摘要
目的探讨注射用重组人Ⅱ型肿瘤坏死因子受体—抗体融合蛋白联合柳氮磺吡啶治疗强直性脊柱炎(AS)与单用注射用重组人Ⅱ型肿瘤坏死因子受体—抗体融合蛋白治疗强直性脊柱炎的临床疗效和安全性。方法 54例强直性脊柱炎患者,按照随机数字表法分为两组各27例。治疗组给予皮下注射注射用重组人Ⅱ型肿瘤坏死因子受体—抗体融合蛋白25mg Biw,联合口服柳氮磺吡啶1 g Bid治疗;对照组给予皮下注射注射用重组人Ⅱ型肿瘤坏死因子受体—抗体融合蛋白25 mg Biw治疗。比较治疗24周后两组疼痛评分、患者总体评估(PGA)、Bath AS疾病活动指数(BASDIA)、Bath AS功能指数(BASFI),炎症指标C反应蛋白(CRP)、血沉(ESR),疗效指标ASAS20、ASAS40,药物不良反应发生比例。经24周诱导缓解治疗后进入维持治疗阶段,分完全停药和柳氮磺吡啶维持治疗两组,继续随访患者疼痛评分、PGA、BASDIA、BASFI。结果诱导缓解治疗阶段,治疗组、对照组第4、12、24周与基线各疗效指标比较差异均有统计学意义(P<0.05)。治疗组和对照组不良反应发生率分别为44.44%、18.52%,差异有统计学意义(P<0.05)。继续12周维持治疗,口服柳氮磺吡啶维持治疗较完全停药病情复发率低,差异有统计学意义(P<0.05)。结论 AS患者给予注射用重组人Ⅱ型肿瘤坏死因子受体—抗体融合蛋白治疗时,联用柳氮磺吡啶与未联用柳氮磺吡啶治疗疗效无差异,联合柳氮磺吡啶治疗不良反应发生率更高。停用注射用重组人Ⅱ型肿瘤坏死因子受体—抗体融合蛋白后,继续柳氮磺吡啶治疗能维持AS患者病情的缓解。
Objective To compare the clinical efficacy and safety of etanercept combined with sulfasalazine with etanercept alone in the treatment of ankylosing spondylitis （ AS）.Methods Fifty-four AS patients were randomly divided into trial or control group,27 in each group.The trial group was given etanercept 25 mg/time,2 times per week,and sulfasalazine 1 g/time,2 times per day.The control group was treated with etanercept,25 mg/time,2 times per week.The pain score,disease activity,Bath AS disease activity index （BASDIA） ,Bath AS functional index （BASFI） ,inflammation index C-reactive protein （CRP） ,blood sedimentation （ESR） effi-cacy indicators ASAS20 and ASAS40 as well as prevalence of adverse drug reactions were evaluated after treatment for 24 weeks in the both groups.After 24 weeks of induced remission treatment,the treatments were into the maintenance phase and each group was divided into two groups to further observe for 12 weeks,in which one group stop medications treatment while another group maintained the treat-ment with sulfasalazine.They were followed up to observe the pain scores, PGA, BASDIA and BASFI.Results During the induced re-mission treatment,the various effective indexes were significantly changed at 4,12 and 24 weeks in the both groups when compared to the baseline （P 〈0.0 5 ） .The incidence of adverse events in the trial and control groups was 44.44% and 18.52% , respectively.The difference was statistically significant （ P 〈0.05 ）.In the maintenance phase, the recurrent rate in the patients with oral sulfasalazine maintenance treatment was lower than that in the patients stopping treatment （ P〈0.05 ）.Conclusion There is no difference in clinical efficacy between etanercept and etanercept combined with sulfasalazine in treatment of ankylosing spondylitis, and the incidence of adverse events is higher in combination of etanercept and sulfasalazine than sulfasalazine alone.Sulfasalazine can successfully maintain remission of AS afte
作者
周益
赵华
林辉
刘毅
ZHOU Yi;ZHA;UN Hui;LIU Yi(Department of Rheumatology and Immunology,West China Hospital,Sichuan University,Chengdu 610041,China)
出处
《实用医院临床杂志》
2018年第5期5-9,共5页
Practical Journal of Clinical Medicine
基金
国家自然科学基金资助项目(编号:81401350)
