小剂量生物制剂联合甲氨蝶呤治疗类风湿关节炎35例  

Clinical Efficacy and Safety of Low-dose rhTNFR: Fc Combined with Methotrexate in Treatment of Rheumatoid Arthritis

作　　者：胡清[1] 曾玉琴[1] 李雪锋[1] 孙明谨[1] 黄成虎[1] 

机构地区：[1]湖北医药学院附属太和医院内分泌风湿科,湖北十堰442000

出　　处：《医药导报》2012年第8期1026-1028,共3页Herald of Medicine

摘　　要：目的观察小剂量重组人型肿瘤坏死因子受体-抗体融合蛋白(rhTNFR:Fc)联合甲氨蝶呤(MTX)治疗活动性类风湿关节炎(RA)的疗效与安全性。方法活动性RA患者65例,分为联合治疗组35例和对照组30例,均每周给予MTX10～15 mg口服,治疗组每周加用rhTNFR12.5 mg,皮下注射。两组均在治疗开始时联合使用一种非甾体抗炎药。记录治疗前、治疗1个月后和治疗24个月后患者关节肿胀数、关节压痛数、晨僵时间、血沉和类风湿因子变化;治疗前、治疗24个月后测定患者X线分期和疾病活动评分(DAS28),记录治疗过程中药品不良反应。结果治疗1个月后,治疗组临床指标变化好于对照组(P<0.01);治疗24个月后,治疗组治疗X线分期变化情况进展明显少于对照组。两组间不良反应差异无统计学意义。结论小剂量rhTNFR:Fc联合MTX治疗RA能快速缓解临床症状,改善关节功能。Objective The aim of this study was to evaluate the efficacy and safety of combination use of low-dose rhTNFR： Fc and methotrexate（MTX） in the patients with active rheumatoid arthritis（RA）.Methods Sixty-five patients with active RA were divided into two groups： Group A（n=35）,treated with combined use of hypodermic injection of low-dose rhTNFR： Fc（12.5 mg·W-1） and orally administration of MTX（10 to 15 mg weekly）,and group B（n=30）,treated with orally administration of MTX（10 to 15 mg weekly）.Arthrocele,joint tenderness,the time of early morning stiffness,and the changes of ESR and RF were recorded before the treatment,one month and 24 months after the treatment.Staging by X-ray and Disease Active Score 28（DAS28） were determined before and 24 months after the treatment.Drug adverse reaction was recorded during the treatment.Results Clinical indicators were significantly improved better in group A than in group B one month after the treatment（P〈0.01）.Changes of staging by X-ray in group A were significantly less than those in group B（P〈0.05）.There was no significant difference in the drug adverse effect between the two groups.Conclusion Low-dose rhTNFR： Fc combined with MTX can reduce joint inflammation,improve physical function rapidly,and retard radiological progression of RA.The efficacy and safety is good.

关 键 词：重组人型肿瘤坏死因子受体-抗体融合蛋白 甲氨蝶呤 类风湿关节炎 

分 类 号：R979.5[医药卫生—药品] R979.1[医药卫生—药学]