rolling from 2004 to 2006 in the previous issues. To research rules of menopausal syndrome, and emotional therapy for menopausal syndrome. To provide theory for the technical specifications and standards of diagnosis and treatment of emotional therapy for menopausal syndrome.
Methods:
Patients fulfilling the diagnostic criteria, inclusion criteria and exclusion criteria, then data integration, pre-processing, format conversion. Data were analyzed by descriptive analysis, groups were analyzed by analysis of variance, group comparison were analyzed by paired t test. To adopt cluster analysis and association rules methods for data mining. Analytical content: (1) The inherent rules of menopausal syndrome:Investigation and Analysis of emotions of Menopausal syndrom. Cluster analysis of depression, anxiety and TCM Syndrome. Association rules of emotion and the general situation, kupperman index (KI), Menopause-Specific Quality of Life (MENQOL) and traditon chinese medicine (TCM) scales. Association rules of sleep problems and somatic symptoms. (2) Internal rules of emotional therapy for menopausal syndrome: Different time points scores compared bewteen four groups of KI、MENQOL scales and TCM score table. Different time points scores compared in emotional group of KI、MENQOL scales and TCM score table before and after treatment. Efficiency Analysis of the various symptoms of each group. Association rules between efficacy and symptoms in the TCM sare table.
Results:
1 The inherent rules of menopausal syndrome
1.1 Investigation and Analysis emotions of menopausal syndrome:
(1) The frequency of anxiety and depression was respectively 89.47%、77.03%, which is he highest frequency in 17 emotions of women with menopausal syndrome.
(2) There were four symptoms that Frequency of symptoms in KI and MENQOL scale was more than 80%, and Frequency of Severe symptoms of women with menopausal syndrome was more than 7%, the symptoms were insomnia, Musculoskeletal pain, fatigue, hot flushes and sweating symptoms. 1.2 Cluster analysis of depression, anxiety and TCM Syndrome:
(1) Cluster analysis of depression and anxiety:Frequency of pure anxiety, anxiety and depressive symptoms, other emotions, pure depression was respectively 18%、63%、13%、6%。
(2) Cluster analysis of depression, anxiety and TCM Syndrome:The frequency of total anxiety and depression in Kidney Yin deficiency Syndrome was respectively 81%、71%. The frequency of total anxiety and depression in Kidney Yang deficiency Syndrome was respectively 81%、69%.
(1)lean body, Severe and moderate disease, university and college education were positively correlated with anxiety. Menopause, junior secondary education, high school education and mild disease were negatively correlated with anxiety. Appropriate body was two-way negatively correlated with anxiety.
(2) Severe and moderate disease, junior secondary education, menopause and fat body were positively correlated with depression. FSH>30U/L and Menopause were two-way positively correlated with depression. High school education, premenopausal, university and college education, FSH≤30U/L were negatively correlated with depression. appropriate body was two-way negative correlated with depression.
(3) Severe disease and FSH>30U/Lwas positive association rules, moderate disease and FSH>30U/L was no association rules, mild disease was positively correlated with FSH>30U/L. Severe disease and and Kidney-yin deficiency was negative association rules, moderate and mild disease were positively correlated with Kidney-yin deficiency. 1.4 Association rules of anxiety, depression and symdrome of MENQOL scale
(1) Asomotor, sexual domains, and anxiety, depression were the two-way positive correlation rules.
(2) Anxiety, depression and physical domains:poor spirit, changes of appearance of skin or complexion, dry skin, lack of energy, frequent urination, sleep problems, physical decline, fatigue or exhaustion, neck pain or headache, backache, muscle and joint pain, and anxiety, depression were two-way positive correlation rules. Swelling and discomfort feeling, weight gain, unable to control urination when cough or laugh, these symptoms and anxiety, depression were positive correlation rules.
1.5 Association rules of anxiety, depression and symptoms of KI scale, TCM sore table:
(1) There were two-way positive rules, btween palpitations, irritability, paresthesia, algopareunia symptoms of KI sale and anxiety, depression. Anxiety and urinary symptoms was two-way positive rules. Urinary symptoms and depression was not relevant rules. Crawing feeling of skin was positively correlated with anxiety and depression.
(2)Gloomy complexion, tinnitus, cold feel of limbs, dizziness, constipation, knees soft, hand and foot fever, nocturia symtoms of TCM sore table were positively correlated with anxiety and depression. Depression and dry mouth, sore waist was two-way positive correlation rules.
1.6 Association rules of Sleep problems and physical domains:Unable to control urination when cough or laugh, Swelling and discomfort feeling were positively correlated with sleep problems. Weight gain and sleep problems were not relevant rules. Other symptoms of MENQOL scale were positively correlated two-way rules with sleep problems.
2 Internal rules of emotional therapy for menopausal syndrome
2.1 Efficiency Analysis of the symptom
(1) TCM score table:Compared with placebo group, total score difference of first visit and the 8th week, first visit and the 12th week in TCM group were significant difference. Total score difference of first visit and the 4th week, first visit and the 8th week, first visit and the 12th week in TCM and emotion group were significant difference. Total score difference of first visit and the 8th week, first visit and the 12th week in emotion group were significant difference.
(2) KI scale:Compared with placebo group, total score difference of first visit and the 8th week in TCM group were significant difference. Total score difference of first visit and the 4th week, first visit and the 8th week, first visit and the 12th week in TCM and emotion group were significant difference. Total score difference of first visit and the 12th week in emotion group were significant difference.
(3) MENQOL scale:Total score difference of four dimensions between first visit and the 12th week in four groups were no significant difference. 2.2 Total score of TCM score table, KI and MENQOL scale in different time in emotion group were compared, there was statistically significant. 2.3 Efficiency Analysis of the symptom
(1) Efficiency Analysis of the symptom in MENQOL scale were more than 50% in four groups:hot flushes, spontaneous perspiration in daytime, night sweats, sleep problems, tired or exhausted, Physical decline, feel a lack of energy, lumbago, anxiety or tension, neck pain or headache, muscle and joint pain. There had also frequent urination, hypomnesia in tcm group, not satisfied with life, work smoothly in the past, depression or low mood and poor spritis in tcm and emotion group, depression or low mood, hypomnesia and a lack of patience in emotion group, work smoothly in the past in placebo group.
(2) Efficiency Analysis of the symptom in TCM score table were more than 50% in four groups:sweating、irritability、hot flushes、dry mouth、insomnia、sore waist. There was hand and foot fever in tcm group, TCM and emotion group had dizzines, depression, hand and foot fever, complexion dark and gloomy. Emotion group had hand and foot fever, depression, complexion dark and gloomy, soft-knee.
(3) The efficiency of each symptom in KI scale was more than 50%:there were hot flushes and sweating, excitability, insomnia, fatigue, paresthesia, muscle, bone and joint pain in four groups. There were palpitations, depression, dizziness in tcm and emotion group. There were palpitations, depression in emotion group.
2.4 Association rules between symptom in TCM score table and efficacy at 12th week:Effect of treatment on efficacy from high to low:
(1) Emotion Group:severe sore waist, severe sweating, moderate complexion dark and gloomy, severe hot flushes, moderate irritability, moderate insomnia, moderate hand and foot fever, moderate soft-knee.
(2) TCM and emotion group:mild irritability, moderat insomnia, moderate hand and foot fever, severe irritability, severe sweating, severe hot flushes, severe depression, moderate dizzines, mild dizzines, moderate soft-knee, moderate hot flushes, moderate dry mouth, mild dry mouth, mild hand and foot fever, mild depression, mild hot flushes, moderate severe sweating, mild sore waist, moderate sore waist, mild sweating, moderate complexion dark and gloomy, mild complexion dark and gloomy, moderate depression.
(3) TCM group:severe irritability, moderate hand and foot fever, moderate dry mouth, moderat insomnia, severe hot flushes, moderate sweating, severe sweating, moderate hot flushes, moderate irritability, mild sore waist.
Conlusion:
1 The symptoms that seriously impacted on life and work of menopausal women were hot flushes and sweating, insomnia, musculoskeletal pain, fatigue symptoms.
2 the Abnormal emotions of women with menopausal syndrome were affected by many factors, such as general situation, vasomotor symptoms, somatic symptoms, sexual symptoms. The emotions were irritability, easy to grief, and anxiety, especially complex emotions. Emotions should have different grade and performance.
3 The emotional therapy can not completely suitable for women with menopausal syndrome and complex emotions. According to the different grade and performance style of emotion, emotional therapy can be adjusted.
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