Rheumatoid arthritis (RA) is a kind of chronic and systemic autoimmune disease, and its pathological feature is joint synovitis. The main clinical manifestation of RA is persistent recurrent synovitis, and they lead to cell infiltration articular cavity, information of pannus and the erosion of articular cartilage, articular cavity and ligament and tendon, which lead to the destruction and dysfunction of joint structure. Even to the extent that it leads to disability. Besides the wrist and knee joints, RA also involves other organs and causes myocarditis, pericarditis, diffuse interstitial pulmonary fibrosis, rheumatoid pneumoconiosis, renal amyloidosis, eye diseases, scleritis, iritis, and complications including vasculitis and peripheral nerve damage, so it is also called rheumatoid. The clinical manifestation of RA includes pain, swelling and movement disorder of joint; morning stiffness; joint deformity in the long term; even to the extent that the loss of labor which leads to disability in the end. The values of RF and ESR of RA patients in laboratory examination are both high. In initial stage, the X-ray display only swelling of soft tissue swelling and osteoporosis. In the mid and late term, joint space may narrow and bone may be eroded in different levels.Object:This research lies on the experience of national famous Professor Wang Luqiu and mentor Professor Wang Yue. We develop the traditional Chinese medicine compound, new "Bitongling" granules, which are on the basic of their theory and experimental prescription, especially for the syndrome of cold-dampness blocking the luo. The syndrome of cold-dampness blocking the luo is the major syndrome of RA. Because the Yin Xie is easy to be eliminated by Yang, the main TCM principle of treating RA are "dispelling cold and dehumidifying" and "removing blood stasis and dredging the luo." Due to RA’s uncertain pathogeny, there is no specific and pertinent western medicine at the present time, and they have many side effects in the long term. In recent years, treating the patients of RA with western medicine combined with traditional Chinese medicine always builds good effect. We inquire into its curative effect and principle in clinical.Method:Fifty RA cases, are divided evenly into two groups at random. Twenty five patients of treatment group take orally "Bitongling" granules with Methotrexate (MTX) and Miele piroxicam tablets. Twenty five patients of control group take orally MTX and Miele tenoxicam tablets. The time lasts twelve weeks.Result:During twelve-week treatment, we observe the curative effect and the main symptoms and signs. The clinical total effective rate is96%, which is significantly surpasses the effective rate (76%) of the control group (p<0.05). After treatment, the main symptoms and signs are much better than before, such as joint pain, joint tenderness, swelling of joint, morning stiffness time, joint cold, joint fever, flexor extensor adverse, the chills and afraid of the wind. The sensitive parameters, such as ESR, RF and CRP have been lowered to some extent or got back to the standard level. Besides, the major symptoms signs and the major TCM symptom indexes of the treatment group are all superior to that of control group.Conclusion:This research discusses the clinical efficacy of new "Bitongling" granules which are on the basic of Professor Wang Luqiu and mentor Professor Wang Yue’s theory and experimental prescription, especially for the syndrome of cold-dampness blocking the luo. The clinical research shows that new "Bitongling" granules are an effective prescription treating the patients of RA, especially the syndrome of the cold-dampness numbness in acute phase. It has the functions of anti-inflammatory analgesia and immune regulation. This research lays a good foundation for the purpose of developing a new TCM drug to cure RA. |