| Objective:Rheumatoid arthritis is a common systemic autoimmune disease with a high morbidity and disability. It significantly impacts the health-related quality of patients whose prognosis is often commonly poor. With the rapid development of modern medicine, we enhance the understanding of the disease, but the exact etiology and pathogenesis have been not clear yet. The regular western medicine may only relieve the pain, be with a long onset time, or be with a lot of side effects. Depend on a long period of clinical practice, my tutor has found that Bushen Huoxue decoction, in combination with methotrexate and leflunomide which are the routine treatment of rheumatoid arthritis recommended by American College of Rheumatology, gets good curative effect in patients diagnosed of rheumatoid arthritis in modern medicine and liver kidney deficiency and blood stasis obstruction syndrome in traditional Chinese medicine. We designed the clinical trial to evaluate the efficacy and safety of the integrative treatment, and direct clinical practice, through the observation of symptoms and signs and the comparison of the laboratory profiles. Materials and methods: We collected 64 patients who were diagnosed of rheumatoid arthritis in modern medicine and liver kidney deficiency and blood stasis obstruction syndrome in traditional Chinese medicine. Based on the stochastic comparison principle, 64 case patients were randomly divided into 2 groups, each of 32 cases. The two groups of patients had no significant difference in sex ratio, age, disease course and joint function grade by statistic analysis, which made sure they were comparable. The control group has been treated with methotrexate and leflunomide, while the experiment group has been treated with Bushen Huoxue decoction in combination with methotrexate and leflunomide for 8 weeks. We recorded the clinical effectiveness and symptoms and signs of the patients every 2 weeks. Patients, with severe or intolerable side effects, would be excluded from the trial. After 8 weeks of the treatment, we rechecked the electrocardiogram, hepatic and renal function, and the routine examination of blood, urine and stool, to judge the safety of the treatment. At last, we statistically computed the index of clinical efficacy, symptoms and signs, and laboratory examination of the two groups before and after the treatment. Results:1. Comparing of comprehensive curative effect between the two groups, the number of patients acquiring ACR20 and ACR50 in the experiment group is significantly higher than that in the control group. So is the number of patients with significant improvement.2. In improving morning stiffness, Bushen Huoxue decoction in combination with methotrexate and leflunomide has a 2-weeks-shorter in onset time than the control group. And after 8 weeks of treatment, the morning stiffness time in the experiment group is significantly shorter than that in the control group. The swollen joint number is significantly decreased after the treatment with Bushen Huoxue decoction in combination with methotrexate and leflunomide for 2 weeks, two weeks earlier than that in the control group. After 6 weeks of treatment, the swollen joint number and the tender joint number in the experiment group are significantly less than the control group. The improvement in the Oswestry disability index and Disease Activity Score in the experiment group acquires statistical significance after 8 weeks of treatment, which is than that in the control group. After 4 weeks of treatment with Bushen Huoxue decoction in combination with methotrexate and leflunomide, the average grip strength of both hands is improved more significantly than the control group. After 4 weeks of treatment, Visual Analogue Score is significantly decreased in the experiment group,2 weeks earlier than the control group. The Health Assessment Questionnaire score is significantly increased after 4 weeks of treatment with bu shen huo xue decoction in combination with methotrexate and leflunomide,2 weeks earlier than the control group. And after 8 weeks of treatment, the Health Assessment Questionnaire score is significantly increased in the experiment group than that in the control group.3. The level of acute-phase reactants,rheumatoid factor and inflammatory factors are significantly decreased after the treatment with Bushen Huoxue decoction in combination with methotrexate and leflunomide for 8 weeks compared with that in the control group. After the 8 weeks of treatment, there is a significant decrease in the level of immunoglobin in both groups, with no significant difference between the two groups.4. Bushen Huoxue decoction does not increase the rate of side effects of the western medicine, such as liver and kidney dysfunction, arrest of bone marrow and so on. Conclusion: While Bushen Huoxue decoction in combination with conventional western medicine does not significantly improve the laboratory index compared with control group, but can improve clinical symptoms and signs, quality of life, and the comprehensive curative effect of patients,with no increase in the rate of side effects, which makes it suitable for patients diagnosed of rheumatoid arthritis in modern medicine and liver kidney deficiency and blood stasis obstruction syndrome in traditional Chinese medicine. |
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