| Objective : We based on the large sample epidemiological studies and animal experiments, The purpose of this study was to evaluate the efficacy of the liver and spleen disorders to further verify its safety in early clinical and ultrasound observation based on paralysis methotrexate treatment of early rheumatoid arthritis pathogenesis,and it offered the therapy of taking care of liver and spleen,getting rid of moisture and curing the pain, it provides reasonable representative drugs for the early treatment of RA spleen disorder.Methods : The 68 standard patients who is early RA patients with liver and spleen disorders were randomly divided into a control group and treatment group, 34 cases in each group. Two different treatment regimens were adopted.The contrast group western medicine methotrexate(7.5mg per week at first,gradually it was increased to 12.5mg during the 4 weeks, once a week), the treatment group ate Bi Fang(ingredients:Angelica, white peony, Atractylodes,herb,root,wind, acutum, Zhongjiefeng, raw licorice) taken two times one day,per 150 ml one time. Methotrexate use the same control group.Both of the two groups were treated for 24 weeks,observerving DAS28,ACR-20,related laboratory parameters [rheumatoid factor(RF), erythrocyte sedimentation rate(ESR), C-reactive protein(CRP), anti-cyclic citrullinated peptide changes in antibody(CCP)] and wrist ultrasound examinations(synovial thickness, synovial blood flow,joint effusion)and other outcome measures, observerving the variation of their therapy indicators before and after treatment,as well as monitoring the function of blood,urine, stool, liver and other safety indicators,using SPSS17.0 statistical software for statistical analysis.Results:1.68 patients conformed with inclusion criteria,among 4 cases are deciduous cases.In treatment group, there appeared 1 case abnormal liver function; 1 case white blood cell reduction(2.18x109/L) and 2 cases abnormal liver function appeared in control group.when stop using RA drug, All cases turned deciduous.64 cases were valid cases which was completed the test effectively.2.Comparing two groups of patients in gender, age, degree of diseases: treatment group had 33 cases,(30 cases of female, 3 cases of male, male to female ratio is 0.1:1),their mean age is 42±9.6, and average course of disease is 5.6±1.6 months. Control group included 31 cases,(29 cases of female, 2 cases of male,) male to female ratio is 0.07:1, the mean age is 43.9±9.5, and the average course of disease is 5.8±1.9 months. age is between 32 to 53.We should notice that women in 43 years old--53 years old are more likely to suffer from early phase RA than men.3.Comparing two groups of patients in Chinese medicine treatment syndromes(morning stiffness time count, joint swelling, joint tenderness, food after abdominal distension, languid, depression),joint symptoms has been improved after 24 weeks treatment which shows the statistical significance(P<0.05,P<0.01).Comparing the two groups after treatment, languid, depression has no statistical significance(P>0.05), The left treatment group is better than that of control group, the difference has statistically significance(P <0.01,P<0.05).4. Comparing laboratory indicators of the two groups of patients, ESR, CRP, RF, CCP was improved obviously after treatment, the difference has statistically significance(P<0.01);Comparing two groups of patients after treatment, the treatment group is better than that of control group except for CCP, which has statistical significance(P<0.01, P<0.05).5.In terms of DAS28 score comparison of two groups of patients,We can find that DAS28 score was significantly reduced after treatment, the difference has statistical significance(P< 0.01); But comparing the two groups after treatment, the therapeutic effect of treatment group was better than that of control group, there has statistical significance(P <0.05),it is fully confirmed that hebi combining methotrexate could improve early RA disease activity.6.Comparing the ultrasonic observation project of the two groups of patients,after treatment,synovial membrane thickness, joint effusion, synovial blood flow had improved greatly(P<0.05, P<0.01);Compare the treatment consequences of two groups after treatment, the treatment group is better than that of control group, the difference has statistical significance(P<0.05, P<0.01).7.Comparing two groups of patients in Chinese medicine treatment syndromes, the total effectiveness rate of treatment group was 83.87%,(markedly effective rate was 36.36%),total effective rate of control group was 60.71%(markedly effective rate 22.58%),total effectiveness of treatment group is better than the control group(P<0.05).8.Comparing two groups of patients in ACR20,the effective rate of the treatment group was 75.76%,the effective rate of the control group was 51.61%,the curative effect of the treatment group is better than that of control group(P<0.05).Conelusion:Through clinical and ultrasound study,it is fully confirmed that hebi parties combined methotrexate could improve the clinical symptoms effectively, reduced Erythrocyte sedimentation rate significantly and Inflammatory markers such as C- reactive protein.In addition, it also improve the synovial blood flow, hydrops articuli,reduce disease activity degree and improve patients’ prognosis effectively. It provides a certain theoretical theory evidence for the clinical treatment of early RA and has certain clinical application value... |
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