原发性失眠症中医证型分布情况及证型间睡眠状况差异的初步研究
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摘要
研究背景:
失眠是一种常见的临床症状,其发生率非常高,严重影响患者的生活质量。原发性失眠症以失眠为几乎唯一的症状,在主诉失眠的患者中比例达到15%,本病是导致长期慢性失眠的主要原因,但发病机制尚未完全明确,化学药物治疗效果欠佳。
中医药治疗失眠已有数千年的经验,近年来的文献报道提示中医药对原发性失眠症的疗效满意。但是目前中医药治疗原发性失眠症的研究尚待完善,如缺乏中医证型分布规律的系统研究,中医辨证标准欠缺直观性和客观性、可操作性不强,中医临床疗效研究缺乏科学设计等。
研究目的:
对原发性失眠症患者进行临床观察,初步描述原发性失眠症患者中医证型的分布情况;通过统计学处理,初步探讨原发性失眠症患者不同中医证型之间睡眠状况(包括失眠中医主症、睡眠测评量表各个测评因子)的差异,以提高中医辨证标准的直观性和客观性。同时期望初步筛选出半定量化的辨证诊断指标,为进一步开展大样本、多中心的原发性失眠症的中医药系统研究打下基础。
研究方法:
采用横断面调查的研究方法,对2004年1月至2005年2月在广东省中医院脑病中心失眠专科门诊就诊的、符合本研究既定中西医诊断标准的原发性失眠症患者,进行调查记录。根据既定的中医辨证标准(参考《中药新药治疗失眠的临床试验指导原则》和第6版《中医内科学》以及其他相关文献制订)对患者进行中医辨证分型。所有病例均按照统一格式填写病例观察表,内容包括:一般资料、自拟《失眠中医症候采集表》、睡眠状态自评量表(Self-Rating Scale of Sleep,SRSS)、匹兹堡睡眠质量指数(Pittsburgh Sleep Quality Index,PSQI)、自评焦虑量表(Self-rating Anxiety Scale,SAS)、自评抑郁量表(Self-rating Depression Scale,SDS)。临床资料收集完毕,使用SPSS11.0统计软件包进行条目编码、数据录入,并进行统计分析。描述性分析方法计算其频数及比例;计量资料组间比较采用方差分析或秩和检验(等级资料);计数资料组间比较采用卡方检验(必要时采用确切概率法);检验水准取a=0.05,采用双侧检验。
研究结果:
1、共收集到符合既定中西医诊断标准的原发性失眠症患者155例,按照既定中医辨证标准进行辨证分型后,共见五种中医证型,各自的频数及比例:肝郁气结证43例(27.7%),肝郁化火证36例(23.2%),气滞血瘀证57例(36.8%),心脾两虚证14例(9.0%),痰热内扰证5例(3.2%);既定辨证标准中的心胆气虚,
Backgroud:Insomnia is a commonly encountered symptom in the clinical practice.It has a high disease incidence rate and lowers the quality of life of patients. Insomia is almost the only symptom of Primary Insomnia, and 15% of those patients who take having a sleepless night as their chief complaints suffer from Primary Insomnia.Primary Insomnia is the main reason leading to chronic insomnia.The pathophysiology of Primary Insomnia has not been clearly, and the efficiency of drug treatment is not satisfied.Traditional Chinese Medicine (TCM) has plentiful exerprinces of insomnia treatment, and literatures make clear that TCM can result in satisfying curative effect of Primary Insomnia. At present there are still vacancies about Primary Insomnia in TCM, such as the absence of systemic research of syndrome distribution, no practically diagnositic standard of syndromes of TCM and the absence of clinical research in scientific principle. Objective:We will make clinical research on Primary Insomnia patients to describe the syndrome distribution in TCM, to probe into the differentiation that display on sleep conditions (include the main symptoms in TCM, factors of sleep rateing scale) between syndromes of TCM by health statistics'analysis, and to raise the visualness and objectivity of the dialectical standard of TCM.We hope the study can initially sieve half-calculation indexs for TCM syndrome diagnosis, make basis for the later systemic study which will proceed in many centers and observe more patients. Methods:The investigation method was cross-section survey. 155 outpatients who came to the insomnia department of Guangdong Hospital of TCM from Jan.2004 to Jan.2005 and were diagnosed as primary insomnia were involved in the study. All of them needed to fill in the "Case Report Form", which included the social demographic characteristics, "Symptom Collection Form of TCM", SRSS(Self-Rating Scale of Sleep), PSQI(Pittsburgh Sleep
Quality Index). SAS (Self-rating Anxiety Scale) and SDS (Self-rating Depression Scale) and were divided into different syndrome groups. SPSS 11.0 for windows was used for item coding, database structure establishment, data entry, database management and analysis.The following statistical methods of the data were adopted: descriptive analysis use frequencies and ratio; measurement data were analyzed with analysis of variance and rank sum test(for grade data); enumeration data were analyzed with chi-square test(necessarily exact probabilities); a =0.05, and double sides analysis were used. Results:1、 There were five syndromes of TCM in 155 primary insomnia patients.Frequency and ratio of every syndrome: the syndrome of stagnation of liver-qi was 43, the syndrome of fire-syndrome due to hyperactivity of liver-qi was 36, the syndrome of blood-stasis due to stagnation of qi was 57, the syndrome of deficiency of both heart and spleen was 14, the syndrome of heart disturbed by phlegm-fire was 5; Three syndromes (the syndrome of deficiency of both the heart-qi and the gallbladder-qi, the syndrome of hyperactivity of the heart-fire and the syndrome of hyperactivity of pathogenic fire due to deficiency of yin) included in old standard of syndromes of TCM were not appearing in the study.2、 By health statistics'analysis (the syndrome of heart disturbed by phlegm-fire were not analysis) .different syndromes of TCM displayed differences in main symptoms such as time of falling sleep、 sleep time、 wish for sleep: displayed differences in PSQI such as factor2 (time of falling sleep)、 factor3 (sleep time) 、 factor4 (sleep efficiency) ; displayed differences in SRSS such as factor3 (lack of sleep)、 factor3 (sleep time) 、 factor5 (difficulty of falling sleep) ; 3、 The differences of sleep conditions between TCM syndromes:The syndrome of stagnation of liver-qi and the syndrome of fire-syndrome due tohyperactivity of liver-qi:The time of falling time was the longest; The subjective sleeptime and The sleep effeet (sleep efficiency) were not specially; had not wish for sleepin daytime; Disorders of motion in daytime was the strongest.The syndrome of blood-stasis due to stagnation of qi : The time of falling time was notspecially; The subjective sleep time was the shortest and The sleep effcet (sleepefficiency) was worst; the wish for sleep in daytime was not clearly; Disorders ofmotion in daytime was strongest.The syndrome of deficiency of both heart and spleen : The time of falling time is theshortest; The subjective sleep time was the longest and The sleep effcet (sleepefficiency) was best; Efficiency decrease in daytime was not clearly.
失眠是一种常见的临床症状,其发生率非常高,严重影响患者的生活质量。原发性失眠症以失眠为几乎唯一的症状,在主诉失眠的患者中比例达到15%,本病是导致长期慢性失眠的主要原因,但发病机制尚未完全明确,化学药物治疗效果欠佳。
中医药治疗失眠已有数千年的经验,近年来的文献报道提示中医药对原发性失眠症的疗效满意。但是目前中医药治疗原发性失眠症的研究尚待完善,如缺乏中医证型分布规律的系统研究,中医辨证标准欠缺直观性和客观性、可操作性不强,中医临床疗效研究缺乏科学设计等。
研究目的:
对原发性失眠症患者进行临床观察,初步描述原发性失眠症患者中医证型的分布情况;通过统计学处理,初步探讨原发性失眠症患者不同中医证型之间睡眠状况(包括失眠中医主症、睡眠测评量表各个测评因子)的差异,以提高中医辨证标准的直观性和客观性。同时期望初步筛选出半定量化的辨证诊断指标,为进一步开展大样本、多中心的原发性失眠症的中医药系统研究打下基础。
研究方法:
采用横断面调查的研究方法,对2004年1月至2005年2月在广东省中医院脑病中心失眠专科门诊就诊的、符合本研究既定中西医诊断标准的原发性失眠症患者,进行调查记录。根据既定的中医辨证标准(参考《中药新药治疗失眠的临床试验指导原则》和第6版《中医内科学》以及其他相关文献制订)对患者进行中医辨证分型。所有病例均按照统一格式填写病例观察表,内容包括:一般资料、自拟《失眠中医症候采集表》、睡眠状态自评量表(Self-Rating Scale of Sleep,SRSS)、匹兹堡睡眠质量指数(Pittsburgh Sleep Quality Index,PSQI)、自评焦虑量表(Self-rating Anxiety Scale,SAS)、自评抑郁量表(Self-rating Depression Scale,SDS)。临床资料收集完毕,使用SPSS11.0统计软件包进行条目编码、数据录入,并进行统计分析。描述性分析方法计算其频数及比例;计量资料组间比较采用方差分析或秩和检验(等级资料);计数资料组间比较采用卡方检验(必要时采用确切概率法);检验水准取a=0.05,采用双侧检验。
研究结果:
1、共收集到符合既定中西医诊断标准的原发性失眠症患者155例,按照既定中医辨证标准进行辨证分型后,共见五种中医证型,各自的频数及比例:肝郁气结证43例(27.7%),肝郁化火证36例(23.2%),气滞血瘀证57例(36.8%),心脾两虚证14例(9.0%),痰热内扰证5例(3.2%);既定辨证标准中的心胆气虚,
Backgroud:Insomnia is a commonly encountered symptom in the clinical practice.It has a high disease incidence rate and lowers the quality of life of patients. Insomia is almost the only symptom of Primary Insomnia, and 15% of those patients who take having a sleepless night as their chief complaints suffer from Primary Insomnia.Primary Insomnia is the main reason leading to chronic insomnia.The pathophysiology of Primary Insomnia has not been clearly, and the efficiency of drug treatment is not satisfied.Traditional Chinese Medicine (TCM) has plentiful exerprinces of insomnia treatment, and literatures make clear that TCM can result in satisfying curative effect of Primary Insomnia. At present there are still vacancies about Primary Insomnia in TCM, such as the absence of systemic research of syndrome distribution, no practically diagnositic standard of syndromes of TCM and the absence of clinical research in scientific principle. Objective:We will make clinical research on Primary Insomnia patients to describe the syndrome distribution in TCM, to probe into the differentiation that display on sleep conditions (include the main symptoms in TCM, factors of sleep rateing scale) between syndromes of TCM by health statistics'analysis, and to raise the visualness and objectivity of the dialectical standard of TCM.We hope the study can initially sieve half-calculation indexs for TCM syndrome diagnosis, make basis for the later systemic study which will proceed in many centers and observe more patients. Methods:The investigation method was cross-section survey. 155 outpatients who came to the insomnia department of Guangdong Hospital of TCM from Jan.2004 to Jan.2005 and were diagnosed as primary insomnia were involved in the study. All of them needed to fill in the "Case Report Form", which included the social demographic characteristics, "Symptom Collection Form of TCM", SRSS(Self-Rating Scale of Sleep), PSQI(Pittsburgh Sleep
Quality Index). SAS (Self-rating Anxiety Scale) and SDS (Self-rating Depression Scale) and were divided into different syndrome groups. SPSS 11.0 for windows was used for item coding, database structure establishment, data entry, database management and analysis.The following statistical methods of the data were adopted: descriptive analysis use frequencies and ratio; measurement data were analyzed with analysis of variance and rank sum test(for grade data); enumeration data were analyzed with chi-square test(necessarily exact probabilities); a =0.05, and double sides analysis were used. Results:1、 There were five syndromes of TCM in 155 primary insomnia patients.Frequency and ratio of every syndrome: the syndrome of stagnation of liver-qi was 43, the syndrome of fire-syndrome due to hyperactivity of liver-qi was 36, the syndrome of blood-stasis due to stagnation of qi was 57, the syndrome of deficiency of both heart and spleen was 14, the syndrome of heart disturbed by phlegm-fire was 5; Three syndromes (the syndrome of deficiency of both the heart-qi and the gallbladder-qi, the syndrome of hyperactivity of the heart-fire and the syndrome of hyperactivity of pathogenic fire due to deficiency of yin) included in old standard of syndromes of TCM were not appearing in the study.2、 By health statistics'analysis (the syndrome of heart disturbed by phlegm-fire were not analysis) .different syndromes of TCM displayed differences in main symptoms such as time of falling sleep、 sleep time、 wish for sleep: displayed differences in PSQI such as factor2 (time of falling sleep)、 factor3 (sleep time) 、 factor4 (sleep efficiency) ; displayed differences in SRSS such as factor3 (lack of sleep)、 factor3 (sleep time) 、 factor5 (difficulty of falling sleep) ; 3、 The differences of sleep conditions between TCM syndromes:The syndrome of stagnation of liver-qi and the syndrome of fire-syndrome due tohyperactivity of liver-qi:The time of falling time was the longest; The subjective sleeptime and The sleep effeet (sleep efficiency) were not specially; had not wish for sleepin daytime; Disorders of motion in daytime was the strongest.The syndrome of blood-stasis due to stagnation of qi : The time of falling time was notspecially; The subjective sleep time was the shortest and The sleep effcet (sleepefficiency) was worst; the wish for sleep in daytime was not clearly; Disorders ofmotion in daytime was strongest.The syndrome of deficiency of both heart and spleen : The time of falling time is theshortest; The subjective sleep time was the longest and The sleep effcet (sleepefficiency) was best; Efficiency decrease in daytime was not clearly.
引文
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