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目的:探讨复方玄驹胶囊内服联合注射用重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白关节腔注射治疗活动期类风湿性关节炎(RA)(肾气虚寒型)的临床观察。方法:将92例RA患者随机按数字表法分为常规治疗组、对照组和联合组,常规治疗组采用塞来昔布胶囊,0.2 g/次,1次/d,口服;甲氨蝶呤片(MTX),10 mg/次,1次/周,口服;来氟米特片(LEF),20 mg/次,1次/d,口服。对照组在常规治疗组治疗的基础上加用注射用重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白关节腔注射,1次/周;联合组在对照组治疗的基础上加服复方玄驹胶囊,3粒/次,3次/d。3组疗程均为3个月。记录治疗前后关节压痛和肿胀数(28个关节)、疼痛程度采用视觉模拟评分法,记录晨僵时间、双手握力及肾气虚寒证评分;检测治疗前后血沉(ESR),C-反应蛋白(CRP),类风湿因子(RF),血清肿瘤坏死因子-α(TNF-α),a酸性糖蛋白(a1-AGP)和免疫球白(Ig A,Ig M,Ig G)水平。结果:治疗后常规治疗组、对照组和联合组的临床总有效率分别为79.31%,90%和96.97%,3组比较差异无统计学意义;治疗后对照组晨僵时间、双手握力、休息痛、关节肿胀个数、关节压痛个数的改善均优于常规治疗组(P<0.01),联合组晨僵时间、双手握力、休息痛、关节肿胀个数、关节压痛个数及肾气虚寒证评分的改善均优于常规治疗组(P<0.01);联合组晨僵时间、双手握力、休息痛和肾气虚寒证评分的改善优于对照组(P<0.05);治疗后对照组TNF-α,RF,a1-AGP水平低于常规组,联合组ESR,CRP,TNF-α,RF,a1-AGP水平均低于常规治疗组和对照组(P<0.05,P<0.01),治疗后对照组Ig G水平低于常规治疗组(P<0.01),联合组Ig A,Ig M,Ig G均低于常规治疗组(P<0.01),也低于对照组(P<0.01)。结论:复方玄驹胶囊内服联合注射用重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白关节腔注射在控制症状、改善关节功能、减轻中医证候、控制炎症方面有一定疗效。
Objective: To investigate the clinical observation of the treatment of rheumatoid arthritis (RA) (Kidney Deficiency Type) by injection of the compound type Xuanju Capsule intraocular injection combined with recombinant human type Ⅱ tumor necrosis factor receptor - antibody fusion protein intra-articular injection. Methods: Ninety-two patients with RA were randomly divided into routine treatment group, control group and combination group according to the digital table method. Conventional treatment group received celecoxib capsules 0.2g once daily, methotrexate Tablets (MTX), 10 mg / time, once a week, orally; LEF, 20 mg / time, once daily, orally. Control group in the conventional treatment group based on the plus injection of recombinant human type Ⅱ tumor necrosis factor receptor - antibody fusion protein intra-articular injection, 1 / week; combined group in the control group based on the treatment plus compound Xuan Ju Capsule, 3 capsules / time, 3 times / d. Three groups of treatment were 3 months. The joint tenderness and swelling (28 joints) before and after treatment were recorded. The degree of pain was recorded by visual analogue scale, and the scores of morning stiffness, hands grip and kidney qi deficiency syndrome were recorded. The levels of ESR, C-reactive protein ), Rheumatoid factor (RF), serum tumor necrosis factor-α (TNF-α), a-glycoprotein (a1-AGP) and immunoglobulin (Ig A, Ig M, Ig G) Results: After treatment, the total clinical effective rates of the conventional treatment group, the control group and the combined group were 79.31%, 90% and 96.97% respectively. There was no significant difference between the three groups after treatment; the morning stiffness time, The pain, the number of joint swelling and the number of joint tenderness were all better than those in the conventional treatment group (P <0.01), the combination group morning stiffness, grip strength, resting pain, swollen joint count, joint tenderness and kidney qi deficiency (P <0.01). The scores of morning stiffness, hands grip, rest pain and kidney qi deficiency syndrome in the combination group were better than those in the control group (P <0.05). After treatment, the levels of TNF The level of ESR, CRP, TNF-α, RF and a1-AGP in the combined group were lower than those in the conventional treatment group and the control group (P <0.05, P <0.01) The level of Ig G in the control group was lower than that in the conventional treatment group (P <0.01). The IgA, Ig M and Ig G in the combined group were lower than those in the conventional treatment group (P <0.01) and also lower than those in the control group (P <0.01). CONCLUSION: The injection of recombinant human Xuanju Capsule intramuscular injection of recombinant human type Ⅱ tumor necrosis factor receptor - antibody fusion protein in the joint cavity has some curative effects in the control of symptoms, improvement of joint function, alleviation of TCM syndromes and inflammation control.