| Purpose:To observe the curative effect of traditional Chinese medicine injection in practical clinical application.By exploring the distribution and evolution of TCM syndrome elements of acute and convalescent ischemic stroke,the main syndromes of stroke were found.The salvianolic acid injection was selected as the target for further research.Through Meta-analysis,the clinical efficacy and safety of salvianolic acid injection were comprehensively understood.The effect of salvianolic acid on promoting blood circulation and removing blood stasis in the recovery stage of ischemic stroke was preliminarily explored by metabonomics strategy,and its clinical efficacy and treatment mechanism were discussed from the perspective of metabolic differential products and metabolic pathways.Methods:In the first part,120 patients with ischemic stroke in the Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine were collected by retrospective study.There were 60 patients in acute phase and 60 patients in recovery phase.The acute phase and recovery phase were divided into conventional treatment group(western medicine+traditional Chinese medicine decoction)with 30 cases,and traditional Chinese medicine injection group(western medicine+traditional Chinese medicine decoction+traditional Chinese medicine injection)with 30 cases.To observe the clinical effect after 14 days and to study the changes of TCM syndrome elements of ischemic stroke from the initial stage of admission to 14 days after onset.The observation indexes were evaluated by diagnostic scale for syndrome elements of ischemic stroke,Barthel index(BI)evaluation scale and National Institute of Health Stroke Scale.SPSS21.0 software was used for statistical description and analysis.In the second part,meta-analysis was carried out by collecting literatures about salvianolic acid injection participating in the treatment of ischemic stroke.Endnote was used to remove duplicate literatures.Meta processing was carried out by Revman5.3 software.Prospective study was carried out.Cases came from 8 ischemic stroke convalescent patients in the Department of Encephalopathy Acupuncture and Moxibustion,Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine and Beichen District Hospital of Tianjin.The course of disease is 2 weeks.Principal component analysis and orthogonal partial least squares discriminant analysis were used to analyze the plasma of patients before and after treatment,to screen and identify the different metabolites and metabolic pathways,and to explore the changes of metabolism level in patients with ischemic stroke during recovery period after treatment with salvianolic acid injection,and the relationship between the changes and promoting blood circulation and removing blood stasis in traditional Chinese medicine.Results: The first part is Clinical Effect of Traditional Chinese Medicine Injection on Ischemic Stroke Treatment and Changes of TCM Syndrome Elements 1 The first two age groups of ischemic stroke patients are 60-70 years old and 70-80 years old,accounting for 35.8% and 28.4% respectively.The proportion of male stroke patients is significantly higher than that of female stroke patients.2 The distribution of stroke sites is mainly multiple,accounting for 67.5%.Followed by basal ganglia infarction,accounting for 24.16%.3 The symptoms of acute stage patients improved after treatment,with Z=-6.680 and P = 0.000 in NIHSS score.In BI,Z=-5.771,P=0.000.4 The symptoms of convalescent patients improved after treatment,and the NIHSS score was Z=-6.871,p = 0.000;In BI,Z=-6.252,P=0.000.5 The median NIHSS score of acute ischemic stroke patients was 1.0(1,2),the median of traditional Chinese medicine injection was 2.0(1.75,3),z =-2.938,P = 0.003,P < 0.05;the median of Bi score of conventional treatment group was 2.5(0,5),the median of Bi of traditional Chinese medicine injection group was 5(0,5),z =-2.111,P = 0.035,P < 0.05.The results showed that the therapeutic effect of Chinese medicine injection group was better than that of conventional treatment group.6 The median NIHSS score of the treatment effect in the convalescent patients with ischemic stroke was 1.0(1,1),the median of the treatment effect of traditional Chinese medicine injection was 2.0(2,2),z =-4.403,P = 0.000,P < 0.001;the median of the treatment effect Bi score in the conventional treatment group was 5(0,5),the median of the treatment effect Bi in the traditional Chinese medicine injection group was 5(0,5),z =-2.047,P = 0.041,P < 0.05.The results showed that the curative effect of Chinese medicine injection group was better than that of conventional treatment group.7 At the beginning of the acute phase,the frequency of TCM syndromes from more to less are wind,blood stasis,phlegm-dampness,internal fire,qi deficiency and yin deficiency.After 14 days,blood stasis,phlegm-dampness,qi deficiency,internal fire,yin deficiency and internal wind were found respectively.8 At the beginning of the recovery period,the frequency of TCM syndromes from more to less were phlegm-dampness,blood stasis,internal fire,qi deficiency,internal wind and yin deficiency.After 14 days,blood stasis,phlegm-dampness,qi deficiency,internal fire,yin deficiency and internal wind were found respectively.9 In the early stage of acute phase,wind,wind blood and blood syndrome are more common.After 14 days,phlegm,blood and phlegm-blood syndrome were the most common.The combination of the two syndromes is mostly wind and blood,wind and fire,wind and phlegm.After 14 days,phlegm and blood,qi and blood,qi and yin were the main components.10 During the recovery period,the top three syndrome combinations in the initial stage of admission are phlegm,phlegm blood and phlegm fire respectively.By the 14 th day of onset,the top three syndrome combinations were blood,phlegm and phlegm.11 With the development of the course of the disease,the combination of syndrome elements in the acute and convalescent phases of stroke gradually changes from changeable to less.After 14 days,the syndrome elements are basically documents or two syndromes.The second part Meta-analysis of Clinical Research on Salvianolic Acid Injection in Treating Ischemic Stroke 1 motor function: the changes of NIHSS before and after treatment with salvianolic acid injection were significantly different [MD =-2.43,95% CI(-2.83,-2.03),p < 0.0000] barche index was statistically different [MD = 11.38,95% ci(9.99,12.76),p < 0.00001];MRS[MD =-0.40,95%CI(-0.72,-0.08),P =0.01];The results of comparative analysis showed that the motor function of patients treated with salvianolic acid was improved,and the difference was statistically significant.2 cognitive function: MOCA was performed after salvianolic acid injection,with significant difference before and after [MD = 2.36,95% CI(1.67,3.05),P <0.00001];MMSE analysis was used [MD = 2.04,95% CI(1.34,2.75)P < 0.00001].The results showed that the cognitive function of patients was improved after salvianolic acid treatment,and the difference was statistically significant.3 comparing the clinical total effective rate of salvianolic acid [RR = 1.39 95% ci(1.28,1.50)z = 7.87 p < 0.00001] shows that the therapeutic effect of salvianolic acid on ischemic stroke is statistically significant.4 adverse reactions of salvianolic acid injection treatment group and conventional western medicine control group were tested by 2 tests,and the difference was statistically significant(2 = 12.383124,p < 0.005).adverse reactions of salvianolic acid were different from conventional western medicine.However,the symptoms were mild and recovered immediately after drug withdrawal.No serious adverse reactions occurred,suggesting that salvianolic acid for injection is safe for ischemic stroke.However,attention should be paid to monitoring digestive tract,liver function and renal function problems.Experimental Study on Metabonomic Strategy Clinical Study on Mechanism of Salvianolic Acid for Injection in Promoting Blood Circulation and Removing Blood Stasis in Recovery Stage of Ischemic Stroke 1 The scores of blood stasis syndrome,NIHSS and BI have been improved to different degrees before and after treatment with drugs(P?0.05).The difference is statistically significant,indicating that the clinical symptoms of the patients have been improved after treatment with salvianolic acid,and the drug treatment is effective.2 Metabonomic method based on liquid chromatography-mass spectrometry was used to evaluate the therapeutic effect of salvianolic acid.The results showed that compared with the treatment before,the plasma metabolic spectrum had obvious changes and 23 different metabolites were detected.Among them,3-hydroxybutyric acid is a compound obtained through nuclear magnetic resonance analysis.The amount before administration is large,and the content after administration decreases.In metabolic group,L-glutamine,1-pyrroline-4-hydroxy-2-carboxylate,(s)-4-amino-5-isovalerate,eicosapentaenoic acid,free fatty acid,sphingomyelin and phosphatidylglycerol decreased after administration.3,4-dihydroxymandelic aldehyde,3,4-dihydroxymandelic acid salt,N-acetanilide,theophylline,caffeine,DL-4-hydroxyphenlactic acid,indole-3-acetic acid,cortisol,uric acid,uridine,Lpyroglutamic acid,L-caninine,triglyceride,phosphatidylethanolamine and lysophosphatidylethanolamine are increased after administration.Salvianolic acid can obviously improve the effect of blood stasis on imbalance indexes in mouse plasma.3 In this experiment,a total of 19 metabolic pathways were detected.Among these pathways,the seven metabolic pathways that have the most significant influence on the mechanism of promoting blood circulation and removing blood stasis are tryptophan metabolism.Tyrosine metabolism;Glycerol phospholipid metabolism;Steroid hormone biosynthesis;Arginine biosynthesis,nitrogen metabolism,caffeine metabolism.It can be seen that the treatment of salvianolic acid promoting blood circulation and removing blood stasis significantly affects the metabolism of phospholipids and amino acids in ischemic stroke.Conclusion: 1 salvianolic acid for injection of traditional Chinese medicine injection has obvious curative effect in treating ischemic stroke and has no serious adverse reactions.2 traditional Chinese medicine injection has certain medical value,combined with conventional treatment can further improve the clinical efficacy.3.Acute stroke is mainly caused by endogenous wind and blood stasis.Phlegm-dampness and blood stasis are the main symptoms in recovery period.In clinical application,the main syndrome should be grasped and treated based on syndrome differentiation.At the same time,blood stasis syndrome runs through the whole process of stroke evolution and should be paid more attention to.4 Metabonomic method based on liquid chromatography-mass spectrometry was used to study plasma samples of patients with ischemic stroke in convalescence period.Metabolic abnormalities of stroke patients before and after treatment were found,and 23 potential biomarkers of biological differences were obtained.Through the analysis of metabolic pathways of these metabolic differences,it is found that amino acid metabolic pathways and lipid metabolic pathways,as the most important pathways,may be closely related to the mechanism of promoting blood circulation and removing blood stasis. |
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