【作者】 赖欣珮；

【导师】 汪悦；

【作者基本信息】 南京中医药大学 ， 中医内科学， 2011， 博士

【摘要】 类风湿关节炎是一种病因未明的慢性、全身性自身免疫炎性疾病。关节和滑膜的损害是其最常见也是最主要的病变,常导致关节软骨的破坏,甚至关节强直。患病率约为1%,女性发病率高于男性,男女发病率之比约为1：2-4。很多的治疗手段可以应用,但一般主张尽早进行病情改善抗风湿药治疗,以期达到早期缓解病情发展的目的。近年来,随着生物制剂的应用,使类风湿关节炎的治疗迈向了靶向治疗的时代,已取得了一定的成效,且逐渐发展为常规疗法。而本病属于中医痹证范畴,主要是因素体亏虚,风寒湿热邪气侵入,痹阻肢体、经络,以致气血运行失畅而成。因病程日久缠绵难愈,常易形成寒热错杂证,且兼见痰浊内生瘀血内停的痰瘀痹阻证。若以中西医联合治疗类风湿关节炎,结合中西药各自优势,既能取得短期快速的疗效,又可使病情长期稳定,且不良反应小,一般患者均可耐受,因此往往能够起得良好疗效。目的：观察以加减桂枝芍药知母汤治疗类风湿关节炎寒热错杂证兼有痰瘀痹阻证的疗效,并通过治疗组与对照组的对比研究,客观评价以桂枝芍药知母汤为基本方加减治疗类风湿关节炎的临床疗效及安全性。方法：根据简单随机、对照、非盲的临床试验原则,选入40例符合类风湿关节炎西医诊断标准以及中医辨证符合寒热错杂证兼有痰瘀痹阻证证候标准的病人。将40例患者随机分为两组,其中治疗组20例,以甲氨蝶呤片每周10mg+非甾体抗炎药(双氯芬酸钠)每日75mg+加减桂枝芍药知母汤治疗；对照组20例,以甲氨蝶呤片每周10mg+非甾体抗炎药(双氯芬酸钠)每日75mg治疗,两组疗程均为8周。结果：治疗组总有效率95%,对照组总有效率75%。治疗组与对照组的临床症状与体征关节压痛度、关节肿胀度、关节活动度、双手握力以及VAS积分等均有显着改善；主要中医证侯,关节疼痛度、晨僵时间、关节发烫、恶寒、阴雨天加重、疲乏无力、口渴或干肢体沉重等均有显着改善,且治疗组上述证候的改善优于对照组；实验室指标治疗组亦优于对照组。两组患者均未出现严重不良反应,轻度不良反应中,治疗组不良反应发生率5%,明显低于对照组10%。结论：中药加减桂枝芍药知母汤结合西药治疗类风湿关节炎寒热错杂证兼痰瘀痹阻证,比单纯西药治疗在改善症状等方面疗效更显着,在控制疾病活动的炎性指标方面亦有确切疗效。同时有着良好的安全性,没有明显毒副作用。更多还原

【Abstract】 Rheumatoid arthritis (RA) is considered a chronic, systemic, inflammatory autoimmune disease. Synovial joints are principally attacked which often leads to the destruction of articular cartilage and even ankylosis of the joints. About 1%of the population is afflicted by it, aind women are two to four times more often than men. Up to date, the precise pathogenesis of it remains unclear. Various treatments are available while DMARDs are required to inhibit or halt the underlying immune process and prevent long-term damage, so it is suggested to use them as early as possible. In recent times, understandings to the cellular and molecular mechanisms of RA have facilitated the progress of the target therapy and increased treatment options. RA belongs to the Bi-syndrome of the scope of Chinese medicine. The causes of it usually are innate body weakness and wind, cold, dampness and heat attack to block meridians and result in qi stagnation and blood stasis. Because of the duration of the disease, it is very easy to become the syndrome of intermingled heat and cold, as well as the syndrome of intermingled phlegm and blood stasis. Applying Western medicine along with Chinese medicine generally has greater effectiveness. By combining their respective advantage, it has not only short-term and rapid effects, but also the long-term stable condition, less adverse reactions, and patients’tolerance.Objective:To observe the effectness of the modified Gui-zhi-shao-yao-zhi-mu Decoction in the treatment of rheumatoid arthritis (the syndrome of intermingled heat and cold combined with the syndrome of intermingled phlegm and blood stasis). To evaluate the clinical efficacy and safety of the decoction with the comparison between the treatment group and the control group.Method:Based on the clinical test principles,40 cases of RA patients are participated in the study. All of them meet the requirements of RA diagnosis and belong to the cold-heat complicated syndrome with phlegm-blood stasis syndrome type of Traditional Chinese Medicine (TCM). Participants are divided into two groups randomly,20 in the treatment group which methotrexate 10mg,po,qw+NSAID(diclofenac)75mg,po,qd+the modified Gui-zhi-shao-yao-zhi-mu Decoction are given, and 20 in the control group which methotrexate10mg,po,qw+NSAID (diclofenac)75mg,po,qd are given. The length of the treatment plan for both groups is 8 weeks.Results:The total effective rates of the treatment group and the control group are 95%and 75%, respectively, which has significant difference between two groups. All of the clinical and TCM symptoms of both groups are significantly improved after treatment. The symptoms of the treatment group are much better improved than those of the control group. Those laboratory indexes of both groups significantly become better after treatment, and there has significant difference between two groups. For both groups, no serious adverse effects are found.Conclusion:The treatment group has greater results than the control group in general. It means the combination of the modified Gui-zhi-shao-yao-zhi-mu Decoction and the Western medicine have better clinical efficacy and safety in treating RA with the cold-heat complicated syndrome with phlegm-blood stasis syndrome than simply using Western medicine.更多还原