| Rheumatoid arthritis (RA) is a chronic inflammatory autoimmune disease. As one of the world’s major disabling disease, the influence of patients with physical and mental health and quality of life is serious. Prevalence in China is about0.32%-0.36%. The disease can cause multi-joints swelling pain, terminal can cause joint deformities, lost of function, and at least50%patients can’t stick to your work sick of10years. In addition, economic burden caused by RA in the family and society is not optimistic. A study reported that in2001-2003in chengdu only ease of rheumatoid arthritis drugs condition, the amount of medicine is as high as29.0739million yuan, the average annual rate of11.6%. RA bone destruction of health, survival, and the influence on the quality of life and the burden of economy increasingly have drawn the attention of rheumatism experts at home and abroad.The primary goal of RA treatment is control inflammation symptoms, prevent joint destruction, keep joint function, maintain normal social activities and maximize the long-term health of the patients, the quality of life. Our department according to active period of pathogenesis of RA characteristics combined with years of the clinical experience, emphasis on heat and dampness stasis is the important active RA pathogenic mechanism and pathological key of bone damage, Qingrehuoxue therapy is basic treatment method of active period RA.This project under the guidance of Qingrehuoxue (QRHX) therapy, scientific development in the capital fund Beijing medical medical health technology project. This multicenter randomized controlled parallel trial, enrolled active RA patients were randomized into in Chinese traditional medicine group (CTMG) and Chinese traditional medicine combined Western medicine group (CWMG), which used Qingrehuoxue decoction+Methotrexate(MTX), to assess RA disease activity (DAS28score), improvementof RA disease condition, curative effect of TCM syndrome, the quality of life and safety. And to our center, we carried on long-term follow-up study to observe77patients, which completed24weeks observation period, to evaluate efficacy of Chinese medicine reducing RA disease activities, controlling disease condition, improve the quality of life of the patients.Therapeutic Study1. By sorting out the Traditional Chinese Medicine (TCM) historical evolution, know RA related problems and symptoms and, the history of the understanding, combed the RA contemporary etiology and pathogenesis research achievements in TCM, summarized heat, dampness and blood stasis are the key TCM pathogenesis of active RA, and is the key pathogenesis of bone destruction.2. Through analysed and summarized the differentiating treatment of RA and modern research results, combed the disease and syndrome differentiation with the diagnosis and treatment, staging RA ideas, and sums up the medical treatment of TCM play a role in RA treatment that improve symptoms, control disease condition, enhance the quality of life, the collaborative western medicine, consolidate curative effect.3. By analyzing and induction of my advisor treatment experience of RA, I summarized his academic thought of dispelling pathogenic factor mainly, consideration to vital qi. At the same time in the syndrome differentiation and treatment based on patients psychological state, he focuses on from treatment through liver differentiation of RA; and focuses on combining traditional Chinese and western medicine treatment of RA. I also summarized his experiences and views on Chinese traditional medicine with NSAIDs, DMARDs and glucocorticoid.4. Through sorting the TCM literature about the quality of life and application of live quality evaluation in TCM treatment of RA, put forward the quality of life(QOL) evaluation can reflect the advantages of TCM in the treatment of RA, and QOL should be introduced of RA clinical studies as important as the evaluation index into Chinese treatment.Clinical StudyObjective:to evaluate Qingrehuoxue decoction reduces RA disease activity, improves disease condition and QOL, curative effect of TCM syndrome and safety.Methods:Clinical trail stage, Enrolled active RA patients were randomized into in CTMG and CWMG. A24weeks of randomized parallel controlled clinic trial was earried out to assess RA disease activity (DAS28score), improvement RA disease condition and by formulating the follow-up list, strict planning to determined the follow-up, a long-term follow-up was carried out to collect related data of RA disease activity and the QOL, so as to evaluate the long-term curative effect of Chinese medicine reduce RA disease activity, control disease condition and improve the QOL.Results:We enrolled in this project142patients which were entered in Full Analysis Set (FAS),129patients completed24weeks of treatment. A total of77patients our center completed24weeks of treatment, there were3cases in CTMG,5cases in CWMG were lost at every follow-up points. Eventually, the cases numbers of two groups were35and34cases. At baseline, two groups of patients’demographic characteristics were balance, the clinical features baseline balance too, were comparable. Until March2012, the longest follow-up case was244weeks; the shortest was158weeks, CTMG average follow-up of202.17weeks, the other203.12weeks; the two groups damp-heat and blocking syndrome stasis resistance duration longest were to4years (242weeks vs208weeks), CTMG group average duration98.62±53.88weeks, the other72.63±9.50weeks. The results show that:1. Both groups RA disease activity were lower, and maintaining the role. After12weeks of treatment, DAS28score started to decreased obviously. After24weeks of treatment, the clinical remission rate of CTMG and CWMG were22.86%,17.44%respectively; the decline of the DAS28scores mean are1.91and1.97of each group. Follow-up to the present, disease activity of two groups remains at24weeks level; the clinical remission rate of CTMG and CWMG were23.08%、42.86%respectively.2. Two groups can long-term control RA disease condition. After12weeks of treatment, CTMG showed that disease control effect obviously, compared with CTMG ACR20,50,70success rate were increased by15.50%,12.60%,1.41%;24weeks after treatment, and this difference gradually diminishing, the ACR20,50,70success rate compared with CTMG were increased only by2.82%,9.85%,0. Follow-up to the present, because all the missing data was deemed to be not reach ACR20substandard, led to the present ACR20success rate has dropped. Two groups of ACR20success rate were67.7%,64.3%, CTMG ACR50,70success rates were higher than CWMG group with5.2%,10.5%.3. Both groups could improve the quality of life of the patients physical function, and keep the body function, improve the quality of life of patients with long-term. Both groups could obviously increase HAQ-DI dimensions after four weeks in which represents the Dressing&Grooming, Arising, Eating, Walking, Activities, effect to faster. Treatment for24weeks later, the quality of life and physical function of two groups increased obviously, of each dimension scores mean<1, present that in mild disability range.4years later the quality of life and physical function of two groups has further improved, except Eating ability, the rest dimensions were still maintain the in mild disability range.At baseline HAQ score was positively correlated with course of the disease, disease activity, tender joints number, the patients evaluation on joint pain VAS, patients evaluation on general health, the doctor evaluation on general health and inflammatory laboratory parameters. Treatment for24weeks later, two groups improvement rate of HAQ score was positively correlated with improvement rate of disease activity, improvement rate of joint swelling number, improvement rate of the patients evaluation on joint pain VAS, improvement rate of patients evaluation on general health, improvement rate of the doctor evaluation on general health and improvement rate of inflammatory laboratory parameters. Follow-up to the present, two groups improvement rate of HAQ score was positively correlated with improvement rate of joint swelling number, improvement rate of the patients evaluation on joint pain VAS, improvement rate of patients evaluation on general health and improvement rate of inflammatory laboratory parameters. Tip us in the treatment of RA, should notice to reduce disease activity (DAS28score), reduce joint swelling number and reduce pain and reduce inflammation index (ESR, CRP), in order to reduce disease activity in patients with the overall evaluation, eventually improve the quality of life of patients with long-term.4. Both groups have good long-term efficacy to improve joint function.0weeks, both groups are in III level the highest percentage (54.98%,58.82%).4weeks after treatment, CWMG group joint function improved obviously,24weeks after treatment, I level with the highest percentage (55.89%); And the CTMG in the treatment of12weeks to see improved obviously,24weeks after treatment, Ⅱ level with the highest percentage (65.72%). Follow-up to the present, both groups to Ⅰ level percentage was highest (73.54%vs67.86%)(P>0.05).5. Both groups can make better syndrome curative effect.4weeks after treatment, total effective rate of syndrome of CTMG and CWMG was29.58%,40.85%respectively; After12weeks of treatment, were64.79%,74.65%respectively;24weeks after treatment, were66.06%,78.87%. Concrete on the mean value, the combination of DMARDs (MTX) can enhance the total effective rate of syndrome.6. Reduce the inflammatory laboratory index (ESR, CRP):in reducing CRP, CWMG worked faster, treatment after4weeks that began to decline, and obviously earlier than CTMG12weeks. In the reducing ESR, two groups were relatively slow, after12weeks treatment to reduce. Two groups of reducing ESR were slower, but CWMG will faster reduce CRP. Follow-up to the present, from CRP, ESR mean on look, both groups has risen, CWMG index level of a slightly lower.7. Safety, RCT stage, CTMG adverse reaction rate was significantly lower than the CWMG (2.82%vs8.45%); During follow-up stage, CTMG adverse reaction rate is still significantly lower than CWMG group (5.71%vs58.82%). Gastrointestinal stimulation in long-term use drug problems, especially the application of the drug in patients with DMARDs should not be ignored.8. Compliance, during follow-up stage, found that RA patients’ non-compliance reason is various; DMARDs drug adverse reaction rate proportion is the largest.Conclusion1. Established the heat, dampness and blood stasis are the key pathogenesis and pathological of active RA, Qingrehuoxue therapy is the basic principle.2. Clinical study confirms:QRHX decoction with lower RA disease activity, control disease condition, and improve patients with physical function and joint function, adhere to the application works long-term, thus improving the long-term quality of life of patients, and may reduce the inflammatory laboratory index. Add DMARDs drugs can improve total effective rate and shorten the dampness-heat and blood stasis syndrome duration.Characteristics and innovative points1. This project uses internationally recognized the European League against-Rheumatism (EULAR) recommended DAS28score, American College of Rheumatology (ACR) recommended ACR Improvement Criteria and RA patients the quality of life (HAQ-D1) questionnaire as the tool, to evaluate the effect of QRHX therapy of RA multicenter randomized controlled parallel trial and follow-up research, is very helpful in the eastern and western medicine talking to each other and using for reference.2. This high quality of randomized controlled clinical research on long-term follow-up study, compared to the traditional Chinese medicine treatment of RA4-year effect, to provide long-term effect of traditional Chinese medicine treatment of RA provide consultation evidence-based medicine evidence.All in all, this project summarized dampness-heat and blood stasis syndrome is the main active period RA syndrome, and put to bi treatment from "XinWen" to "Xinliang" change. Further more from the theory to clinical use, uesd international recognized RA curative effect indexes and the Health Assessment Questionnaire, to evaluate Qingrehuoxue therapy of RA multicenter randomized controlled parallel trial and follow-up research, looking for traditional Chinese medicine in the treatment of chronic disease advantages to explore the effect of traditional Chinese medicine to RA provides evidence-based medical evidence. |
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