Heat Blood Circulation Prescription Treatment Of Active Rheumatoid Arthritis Clinical Efficacy Studies

Rheumatoid arthritis (RA) is a chronic, inflammatory, autoimmune disease. The cause of RA is not clear up to now. The key pathology is that the inflammation and proliferation of joint synovium, invading and destroying articular cartilage, subchondral bone, tendons and ligaments. Moreover, it can attack the major organ system like the cardiac, pulmonary, renal, etc. Destruction of the joints at the active stage is the most serious, thus more and more attention is paid to the research for active RA. To date, non-steroidal anti-inflammatory drugs (NSAIDs) and disease-modifying anti-rheumatic drugs (DMARDs) are the main managements for RA; biological agents are available in the clinic, including tumor necrosis factor inhibitors, CTLA-4 Ig, CD 20 monoclonal antibody, IL-6 monoclonal antibody, etc. Biological agents are effective in protecting the joints from destruction before they are destroyed, and they are more effective than DMARDs in controlling the active disease, but they are so expensive that it needs a long time to be widely used. As a result, it is a good idea to apply traditional Chinese medicine and herbs to treat RA at the active stage.Based on the clinical experiences of our department, according to the law of the disease, aiming at the features of active RA characterized by obstruction of dampness-heat and blood stasis, we prescribed a compound recipe with the therapeutic principle of clearing heat and draining dampness, promoting the blood circulation and removing obstruction in the channels. In the early clinical observation, the prescription had got an obvious therapeutic effect. As the observation periods of clinical research at the present mostly were 1-3 months, lacking long-term observation, and in order to evaluate the mid-term and long-term clinical therapeutic effect, safety and life quality improvement of the prescription in treating active RA, we performed this research.We enrolled in this study 78 patients with active RA and with the syndrome of obstruction of dampness-heat and blood stasis. The patients were separated at random into herbs group (39 patients) and herbs plus methotrexate group (39 patients). Efficacy of the syndrome, the changes of life quality, disease activity and laboratory measures, and the evaluation of safety after six-month treatment was assessed, and the results was compared with methotrexate group by cohort study . The results were:1 According to the criteria of ACR, we evaluated the efficacy between these two groups by the proportions of patients achieving ACR20, ACR50 and ACR70. The results showed that the effect of herbs plus methotrexate group was the best, but both the effects of herbs plus methotrexate group and herbs group were better than that of methotrexate group.2 Disease activities: there were no differences between the two groups in relieving active disease, but the results of both groups were better than methotrexate group.3 Indexes of assessing therapeutic effect: all of the three groups were effective in reducing the counts of tender joints and swollen joints, and lowering the grades of pain assessment by VAS; however, herbs group and herbs plus MTX group took effects much earlier than MTX group. Herbs plus MTX group could relieve joints pain a little earlier, but there were no significant differences between herbs plus MTX group and herbs group in long-term effect.4 Assessment of fatigue by VAS: both the herbs group and herbs plus MTX group could well lower the grades of fatigue assessment, and they took effect after three-month treatment.5 Improvement of life quality: all of the three groups could improve the patients' life quality and there were no obvious difference among. All of them took effect after 3-month treatment.6 Physician global assessment and patient global assessment: all of the three group could reduce the grades of the two assessments. Herbs plus MTX group was of better efficacy at the early stage of the treatment.7 Laboratory measures: herbs group and herbs plus MTX group could reduce the level of ESR, while MTX group showed no difference after treatment. Herbs plus MTX group could better and faster reduce the level of C reactive protein. None of them could reduce the level of rheumatoid factor (RF).8 Safety: the number of patients experiencing adverse events in herbs group was smaller than the herbs plus methotrexate group.