【作者】 王培民；

【导师】 周福贻；

【作者基本信息】 南京中医药大学 ， 中医骨伤科， 2005， 博士

【摘要】 膝关节骨关节炎(膝OA)是一种因关节软骨退行性变所引起的以膝关节疼痛、肿胀、骨质增生为主要表现的关节病变。本病为中老年人临床常见病，随着社会的老龄化，其发病率呈上升趋势。由于膝关节疼痛、肿胀，使患者的生活质量受到极大影响，迄今尚无有效措施能够逆转骨质增生或抑制病变进展。中医药治疗本病具有一定优势，本研究在整理历代中医对本病认识的基础上，结合现代医学的治疗研究进展，对膝OA的诊断与治疗问题进行了总结，同时采用平行对照、区组随机的研究方法，客观评价了膝宁方对膝OA肝肾亏虚证平地行走疼痛治疗作用的临床疗效。 首先，通过对历代中医文献的系统整理，认为本病多以肝肾亏虚为基础，闪挫劳损及感受外邪为诱因，从而使气血瘀滞，痰湿内生，经脉痹阻，气血运行不畅，遂致关节肿胀、疼痛。治当益气养血、补益肝肾，扶正祛邪、标本兼顾。其次，通过对现代医学文献的调研，指出诊断膝OA应临床与影像学检查相结合，应重视病情轻重程度的评估，治疗宜中西医互参，取长补短，内外结合。采用药物改善血循环以降低骨内压、抑制活化的细胞因子及生长因子、清除氧自由基、提高组织局部透明质酸以保护受损的软骨细胞是膝OA的治疗研究方向。同时介绍了目前尚处于动物实验阶段的基因疗法，这是一种把治疗基因运用基因转导技术转移到患病关节内的治疗方法，具有较好的应用前景。 临床研究方面，以平地行走疼痛为主要效应指标，对膝宁方治疗膝OA肝肾亏虚证的临床疗效与扶他林治疗相对照进行了研究观察，共设治疗组20例、对照组20例。结果表明膝宁组治疗后患者平地行走疼痛、晨僵、僵直程度、下楼及上楼的关节活动情况均较治疗前明显改善，与扶他林组疗效相当，膝宁方对膝关节平地行走疼痛的缓解起效较慢，但至治疗后第4周对疼痛的缓解与扶他林治疗相似，且膝宁方在治疗后第4周对病情的整体改善有优于扶他林的趋势，总有效率为85％。安全性方面的观察结果表明，膝宁组胃肠道不适等不良反应明显少于扶他林治疗组，提示该方具有良好的安全性。更多还原

【Abstract】 Osteoarthritis of knee is an arthropathy characterized by hyperosteogeny due to degenerative articular cartilage. It is a common disease of middle- and old-aged people, of which incidence is on a steady increase along with longer life span and increasing number of old people. Patients with osteoarthritis of knee suffer a lot in daily life for swelling and painful knee, however effective treatment to reverse hyperosteogeny or check the deterioration has not yet been available. Since TCM has certain advantages on it, this research summarized the diagnosis and treatment of osteoarthritis of knee on the basis of TCM understanding and study development of modern treatment. Meanwhile research methods of parallel control and randomized group were adopted and objective evaluation was made of XINING Formula’s clinical effect on walking pain due to osteoarthritis of knee with deficiency of liver and kidney.Firstly, after arranging systematically previous literature of TCM, it holds that osteoarthritis of knee is based mainly on the deficiency of liver and kidney and precipitated by sprain, strain and invasion by exogenous pathogens and that swelling and painful knee results from stagnation of Qi, blood and endogenous phlegm and damp as well as obstruction of meridians. Therefore, the treatment should highlight the following principles: invigorating Qi and replenishing blood, tonifying liver and kidney, supporting vital Qi and dispelling evil Qi as well as emphasizing root causes and branch symptoms.Then through studying literature of western medicine, it believes that osteoarthritis of knee should be diagnosed with combination of clinic examination and radiology and that evaluation of degree of condition and integrative treatment of TCM and western medicine should be stressed to enhance therapeutic effect. The treatment of osteoarthritis of knee is targeted at improving blood circulation, reducing intraosseous pressure, inhibiting activated cell factors and growth factors, eliminating oxygen free radicals, increasing hyaloplasmic acid of local tissues to protect impaired cartilage cells. In addition, this thesis introduced gene therapy that is still under the stage of animal experiment, in which therapeutic gene is transplanted into affected joint. Therefore, it is promising in clinical application.In clinical research, clinical effect of XINING Formula, taken walking pain as chief effect index, on treating osteoarthritis of knee with deficiency of liver and kidney was compared with Votalin. There were 20 cases in treatment group and 20 in control group. The results showed that XINING group improved significantly in terms of walking pain, morning stiffness, the severity of stiffness and knee activities during climbing upstairs and downstairs after treatment, which had no significance comparing with Votalin group. Walking pain was improved with XINING Formula in slow start which then showed similar effect with Votalin in the 4th week of treatment and had the tendency of better effect in improving general conditions in the 4th week with 85% totally effective rate. The result in safety showed that gastrointestinal discomfort in XINING group was less than that in Votalin group, which indicated this formula was better in safety.更多还原