台北地区慢性失眠症与记忆功能损害相关性调查及中药干预研究
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摘要
研究一:台北地区慢性失眠症与记忆功能损害相关性调查研究
     目的:
     在系统回顾文献的基础上,应用流行病学调查、评估量表评定等方法进行研究。旨在对台北地区失眠症患者一般流行病学情况、中医症状、中医证候、不同中医证型SRSS各因子积分差异以及记忆功能状况进行调查,并对失眠与记忆功能进行相关性分析,为台北地区失眠症患者中医药治疗提供流行病学依据,力求为失眠患者制定一份有效的临床调查表。
     方法:
     1.本研究采用失眠流行病学的诊断标准、纳入排除标准选择台北地区300例失眠症患者。观察此地患者年龄、性别、受教育程度、职业等分布情况。
     2.失眠专科医生进行测量并填写《失眠中医临床调查表》,了解失眠患者中医症状、证候学特点。
     3.患者自行填写睡眠状态自评量表(SRSS),以了解患者失眠状况以及不同中医证型SRSS各因子积分差异;
     4.应用临床记忆量表(CMS)对失眠患者记忆力水平进行评估,了解失眠患者记忆力功能损害情况,并进行相关性分析。
     结果:
     1.台北地区失眠症患者中,男女失眠症患者比率约为1:2.09,发病人群集中在中老年,大专以上学历,脑力劳动和失业几类人群中,失眠伴随记忆力减退患者的检出率与性别、年龄、受教育程度以及职业分布具有相似趋势。
     2.台北地区失眠症患者中医症状排在前15位的分别为:脉弦76.00%,不易入睡74.00%,夜寐不安、多梦71.33%,健忘63.67%,烦躁易怒55.33%,头晕眼花54.00%,嗳气51.00%,情绪抑郁48.33%,喜欢叹息45.00%,气短懒言44.33%,胁痛嘈杂43.00%,舌瘀点瘀斑40.83%,易醒、早醒,醒后困倦37.66%,胸闷痰多36.67%,吞酸35.67%。
     3.台北地区失眠症患者中医证候类型分布为肝郁脾虚(34.00%),心脾两虚(28.33%),瘀血阻络(14.00%),心肾不交(12.00%),痰热扰心(11.67%)。
     4.SSRS量表中:肝郁脾虚证患者多见睡眠质量下降,入睡困难,睡后易醒及睡时多梦等情况;心脾两虚证患者多见睡眠不足或觉醒不够,睡眠时间较短;痰热扰心证患者多见入睡困难,睡时多梦等情况,其中多梦、噩梦较肝郁脾虚证患者更甚;瘀血阻络证患者多见睡后易醒的情况。
     5.台北地区慢性失眠患者临床记忆量表CMS分项检测分值降低发生频率又高到低分别为图象自由回忆(90.33%),联想学习(89.67%),指向记忆(84.00%),无意义图形再认(78.67%),人像特点联系回忆(72.33%),记忆商分值<70分212人,占总调查人群的70.67%。失眠症患者CMS各分项及记忆商分值与SRSS各因子及总分分值间呈负相关性,并且性别、年龄、受教育程度SRSS量表总分与记忆商分值间存在回归关系。
     结论:
     1.在台北地区300例慢性失眠症患者以女性,中老年为主,受教育程度高,脑力劳动或失业人群出现率较高,伴记忆力损害患者检出率与性别、年龄分布、受教育程度、职业特点相似。
     2.台北地区失眠症患者失眠的症状排在前15位的肝郁、脾虚症状群为主,中医证型以肝郁脾虚、心脾两虚、瘀血阻络证最为常见。
     3.SSRS量表中调查显示不同中医证侯类型失眠症表现形式不同。
     4.台北地区慢性失眠患者约70.67%记忆力呈不同程度损害。
     研究二:疏肝健脾法治疗慢性失眠伴记忆力损害患者临床研究
     目的:
     通过观察疏肝健脾法中药对台北地区慢性失眠伴记忆力损害患者的睡眠质量,中医症状、症候及记忆力水平的影响,客观评价中医药疏肝健脾法治疗失眠症的疗效。
     方法:
     本研究采用随机、平行对照临床试验方法,将符合诊断要求的失眠伴记忆力损害患者(中医辨证为肝郁脾虚证)60例,随机分为治疗组与对照组,治疗组采用疏肝健脾法中药,对照组采用艾司唑仑片,共治疗4周,观察患者2周、4周匹兹堡睡眠质量指数(PSQI)得分、中医症候、症状积分变化情况、记忆力功能恢复情况,以及随访1周后PSQI及中医症候积分总分值变化情况,以评价疏肝健脾法的临床疗效。
     结果:
     1.治疗2周时,治疗组PSQI评分各分项及总分均较治疗前改善,组内比较p<0.05,差异具有统计学意义;对照组PSQI评分各分项中除“睡眠质量”,“睡眠效率”“日间功能”与自身治疗前对比p>0.05,差异无统计学意义,其余各分项及总分均较治疗前改善,p<0.05,差异具有统计学意义;
     治疗4周时,治疗组PSQI评分各分项及总分均较治疗前改善,组内比较p<0.05,p<0.01,差异具有统计学意义,其中在“睡眠效率”,“日间功能”及总分值较治疗前有显著性差异p<0.01;对照组PSQI评分各分项及总分除“睡眠效率”,“日间功能”(p>0.05)外,均较治疗前改善(p<0.05);两组间比较,除“睡眠时间”,“睡眠障碍”(P>0.05)差异无统计学意义外,PSQI评分其余各分项及总分组间比较(P<0.05),差异具有统计学意义,其中治疗组在“睡眠效率”,“日间功能”改善作用明显优于对照组(P<0.05),差异具有显著性。
     随访1周,治疗组与治疗4周时PSQI总分比较,p>0.05,差异无统计学意义;对照组与治疗4周PSQI总分比较,p<0.05,差异具有统计学意义;组间比较,P<0.05,差异具有统计学意义。
     2.单项中医症状疗效评价:治疗后观察两组对“睡眠时间”“入睡困难”症状的改善情况(P>0.05),无显著性差异;治疗后观察两组对“易醒”“多梦”“困倦乏力”症状的改善情况(P<0.05),具有显著性差异。
     3.中医症侯积分比较:两组治疗前中医症侯积分比较P>0.05,差异无统计学意义,具有可比性;治疗4周后组内比较,治疗组与治疗前比较p<0.01,差异具有显著性,具有统计学意义,对照组与治疗前比较△p<0.05,差异具有统计学意义;组间比较,※P<0.05,说明治疗后两组中医症候积分差异具有统计学意义。
     随访1周,治疗组与治疗4周比较,p>0.05,差异无统计学意义;对照组与治疗4周比较,p<0.05,差异具有统计学意义,两组随访1周PSQI总分比较,P<0.05,差异具有统计学差异。
     4.中医症候总有效率为89.66%,与对照组比较P<0.05,两组总体症候疗效具有显著性差异。
     5.记忆力水平评价:治疗4周后组内比较,两组在5项因子分值均较治疗前改善,差异具有统计学意义(△p<0.05,△△p<0.01);组间比较,对照组5项因子分值改善上均明显优于对照组,差异具有统计学意义(※P<0.05)。
     结论:
     1.疏肝健脾法中药制剂能较为平稳持续改善患者睡眠质量,并且具有较好的远期疗效。
     2.疏肝健脾法中药制剂能有效改善患者单项症状,中医症候积分以及中医症候总有效率。
     3.疏肝健脾法中药制剂能有效改善慢性失眠症患者记忆功能障碍,提高记忆水平,改善生活质量。
Research one:Research of Correlation Survey between chronic insomnia and memory impairment in Taipei area
     Objective:
     The research based on method of reviewing the literature, application of epidemiology investigation, evaluation of assessment scale. The study aimed to investigating general epidemiological situation of insomnia, the TCM symptoms, the TCM syndromes, differences of scores of each factor of SRSS in different TCM syndromes and memory function status in insomnia patients in Taipei area. The research also analyzed the correlation between chronic insomnia and memory function, provided epidemiological basis for TCM therapy to insomniacs in Taipei area, strived to develop a effective clinical questionnaire for insomnia patients.
     Method:
     1.This study chose 300 insomnia patients according to insomnia epidemiological diagnostic criteria, inclusion criteria and exclusion criteria in Taipei area. We observed the distribution of age, sex, education degree, profession of the patients.
     2.The doctors specialized in treating insomnia measured and filled in "TCM insomnia clinical questionnaire", learned the TCM symptoms, syndrome features of insomnia patients.
     3. Patients filled in the Self-Rating Scale of Sleep (SRSS), in order to learn the condition of insomnia as well as differences of scores of each factor of SRSS in different TCM syndrome.
     4. Evaluate the memory level of insomnia patients by clinical memory scale(CMS), inorder to find out the situation of memory deficits of chronic insomnia patients, and do the correlation analysis.
     Results:
     1. The patients are mostly elderly people. by education degree in primarily, Education degree mainly distributed in the college degree or above. The morbidity in mental labor people and unemployment people is higher. The condition of memory loss was similar with the detection rate in patients gender, age, educational level and occupational distribution.
     2. The top 15 symptoms of insomnia patients in Taipei area:taut pulse 76.00%, not easy to sleep 74.00%, insomnia and dreaminess 71.33%, forgetfulness 63.67%, irritability and susceptibility to rage 55.33%, dizziness 54.00%, belching 51.00%, dispiritedness 48.33%, frequent sigh 45.00%, shortness of breath and not desire to speak 44.33%, hypochondria pain and gastric discomfort 43.00%, purplish macules on the surface of the tongue 40.83%, easy to wake up, wake up early, wake up sleepy 37.66%, chest oppression and much sputum 36.67%, acid regurgitation 35.67%.
     3. The syndromes of insomnia patients in Taipei area:syndrome of liver qi stagnation and spleen asthenia (34.00%), asthenia syndrome of heart and spleen (28.33%), Blood stasis syndrome(14.00%), disturbance of the heart by phlegmatic fire(12.00%), syndrome of disharmony of the heart and kidney (11.67%).
     4. SSRS scale:More common in patients with liver spleen deficiency decreased sleep quality, difficulty falling asleep, sleep and sleep easily after waking dreams while other conditions; deficiency of both heart and spleen were not more common lack of sleep or wake, sleep time is shorter; phlegm disturbance of evidence More common in patients with difficulty falling asleep, dreams while sleeping, etc., of which more than a dream/nightmare even worse than the liver in patients with spleen deficiency; blood stasis syndrome more common sleep easily after waking situation.
     5. Patients with chronic insomnia in Taipei CMS Clinical Memory Scale test scores lower sub-frequency to low-and high image free recall, respectively (90.33%), associative learning (89.67%), point to memory (84.00%), nonsense figure Recognition (78.67%), Portrait Features Contact recall (72.33%), memory quotient score of<70 212 people,70.67% of the total survey population. CMS patients with insomnia and memory quotient of the sub-scores and the SRSS total score of each factor and the negative correlation between score and gender, age, educational level, SRSS total score and memory scores between the regression relationship between business.
     Conclusion:
     1.300 patients in the Taipei area with chronic insomnia were almost female, middle-aged, highly educated, mental, or unemployed people. The rate in patients with memory deficits were similar with gender, age distribution, educational level, occupation characteristics.
     2. Patients with chronic insomnia Taipei area behind former 15 symptoms were mainly the symptoms of liver qi stagnation and spleen asthenia. And TCM syndrome type of liver depression and spleen deficiency, heart and spleen deficiency, blood stasis permits the most common.
     3. In SSRS scale survey, different forms of insomnia had different types of TCM symptoms
     5. There was about 70.67% of patients with chronic insomnia in Taipei associated with memory deficits.
     Research two:Clinical Research of Shuganjianpi Therapy for Chronic Insomnia Patients with Memory Deficits Objective: Objective:
     Observing the influence in sleep quality, clinical symptoms, signs and memory levels of chronic insomnia patients with memory deficits inTaipei treated by Shuganjianpi therapy of Chinese herb, and evaluation the curative effect of Shuganjianpi therapy for insomnia.
     Method:
     Our research used randomized, parallel controlled clinical trial methods. We chose 60 patient met the diagnostic requirements of the memory deficits in patients with insomnia (TCM as the ganyupixu syndrome),and randomly divided into treatment group and control group. Treatment group used Shuganjianpi therapy of Chinese herbs, control group took estazolam tablets for 4 weeks. Observed Pittsburgh Sleep Quality Index (PSQI) scores, TCM syndrome, changes in symptom scores, memory function recovered,2 weeks,4 weeks as well as follow-up after 1 week TCM syndrome score and PSQI total score changes,inoder to evaluate the curative effect of ShuganJianpi therapy.
     Results:
     1.Treatment for 2 weeks, the treatment group PSQI sub-item and total score were improved than before treatment,group compared p<0.05, significantly different; control group PSQI score, in addition to the sub-items "sleep quality ","Sleep efficiency, "" daytime function, "compared with their pre-treatment p> 0.05, the difference was not statistically significant, the remaining sub-items and total score than those before treatment to improve, p<0.05, significantly different.
     After 4 weeks, the treatment group PSQI score and total score of the sub-items than before treatment improved group compared p<0.05, p<0.01, statistically significant differences, which in the "sleep efficiency", "Day between the function "and total scores were significantly higher than before treatment difference p<0.01; control group PSQI score and total score than the sub-item" sleep efficiency "," Day feature "(p> 0.05), but were improved compared with before treatment (p<0.05); between the two groups, in addition to "sleep time", "sleep disorders" (P> 0.05) difference was not statistically significant outside, PSQI score and the total breakdown of the remaining comparison groups (P<0.05), the difference was significant, the treatment group in the "sleep efficiency", "Day function" was superior to the control group improved (P<0.05), differences were significant.
     1 week follow-up, treatment group and treated for 4 weeks compared PSQI scores, p> 0.05, the difference was not statistically significant; the control group and treated for 4 weeks compared PSQI scores, p<0.05, significantly different; group Comparison, P<0.05, statistically significant difference.
     2. Clinical evaluation of individual clinical symptoms:two groups were observed after treatment of "sleep time "and"difficulty falling asleep, " the improvement in symptoms (P> 0.05), no significant difference; treatment were observed on the "easy wake""more than a dream""Sleepy fatigue "improvement of symptoms (P<0.05), with significant differences.
     3.Comparison of TCM symptom points:two points before treatment compared TCM symptom P> 0.05, the difference was not statistically significant, comparable; group 4 weeks after treatment compared to the treatment group compared with before treatment p<0.01, Significant difference, statistically significant, the control group before treatment p<0.05, significantly different; between the two groups, P<0.05, that TCM symptoms after treatment, both groups were statistically significant differences between points.
     1 week follow-up, the treatment group compared with 4 weeks of treatment, p> 0.05, the difference was not statistically significant; the control group compared with 4 weeks of treatment, p<0.05, statistically significant differences between the two groups were followed up 1 week PSQI total score Comparison, P<0.05, difference statistically significant.
     4. Chinese total effective rate was 89.66% symptom, compared with control group P<0.05, overall symptom efficacy of the two groups was significant difference.
     5. Memory Evaluation:After 4 weeks of treatmen' group in two groups in the five factor scores improved compared with before treatment, the difference was statistically significant (p<0.05, p<0.01); group compared with the control group Five factor scores were significantly better than the improvement of the control group, the difference was statistically significant(P<0.05).
     Conclusion:
     1. ShuganJianpi therapy of Chinese herb can improve sleep quality more sustainly and stably, and has good long-term effect.
     2. ShuganJianpi therapy of Chinese herb can improve the patients individual symptoms, TCM symptom score and total effective rate of TCM symptoms effectively.
     3.ShuganJianpi therapy of Chinese herb can effectively improve memory dysfunction in patients with chronic insomnia, improve memory levels, enhance the quality of life
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