基于三型辨证理论体系的2型糖尿病交叉对照临床研究
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摘要
本课题研究来源于中国中医科学院“优势病种课题2型糖尿病三型辨证规范与疗效评价指标体系的研究”,课题编号820102。导师在对糖尿病多年研究的基础上,提出了中医治疗糖尿病的“三型辨证”学术体系。三型即阴虚热盛型,多见于糖尿病早期,患者表现以热证、实证为主；气阴两虚型,本型见于糖尿病中期阶段,多为热盛耗伤气阴,而衍变为气阴两虚型。阴阳两虚型,本型多因糖尿病久病难复,阴阳俱虚,或阴损及阳而导致全身阴阳俱虚,功能衰退的病变,见于并发症多而重的糖尿病后期阶段。三型辨证反映了糖尿病早、中、晚三个阶段,阴虚热盛为早期、气阴两虚为中期、阴阳两虚为晚期,这种演变符合西医中将糖尿病的进展：分为胰岛素抵抗、胰岛β细胞功能紊乱、p细胞功能衰竭的规律。基于以上理论导师创制了清润方、滋益方、双调方分别对应治疗三型糖尿病。
本文分为两大部分,第一部分为文献综述部分,综述一总结了导师“三型辨证”学术体系的提出和形成过程及其应用现状,综述二介绍中医糖尿病临床试验的发展现状及交叉对照研究的设计方法和统计学特点。第二部分临床研究部分,采用交叉设计的研究方法,按照“三型辨证”学术体系将204例2型糖尿病患者分为阴虚热盛型、气阴两虚型、阴阳两虚型,并评价对应的中药复方颗粒剂清润方、滋益方、双调方的临床疗效。
1.清润方的疗效评价研究
目的：观察滋阴清热的清润方治疗阴虚热盛型2型糖尿病的临床疗效。方法：采用交叉对照的方法,将47例受试者随机分为两组,甲组在第一阶段甲组接受清润方+西药常规用药(A药)的治疗,乙组仅接受西药常规用药(B药)的治疗,第二阶段两组交换。用SAS统计软件分析数据。结果：第一阶段和第二阶段结束时,两组的空腹血糖(FBG),餐后2小时血糖(2hPBG),糖化血红蛋白(HbAlc),中医症状积分与基线比较有显著差异；应用一般统计学检验,重复测量方差分析,广义估计方程(GEE)分析综合疗效均证实服用A药阶段的疗效均优于服用B药阶段,且周期效应和后遗效应均无统计学意义。结论：清润方+西药常规用药治疗比单用西药治疗阴虚热盛型2型糖尿病能更好地控制血糖,缓解临床症状。
2.滋益方的疗效评价研究
目的：观察益气养阴的滋益方治疗气阴两虚型2型糖尿病的临床疗效。方法：采用交叉对照的方法,将107例受试者随机分为两组,甲组在第一阶段甲组接受滋益方+西药常规用药(A药)的治疗,乙组仅接受西药常规用药(B药)的治疗,第二阶段两组交换。用SAS统计软件分析数据。结果：第一阶段和第二阶段结束时,两组的FBG,2hPBG, HbA1c,中医症状积分与基线比较有显著差异；应用一般统计学检验,重复测量方差分析,广义估计方程(GEE)分析综合疗效均证实服用A药阶段的疗效均优于服用B药阶段,且周期效应和后遗效应均无统计学意义。基线中医症状积分越高,综合疗效显效或有效可能性更大。结论：滋益方+西药常规用药治疗比单用西药治疗气阴两虚型2型糖尿病能在一定程度上更好的稳定血糖,并有效缓解临床症状。
3.双调方的疗效评价研究
目的：观察调补阴阳的双调方治疗阴阳两虚型2型糖尿病的临床疗效。方法：采用交叉对照的方法,将50例受试者随机分为两组,甲组在第一阶段甲组接受双调方+西药常规用药(A药)的治疗,乙组仅接受西药常规用药(B药)的治疗,第二阶段两组交换。用SAS统计软件分析数据。结果：第一阶段和第二阶段结束时,两组的FBG,2hPBG, HbA1c,中医症状积分与基线比较有显著差异；应用一般统计学检验,重复测量方差分析均证实服用A药阶段的疗效均优于服用B药阶段,且周期效应和后遗效应均无统计学意义。广义估计方程(GEE)分析综合疗效显示药物效应和周期效应有统计学意义。结论：双调方+西药常规用药比仅用西药有助于更好地控制阴阳两虚型糖尿病患者的血糖,并改善症状,提高生活质量,但甲组第一阶段的综合疗效优于乙组第二阶段。
4.三个证型的综合疗效评价
目的：比较三个证型的综合疗效区别,探讨证型是否影响综合疗效,影响综合疗效是否还有其他因素。方法：对三个证型受试者的基线情况进行比较分析,并将基线差异、证型差异作为协变量,采用广义估计方程进行综合疗效评价。结果：三个证型综合来看,只有药物效应是有显著差异的(p<0.01),即A药(中医辨证方药+西药常规用药)的疗效显著高于B药(西药常规用药)。清润方、滋益方的药物效应、周期效应、后遗效应与双调方相比,均未能检验出显著差异。在其他因素中,病程对综合疗效的影响是显著的,病程越长,显效或有效的可能性更小(P<0.05)。结论：不同证型的受试者其综合疗效无统计学差异,但病程是影响综合疗效的因素。
中医治疗2型糖尿病应注重辨证论治,评价疗效时应注重整体评估。三型辩证理论学术体系,既发扬了中医辨证论治的特点,又兼顾了现代中医临床急需的辨证规范化,本文基于三型辨证学术体系治疗2型糖尿病的交叉对照设计临床研究,并应用重复测量方差分析、广义估计方程等统计学模型进行疗效评价,结果证明中西医结合治疗2型糖尿病比单用西医治疗有更好的疗效,结论确切可靠。
This study is from the subject type2diabetes(T2DM) dialectical norms and efficacy evaluation system,subject number:820102.My Instructor professor Linlan based on years of research on T2DM,raised the"three types of dialectical "theoretical system of Chinese medicine treatment of T2DM.Three types namely excessive heat with yin deficiency type,more common in the early stage of T2DM,patients showed a heat syndrome,and a excess syndrome; Deficiency of both qi and yin type, which is mostly founded in middle stage of T2DM, qi and yin are both deficient because of the excessive heat, and the evolution of qi and yin deficiency type.The deficiency of yin and yang type,of this type more thanalong illness due to diabetes irreducible,yin and yang deficiency, orsinister and positive result of the deficiency of both yin and yang, and functional decline lesions,seen in more complications and T2DM of late stage.Three types of dialectical reflects T2DM as early as the middle and later stage of heat excessive with yin deficiency early,deficiency of both qi and yin medium term,deficiency of both yin and yang of late,this evolution in line with the progress of Western medicine in T2DM:is divided into insulin resistance pancreatic p-cell dysfunction and β-cell failure of law.Based on the above theory professor Lin to create the QingRun granules,ZiYi granules,and ShuangTiao granules,correspond to the treatment of three types.
The paper is divided into two parts,the first part is the literature review section, review a summary of Professor Lin Lan three types dialectical academic system and the formation process and their applications,review of two introduce the development of Chinese medicine clinical trials of diabetes status and cross-over control study design and statistical characteristics.Second part is the clinical research component,cross-over study,204cases of T2DM patients were divided into heat excessive with yin deficiency type,deficiency of both qi and yin type,deficiency type in accordance with the"three type dialectical"academic system,and to evaluate the traditional Chinese medicine Qingrun granules,Ziyi granules,and Shuangtiao granules corresponds to the three types.
1. Efficacy evaluation of the Qingrun granules
Objective:To observe the clinical efficacy of Qingrun granules treatment of heat excessive with Yin deficiency type of T2DM.Methods:A cross-over design method,47subjects were randomly divided into two groups,Group1in the first period to accept the treatment of the Qingrun granules+conventional western medicine(drug A),and group2only accept western conventional medicine(drug B),in the second period of the two groups exchange.Using the SAS statistical software to analyzethe data.Results:The end of the first period and second period,compare to baseline there are significant differences in fasting blood glucose(FBG),2-hour postprandial blood glucose(2hPBG),glycosylated hemoglobin(HbAlc),TCM symptom score of both groups,the application of general statistical test,repeated measures analysis of variance, generalized estimating equations(GEE) analysis of overall efficacy are co-nfirmed to take the stage of drug A treatment was better than taking drug B,and cycle effects and residual effects were not statistically significant.Conclusion:Qingrun granules+conventional western medicinetreatment can control blood sugar and the body symptoms better than single western medicine of heat excessive and yin deficiency type in T2DM.
2. Efficacy evaluation of the Ziyi granules
Objective:To observe the clinical efficacy of Ziyi granules in treatment of T2DM.Methods:A cross-over design method,107subjects were randomly divided into two groups,Group1in the first period to accept the treatment of the Ziyi granules+conventional western medicine(dragA),Group2only accept western conventional medicine(drug B) treatment,In the second period of the two groups exchange.Using the SAS statistical software to analyze the data.Results:At the end of the firstperiod and the second period,in both of the two groups the FBG,2hPBG, HbAlc,and TCM symptoms scores are all have significant differences compare to the baseline;with the application of general statistical tests,repeated measures analysis of variance,GEE analysis efficacy areconfirmed to take the period of drug A treatment was better than taking drug B period,and cycle effects and residual effects were not statistically significant.The higher the baseline TCM symptom score themore possibility of the overall efficacy markedly effective or more effective. Conclusion: Ziyi granules+conventional western medicine treatment of both qi and yin deficiency type in T2DM can stabilize bloodsugar better,and effectively relieve symptoms than single western medicine.
3. Efficacy evaluation of the Shuangtiao granules
Objective:To observe Shuangtiao granules treatment of both yin and yang deficiency type in T2DM petions of clinical efficacy.Methods:A cross-over design method,50subjects were randomly divided into two groups,group1in the first period to accept the treatment of Shuangtiao granules+conventional western medicine(duag A)and group2only accept western conventional medicine(drug B),in the second period the two groups exchange.Using the SAS statistical software to analyze the data.Results:At the end of the first and second period of the two groups of the FBG,2hPBG,HbAlc,and TCM symptom score have significant differences compare to the baseline;With application of general statistical tests,repeated measures analysis confirmed the efficacy of taking drug A period are better than taking the drug B period, the cycle effects and residual effects were not statistically significant.GEE analysis of the synthetic effect of drug effect and period effect was statistically significant. Conclusion:The Shuangtiao granules+conventional western medicine helps to better control blood sugar in diabetics yin and yang both deificiency than only western medicine,and to improve symptoms,improve quality of life,but group1in first period more effective than group2in the second period.
4. Comprehensive efficacy evaluation of three types
Objective:To compare efficacy of the three types and to explore whether the syndrome type affect the overall efficacy,if there are other factors impact of comprehensive therapeutic effect.Methods:a comparative analysis of baseline data of subjects of three types,and take the baseline differences,type differences as covariates, using generalized estimating equations integrated efficacy evaluation.Results:in all three types,drug effect is a significant difference(P<0.01), the efficacy of drug A (TCM recipe+conventional western medicine)was significantly higher than drug B(conventional western medicine).Compared to the Shuangtiao granules,the drug effect,period effect,carryover effect of Qingrun granules and Ziyi granules,we were unable to test out a significant difference.Among other factors,the duration of T2DM was significantly affect the comprehensive efficacy,the longer the duration,the less possibility of markedly effective or more effective (P<0.05).Conclusion: Comprehensive efficacy of different type syndromes subjects no significant difference, but the duration of the factorsaffecting the integrated efficacy.
Chinese medicine treatment of T2DM should focus on treatment on the basis of syndrome differentiation,and evaluation of efficacy should focus on the overall assessment.The three types dialectical theory of academic system,not only carry forward the characteristics of Chinese medicine syndrome,butalso take into account the dialectical standardization of modern Chinese medicine clinical need,based on three types dialectical academicsystem,cross-over design of the treatment of T2DM clinical research,and application of repeated measures ANOVA,generalized estimating eq-uations statistical model for efficacy evaluation,the results proved integrative treatment(TCM recipe+conventional western medicine)of T2DM than only western medicine treatment have better outcomes,the conclusions are precise and reliable.
本文分为两大部分,第一部分为文献综述部分,综述一总结了导师“三型辨证”学术体系的提出和形成过程及其应用现状,综述二介绍中医糖尿病临床试验的发展现状及交叉对照研究的设计方法和统计学特点。第二部分临床研究部分,采用交叉设计的研究方法,按照“三型辨证”学术体系将204例2型糖尿病患者分为阴虚热盛型、气阴两虚型、阴阳两虚型,并评价对应的中药复方颗粒剂清润方、滋益方、双调方的临床疗效。
1.清润方的疗效评价研究
目的：观察滋阴清热的清润方治疗阴虚热盛型2型糖尿病的临床疗效。方法：采用交叉对照的方法,将47例受试者随机分为两组,甲组在第一阶段甲组接受清润方+西药常规用药(A药)的治疗,乙组仅接受西药常规用药(B药)的治疗,第二阶段两组交换。用SAS统计软件分析数据。结果：第一阶段和第二阶段结束时,两组的空腹血糖(FBG),餐后2小时血糖(2hPBG),糖化血红蛋白(HbAlc),中医症状积分与基线比较有显著差异；应用一般统计学检验,重复测量方差分析,广义估计方程(GEE)分析综合疗效均证实服用A药阶段的疗效均优于服用B药阶段,且周期效应和后遗效应均无统计学意义。结论：清润方+西药常规用药治疗比单用西药治疗阴虚热盛型2型糖尿病能更好地控制血糖,缓解临床症状。
2.滋益方的疗效评价研究
目的：观察益气养阴的滋益方治疗气阴两虚型2型糖尿病的临床疗效。方法：采用交叉对照的方法,将107例受试者随机分为两组,甲组在第一阶段甲组接受滋益方+西药常规用药(A药)的治疗,乙组仅接受西药常规用药(B药)的治疗,第二阶段两组交换。用SAS统计软件分析数据。结果：第一阶段和第二阶段结束时,两组的FBG,2hPBG, HbA1c,中医症状积分与基线比较有显著差异；应用一般统计学检验,重复测量方差分析,广义估计方程(GEE)分析综合疗效均证实服用A药阶段的疗效均优于服用B药阶段,且周期效应和后遗效应均无统计学意义。基线中医症状积分越高,综合疗效显效或有效可能性更大。结论：滋益方+西药常规用药治疗比单用西药治疗气阴两虚型2型糖尿病能在一定程度上更好的稳定血糖,并有效缓解临床症状。
3.双调方的疗效评价研究
目的：观察调补阴阳的双调方治疗阴阳两虚型2型糖尿病的临床疗效。方法：采用交叉对照的方法,将50例受试者随机分为两组,甲组在第一阶段甲组接受双调方+西药常规用药(A药)的治疗,乙组仅接受西药常规用药(B药)的治疗,第二阶段两组交换。用SAS统计软件分析数据。结果：第一阶段和第二阶段结束时,两组的FBG,2hPBG, HbA1c,中医症状积分与基线比较有显著差异；应用一般统计学检验,重复测量方差分析均证实服用A药阶段的疗效均优于服用B药阶段,且周期效应和后遗效应均无统计学意义。广义估计方程(GEE)分析综合疗效显示药物效应和周期效应有统计学意义。结论：双调方+西药常规用药比仅用西药有助于更好地控制阴阳两虚型糖尿病患者的血糖,并改善症状,提高生活质量,但甲组第一阶段的综合疗效优于乙组第二阶段。
4.三个证型的综合疗效评价
目的：比较三个证型的综合疗效区别,探讨证型是否影响综合疗效,影响综合疗效是否还有其他因素。方法：对三个证型受试者的基线情况进行比较分析,并将基线差异、证型差异作为协变量,采用广义估计方程进行综合疗效评价。结果：三个证型综合来看,只有药物效应是有显著差异的(p<0.01),即A药(中医辨证方药+西药常规用药)的疗效显著高于B药(西药常规用药)。清润方、滋益方的药物效应、周期效应、后遗效应与双调方相比,均未能检验出显著差异。在其他因素中,病程对综合疗效的影响是显著的,病程越长,显效或有效的可能性更小(P<0.05)。结论：不同证型的受试者其综合疗效无统计学差异,但病程是影响综合疗效的因素。
中医治疗2型糖尿病应注重辨证论治,评价疗效时应注重整体评估。三型辩证理论学术体系,既发扬了中医辨证论治的特点,又兼顾了现代中医临床急需的辨证规范化,本文基于三型辨证学术体系治疗2型糖尿病的交叉对照设计临床研究,并应用重复测量方差分析、广义估计方程等统计学模型进行疗效评价,结果证明中西医结合治疗2型糖尿病比单用西医治疗有更好的疗效,结论确切可靠。
This study is from the subject type2diabetes(T2DM) dialectical norms and efficacy evaluation system,subject number:820102.My Instructor professor Linlan based on years of research on T2DM,raised the"three types of dialectical "theoretical system of Chinese medicine treatment of T2DM.Three types namely excessive heat with yin deficiency type,more common in the early stage of T2DM,patients showed a heat syndrome,and a excess syndrome; Deficiency of both qi and yin type, which is mostly founded in middle stage of T2DM, qi and yin are both deficient because of the excessive heat, and the evolution of qi and yin deficiency type.The deficiency of yin and yang type,of this type more thanalong illness due to diabetes irreducible,yin and yang deficiency, orsinister and positive result of the deficiency of both yin and yang, and functional decline lesions,seen in more complications and T2DM of late stage.Three types of dialectical reflects T2DM as early as the middle and later stage of heat excessive with yin deficiency early,deficiency of both qi and yin medium term,deficiency of both yin and yang of late,this evolution in line with the progress of Western medicine in T2DM:is divided into insulin resistance pancreatic p-cell dysfunction and β-cell failure of law.Based on the above theory professor Lin to create the QingRun granules,ZiYi granules,and ShuangTiao granules,correspond to the treatment of three types.
The paper is divided into two parts,the first part is the literature review section, review a summary of Professor Lin Lan three types dialectical academic system and the formation process and their applications,review of two introduce the development of Chinese medicine clinical trials of diabetes status and cross-over control study design and statistical characteristics.Second part is the clinical research component,cross-over study,204cases of T2DM patients were divided into heat excessive with yin deficiency type,deficiency of both qi and yin type,deficiency type in accordance with the"three type dialectical"academic system,and to evaluate the traditional Chinese medicine Qingrun granules,Ziyi granules,and Shuangtiao granules corresponds to the three types.
1. Efficacy evaluation of the Qingrun granules
Objective:To observe the clinical efficacy of Qingrun granules treatment of heat excessive with Yin deficiency type of T2DM.Methods:A cross-over design method,47subjects were randomly divided into two groups,Group1in the first period to accept the treatment of the Qingrun granules+conventional western medicine(drug A),and group2only accept western conventional medicine(drug B),in the second period of the two groups exchange.Using the SAS statistical software to analyzethe data.Results:The end of the first period and second period,compare to baseline there are significant differences in fasting blood glucose(FBG),2-hour postprandial blood glucose(2hPBG),glycosylated hemoglobin(HbAlc),TCM symptom score of both groups,the application of general statistical test,repeated measures analysis of variance, generalized estimating equations(GEE) analysis of overall efficacy are co-nfirmed to take the stage of drug A treatment was better than taking drug B,and cycle effects and residual effects were not statistically significant.Conclusion:Qingrun granules+conventional western medicinetreatment can control blood sugar and the body symptoms better than single western medicine of heat excessive and yin deficiency type in T2DM.
2. Efficacy evaluation of the Ziyi granules
Objective:To observe the clinical efficacy of Ziyi granules in treatment of T2DM.Methods:A cross-over design method,107subjects were randomly divided into two groups,Group1in the first period to accept the treatment of the Ziyi granules+conventional western medicine(dragA),Group2only accept western conventional medicine(drug B) treatment,In the second period of the two groups exchange.Using the SAS statistical software to analyze the data.Results:At the end of the firstperiod and the second period,in both of the two groups the FBG,2hPBG, HbAlc,and TCM symptoms scores are all have significant differences compare to the baseline;with the application of general statistical tests,repeated measures analysis of variance,GEE analysis efficacy areconfirmed to take the period of drug A treatment was better than taking drug B period,and cycle effects and residual effects were not statistically significant.The higher the baseline TCM symptom score themore possibility of the overall efficacy markedly effective or more effective. Conclusion: Ziyi granules+conventional western medicine treatment of both qi and yin deficiency type in T2DM can stabilize bloodsugar better,and effectively relieve symptoms than single western medicine.
3. Efficacy evaluation of the Shuangtiao granules
Objective:To observe Shuangtiao granules treatment of both yin and yang deficiency type in T2DM petions of clinical efficacy.Methods:A cross-over design method,50subjects were randomly divided into two groups,group1in the first period to accept the treatment of Shuangtiao granules+conventional western medicine(duag A)and group2only accept western conventional medicine(drug B),in the second period the two groups exchange.Using the SAS statistical software to analyze the data.Results:At the end of the first and second period of the two groups of the FBG,2hPBG,HbAlc,and TCM symptom score have significant differences compare to the baseline;With application of general statistical tests,repeated measures analysis confirmed the efficacy of taking drug A period are better than taking the drug B period, the cycle effects and residual effects were not statistically significant.GEE analysis of the synthetic effect of drug effect and period effect was statistically significant. Conclusion:The Shuangtiao granules+conventional western medicine helps to better control blood sugar in diabetics yin and yang both deificiency than only western medicine,and to improve symptoms,improve quality of life,but group1in first period more effective than group2in the second period.
4. Comprehensive efficacy evaluation of three types
Objective:To compare efficacy of the three types and to explore whether the syndrome type affect the overall efficacy,if there are other factors impact of comprehensive therapeutic effect.Methods:a comparative analysis of baseline data of subjects of three types,and take the baseline differences,type differences as covariates, using generalized estimating equations integrated efficacy evaluation.Results:in all three types,drug effect is a significant difference(P<0.01), the efficacy of drug A (TCM recipe+conventional western medicine)was significantly higher than drug B(conventional western medicine).Compared to the Shuangtiao granules,the drug effect,period effect,carryover effect of Qingrun granules and Ziyi granules,we were unable to test out a significant difference.Among other factors,the duration of T2DM was significantly affect the comprehensive efficacy,the longer the duration,the less possibility of markedly effective or more effective (P<0.05).Conclusion: Comprehensive efficacy of different type syndromes subjects no significant difference, but the duration of the factorsaffecting the integrated efficacy.
Chinese medicine treatment of T2DM should focus on treatment on the basis of syndrome differentiation,and evaluation of efficacy should focus on the overall assessment.The three types dialectical theory of academic system,not only carry forward the characteristics of Chinese medicine syndrome,butalso take into account the dialectical standardization of modern Chinese medicine clinical need,based on three types dialectical academicsystem,cross-over design of the treatment of T2DM clinical research,and application of repeated measures ANOVA,generalized estimating eq-uations statistical model for efficacy evaluation,the results proved integrative treatment(TCM recipe+conventional western medicine)of T2DM than only western medicine treatment have better outcomes,the conclusions are precise and reliable.
引文
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