| Objective:GEE model to evaluate early ischemic stroke rehabilitation program on traditional Chinese medicine in patients with ischemic stroke neurological deficits, the clinical effect of sports injury. And drawing on proven effective evaluation system of modern rehabilitation medicine, traditional Chinese medicine in the year of follow-up observation period of comprehensive rehabilitation programs in patients with ischemic stroke mortality, relapse rate, disability and quality of life.Methods:This study was the National High Technology Research and Development Program (863) Topics-ischemic stroke to prevent recurrence of early rehabilitation and programs of traditional Chinese medicine (issue number:2007AA02Z4B2) part. Randomized controlled trials using practical, multi-center cooperation, Chinese integrated stroke unit rehabilitation programs and rehabilitation programs western mode as the control. A total of 260 patients with ischemic stroke patients, according to the ratio of 2:1 by the central system is divided into random group of 175 patients with comprehensive treatment of traditional Chinese medicine, Western medicine control group 85 cases.Practitioners with ischemic stroke in early rehabilitation medicine programs, rehabilitation programs during hospitalization as a "comprehensive medical rehabilitation based on traditional Chinese medicine treatment of and Technology "; hospital discharge after the intervention in the treatment group, based on an increase of six-month oral capsule lamp Shengmai Or brain suppository capsule, characteristic of Chinese medicine health education.Treatment group stroke unit model with Western medicine under the guidance of rehabilitation programs, rehabilitation programs during hospitalization as a "basic treatment+ modern rehabilitation medicine technology. " After discharge according to different causes in a targeted manner to develop a reasonable rehabilitation program after discharge. Including anti-platelet aggregation, anticoagulation drugs, blood pressure, blood lipid and blood sugar management, health education and behavioral intervention on risk factors such as smoking, limit alcohol, reasonable meals.Endpoint reference recognized the efficacy of modern rehabilitation medicine evaluation criteria. Clinical Evaluation during hospitalization by the United States National Institutes of Health Stroke Scale (NIHSS) evaluation of neurologic impairment, motor function score (Fugl-Meyer) evaluation of motor function, the revised rating scale evaluation AshWorth spasm spasticity. And the State Administration of Traditional use of collaborative group developed acute stroke, "stroke syndrome diagnostic criteria"for the quantitative diagnosis of syndromes; follow-up outcomes of the end use of mortality, relapse rate, disability and quality of life observed. Safety index for the adverse events observed. Chinese Medicine and Western medicine treatment groups were observed during hospital stay of 14 days. Both groups were followed up after discharge for 1 year.Statistical methodology for this program on some of the characteristics of the data for the longitudinal data, using the GEE model for data processing, not only takes into account the interdependence among the data, but also solves the problem of the relevance of longitudinal data, full use of the Longitudinal data, the results of each measurement, greatly reducing the loss of information to improve the objectivity of the research conclusions.Results: 1 hospital observation:Simple Fugl-Meyer of the GEE model:Chinese Medicine and Western medicine treatment group with time, its treatment were improved, and the Chinese group on the improvement of Fugl-Meyer score better than the treatment group, and statistically significant. NIHSS score of the GEE model:Chinese Medicine and Western medicine treatment group with time, its treatment were improved, and the Chinese group on the improvement of NIHSS score better than the treatment group, but statistically no significant difference. Traditional Chinese Medicine Practitioners Board in improving the symptoms of certain significant differences exist, and are superior to western medicine group medicine group.2 one year follow up results of observation:3 year follow-up two patients died, Chinese group 1 patients, treatment group 2 patients. Two year follow-up of 8 recurrent cases,2 cases of Chinese Medicine, Western medicine group in 6 cases.The KM cumulative survival estimate:into the use of traditional Chinese medicine and western medicine group program of comprehensive rehabilitation of people value the survival function are 1, over time, recurrent cases increased, the survival function gradually decreased; until the end of 360 days follow-up, The Board reduced the value of the survival function to near 0.99, the value of the survival function treatment group decreased to 0.93.Through the test of survival curves:survival curves of Chinese Medicine has been the top of the Western group, indicating that each observation point in the TCM group without recurrence rate has been higher than the treatment group, which is the Chinese group, the recurrence rate has been lower than Western medicine group, And this difference is significant (P<0.01).Between the two groups of patients were followed up for 1 year event on the effects of stroke compared, there were significant differences (P<0.05). Between the two groups were followed up for 1 year efficacy of self-care ability of patients with stroke compared there were significant differences (P<0.05).Between the two groups of 180 days,360 days compared with different levels of disability, the Mantel-Haenszel chi-square test, the Board of disability was significantly lower than the WM group (P<0.05).3. program safety analysis: Year follow-up period of this study found no serious adverse reactions, there's a few cases of adverse events were determined by clinical investigators certainly has nothing to do with the program, indicating that the two rehabilitation in the treatment of ischemic stroke is safe.Conclusion:Early ischemic stroke rehabilitation programs to improve motor function in patients with ischemic stroke impairment than Western advantage of rehabilitation programs are effective to improve neurological deficits and spasticity with Western medicine, the efficacy of rehabilitation programs similar.Traditional comprehensive rehabilitation program outcomes in reducing the mortality end point, relapse rates, reduce disability, increase mobility and self-care ability of patients have the exact effect on.
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