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目的探讨TNF-α拮抗剂联合复方倍他米松单次关节腔注射治疗类风湿关节炎的疗效与安全性。方法将类风湿关节炎活动患者102例随机分为A、B、C、D四组各34例。所有患者均仅行1次关节腔穿刺,有积液者吸净关节积液后再注射药物。A组注射TNF-α拮抗剂—商品名益赛普(25mg/1ml),B组注射复方倍他米松—商品名得宝松(7mg/1ml),C组注射益赛普25mg/1ml+得宝松7mg/1ml,D组注射生理盐水1ml。注射后48h,注射后4周分别观察各组改良纽约特种外科医院膝关节评分(HSS)、关节总体状况评分(PVAS),医师对患者关节总体状况评分(DVAS),行走或站立时关节疼痛评分(AVAS),血液C反应蛋白(CRP),血液红细胞沉降率(ESR)和不良反应发生情况。结果治疗后48h、治疗后4周与治疗前组内比较,A、B、C组HSS较高,CRP、PVAS、DVAS均较低,差异均有统计学意义(P<0.05)。D组治疗后48h、治疗后4周HSS、CRP、PVAS及DVAS比较无统计学意义(P>0.05)。A、B、D组ESR治疗后48h与治疗前组内比较差异无统计学意义(P>0.05)。C组治疗后4周与治疗前组内比较ESR较低,差异有统计学意义(P<0.05)。A、B、C组治疗后4周与治疗前组内比较ESR较低,差异均有统计学意义(P<0.05)。治疗后48h和治疗后4周组间比较,A、B组之间差异无统计学意义(P>0.05)。C组与A组,C组与B组,C组与D组之间HSS、CRP、PVAS、DVAS差异均有统计学意义(P<0.05)。A组与D组,B组与D组之间HSS、CRP、PVAS、DVAS差异均有统计学意义(P<0.05)。A组再次出现关节肿胀积液2例,B组再次出现肿胀积液3例。C无一例出现再次肿胀积液。A组,C组各有1例局部皮疹,1d后消失。无其他不良反应。结论 TNF-α拮抗剂联合复方倍他米松单次关节腔注射治疗类风湿关节炎均有效,单药应用疗效相似,两药联合应用优于单药,能迅速改善类风湿关节炎的症状及试验室指标,具有良好的安全性。
Objective To investigate the efficacy and safety of TNF-α antagonist and compound betamethasone single intra-articular injection in the treatment of rheumatoid arthritis. Methods 102 patients with rheumatoid arthritis were randomly divided into A, B, C, D four groups of 34 cases. All patients were only a joint cavity puncture, there are fluid effusion suction net joint fluid injection. Group A was injected with TNF-α antagonist - trade name Yi Sipu (25mg / 1ml), group B was injected with compound betamethasone - buxusone (7mg / 1ml), group C was injected with 25mg / Loose 7mg / 1ml, D group injected normal saline 1ml. At 48 hours after injection and 4 weeks after injection, the knee joint scores (HSS), joint overall condition score (PVAS), physician’s joint condition score (DVAS), joint pain score (AVAS), blood C-reactive protein (CRP), erythrocyte sedimentation rate (ESR) and adverse reactions. Results The HSS in groups A, B and C were higher, and the CRP, PVAS and DVAS were lower at 48h after treatment and 4 weeks after treatment than those before treatment. The differences were statistically significant (P <0.05). There was no significant difference in HSS, CRP, PVAS and DVAS between group D at 48h and 4 weeks after treatment (P> 0.05). There was no significant difference between the groups A, B, D 48h after ESR treatment and before treatment (P> 0.05). ESR was lower in group C at 4 weeks after treatment than before treatment, with significant difference (P <0.05). ESR was lower in groups A, B and C at 4 weeks after treatment than before treatment, with significant differences (P <0.05). There was no significant difference between A and B groups at 48h after treatment and 4 weeks after treatment (P> 0.05). The differences of HSS, CRP, PVAS and DVAS between C group and A group, C group and B group, C group and D group were statistically significant (P <0.05). There were significant differences in HSS, CRP, PVAS and DVAS between group A and group D, group B and group D (P <0.05). In group A, there were 2 cases of swollen joint fluid and 3 cases of swollen effusion in group B. C no case of re-swelling fluid. A group, C group had 1 case of local rash, disappeared after 1d. No other adverse reactions. Conclusions The single intra-articular injection of TNF-α antagonist and combination betamethasone is effective in the treatment of rheumatoid arthritis. The efficacy of single-agent combination is similar to that of single-agent combination, which can rapidly improve the symptoms and test of rheumatoid arthritis Room indicators, with good safety.