代谢综合征中医证候研究
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摘要
1研究目的
通过多中心、大样本的临床流行病学调查,系统研究和探讨我国成人MS中医证候类型及分布情况,确立其主要症状分布,为今后更好地指导代谢综合征的中医干预提供参考依据。对MS各证候主要组分检测指标(体重指数、腰臀比、血压、血糖、血脂)进行比较,为各证候的判定提供可能的客观化临床检测参考依据。
2研究对象
2010年10月至2011年4月北京市羊坊店医院、南京建中中医院、山东济宁市中医院、山东日照华方医院、山西长治市中医院、山西潞安矿业集团医院、辽宁本溪中医院、河北省保定市第一中医医院,共8家医院依从性较好的,符合纳入标准、排除标准的门诊或体检中心的代谢综合征患者和健康人。
3研究内容与方法
3.1研究内容
①MS中医证候研究—确立MS常见证候类型及分布,②MS各中医证候主要组分检测指标之间的比较。
3.2研究方法：
3.2.1数据采集
以2005年国际糖尿病联盟(IDF)关于代谢综合征的定义为诊断标准,纳入代谢综合征患者1842例为观察组,同时纳入312例健康样本作为正常对照组。所有受试者填写课题组通过专家深度访谈、专家问卷调查及文献查阅后制定的《代谢综合征中医证候临床调查表》。采集内容包括一般资料(人口学资料、人体测量学资料、病史、家族史、饮食、运动、生活习惯等)、中医四诊信息(脾胃症状15项、肝部症状15项、心脑症状12项、肾部症状12项、躯体及其他症状12项,共计66项。舌脉部分包括胖大舌、齿痕舌、脉滑、脉弦等36条项目。其他包括头发、颜面、五官、躯体、四肢、皮肤、大便、小便、痰、泛吐物、声音、气味共12类内容)和临床相关理化指标(血压、血尿常规、肝肾功能、空腹血糖、TG、TC、LDL-C、HDL-C、血尿酸、血流变、肝胆超声)；全部数据进行双人双机核对录入,经管理员核对后上传至中国中医科学院中医临床基础医学研究所网络数据库；技术人员导出数据；将数据创建为SPSS数据库。
3.2.2数据分析
①四诊信息单变量分析
计算各指标出现的阳性率,根据阳性率大小进行排序,将四诊信息的各指标进行观察组和对照组的卡方检验,将阳性率在10%以上且有统计学意义(P<0.05)的指标直接纳入下一步分析,对于阳性率在10%以下或阳性率在10%以上但没有统计学意义的指标,征求中医专家和课题负责人的意见进行取舍。
②探索性因子分析和聚类分析
采用主因子法估计因子载荷,输出因子得分系数和特征根,选取特征根大于1的因子。同时得到因子轴旋转后的因子载荷系数矩阵。运用回归法计算每个病例在因子中的得分情况。对因子载荷系数矩阵数据进行系统聚类分析。
③证候判定和证候分布
根据因子分析和聚类分析结果,结合中医理论,参考1997年中华人民共和国家标准《中医临床诊疗术语·证候部分》(GB/T16751.2-1997)诊断标准,将公因子用规范的证候名称命名,确立MS常见证候。根据因子得分,取最大值确立证候分布情况。
④MS各中医证候主要组分的比较
观测指标：包括体重指数(BMI)、腰臀比(WHR)、血压(SBP. DBP)、空腹血糖(FPG)、血脂(TC、TG、HDL-C、LDL-C)。
数据符合正态分布和方差相等,两组独立样本间均数比较采用独立样本T检验,多组间两两比较采用最小显著性差异法(LSD)进行单变量方差分析,数据符合正态分布但是方差不齐则两两比较采用Tamhane's T2检验,即用T检验进行各组均值配对比较。
4研究结果
4.1MS中医证候分析
在因子分析和聚类分析的统计结果基础上,征求专家意见,确定代谢综合征的初步证候名称及分布规律为肝肾阴虚证(占17.9%)、肝火亢盛证(占22.3%)、痰热互结证(占28.4%)、脾虚湿盛证(占17.7%)、痰湿中阻证(占7.8%)兼夹血瘀证(占5.9%)。
按照中国年龄段划分标准,将MS观察组病例分为青年组(20-40岁)、中年组(41-65岁)、老年组(65岁以上)。各年龄段证候分布为：20-40岁阶段肝火亢盛证和痰热互结证最多,二者相加占本组的60.92%,其次为脾虚湿盛证,占20.59%；41-65岁阶段仍然是肝火亢盛证和痰热互结证最多,二者相加占本组人数的60.96%,但肝肾阴虚证明显增多,占本组人数的18%,脾虚湿盛证次之,占17%；65岁以上的老年阶段肝肾阴虚证最多,占26.35%,其次为痰热互结证和脾虚湿盛证,分别占21.66%和20.22%。
4.2MS各中医证候主要组分指标的比较
本研究对MS的6个中医证候主要组分指标进行了比较,得出如下结果：
BMI：兼夹血瘀证高于其他组,与肝肾阴虚证、脾虚湿盛证、痰湿中阻证、肝火亢盛证有统计学意义；痰热互结证与肝肾阴虚证、脾虚湿盛证之间有统计学意义(P<0.01或P<0.05)；WHR：兼夹血瘀证明显高于其他各组,与各组均有统计学意义；痰热互结证与肝肾阴虚证之间差异显著。
SBP：痰热互结证与肝肾阴虚证有统计学意义(P<0.01)；肝火亢盛证与肝肾阴虚证(P<0.01)、脾虚湿盛证(P<0.05)有统计学意义；DBP：兼夹血瘀证与其他各组均有统计学意义,明显高于其他各组(P<0.01)；肝肾阴虚证与痰热互结证、肝火亢盛证之间有统计学意义(P<0.01)；脾虚湿盛证与肝火亢盛证之间有统计学意义(P<0.05)
FPG：肝火亢盛证高于其他各组,与肝肾阴虚证和兼夹血瘀证有统计学意义(P<0.01)。
HDL-C:痰热互结证与其他各证型组之间均有统计学意义(P<0.01)。
5结论
“痰湿”贯穿MS始终,早、中期以痰热互结证、肝火亢盛证为主,晚期则肝肾阴虚证、脾虚湿盛证增多。MS的主要中医证候分布说明痰、虚、热、瘀是其辨证的关键要点。通过中医辨证结合统计学方法所得的结果与代谢综合征临床发病规律基本相符,本次“代谢综合征常见证候的探索性研究”可为本病的进步标准化研究提供方法学参考。
基于中医证候研究的MS各中医证候主要组分指标的比较显示MS的中医证候与BMI、WHR、BP、WHR、FPG、血脂等可能具有一定的相关性,在临床辨证过程中可作为参考。
Objective:To investigate the relationship between TCM and MS group, provide objective basis for clinical detection of possible to determine various syndromes, through clinical epidemiological investigation of multi-center, large sample, study and explore the adult MS TCM Syndrome Types and distribution system in China, the establishment of the main symptoms, provides the reference for the Chinese intervention in the future to better guide the metabolic syndrome.
Methods:By the study group interviews and a questionnaire survey made by experts "metabolic syndrome clinical questionnaire", Beijing Yangfangdian Hospital, Nanjing built in the hospital of traditional Chinese medicine, Shandong traditional Chinese Medicine Hospital of Jining City, Shandong Rizhao Huafang hospital, Shanxi Chinese medicine hospital in Changzhi City, Shanxi Luan Mining Group Hospital, Liaoning Benxi Chinese medicine hospital, Hebei Province, Baoding First Hospital of traditional Chinese medicine8centers, cross-sectional survey. A cross-sectional survey in2005, the International Diabetes Federation (IDF) on the metabolic syndrome was defined as the diagnostic criteria of TCM syndrome, by1997of the people's Republic of the national standard "TCM clinical terminology syndrome part"(GBVT16751.2-1997) diagnostic criteria. A choice of8centers in Beijing, Nanjing, Benxi, Luan, Changzhi, Jining, Rizhao, Baoding, included1842cases of patients with metabolic syndrome as the observation group, at the same time into312healthy samples as normal control group, collect the general information and the information of four diagnostic methods, and the human body measurement, medical history, diet, exercise, living habits and related clinical lab index detection etc.. Establish a network database, these data double double entry database, statistical analysis was performed using SPSS19.0statistical software. Using frequency statistics analysis (frequency analysis) method of TCM four diagnostic information, including the calculation of the positive rate of the clinical symptoms, signs and tongue pulse index, and the case group and control group. Chi-square test analysis (Chi-square analysis), combined with the clinical diagnosis and expert opinion, preliminary screening index. Using exploratory factor analysis (EFA) method for further research on the four diagnostic information, extract the common factor, and the theory of traditional Chinese medicine will be common factor with syndrome name specification name, establishment of metabolic syndrome common syndrome. After calculating the factor scores, the highest value to determine the metabolic syndrome syndrome distribution. At the same time, to investigate the relationship between TCM and MS group MS every card points.
Results:Based on the statistical results of factor analysis and cluster analysis, expert opinion, determine the initial syndrome name of metabolic syndrome and the distribution rules of syndrome of liver and kidney yin deficiency (17.9%), hyperactivity (22.3%), phlegm stasis syndrome (28.4%), spleen dampness syndrome (17.7%), stagnation of phlegm-dampness syndrome (7.8%), accompanied with blood stasis syndrome (5.9%)
To explore the relationship between6syndrome and MS syndrome main group of MS, the results are as follows:
①High BMI and high WHR may microcosmic syndrome differentiation based on blood stasis as MS and folders. At the same time, but also as judge the deficiency and empirical reference.
②SBP can be as reference judge MS anger hyperactivity card, phlegm each node card, for deficiency identification, and DBP can be used as MS and folders microcosmic syndrome of blood stasis basis, but also as a judgment MS anger hyperactivity card, phlegm each node card reference.
③FPG Overabundant Liver-Fire, phlegm stagnation syndrome, phlegm each end to permit the highest. Anger hyperactivity syndrome and liver kidney yin and folders blood stasis was statistically significant (P<0.01). More than in the hot the Yin stage of MS patients with FPG relative maximum. Accordingly, the clinical syndrome reference.
④TC aspects, liver and kidney, the lowest card, and each node card with the top three phlegm, Overabundant Liver-Fire Spleen wet Sheng card statistically significant. TG, liver and kidney highest certificate, phlegm each knot card, Overabundant Liver-Fire Spleen wet Sheng card lower. HDL-C, phlegm each node card minimum, with other syndromes groups were significantly different (P<0.01), can be used as MS phlegm each knot card micro-dialectical basis.
Conclusion:Distribution of TCM Syndromes of metabolic syndrome, phlegm heat, deficiency, that blood stasis is the key point of the differentiation. Combined with statistical method the results obtained with the metabolic syndrome clinical onset regularity basically by syndrome differentiation of traditional Chinese medicine, the "metabolic syndrome common syndrome study" for this disease further standardization research and provide methodology reference, and also provide reference and basis for the clinical diagnosis and differentiation of the disease treatment the implementation of.
通过多中心、大样本的临床流行病学调查,系统研究和探讨我国成人MS中医证候类型及分布情况,确立其主要症状分布,为今后更好地指导代谢综合征的中医干预提供参考依据。对MS各证候主要组分检测指标(体重指数、腰臀比、血压、血糖、血脂)进行比较,为各证候的判定提供可能的客观化临床检测参考依据。
2研究对象
2010年10月至2011年4月北京市羊坊店医院、南京建中中医院、山东济宁市中医院、山东日照华方医院、山西长治市中医院、山西潞安矿业集团医院、辽宁本溪中医院、河北省保定市第一中医医院,共8家医院依从性较好的,符合纳入标准、排除标准的门诊或体检中心的代谢综合征患者和健康人。
3研究内容与方法
3.1研究内容
①MS中医证候研究—确立MS常见证候类型及分布,②MS各中医证候主要组分检测指标之间的比较。
3.2研究方法：
3.2.1数据采集
以2005年国际糖尿病联盟(IDF)关于代谢综合征的定义为诊断标准,纳入代谢综合征患者1842例为观察组,同时纳入312例健康样本作为正常对照组。所有受试者填写课题组通过专家深度访谈、专家问卷调查及文献查阅后制定的《代谢综合征中医证候临床调查表》。采集内容包括一般资料(人口学资料、人体测量学资料、病史、家族史、饮食、运动、生活习惯等)、中医四诊信息(脾胃症状15项、肝部症状15项、心脑症状12项、肾部症状12项、躯体及其他症状12项,共计66项。舌脉部分包括胖大舌、齿痕舌、脉滑、脉弦等36条项目。其他包括头发、颜面、五官、躯体、四肢、皮肤、大便、小便、痰、泛吐物、声音、气味共12类内容)和临床相关理化指标(血压、血尿常规、肝肾功能、空腹血糖、TG、TC、LDL-C、HDL-C、血尿酸、血流变、肝胆超声)；全部数据进行双人双机核对录入,经管理员核对后上传至中国中医科学院中医临床基础医学研究所网络数据库；技术人员导出数据；将数据创建为SPSS数据库。
3.2.2数据分析
①四诊信息单变量分析
计算各指标出现的阳性率,根据阳性率大小进行排序,将四诊信息的各指标进行观察组和对照组的卡方检验,将阳性率在10%以上且有统计学意义(P<0.05)的指标直接纳入下一步分析,对于阳性率在10%以下或阳性率在10%以上但没有统计学意义的指标,征求中医专家和课题负责人的意见进行取舍。
②探索性因子分析和聚类分析
采用主因子法估计因子载荷,输出因子得分系数和特征根,选取特征根大于1的因子。同时得到因子轴旋转后的因子载荷系数矩阵。运用回归法计算每个病例在因子中的得分情况。对因子载荷系数矩阵数据进行系统聚类分析。
③证候判定和证候分布
根据因子分析和聚类分析结果,结合中医理论,参考1997年中华人民共和国家标准《中医临床诊疗术语·证候部分》(GB/T16751.2-1997)诊断标准,将公因子用规范的证候名称命名,确立MS常见证候。根据因子得分,取最大值确立证候分布情况。
④MS各中医证候主要组分的比较
观测指标：包括体重指数(BMI)、腰臀比(WHR)、血压(SBP. DBP)、空腹血糖(FPG)、血脂(TC、TG、HDL-C、LDL-C)。
数据符合正态分布和方差相等,两组独立样本间均数比较采用独立样本T检验,多组间两两比较采用最小显著性差异法(LSD)进行单变量方差分析,数据符合正态分布但是方差不齐则两两比较采用Tamhane's T2检验,即用T检验进行各组均值配对比较。
4研究结果
4.1MS中医证候分析
在因子分析和聚类分析的统计结果基础上,征求专家意见,确定代谢综合征的初步证候名称及分布规律为肝肾阴虚证(占17.9%)、肝火亢盛证(占22.3%)、痰热互结证(占28.4%)、脾虚湿盛证(占17.7%)、痰湿中阻证(占7.8%)兼夹血瘀证(占5.9%)。
按照中国年龄段划分标准,将MS观察组病例分为青年组(20-40岁)、中年组(41-65岁)、老年组(65岁以上)。各年龄段证候分布为：20-40岁阶段肝火亢盛证和痰热互结证最多,二者相加占本组的60.92%,其次为脾虚湿盛证,占20.59%；41-65岁阶段仍然是肝火亢盛证和痰热互结证最多,二者相加占本组人数的60.96%,但肝肾阴虚证明显增多,占本组人数的18%,脾虚湿盛证次之,占17%；65岁以上的老年阶段肝肾阴虚证最多,占26.35%,其次为痰热互结证和脾虚湿盛证,分别占21.66%和20.22%。
4.2MS各中医证候主要组分指标的比较
本研究对MS的6个中医证候主要组分指标进行了比较,得出如下结果：
BMI：兼夹血瘀证高于其他组,与肝肾阴虚证、脾虚湿盛证、痰湿中阻证、肝火亢盛证有统计学意义；痰热互结证与肝肾阴虚证、脾虚湿盛证之间有统计学意义(P<0.01或P<0.05)；WHR：兼夹血瘀证明显高于其他各组,与各组均有统计学意义；痰热互结证与肝肾阴虚证之间差异显著。
SBP：痰热互结证与肝肾阴虚证有统计学意义(P<0.01)；肝火亢盛证与肝肾阴虚证(P<0.01)、脾虚湿盛证(P<0.05)有统计学意义；DBP：兼夹血瘀证与其他各组均有统计学意义,明显高于其他各组(P<0.01)；肝肾阴虚证与痰热互结证、肝火亢盛证之间有统计学意义(P<0.01)；脾虚湿盛证与肝火亢盛证之间有统计学意义(P<0.05)
FPG：肝火亢盛证高于其他各组,与肝肾阴虚证和兼夹血瘀证有统计学意义(P<0.01)。
HDL-C:痰热互结证与其他各证型组之间均有统计学意义(P<0.01)。
5结论
“痰湿”贯穿MS始终,早、中期以痰热互结证、肝火亢盛证为主,晚期则肝肾阴虚证、脾虚湿盛证增多。MS的主要中医证候分布说明痰、虚、热、瘀是其辨证的关键要点。通过中医辨证结合统计学方法所得的结果与代谢综合征临床发病规律基本相符,本次“代谢综合征常见证候的探索性研究”可为本病的进步标准化研究提供方法学参考。
基于中医证候研究的MS各中医证候主要组分指标的比较显示MS的中医证候与BMI、WHR、BP、WHR、FPG、血脂等可能具有一定的相关性,在临床辨证过程中可作为参考。
Objective:To investigate the relationship between TCM and MS group, provide objective basis for clinical detection of possible to determine various syndromes, through clinical epidemiological investigation of multi-center, large sample, study and explore the adult MS TCM Syndrome Types and distribution system in China, the establishment of the main symptoms, provides the reference for the Chinese intervention in the future to better guide the metabolic syndrome.
Methods:By the study group interviews and a questionnaire survey made by experts "metabolic syndrome clinical questionnaire", Beijing Yangfangdian Hospital, Nanjing built in the hospital of traditional Chinese medicine, Shandong traditional Chinese Medicine Hospital of Jining City, Shandong Rizhao Huafang hospital, Shanxi Chinese medicine hospital in Changzhi City, Shanxi Luan Mining Group Hospital, Liaoning Benxi Chinese medicine hospital, Hebei Province, Baoding First Hospital of traditional Chinese medicine8centers, cross-sectional survey. A cross-sectional survey in2005, the International Diabetes Federation (IDF) on the metabolic syndrome was defined as the diagnostic criteria of TCM syndrome, by1997of the people's Republic of the national standard "TCM clinical terminology syndrome part"(GBVT16751.2-1997) diagnostic criteria. A choice of8centers in Beijing, Nanjing, Benxi, Luan, Changzhi, Jining, Rizhao, Baoding, included1842cases of patients with metabolic syndrome as the observation group, at the same time into312healthy samples as normal control group, collect the general information and the information of four diagnostic methods, and the human body measurement, medical history, diet, exercise, living habits and related clinical lab index detection etc.. Establish a network database, these data double double entry database, statistical analysis was performed using SPSS19.0statistical software. Using frequency statistics analysis (frequency analysis) method of TCM four diagnostic information, including the calculation of the positive rate of the clinical symptoms, signs and tongue pulse index, and the case group and control group. Chi-square test analysis (Chi-square analysis), combined with the clinical diagnosis and expert opinion, preliminary screening index. Using exploratory factor analysis (EFA) method for further research on the four diagnostic information, extract the common factor, and the theory of traditional Chinese medicine will be common factor with syndrome name specification name, establishment of metabolic syndrome common syndrome. After calculating the factor scores, the highest value to determine the metabolic syndrome syndrome distribution. At the same time, to investigate the relationship between TCM and MS group MS every card points.
Results:Based on the statistical results of factor analysis and cluster analysis, expert opinion, determine the initial syndrome name of metabolic syndrome and the distribution rules of syndrome of liver and kidney yin deficiency (17.9%), hyperactivity (22.3%), phlegm stasis syndrome (28.4%), spleen dampness syndrome (17.7%), stagnation of phlegm-dampness syndrome (7.8%), accompanied with blood stasis syndrome (5.9%)
To explore the relationship between6syndrome and MS syndrome main group of MS, the results are as follows:
①High BMI and high WHR may microcosmic syndrome differentiation based on blood stasis as MS and folders. At the same time, but also as judge the deficiency and empirical reference.
②SBP can be as reference judge MS anger hyperactivity card, phlegm each node card, for deficiency identification, and DBP can be used as MS and folders microcosmic syndrome of blood stasis basis, but also as a judgment MS anger hyperactivity card, phlegm each node card reference.
③FPG Overabundant Liver-Fire, phlegm stagnation syndrome, phlegm each end to permit the highest. Anger hyperactivity syndrome and liver kidney yin and folders blood stasis was statistically significant (P<0.01). More than in the hot the Yin stage of MS patients with FPG relative maximum. Accordingly, the clinical syndrome reference.
④TC aspects, liver and kidney, the lowest card, and each node card with the top three phlegm, Overabundant Liver-Fire Spleen wet Sheng card statistically significant. TG, liver and kidney highest certificate, phlegm each knot card, Overabundant Liver-Fire Spleen wet Sheng card lower. HDL-C, phlegm each node card minimum, with other syndromes groups were significantly different (P<0.01), can be used as MS phlegm each knot card micro-dialectical basis.
Conclusion:Distribution of TCM Syndromes of metabolic syndrome, phlegm heat, deficiency, that blood stasis is the key point of the differentiation. Combined with statistical method the results obtained with the metabolic syndrome clinical onset regularity basically by syndrome differentiation of traditional Chinese medicine, the "metabolic syndrome common syndrome study" for this disease further standardization research and provide methodology reference, and also provide reference and basis for the clinical diagnosis and differentiation of the disease treatment the implementation of.
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