| Background:Multiple sclerosis (MS) is a chronic inflammatory demyelinating autoimmune disease which is caused by genetic and environmental factors. With the constant progress the treatment of MS and efficiency of different theraputic methods, MS is still an incurable, chronic and disabling disease. At the same time, the conventional treatments have some clinical adverse reactions and the cost is expensive. At present, the Western medicine treatment is not completely solve the problem of MS disability and relapse. Existing clinical and basic studies have shown that Chinese herbal medicine (CHM) used in the treatment for MS, achieves a certain clinical efficacy, like shorting the course of MS acute phase, reducing the neurological deficit, reducing side effects by the hormonal and smoothly decreasing hormones or immunosuppressive agents. However, there is no scientific efficacy estimation indices and specific classification and staging. Due to the lack of scientific evaluation system, it directly affects the clinical outcome measure, determine and achievement promotion. Therefore, according to the different MS typing and staging, and displaying the efficacy of traditional Chinese medicine in the treatment of MS in different aspects, to establish the corresponding treatments immediately, and a matched set its own rules in line with the traditional Chinese medicine curative effect evaluation method.In addition, because of the low incidence of MS and large individual differences, to establish the evaluation methods of TCM clinical efficacy is difficult via randomized controlled clinical trials.Objective:With the relapsing-remitting MS (RRMS) which is the most common clinical type in the MS as the starting point, to explore the RRMS TCM distribution characteristics in the acute stage and the remission stage, and to initially establish the scheme in syndrome differentiation and treatment by stages and the method of evaluation in the relapsing and remitting stages of RRMS.Method:1. According to the research results, to review clinical curative effect evaluation method by domestic and foreign MS researches. To systematically review randomized controlled trials by CHM in the treatment of MS, and to evaluate the efficacy and safety by CHM in the treatment of MS. Simultaneously, to summarize the treatment protocols and the evaluation methods.2. To establish item pool of TCM symptoms in MS in order to form the MS clinical information of case scale. This research combined prospective study and cross-sectional survey, using the MS clinical information of case scale to collect TCM four diagnostic information of RRMS in the relapsing and remitting stages. To collect information on the first day, the day after 1 week, the day after 2 weeks and the day after 4 weeks in the relapsing stage of MS. And to collect information on the first day, the day after 3 months, the day after 6 months and the day after 9 months. So we can explore the distribution characteristics of TCM syndromes in the relapsing and remitting stages of RRMS.3. According to the experience in the treatment of MS by Professor Gao Ying for many years, her experimental research results and the above research results, we establish the scheme in syndrome differentiation and treatment by stages. Using Single-group design, patients in the relapsing stage of RRMS received routine hormonotherapy combined with CHM and Qingkailing injection. To evaluate scales on the first day, the day after 1 week, the day after 2 weeks and the day after 4 weeks. At the same time, we collected blood samples on the first day and the day after 2 weeks in order to detect cytokines, containing INF-γ, IL-10 and IL-17. Patients in the remitting stage of RRMS received CHM. with Bushen Huoxue Tongluo Method. To evaluate scales in the first day, the day after 3 months, the day after 6 months and the day after 9 months. Simultaneously, we collected blood samples in the remitting stage in order to detect cytokines, containing INF-γ, IL-10 and IL-17.To analyze the data of record various scales and evaluate the efficacy by multiple dimensions and many time points, we establish the method of evaluation in the relapsing and remitting stages of RRMS.Results:1. After merger of the include trials, sixteen eligible RCTs with 913 cases were included. Thirteen studies adopted EDSS (Kurtzke extended disability status scale) and 2 of them showed that EDSS in the treatment group was lower than that in the control group, and the MD and 95%CI were-0.88 [-1.26,-0.50]. We performed descriptive analysis on other 8 studies which showed EDSS in the treatment group was lower than that in the control group. Five studies adopted recurrent frequency and 2 of them showed that recurrent frequency in the treatment group was lower than that in the control group, and the MD and 95%CI were-0.34 [-0.52,-0.16]. We performed descriptive analysis on the other 3 studies which showed EDSS in the treatment group was lower than that in the control group. Analyses of secondary outcomes such as clinical symptom score, neurological signs score and immune indices showed that integrated TCM and WM therapy was more effective than WM treatment alone. The studies displayed that the number or range of MRI lesion in the treatment group was lower than that in the control, but there was no statistical significance. The reported adverse effects of CHM was less than control group, and reduced the side effect of hormone.2. By frequency analysis and principal component analytical method, damp-heat syndrome obviously intensified in the relapsing stage, and gradually decreased with the passage of time. In the remitting stage, there were qi deficiency and blood stasis syndrome, yang deficiency of spleen and kidney syndrome, damp-heat syndrome, qi deficiency and blood stasis and liver-kidney yin deficiency syndrome, kidney-Yang deficiency and accumulation of blood stasis and accumulation of blood stasis, kidney deficiency syndrome was the most frequent diagnoses in the remitting stage, and the kidney yang deficiency syndrome was more than the kidney yin deficiency syndrome.3. The scheme in syndrome differentiation and treatment by stages contains oral Simiao Wan or Decoction of three kinds of kernels and intravenous Qingkailing in the relapsing stage and treated with modified Yinshendaluo in the remitting stage.In the neurological deficit, the EDSS scores the day after 4 weeks was significantly lower than the first day. In the Neuropsychology, Except the day after 1 week, the HAMD scores in the other time points were significantly lower than the first day. In the cognitive function, There was no statistical difference in PDQ scores. In the quality of life, MSQOL-54 physical health composite score and mental health composite score in the day after 4 weeks were significantly more than the first day. In the neurological deficit, the EDSS scores the day after 9 months was significantly lower than the first day. In the Neuropsychology, the HAMD scores in the day after 9 months were significantly lower than the first day. In the cognitive function, the PDQ scores in the day after 9 months showed significant improvement. In the quality of life, MSQOL-54 physical health composite score in the day after 3 months were significantly increased. MSQOL-54 mental health composite score in the day after 6 months were significantly more than the first day.Conclusion:1. To treat RRMS through TCM differential diagnosis by stages, focus on the damp-heat syndrome in the relapsing stage and focus on the kidney deficiency syndrome in the remitting stage.2. To initially establish the scheme in syndrome differentiation and treatment by stages. CHM treated RRMS with the tendency of improving the neurological deficit, the Neuropsychology, the cognitive function, the quality of life and the immune status and had no side effect.3. To initially establish the method of evaluation in the relapsing and remitting stages of RRMS containing recurrence rate, EDSS, PDQ, HAMD, MSQOL-54 and serological detection index. |
PDF Full Text Request