| BackgroundDiabetes is a major disease that endangers public health and has a high rate of disability and mortality.After diabetes combined with coronary heart disease,the risk of cardiovascular events increased significantly and the prognosis was worse,which brought a heavy burden to the society and the economy.Modern medical interventions can not effectively prevent or reverse the progress of disease,such as control blood sugar,regulation of blood pressure,regulation of blood lipid,dilating coronary artery,reconstruction of blood channeland so on.The advantages of TCM in the treatment of this disease are prominent.As a gold standard of clinical evidence,the randomized controlled trial(RCT)has some limitations in clinical efficacy evaluation of TCM,which cannot objectively and truly reflect the clinical efficacy of TCM.The real-world study(RWS)coincides with the characteristics of the TCM diagnosis and treatment model.On the premise of not violating TCM syndrome differentiation,we should use the data in the real medical environment to intervene in accordance with the clinical practice and the wishes of the patients.Long-term evaluation is carried out with the outcome index as the effect index to further evaluate the effectiveness of the intervention measures.Therefore,based on RWS,carrying out the research of TCM prevention and treatment of diabetes combined with coronary heart disease will help to get evidences of high level evidence-based medicine and explore a new method suitable for clinical efficacy evaluation of Chinese medicine.ObjectiveTo explore the risk factors affecting the prognosis of diabetes with coronary heart disease and provide a new strategy for clinical prevention and treatment.To evaluate the clinical efficacy of Chinese medicine in the treatment of diabetes with coronary heart disease and provide a scientific basis for clinical application.Methods1.Use the real-world stuy model in our stuy.Electronic medical records and follow-up data were used as data sources.The patients with diabetes combined with coronary heart disease were selected as the research object.Historical cohort study is the design method.The data of demography,past history,combined disease,other complications of diabetes mellitus,laboratory,traditional Chinese medicine syndrome and traditional Chinese and Western medicine were collected.The outcome of the complex cardiovascular terminal event was the outcome measure.The Cox proportional risk regression model was used to analyze the risk factors for the prognosis of the disease.The survival analysis was carried out by Kaplan-Meire survival curve and Log-rank test.2.The subjects and data collection are the same as the previous part.The patients were divided into the treatment group of traditional Chinese medicine(TCM group)and the non Chinese medicine group(NTCM group)for the treatment of Chinese medicine.The outcome of the cardiovascular event was the result of the outcome.The propensity score method(propensity score matching method,propensity score regression adjustment method,propensity score regression adjustment method,propensity score stratification,propensity score inverse probability of treatment weighting method and propensity score standardized mortality ratio weighting method)were used as tools to control confounding factors.The Cox proportional risk regression model,the Kaplan-Meire survival curve method and the Log-rank test were used to evaluate the clinical efficacy of traditional Chinese medicine in the treatment of diabetes with coronary heart disease.Results1.A total of 759 cases of medical records were included in this study.108 cases with incomplete data were excluded and 615 cases entered the statistical analysis.The time of follow-up was 4.46(4.87 ±2.41)years.The endpoint event occurred in 231 cases.Cox univariate analysis showed that: TC=4.5mmol/L,TG=1.7mmol/L,LDL-C=1.8mmol/L,HbA1c(7~8.5% and >8.5%),UA(360~420mmol/L and >420mmol/L,Hs-CRP>3mg/L),the type of coronary heart disease(after PCI),smoking,cerebrovascular disease,fatty liver,peripheral vascular lesions of diabetes,diabetic peripheral neuropathy,insulin sensitizing agents,diuretic,clopidogrel,nitroglycerin were closely related to the prognosis.Cox multivariate analysis showed: TG=1.7mmol/L,LDL-C=1.8 mmol/L,HBA1c(7~8.5% and >8.5%),Hs-CRP,3mg/L,fatty liver,cerebrovascular disease,peripheral vascular lesions of diabetes,diabetic peripheral neuropathy,insulin sensitizing agents,diuretics were independent risk factors of the prognosis of the disease.Traditional Chinese medicine was independent protective factors of the prognosis of the disease.2.After the PS matching,the baseline data of the two groups of diabetic patients with coronary heart disease were balanced.(1)The composite cardiovascular endpoint:The risk of endpoint in the NTCM group was higher than in the TCM group。The results are as follows: unadjusted Cox(HR=1.83,95%CI:1.4 ~2.41),PS matching method(HR=2.06,95%CI:1.32~3.22),PS regression adjusttment method(HR=1.64,95%CI:1.24~2.15),PS layer method(5 layers)(HR=1.67,95%CI:1.26~2.19),PS layer method(10 layers)(HR= 1.64,95%CI: 1.24~2.16),PS inverse probability of treatment weighting method(HR:2.13,95%CI: 1.44~ 3.15),PS standardized mortality ratio weighting method(HR=2.07,95%CI:1.08 ~3.95).(2)The single cardiovascular endpoint:(1)readmission of angina pectoris:the readmission rate of the NTCM group was higher than that of the TCM group.The results are as follow:unadjusted Cox(HR=1.94,95%CI:1.3~2.89),PS regression adjustment method(HR=1.77,95%CI: 1.18~2.64),PS layer method(5 layers)(HR=1.79,95%CI:1.2~2.68),PS layer method(10 layers)(HR=1.8,95% CI:1.2~2.7),PS inverse probability of treatment weighting method(HR=2.2,95%CI:1.26~3.86),PS standardized mortality ratio weighting method(HR=2.33,95%CI: 0.94~5.76),PS matching method(P>0.05).(2)There was no significant difference in all-cause mortality,myocardial infarction readmission,cardiovascular recanalization(PCI or CABG),stroke and TIA between the two groups(P>0.05).Subgroup analysis(diabetes combined with stable angina pectoris):(1)The composite cardiovascular endpoint: the risk of endpoint in the TCM group was lower than in the NTCM group.The results are as follow:unadjusted Cox(HR= 2.33,95%CI:1.55~3.5),PS matching method(HR=1.91,95%CI:1.01~3.6),PS regression adjustment method(HR=1.98,95%CI:1.31~3.0),PS layer method(5 layers)(HR=1.98,95%CI:1.3~3.02),PS layer method(10 layers)(HR=1.74,95%CI:1.14 ~2.67),PS inverse probability weighted method(HR:3.29,95%CI: 1.9~5.7),PS standardized mortality ratio weighting method(HR=2.66,95%CI: 1.12~6.29).(2)The single cardiovascular endpoint:(1)readmission of angina pectoris:the readmission rate of the NTCM group was higher than that of the TCM group。The results are as follow:unadjusted Cox(HR=2.6,95%CI: 1.58~4.26),PS regression adjustment method(HR=2.3,95%CI: 1.39~3.81),PS layer method(5 layers)(HR=2.26,95%CI:1.35~3.78),PS layer method(10 layers)(HR=2.07,95%CI:1.23-3.48,PS inverse probability of treatment weighting method(HR=3.6,95%CI: 1.88~6.91),PS standardized mortality ratio weighting method(HR=3.01,95%CI: 1.08~8.38);PS matching method(P>0.05).(2)There was no significant difference in all-cause mortality,myocardial infarction readmission,cardiovascular recanalization(PCI or CABG),stroke and TIA between the two groups(P>0.05).Conclusion1.For the prognosis of diabetes combined with angina pectoris:TG=1.7 mmol/L,LDL-C=1.8mmol/L,HBA1c(7~8.5% and > 8.5%),Hs-CRP>3mg/L,fatty liver,cerebrovascular disease,peripheral vascular lesions of diabetes,diabetic peripheral neuropathy,insulin sensitizing agents,diuretics were independent risk factors,traditional Chinese medicine was independent protective factors.2.Traditional Chinese medicine can reduce the risk of composite cardiovascular endpoint in patients with diabetes combined with angina pectoris. |
PDF Full Text Request