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Objective and significanceOsteoarthritis (OA) is a degenerative joint disease, also known as proliferative arthritisits main pathological characteristics were the degeneration destruction and loss of articular cartilage、the osteophyte formation of articular surface、synovial cell proliferation、synovitis and joint space narrowing, etal,, leading to joint pain, deformity and dysfunction, to influence the daily life activities of patient, therefore, its belongs to age-related disorders。 The knee as a main affected areas of body, along with the growth of the age, its incidence is rising year by year, therefore, the knee osteoarthritis (KOA) is the most common cause to cause the pain of bone and joint in the elderly。The etiopathogenisis and pathogenesis of Knee osteoarthritis were usually concerned with age, biomechanical balance changes, obesity, elevated intraosseous pressure, free radical theory, cell factor theory, cartilage enzymatic degradation theory, immune theory, etal。About to Cytokine, its plays a regulatory role in the occurrence and development process of osteoarthritis. Many research data to proved, The level of cytokine was obviously elevated, for instance IL-1, TNF and NO and so on, which come from the joint fluid of KOA patients。IL-1present in chondrocytes, peripheral pannus and lymphocytic aggregation site of articular cartilage, which can be applied to the cartilage cells, inhibition the synthesis of type II collagen, induces the expression of type Ⅰ and Ⅲ collagen, inhibition substance synthesis, promoting chondrocytes dedifferentiatedc The products come from Cartilage damage grinding particles and cartilage matrix damage can induce and aggravate the synovitis and mononuclear macrophages and other inflammatory infiltrates, promote IL-1release increased, so that the synovial cell, inflammatory cell reactivity enhancement, and cartilage cells secrete more metalloproteinase, forming a vicious spiral, elicited greater cartilage destruction.TNF through to stimulus for synovial cells synthesize PGE2and collagenase, promote MMP synthesis and secretion, cause cartilage absorption, degradation and destruction, meanwhile, promoting the proliferation of fibroblast, the local vascular endothelial cell permeability increases, aggravate local inflammatory infiltration and edema, and IL-1are induced, participate in the cytokine network, resulting in the change of KOA joint matrix。At present, the treatment of KOA mainly focuses on relief of symptoms, improve joint function, delaying disease progression and the reconstruction of the damaged cartilage and bone structure.。The drug, to control the symptoms of KOA main still with non-steroidal anti-inflammatory drugs, but non-steroidal anti-inflammatory drugs have obvious gastrointestinal tract side effects; Glucosamine sulfate by stimuli into chondrocyte proteoglycan synthesis to protect and repair the cartilage matrix; Intra articular injection of sodium hyaluronate solution can restore joint viscoelastic, have stage protection on articular cartilage, its only can slow the progress of the disease but not morbidostatic progression。Artificial joint replacement is an important part for osteoarthritis operation treatment, knee arthroplasty starts late in our country, the short term clinical effect is satisfactory, but the shortcomings is high cost, technology still not pervasion and so on。Diacerein as IL-l’s primary inhibitors, Through lymphocyte to inhibition cytokine such as IL-1, MMPs, NO and so on, to induces chondrogenesis, which have analgesic, anti-inflammatory and antipyretic action, not refrain the prostaglandin synthesis, can slow the progression of the disease on osteoarthritis, Therefore, its curative effect obviously better than non-steroid anti-inflammatory drug on knee osteoarthritis, but some patients have obviously diarrhoea after taking, the incidence of about7%, long-term use can affect the gastrointestinal function, and asked to take6months shall conduct liver kidney function and blood, urine routine examination。In the study for traditional Chinese medicine, primary disease belong to" arthromyodynia"" bi-bone" category, past dynasties doctors to make a systemic discuss for the disease etiology, pathogenesis, syndrome classification, prognosis and so on。Traditional Chinese medicine deem that kidney dominating bone, liver controlling tendon、liver and kidney deficiency, blood and essence loss, cannot nurture the skeleton is the internal cause for disease occurred, also cold and dampness and other evils are the external cause, flexion and extend disadvantage due to stagnation of QI and blood may bring about pain, and deficiency nonlustre tendon。 Therefore, its should support healthy energy, especially lay stress on tonification liver and kidney, and stretch tendon and dia-collaterals in treatment。Qiangguguanjie Granule (QGG) is composed by aceranthus sagittatus S.et Z., eucommia bark, gentiana macrophylla, danshen root, achyranthis,radix, rehmannia dride rhizome, anemarrhenae, corydalis tuber and so ont, this formula play its role by nourishing liver and kidney, gluten bone health, promoting blood circulation and removing blood stasis, relax and activate the tendons, these drugs compatibility have satisfactory clinical efficacy on the liver and kidney deficiency and vein stasis type knee osteoarthritis, and no toxic side effect, its has a certain advantage to treat KOA。 In recent years on the KOA clinical study report showed, the integrated traditional Chinese and Western medicine treatment for knee osteoarthritis etiology, can significantly reduce joint pain, improve joint function, its effect is superior to single drug treatment。This study was designed to observe the clinical efficacy of Qiangguguanjie granule combined with diacerein treatment on knee osteoarthritis, analysis its improvement mechanism for patients with symptoms and signs, approach the clinical advantage of combining traditional Chinese and Western medicine treatment for knee osteoarthritis。2. Methods and content2.1Case selection2.1.1Case inclusion criteria:①The age40-65years old;②The traditional Chinese medicine with the State Administration of traditional Chinese medicine formulation of diagnosis standard on the deficiency of liver and kidney vein stasis type knee osteoarthritis in the" Chinese medicine clinical research guiding principle"③The diagnosis of Western medicine with the American College of Rheumatology1995knee osteoarthritis diagnosis table;④The patients,which were informed consent, voluntary acceptance of three months treatment and examination;⑤The treatment within the first7days, not taking non-steroidal anti-inflammatory drugs and the equivalent efficacy of traditional Chinese medicine。2.1.2case exclusion criteria:①Of joint gap significant stenosis or between joint formed the bone bridge connected and form a bony ankylosis;②The knee joint tumors, rheumatoid arthritis, tuberculosis, suppurative and intra-articular fracture in acute stage;③Those who have the obvious knee joint varus and ecstrophy deformity and limb vascular nerve injury history;④Those who have the significant organ organic disease and psychiatric patients;⑤Under40years of age or over65years of age, women in pregnancy and lactation;⑥Not to take medication as prescribed,and assessment the efficacy, or incomplete information affect the efficacy or safety judgement<,2.2. Case information90patients, from integrated traditional and Western medicine rheumatology outpatient clinic of Southern Medical University South Hospital, according to clinic were randomly divided into three groups:traditional Chinese medicine treatment group (30case,),Western medicine treatment group (30case,),The combination therapy group (30case,); Age40-65years old; course of disease of0.5-5years; Three groups in gender, age, course of disease showed no significant difference (P>0.05), have comparability。2.3. Treatment methodTraditional Chinese medicine treatment group:treated by Qiangguguanjie Granule (aceranthus sagittatus S.et Z.30g, eucommia bark20g, gentiana macrophylla20g, danshen root30g, achyranthis,radix20g, rehmannia dride rhizome30g, anemarrhenae20g, corydalis tuber20g) convention take medicine after mixing with aqua bulliens. a dosis everyday, Morning and evening of two minutes, every time300ml; Western medicine treatment group:treated by Diacerein Capsule (DC), every time50mg,2times a day, after meals oral; The combination therapy group:treated by Qiangguguanjie Granule and Diacerein Capsule (QGG+DC), method of administering the same as Chinese medicine group and Western medicine group; three months later, as the efficacy evaluation。2.4. Observation index2.4.1Safety observation index:①The general physical examination project:blood pressure, heart rate, respiration;②The blood, urine, stool routine examination;③The liver, kidney function tests;④The electrocardiogram examinationo2.4.2Efficacy observation index:①The signs and symptoms observed:joint pain, joint tenderness, joint movement disorder;②The laboratory observation index:CRP, ESR,TNF-a,IL-1,MMP-1。2.5Evaluation of curative effect2.5.1Symptom and obj ective sign score standards:Patient evaluation:using visual analog scale (visual anal ogue scales, VAS); The doctor evaluation:using Lequesne OA severity and activity index assessment method。2.5.2The comprehensive effect of score standards:According to the patients’scores of symptoms, motion of the knee joint and knee function, divided into three class, excellence, valid, invalid。①excellence: The symptoms disappear, joint activity donot limited,70%<knee function scores decreased<95%;②Valid:The symptoms basic elimination, joint activity mild limitation,30%<knee function scores decreased<69%;③Invalid:symptoms and joint activities without obvious improvement, knee function scores decreased<30%。Note:the score decreased percentage=[(before treatment score-after treatment score)/treatment before scoring]×100%(nimodipine method)2.6Standard for safety evaluation of adverse events and observations:If treated during or after, the safety index found out abnormal, must be immediate review, and to conduct a aggregate analysis, and according to whether the patient allergies, nausea, vomiting, abdominal pain, diarrhea, and according to their severity classification。Level1:safety, without any adverse reaction; Level2:the relative safety, adverse reactions, but do not need any treatment can continue to medicine; Level3:there is a moderate degree of adverse reactions, after treatyed may continue to give medicine; Level4:because of adverse reaction test was discontinued。2.7Statistical analysis:Using SPSS13.0statistical analysis software, the measurement data based on mean+SD representation。Each group before and after treatment were compared using the paired t test; The three groups were compared using univariate analysis of variance, variances are corrected; Rank data using the Kruskal-Wallis test; P<0.05was considered statistically significant。3. ResultsThe three groups were all obviously ease pain, improve joint function and the quality of daily life in patients。Before and after treatment in patients with symptoms and signs of score and laboratory indexes by using the paired t test, the differences were significant statistically significant (P<0.01)。 Between the three groups of symptoms and signs and ESR, CRP, TNF-a, MMP-1levels in after treatment, traditional Chinese medicine group compared with Western medicine group, the difference was not statistically significant (P>0.05), but the combined treatment group was better than the first two groups, and the difference was statistically significant (P<0.05); The improvement situation of IL-1levels in serum, the western medicine group and combined treatment group were superior to the Chinese traditional medicine group, the difference was statistically significant (P<0.05), while the combined treatment group and Western medicine group compared the difference was not statistically (p=0.054)。The three overall clinical efficacy comparison, traditional Chinese medicine group and Western medicine group efficiency quite, the difference was not statistically significant (P>0.05), combination of TCM and Western medicine therapy group overall effect is better than the first two, the difference was statistically significant (P<0.05)。Comparison of adverse drug reactions between the three groups, there were no obvious adverse reactions in traditional Chinese medicine group, western medicine group has6cases of epigastric discomfort and mild diarrhea, combination of TCM and Western medicine therapy group has2cases appeared epigastric discomfort, the safety rank are all2levels, without any treatment, spontaneous remission after administration 3-5days.4. Conclusion(1) Three therapeutic schemes all have obvious curative effect in the treatment of knee osteoarthritis (liver and kidney deficiency vein stasis type)。(2) Qiangguguanjie Granule treatment group compared with diacerein treatment group, the overall efficacy is correspondent, but traditional Chinese medicine group side reaction has obviously less than Western medicine group。(3) Qiangguguanjie Granule combined with diacerein treatment group, whether to alleviate patient signs and symptoms, or improve laboratory markers of inflammation, its curative effect is obviously superior to the former two groups. The comprehensive effect is also significantly better than single with Qiangguguanjie Granule or diacerein treatment group, and not found out obviously side effects，(4) Qiangguguanjie Granule combined with diacerein treatment knee osteoarthritis is a safe and effective method. Two drug combination therapy can foster strengths and circumvent weaknesses, play advantage of two drugs, improve the comprehensive curative effect, to improve the patient’s condition and their quality of life。... |
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