Clinical Study Of Peiyuan Tongnao Capsule In The Treatment Of Cerebral Infarction In The Convalescent Period

Objective:To evaluate the effectiveness and safety of Peiyuan Tongnao Capsule in the treatment of cerebral infarction in the recovery period(the syndrome of meridian and kidney deficiency in stroke,blood stasis blocking the collaterals).Methods:This research is divided into two parts.Research content one is mainly based on psychometric methods,through the modified Delphi method to obtain items,confirm the items and filter and analyze the items,compile the diagnostic criteria of TCM syndromes of ischemic stroke with kidney deficiency syndrome,and provide them for the application of research content two.Research content 2 Selected patients who met the diagnostic criteria of Western medicine for cerebral infarction in the recovery period,the diagnostic criteria of the meridian in TCM stroke and the syndrome of kidney deficiency and blood stasis obstructed collaterals.A randomized,double-blind,positive drug parallel controlled trial design was adopted.Cases are allocated in a ratio of 3:1,with first-level blinding and double-blind and double-simulation measures.The experimental group was orally administered Peiyuan Tongnao Capsules and Danxi Granules simulation agent,and the control group was orally administered Danxi Granules and Peiyuan Tongnao Capsules simulation agent.The course of treatment was 12 weeks and the follow-up was up to 180 days after the onset of disease.Efficacy evaluation indicators are modified Rankin scale,TCM syndromes,NIHSS scale,activity of daily living scale(Barthel index),and safety indicators are laboratory tests and adverse events.Results:There are 158 cases in the PPS data set and 183 cases in the SS data s et.1.Baseline:The two groups were comparable in age,height,weight,course of dis ease,and gender at the time of entry.The scores of kidney deficiency syndrome,bloo d stasis blocking collaterals syndrome and NIHSS scale scores were comparable betwe en the two groups before treatment.2.Efficacy evaluation:(1)Degree of disability:at 12 weeks of medication and 180 days of onset,the difference in the percentage of m RS scores?2 between the two groups was statistically significant(P<0.05),and t he test group was higher than the control group;(2)TCM syndromes:after 4 weeks of treatment,8 weeks,90 days after onset,12 weeks after medication,and 180 days after onset,the scores of the two groups of kidney deficiency syndrome and blood sta gnation syndrome were statistically significant(P<0.05),with the extension of the vi sit time,the difference was significant(P<0.01);(3)The degree of neurological imp airment:4 weeks after treatment,8 weeks after treatment,90 days after onset,12 wee ks after medication,and 180 days after onset,The two groups of NIHSS scale score s were compared with the baseline change value statistical analysis,the difference was statistically significant,P<0.05,the test group change value was greater than the co ntrol group;(4)daily living ability:after 4 weeks of treatment,8 weeks after treatme nt and after onset At 90 days,12 weeks after medication,and 180 days after the ons et,the difference in the percentage of Barthel index score?75 points between the t wo groups was statistically significant(P<0.05),and the test group was higher than the control group.3.Safety evaluation:15 adverse events occurred in 14 subjects in t he experimental group,and 5 adverse events occurred in 4 subjects in the control gro up.There were no significant changes in laboratory examinations before and after treat ment.Conclusions:Peiyuan Tongnao Capsule in the treatment of the recovery period of cerebral infarction(the syndrome of meridian and kidney deficiency in stroke,blood stasis blocking the collaterals)can improve the syndrome,reduce the degree of neurological deficit and disability,improve the ability of daily living,and has a good effect.