复方玄驹胶囊口服联合关节腔注射肿瘤坏死因子拮抗剂治疗类风湿关节炎  

Compound Xuanju Capsule Combined with Intra-articular Injection of Tumor Necrosis Factor Antagonists Treating Patients with Rheumatoid Arthritis

作　　者：孙琳[1] 潘秀霞[1] 刘冬松[1] 邢国荣[1] 王兆芬[1] 

机构地区：[1]山东省安丘市人民医院,山东安丘262100

出　　处：《中国实验方剂学杂志》2015年第3期196-200,共5页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：山东省潍坊市卫生局科研项目(2013)年第152号

摘　　要：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Objective： To discuss the curative efficacy of compound Xuanzhu capsules combined with recombinant human tumor necrosis factor-α receptor Ⅱ ： IgG fusion protein in treating rheumatoid arthritis （RA） patients of Shen and Qi deficiency syndrome. Method： Ninety-two patients with RA were randomly divided into the conventional treatment group, the control group and the combination group by random number table. Patients in conventional treatment group received celebrex, 0.2 g, once daily, methotrexate tablets, 10 mg, once weekly, and leflunomide tablets, 20 mg, once daily for oral administration. Based on the treatment of the conventional treatment group, patients in the control group added recombinant human tumor necrosis factor-α receptor Ⅱ ： IgG Fc fusion protein for articular cavity injection once weekly. Based on the treatment of control group, patients in combination group added compound Xuanzhu capsules, 3 gains, thrice daily. All patients received 3-month treatment. Before and after treatment, numbers of swollen and tender joint （28 joints） were recorded and pain degree was assessed by visual analogue scales. Scores of morning stiffness, grip strength and Shen deficiency cold syndrome were recorded. Levels of erythrocyte sedimentation rate （ESR） , c-reactive protein （CRP） , rheumatoid factor （RF） , tumor necrosis factor （TNF-α）, al-acidoglycoprotein （al-AGP） and immune globulin （IgA, IgM, IgG） were detected. Result： After treatment, the clinical total effective rate in the conventional treatment group, the control group and the combined group were 79.31%, 90% and 96.97%, respectively. There was no statistically significant difference between any two of the three groups. The improvements of time of morning stiffness, grip strength, the number of hands rest pain, joint swelling, joint tenderness count for the control group were superior to those for the conventional treatment group （P 〈0. 01 ）. The improvements of hard-shelled time in the morning, grip streng

关 键 词：类风湿性关节炎 复方玄驹胶囊 注射用重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白 

分 类 号：R287[医药卫生—中药学]