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加减桂枝芍药知母汤治疗类风湿关节炎疗效观察及生存质量的临床研究
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摘要
类风湿关节炎(RA)是一种病因尚未明了的慢性全身性炎症性疾病,以慢性、对称性、多关节炎和关节外病变为主要临床表现,属于自身免疫性疾病。临床上以双手关节,腕关节,膝和踝关节疼痛及肿胀、僵硬等对称的多关节炎表现为主要症状。本病可引起软骨破坏和骨侵蚀,造成关节畸形、残疾,最终丧失劳动力,对患者的生理功能、心理功能、社会活动和日常生活等带来不良影响,严重影响患者的生活质量。根据RA的临床表现,该病应属于中医“痹证”范畴,文献中也称之为“历节”、“白虎历节”、“鹤膝风”、“顽痹”、“旭痹”等病。痹证病因多种多样,既有外感,又有内生;既有邪又有正虚。一般认为风寒湿热等外邪侵袭,或内生寒痰湿热侵袭人体引发本病。先天禀赋不足、后天失养、房劳过度、年老肾虚、劳逸失度、产后及病后等皆可导致人体的正气不足,也是本病产生的重要原因。本病基本病机是素体本虚,气血不足,肝肾亏损,痰瘀互结,风寒湿邪痹阻脉络,流注关节。脏腑内伤既是痹证发生发展的重要原因,也是痹证经久不愈,内传入里的结果。
     目的:运用症状积分的方法,观察加减桂枝芍药知母汤对类风湿关节炎寒热错杂证的临床疗效和研究加减桂枝芍药知母汤对类风湿关节炎生存质量的影响。
     方法:本研究选入60例符合RA诊断标准,以及中医辨证符合寒热错杂证标准的患者,皆完成研究。将60例RA患者随机分为两组,治疗组和对照组各组30例,治疗组给予甲氨蝶呤+加减桂枝芍药知母汤;对照组给予甲氨蝶呤+雷公藤多苷片:每组疗程均2个月。
     结果:治疗组总有效率93.3%,对照组总有效率86.7%,两者比较有统计学意义(P<0.05)。两组的中医证候和临床症状即关节压痛数、关节肿胀数、双手握力、DAS28、 HAQ、VAS积分及相关实验室检查等均有显著改善(P<0.01)。治疗组在改善中医证候总分、关节发烫、恶寒、疲乏无力、HAQ不适指数的减少数高于对照组(P<0.05或(P<0.01), PLT的减少数低于对照组(P<0.05)。两组患者均出现轻度不良反应,但治疗组不良反应发生率3.3%明显低于对照组10%,两组均未出现严重不良反应。
     结论:加减桂枝芍药知母汤结合甲氨蝶呤治疗RA寒热错杂证比甲氨蝶呤结合雷公藤多苷片治疗在改善症状及降低病人HAQ评分、提高病人的生活质量等方面疗效更显著。同时有着良好的安全性,没有明显毒副作用。
Rheumatoid arthritis (RA), cause is not clear yet, is a chronic systemic autoimmune disease, the main clinical manifestations are both side Hand joints, wrist joints, knee joints and ankle joints pain and swelling, stiffness. The disease can be caused by the destruction of cartilage and bone erosion, joint deformity, disability, and eventually loss of function and adversely impact the patient's physiologically and psychologically. it also afects social activities and daily activity life, sometimes seriously affecting the quality of life of patients. According traditional Chinese medicine, the clinical manifestations of RA belongs to,"Arthralgia" category. Generally we believe that cold, air, damp and heat etc. Exogenous pathogens invasion, or the endogenous production of cold, pleghm, hot and humid etc. invade inside the body can cause this disease. Congenital deficiency, acquired deficiency, excessive labor, oldage kidney deficiency, after give a birth and after disease etc. can cause lack of the body's energy, which are an important reason for this disease. The basic pathogenesis of this disease is loss of body energey, lack of Qi and blood, liver and kidney deficiency, phlegm and stasis, wind cold dampness evil all Blockage the meridian and collected in joints. The injuries of internal organs is the important reason of Arthralgia, and also results Arthralgia prolonged and dificult to treat.
     Objective:using the symptom score methods, study the clinical efficacy and evaluation of addition and subtraction Guizhishaoyaozhimu decoction on hot and cold mixed type rheumatoid arthritis and study on impact of quality of life of rheumatoid arthritis patients.
     Methods:In this study, selected60patients who met the RA diagnostic criteria, as well as the with cold and heat mixed type TCM diagnostic criteria, both completion of the study.60RA patients were randomly divided into two groups, the treatment group and the control group, each group of30patients, the treatment group is given methotrexate10mg once in a week oral+addition and subtraction Guizhishaoyaozhimu decoction; control group is given Methotrexate10mg once weekly oral+Tripterygium glycosides tablets10mg,3times a day oral; duration of treatment for each group is two months.
     Results:The total effective rate of treatment group is93.3%, and the control group is86.7%, both statistically significant (P<0.05). In both treatment and control groups, TCM syndromes and clinical symptoms eg. joint tenderness count, joint swollen count, two-hand grip, DAS28, HAQ, VAS score and laboratory tests improved significantly (P<0.01). Treatment group in improving TCM syndrome score, joint hot, chills, fatigue, weakness, HAQ reduce discomfort index number higher than that of the control group (P<0.05or P<0.01), the reduction in the number of the PLT is lower than the control group (P<0.05). During the treatment, none of the groups of patients have serious adverse reactions, mild adverse reaction was seen, treatment group is of3.3%, which is significantly lower than that of control group10%.
     Conclusion:The addition and subtraction Guizhishaoyaozhimu decoction combination with Methotrexate treatment is better than methotrexate combination Tripterygium glycosides tablets in the effect in improving the symptoms of cold and heat mixed type the RA; also can reduce patient HAQ scores, patient quality of life etc. improved significantly. At the same time, this is a safe treatment method and there is no significant side effects.
引文
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