Clinical Research On The Treatment Of Rheumatoid Arthritis With Cold And Dampness Syndromes With The Kunxian Capsule And The Methotrexate

Objective: The purpose of this paper is to investigate the clinical effect and safety of Kunxian capsule combined with Methotrexate in the treatment of rheumatoid arthritis with Cold and Dampness Syndromes, so as to provide some reference value in the optimal treatment of rheumatoid arthritis.Methods: The observation includes 60 patients with rheumatoid arthritis with Cold and Dampness Syndromes. Used a random, open, parallel, comparative trial, The 60 cases were randomly divided into two groups. The observation group and the control group both comprised 30 cases. Control group using methotrexate 10 mg/week. On the basis of the control group, add Kunxian capsule,2 pills, tid, to the treatment group. To take the Nimesulide Capsules depending on the patient's condition in both groups. The Observation lasts for 12 weeks. Observation indexes include TJC, SJC, the variation of morning stiffness time, laboratory indexes(ESR, CRP, RF, CCP), the variation of Chinese medicine symptom integral and clinical adverse reactions.Results: 1. Influences on the joint pain, swelling and morning stiffness In the treatment of various stages, both groups can relieve joint pain, swelling, and morning stiffness, statistically significant difference compared with pretreatment(P < 0.05). Compared between two groups, the curative effect of observation group improving the symptoms is significantly better than the control group. 2.Influences on the targets of laboratory In the aspects of improving laboratory index of ESR, CRP, RF and CCP,observation group begin to reduce the index value after 4 weeks, while the control group begin to decline the index after 8 weeks. The two groups both can reduce the laboratory index, but the laboratory index in the observation group is lower than the control group. In conclusion, observation group has the characteristics of effective and fast in improving laboratory index. 3. The impact on the disease activity The disease activity in two groups is lower than pretreatment at various stages. But difference between the two groups is statistically significant after 12 weeks. The disease activity in observation group reduces significantly than the control group after 12 weeks. 4. The influence on the clinical efficacy For the effect of ACR, ACR20 and ACR50 is not different between the two groups, observation group is better than control group on the improvement of the ACR70 after 12 weeks. On the curative effect of traditional Chinese medicine side, group total effectiveness is 93.3%, significantly higher than the control group 66.7%, the difference was statistically significant(P < 0.05), the observation group is better than the control group. 5.The influence on TCM syndrome integral To improve joint pain, joint swelling, morning stiffness, heavy body, two groups have been effective after treatment of 4 weeks, comparison between the two groups, the curative effect in observation group is superior to the control group; In the liambs heaviness, joints disliking cold or liking warmth, aggravation in rainy day, tongue and pulse, the observation group began to take effect after 4 weeks of treatment, the control group began to take effect after 8 weeks of treatment. After comparison between groups, the observation group after 8 weeks of treatment to reduce the index is better than the control group.Observer Group has the characteristics of effective and fast on the aspects of the liambs heaviness, joints disliking to cold or liking for warmth, aggravation in rainy day, tongue and pulse 6.The safety in the treatment by Kunxian capsule combined with methotrexate In the process of treatment, the overall incidence of adverse reactions of no obvious difference in the observation group compared with control group. So on the basis of methotrexate linked with Kunxian capsule did not increase the rate of adverse reactions.Conclusions: Methotrexate, Methotrexate combined kunxian capsule both can reduce the amounts TJC and SJC, the activity of disease, modiofy the TCM symptoms.Kunxian capsule combined with methotrexate for RA with Cold and Dampness has more obviously curative effect than methotrexate single application. Especially in joint disliking to cold or liking for warmth, aggravation in rainy day, lingual arteries and veins, etc. In addition, there is no statistically significant difference of adverse reactions in Kunxian capsule combined methotrexate and methotrexate alone. So Kunxian capsule combined methotrexate is relatively safe.