| 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 granulesObjective: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 granulesObjective: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 granulesObjective: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 typesObjective: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. |
PDF Full Text Request