Efficiency And Mechanism Research Of Yangxin Decoction For The Treatment Of Patients With Qi And Blood Deficiency Syndrome Of Chronic Stable Angina Based On The Methods Of Evidence-based Medicine And Metabonomics

Objective:To assess the efficacy and safety of Yangxin Decoction and Yangxin Granules for angina pectoris with RCT and the meta-analysis;To study on the plasmic metabonomics characteristic and determinethe metabolic markers of patients with qi and blood deficiency syndrome of chronic stable angina.Observe the change of metabolites on patients with qi and blood deficiency syndrome of chronic stable angina before and after Yangxin Granules intervented.Expore the metabolic pathway and mechanism of Yangxin Granules on qi and blood deficiency syndrome of chronic stable angina.Methods:1.All clinical studies of Yangxin Decoction for angina pectoris were searched from Cochrane library,Medline,CBM,CNKI,VIP and Wanfang.Quality assessment and information extraction were done and screened by two independent reviewers.The quality of the included studies was evaluated according to the Cochrane Collaboration's tool for assessing risk of bias and allocation concealment.Revman5.3 software was used for data analysis.2.The 42 cases of qi and blood deficiency syndrome of chronic stable angina were divided randomly into the trial group(n=21)and the control group(n=21),and were given for 4 weaks Yangxin Granules and placebo continuously based on the routine treatment respectively.Both groups were Followde up for 1 month.The trail was double-blind in the process of implementation.We observed the weekly angina frequency,Seattle Angina Questionnaire(SAQ),angina pectoris grade,symptom integral,TCM syndrome treatment efficacy,The incidence of total cardiovascular events in two groups before and after treatment.The data was described and analysised by S AS9.3 software.3.The top 10 cases were selected from the trial group as the qi and blood deficiency angina group and Yangxin Granules group with the standard of TCM symptom therapeutic index.10 healthy people were randomly selected as the healthy control group.Then we graw the plasma of the subjects in the morning and study the metabolomics.We used the LC-MS platform and SIMCA-P software to detect and analysis the plasma,furthermore constructed the PCA,PLS-DA and OPLS-DA models.At last,we adopted the VIP value(threshold>1)of the OPLS-DA model,and the p value of t-test(p<0.05)to find the differentially expressed metabolites,and search online database(Metlin)for the qualitative differences of metabolites.Results:1.A total of 5 trials with 464 patients were included in this systematic review,but their methodology quality was lower.Meta-analysis showed that group of Yangxin Decoction adding conventional treatment was better than the conventional treatment group in improving ECG efficacy[OR=1.78,95%CI:1.1 6-2.72].There were no diference between the two group in term of the efficiency of anti-angina[OR=0.08,95%CI:-0.01-0.16]and reduction of nitroglycerin[OR=1.77,95%CI:1.00-3.14].There were no adverse reaction reported in trials regarding Yangxin Decoction.2.After treatmen all indexes(except for the blood lipid)in both group have improved in different levels.Among these the TCM symptom score and grade of angina pectoris after 4 weaks treatment,the Seattle angina scale(DP)in the follow-up period in the trial group is obviously better than the control group.That points out Yangxin Granules has certain curative effect in improving TCM symptoms and quality of life of patients.There were 2 cases of abnormal liver function and 1 cases fasting blood glucose increased in the trial group over the course of the experiment,which were judged as suspected adverse drug reactions.No other serious adverse events and adverse reactions occurred.3.A total of 38 different compounds were selected from the qi and blood deficiency angina group and healthy control group,Several metabolic pathways were involved,such as lipid metabolism,amino acid metabolism,bile acid metabolism,etc.And the product of lipid metabolism is most.The intervention of Yangxin Granules made the Yangxin Granules group approach to the control group.And can make the 5-Aminopentanamide,tracosahexaenoicacid,TraumaticAcid,LysoPC(1 8:4(6Z,9Z,12Z,1 5Z,))in the qi and blood deficiency angina group get callback.Conclusion:1.Yangxin Decoction on the basis of conventional treatment could improve the efficacy of ECG on angina pectoris.However,due to the sample size of included studies was small and of lower quality,conclusions above still need high-quality trials to be confirmed.2.Yangxin Granules can improve the TCM symptoms integral,angina classification,disease awareness on patients with qi and blood deficiency syndrome of chronic stable angina.No serious adverse reactions occurred,curative effect and the security is good.Yangxin Granules in the trial did not cause serious adverse reactions occur,Yangxin Granules had good efficacy and safety.3.The disorder of plasma metabolism of chronic stable angina(Qi and blood deficiency type)were mainly lipid metabolism,amino acid metabolism disorder,and with energy metabolism,oxidative stress and inflammation related.4.Yangxin Granules can partial adjustment to chronic stable angina(Qi and blood deficiency)plasma metabolic disorder,mainly through the regulation of fatty acid metabolism,improve the body energy metabolism plays a role in the treatment.