| Objective1.The purpose of this study is to evaluate the efficacy and safety of the Chinese patent medicine of promoting blood circulation and removing blood stasis through observing the recurrence rate and all-cause mortality rate in 1 year and disability rate in the 12 weeks after the treatment of Chinese patent medicine of promoting blood circulation and removing blood stasis combined antiplatelet drugs for acute ischemic stroke(AIS),further providing more reliable evidence-based medical evidence for the prevention and treatment of ischemic stroke(IS).2.To explore the related factors of one-year recurrence of AIS and evaluate the correlation between TCM syndromes or TCM constitutions and recurrence of IS,so as to provide theoretical basis for the application of TCM syndrome differentiation for treatment and physical conditioning in secondary prevention of IS.MethodsThis study relied on the project of Ischemic Stroke Recurrence Risk Assessment System for Chinese Medicine Characteristic Health Management"which is the scientific research project of Chinese medicine industry in 2015.This study prospectively included the patients with AIS admitted to 18 sub-centers in Guangdong from September 2016 to April 2018.The patients were divided into two groups according to whether they took Chinese patent medicine for promoting blood circulation and removing blood stasis on the basis of using antiplatelet drugs.The course of treatment of Chinese patent medicines was more than 12 weeks.The recurrence rate and all-cause mortality rate in the two groups were compared after 1 year follow-up.The disability rate at 12 weeks and adverse events/reactions were recorded.The changes of liver function,renal function and coagulation function before and after treatment were compared between the two groups.The related factors affecting the recurrence of AIS in 1 year were analyzed.ResultsIn this study,a total of 393 patients of AIS that met the exclusion criteria were finally included,the group of combined Chinese patent medicine and the group of antiplatelet drugs were 258 patients and 135 patients respectively,58 cases were lost follow-up(14.8%),and 335 cases finally were analysed in the Per-Protocol population Set(PPS).The statistical results showed that the incidence of recurrence and all-cause mortality in 1 year between the two groups had no difference(P>0.05),and the incidence of disability rate in 12 weeks between the two groups had no clifference(P>0.05).6 patients in the combination group had adverse reactions which could be relieved without treatment.In addition,liver function,renal function and coagulation function of the two groups had no significant changes before and after treatment.Univariate analysis showed that NIHSS,mRS,SAS and phlegm-dampness constitution at admis,sion were the related factors of recurrence of ischemic stroke(P<0.05).Multivariate logistic regression analysis showed that high mRS score at admission might be the related factors of recurrence of ischemic stroke patients.The higher mRS score,the higher risk of recurrence(P=0.010,OR=1.628,95%CI[1.124,2.359])?Conclusion1.The small sample cohort study suggests that the Chinese patent medicine on the basis of using antiplatelet drugs cannot reduce the recurrence rate and all-cause mortality rate of AIS in 1 year,nor the disability rate for 12 weeks.However,considering the limited resource and time,this study failed to achieve statistical efficiency,which should be further validated in a larger sample size study.2.In this study,Chinese patent medicines for promoting blood circulation and removing blood stasis have fewer adverse events/reactions,and the safety of Chinese patent medicine was belter.It is suitable for further research on enlarging sample size.3.High mRS score may be the risk factor affecting the recurrence of ischemic stroke patients within 1 year. |
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