| Ischemic stroke has the characteristics of high incidence,high disabilities and high mortality.With the stroke incidence increasing year by year,stroke rehabilitation has become a hot medical research.The important research of ischemic stroke rehabilitation focuses on integration of herbal decoction after syndrome differentiation, intravenous drip of herbal medical preparation,external wash,medicated bath, acupuncture,massage,spirit caring and other measures for differentiation therapy,and being attached much importance to early rehabilitation.Therefore,our team developed the TCM early rehabilitation project for ischemic stroke characterized with differentiation and individualized therapy on the basis of previous work and modern medical research in stroke.Since ancient times,the ultimate goal of medical research is to explore the causal relationship between things.The clinical effectiveness evaluation of TCM in nature is to study the causal relationship between TCM measures and the corresponding clinical outcomes.Traditional statistical methods can usually get correlation,while counterfactual model can define a causal relationship precisely.Therefore,we explore the TCM project effectiveness evaluation methodology based on counterfactual model.1.ObjectivesThe primary objective is to study the clinical effectiveness evaluation of TCM stroke early rehabilitation project on neurological deficit,motor function impairment and convulsion degree based on counterfactual model.Secondary objective is to study the effective time window and the best target syndrome of TCM stroke early rehabilitation project. 2.MethodsDepending on Multi-center collaboration and online randomized system,300 patients were randomly divided into two groups:the treatment group with 200 cases and the control group with 100 cases.The treatment group was treated with the TCM rehabilitation project which integrates the basic treatment of internal medicine,TCM comprehensive rehabilitation technology.The control group was treated with the western medicine rehabilitation project consisting of the basic treatment of internal medicine and the modern rehabilitation technology.The clinical effectiveness evaluation indexes refer to the recognized criterion of diagnosis and treatment of cerebrovascular diseases.The indexes include NIHSS used for evaluating the neurological deficit degree,the motor function score(Fugl-Meyer) for evaluating motor function and the modified Ashworth convulsion rating scale for evaluating the convulsion degree.The literature "Differentiation diagnosis standard of stroke" compiled by the stroke emergency collaboration group of state administration of TCM is utilized for quantized diagnosis of TCM syndromes.The safety index is defined by adverse observation event.The treatment course is 14 days.3.Results3.1 Therapeutic evaluationAmelioration motor function's score in the treatment group was better than that in the control group,and there was statistical difference between two groups(P<0.05). Amelioration neural function's score and convulsion's score in the treatment group were both better than those in the control group,but there were no statistical difference between these two groups(P>0.05).The results indicated that the treatment group has the therapeutic strength in improving the motor function.3.2 Effective time window3.2.1 Effective time window in improving the neurological function deficitThe improvement of the neurological function deficit in the control group was superior to the treatment group within 6 hours,but there was no statistical difference between two groups(P>0.05).The improvement of the neurological function deficit in the treatment group was superior to the control group between 6-hour disease course and 24-hour disease course,but there was no statistical difference between two groups(P>0.05).The improvement of the neurological function deficit in the treatment group was superior to the control group between 24-hour disease course and 14-day disease course and there was statistical difference between two groups (P<0.05).The results showed that effective time widow in improving the neurological function deficit of TCM rehabilitation project maybe is disease course between 24-hour and 14-day.3.2.2 Effective time widow in improving motor function impairmentAmelioration motor function's score in the treatment group were better than those in the control group within 6-hour disease course,between 6-hour and 24-hour, between 24-hour and 14-day respectively,but there were no statistical differences between two groups(P>0.05).The results showed that effective time widow in improving motor function impairment of TCM rehabilitation project maybe is disease course between 6-hour and 24-hour.3.2.3 Effective time widow in improving convulsion degreeThe score of improving the convulsion degree in the treatment group was better than that in the control group within 6-hour disease course,between 24-hour and 14-day disease course respectively,but there were both no statistical difference between two groups.The score of improving the convulsion degree in the control group was better than that in the treatment group,but there is no statistical difference between two groups.The results showed that the effective time widow in improving convulsion degree of TCM Ischemic stroke rehabilitation project maybe between 24-hour and 14-day disease course.3.3 Best target syndromeThe improvement of phlegm syndrome in the treatment group was better than that in the control group,and there was statistical difference between two groups (P<0.05).The improvement scores of wind syndrome and blood stasis in the treatment group were better than those in the control group respectively,but there were no differences between two groups(P>0.05).The improvement scores of fire-heat syndrome and of qi-deficiency syndrome,hyperactivity of yang due to yin-deficiency in the control group were better than those in the treatment group respectively,but there were no statistical differences between two groups(P>0.05). Therefore,the TCM best target syndrome in the treatment group is phlegm syndrome.3.4 Safety analysisThere was no adverse event related to the TCM rehabilitation project of ischemic stroke found in the study,which indicateed that the TCM project was safety.4.ConclusionsWe can draw some primary conclusions:(1)TCM rehabilitation project of ischemic stroke showed some superiority to western medicine rehabilitation program on improving the motor function,while both groups can improve neural function, spasmodical degree and there are no differences between them.(2) For TCM early rehabilitation project,the effective time window of disease course on improving the neurological deficit,the motor function and the limb spasticity maybe are from 24 hours to 14 days,6 hours to 24 hours,24 hours to 14 days respectively.(3)The target population of TCM rehabilitation project for Ischemic stroke is patients with phlegm syndrome.(4)Counterfactual model can evaluate the clinical efficacy of Pagmatic randomized controlled trial..The study explored a new method for clinical effectiveness evaluation of Pragmatic randomized controlled trial and provide scientific evidence for clinical effectiveness and operability of TCM Ischemic stroke early rehabilitation project,which has certain innovative.
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