Clinical Effect Of Integrated Traditional Chinese And Western Medicine On Patients With Acute Ischemic Stroke After Mechanical Thrombectomy

Research objectiveEndovascular therapy represented by mechanical thrombectomy is still an important treatment for ischemic stroke;At present,many studies have shown that compared with intravenous thrombolysis,mechanical thrombectomy has the advantages of vascular recanalization rate,less treatment time window restrictions,obvious prognosis benefits and other advantages,with significant clinical efficacy.However,relevant studies at home and abroad have shown that many patients have not achieved good prognosis after operation,accounting for about 43%-50% of the total treatment [1-5],and there are significant differences between different clinical studies,including thrombectomy method,successful rate of vascular recanalization,preoperative collateral circulation Aspects score and postoperative complications will affect the clinical outcome of patients after operation;Postoperative hemorrhage transformation is the main complication affecting the prognosis of ischemic stroke.The current mainstream intervention programs still focus on the prevention and treatment of excessive reperfusion,the monitoring of symptomatic hemorrhage transformation(Sich),the symptomatic treatment of intracranial hematoma,and the balance of antiplatelet therapy,but the clinical effect is not ideal;Considering that there is no systematic study on the clinical management of mechanical thrombectomy with traditional Chinese medicine,this study is based on the "Qi and blood theory" of traditional Chinese medicine,based on the basic understanding that the syndrome of "Qi deficiency and blood stasis" runs through the whole pathological stage of stroke,and combined with Hongshen Sanqi powder with the effect of "supplementing qi and activating blood" to participate in the clinical management of postoperative patients.By observing the difference of curative effect between the clinical patients treated with Hongshen Sanqi powder combined with conventional western medicine and those treated with western medicine alone,and based on the influence of the pathological syndrome of "Qi deficiency and blood stasis" on the transformation of postoperative intracranial hemorrhage,the focus absorption of patients in the transformation subgroup of hemorrhage was observed,the influence of the combination of traditional Chinese and Western Medicine on the clinical efficacy,prognosis,living ability and other aspects of postoperative patients was evaluated,and the safety of the combination of Hongshen Sanqi powder was evaluated,It provides a new idea for the next step to develop a scheme of integrated traditional Chinese and Western medicine for the treatment of patients with acute ischemic stroke after mechanical embolectomy and the prevention and treatment of bleeding transformation.Research contentsThis study is a prospective clinical randomized controlled trial,which is conducted by a double center,randomized controlled clinical research method;Fifty patients with acute large vessel occlusive ischemic stroke who met the inclusion criteria and exclusion criteria from the Affiliated Hospital of Chengdu University of traditional Chinese medicine and Meishan Hospital of traditional Chinese medicine were randomly assigned to the treatment group and the control group according to the random number method;The control group was treated with routine western medicine,and the treatment group was treated with Hongshen Sanqi powder;The treatment course of the trial lasted until 3 months after operation,and the follow-up period lasted until 6 months after operation.During the trial period,7 patients died of clinical outcomes,and 1 patient failed to fall off due to follow-up;A total of 42 patients completed the 3-month course of treatment,21 in the treatment group and 21 in the control group;The control group was treated with mechanical thrombectomy and routine western medicine after operation,while the treatment group was treated with Hongshen Sanqi powder on this basis;According to the difference of NIHSS score,postoperative Mrs score,Bi score and TCM syndrome score of the two groups at different time after operation,the clinical and TCM efficacy were evaluated.Research results1)Baseline comparison: there was no significant difference between the two groups in terms of age,gender,previous history,vascular recanalization,occurrence of large-area cerebral infarction,distribution of stroke subtypes,NIHSS score,aspects score and collateral circulation score on the first day after operation(P > 0.05);Comparison of general conditions: there was no significant difference between the two groups in blood routine examination(white blood cells,neutrophils,lymphocytes,red blood cells,hemoglobin),coagulation function(PT,APTT,INR),liver and kidney function(AST,alt,creatinine),preoperative blood pressure,blood glucose,etc.(P > 0.05);Comparison of postoperative complication distribution: there was no significant difference between the two groups in the distribution of postoperative complications such as symptomatic bleeding transformation,asymptomatic bleeding transformation,secondary epilepsy,gastrointestinal bleeding and pulmonary infection(P > 0.05).2)Clinical outcome: among the 50 postoperative patients 28 days after operation,38 cases were effective,and the total effective rate was 76%.The total effective rate in the treatment group(80.0%)was higher than that in the control group(72.0%).In the treatment group 28 days after operation,6 cases were cured,9 cases were markedly effective,5 cases were effective,1 case had no effect or worsened outcome,3 cases died of clinical outcome,and 1 case failed to follow up;In the control group,1 case was cured,12 cases were markedly effective,5 cases were effective,3 cases were ineffective or deteriorated,and 4 cases died of clinical outcomes.3)Overall NIHSS score: intra group comparison: NIHSS scores of the two groups showed a downward trend throughout the treatment process;In the control group,there was no significant difference in NIHSS scores before and after the first day and the third day after operation(P > 0.05),and there was significant difference in NIHSS scores at other time points compared with the previous time point(P < 0.05);There was no significant difference in NIHSS scores before and after 3 and 7 days in the treatment group(P > 0.05),and there was significant difference in NIHSS scores at other time points compared with the previous time point(P < 0.05);That is to say,the two treatment schemes can effectively reduce the functional damage of nervous system at different pathological stages,and then improve the clinical efficacy of acute ischemic stroke(AIS);Comparison between groups: there was no significant difference in preoperative NIHSS score between the two groups(P > 0.05);There was no significant difference in NIHSS scores at 1 day,3 days,7 days and 14 days after operation(P > 0.05);The NIHSS scores of the treatment group were significantly lower than those of the control group at 28 days and 3 months after operation(P < 0.05).4)Comparison of clinical efficacy: 28 days after operation,the significant and effective rates of the treatment group were higher than those of the control group;There was no significant difference in the distribution of clinical efficacy between the two groups(P > 0.05).5)Evaluation of stroke severity grading: the severity of stroke severity grading in the two groups showed an overall improvement trend during the whole treatment process;There was no significant difference in the severity of stroke between the two groups before and 1 day after operation(P > 0.05);The grade of stroke in the treatment group was lower than that in the control group 28 days after operation,and the difference was statistically significant(P < 0.05).6)Overall Mrs score: intra group comparison: the overall Mrs score of the two groups showed a downward trend during the whole treatment process;In the control group,there was a statistically significant difference in the Mrs score between 1 day and 28 days after operation(P < 0.05),and the overall Mrs score was lower at 28 days after operation;There was no significant difference in Mrs score between 28 days and3 months after operation(P > 0.05);The Mrs score of the treatment group decreased gradually at 28 days and 3 months after operation,and the difference was statistically significant.Comparison between groups: there was no significant difference in Mrs scores between the two groups on the 1st day and the 28 th day after operation(P > 0.05),but there was significant difference in the 3rd month after operation(p<0.05),and the overall level of Mrs scores in the treatment group was lower than that in the control group;That is,Hongshen Sanqi powder combined with conventional western medicine can further reduce the Mrs score level 3 months after operation,improve the clinical prognosis of patients undergoing mechanical thrombectomy,and reduce the occurrence of disability outcomes.7)Overall Bi score: intra group comparison: the Bi scores of the two groups showed an upward trend during the whole treatment process;The Bi scores of the two groups at different time points 28 days and 3 months after operation showed an upward trend compared with the previous time point,and the difference was statistically significant;Comparison between groups: there was no significant difference in Bi scores between the two groups on the 1st day and the 28 th day after operation(P > 0.05),and the treatment group was higher than the control group;Three months after operation,the Bi scores of the two groups showed that the treatment group was higher than the control group,and the difference was statistically significant(P < 0.05).In the stroke recovery period within 3 months after operation,based on the combination of Hongshen Sanqi powder and conventional western medicine,it can more effectively improve the patients’ ability of daily living,and the treatment effect is better than the control group based on conventional western medicine.8)TCM syndrome score: intra group comparison: the TCM syndrome score of the two groups at different time points after operation showed a downward trend.The TCM syndrome score of the two groups at the observation time points of 1 day,28 days and 3 months after operation showed a downward trend compared with the previous time point,and the difference was statistically significant(P < 0.05);That is,both of the two treatment schemes can improve the TCM Syndromes of patients with ischemic stroke;Comparison between groups: there was significant difference in TCM syndrome score between the two groups at 1 day,28 days and 3 months after operation(p<0.05),and the treatment group was lower than the control group,which confirmed that the combination of red ginseng and Sanqi powder could further effectively improve the TCM syndrome of postoperative patients.9)Curative effect of traditional Chinese medicine: the total effective rate of the treatment group was 93.33%,which was better than that of the control group,which was 68.97%.In the treatment group,4 cases were cured,9 cases were markedly effective,8 cases were effective and 0 case was ineffective,while in the control group,2 cases were cured,5 cases were markedly effective,11 cases were effective and 3cases were ineffective;Compared the curative effect of the two groups,the effective rate of the treatment group was higher than that of the control group,and the difference was statistically significant(P < 0.05).10)Comparison of NIHSS scores of postoperative bleeding transformation group:NIHSS scores of patients with bleeding transformation during the whole treatment follow-up were higher than the average level.Considering that the occurrence of bleeding transformation had adverse effects on the condition of stroke,it would aggravate the neurological function damage of postoperative patients;Intra group comparison: the hinss scores of the two groups showed a downward trend at different time points in the whole treatment process;There was no significant difference in the degree of NIHSS score decline between the control group and the treatment group within 1,3 and 7 days after operation(P > 0.05).The NIHSS score at other different time points in the two groups showed a downward trend compared with that at the previous time point(P < 0.05);The NIHSS score of the two groups decreased more significantly after 14 days.Comparison between groups: there was no significant difference in NIHSS scores between the two groups on the 1st,3rd,7th and 14 th day after operation(P >0.05);The NIHSS score of the treatment group was lower than that of the control group at 28 days and 3 months after operation(P < 0.05).11)Duration of hemorrhagic transformation focus: there was no significant difference between the two groups(P > 0.05);The comparison of the duration of intracranial hemorrhage focus after operation showed that the duration of intracranial hemorrhage focus in the treatment group was shorter than that in the control group(P< 0.05).12)The recurrence rate in the treatment group was lower than that in the control group,and the difference was not statistically significant(P > 0.05).13)Comparison of neutrophil / lymphocyte ratio(NLR): intra group comparison:NLR in the control group showed an overall upward trend within 14 days after operation,that is,there was inflammatory reaction damage in the acute stage of stroke,and NLR decreased significantly after 14 days(P < 0.01);NLR in the treatment group showed a downward trend as a whole,and decreased significantly 14 days after operation(P < 0.01),but there was no significant difference in the decline of NLR in the acute stage of stroke(P > 0.05);Considering that Hongshen Sanqi powder can help to improve the inflammatory response damage in the acute phase of stroke,it still needs to further expand the sample size and further study.Comparison between groups: the NLR of the two groups after operation showed that the NLR of the treatment group was lower than that of the control group at 1,7,14 and 28 days after operation,and the difference was not statistically significant(P >0.05).14)Safety indicators: during the clinical trial,among the 50 postoperative patients,7 died due to severe complications such as cerebral hernia,subarachnoid hemorrhage,acute renal failure and hemorrhagic shock,and 1 patient failed to fall off due to follow-up;The other 42 patients who participated in the clinical trial had 3cases of abnormal liver and kidney function within 28 days after operation,and 2patients in the control group had abnormal liver function(elevated AST and ALT).After stopping the treatment of atorvastatin calcium tablets,protecting the liver and stopping the treatment of Hongshen Sanqi powder for 3 days,the patients’ liver function returned to normal;One patient in the treatment group had abnormal renal function(increased creatinine).After routine treatment such as correcting the access volume,the renal function index of the patient returned to normal,and the above patients could continue the clinical trial;Other patients did not have abnormal liver and kidney function indexes during the treatment period;No adverse drug reactions related to Hongshen Sanqi powder occurred during the test period.Research conclusion(1)In this study,mechanical thrombectomy is the basis of vascular recanalization reperfusion therapy in patients with acute ischemic stroke;The two groups of treatment schemes based on this can help to reduce the neurological deficit of patients with acute ischemic stroke,improve the clinical efficacy and prognosis,and improve the ability of daily living of patients;(2)The application of Hongshen Sanqi powder in the clinical management of postoperative patients with "Qi deficiency and blood stasis" type is helpful to improve the neurological deficit,long-term prognosis,ADL and TCM Syndromes of postoperative patients with "Qi deficiency and blood stasis" type ischemic stroke,and reduce the severity of stroke;And no drug-related adverse reactions were found during the treatment,which has certain clinical application value;(3)Hongshen Sanqi powder can help to shorten the time of intracranial hemorrhage in patients with ischemic stroke bleeding transformation after mechanical thrombectomy of "Qi deficiency and blood stasis" type,promote the absorption of focus,and improve the neurological deficit in patients with postoperative bleeding transformation of "Qi deficiency and blood stasis" type.No obvious adverse drug reactions were observed during the treatment.