重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白联合益肾蠲脾丸治疗强直性脊柱炎的效果观察  

作　　者：徐春慧[1] 魏安银[2] 梁少辉[2] 刘亚东[1] 黄月秀 

机构地区：[1]中国人民解放军北京军区北戴河疗养院,066100 [2]国家安全生产监督管理总局北戴河职业病防治院,066104

出　　处：《中国疗养医学》2017年第1期92-94,共3页Chinese Journal of Convalescent Medicine

摘　　要：目的观察重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白联合益肾蠲脾丸治疗强直性脊柱炎的效果。方法选取2012-07—2014-06北戴河职业病防治院骨病专科收治的强直性脊柱炎活动性患者32例,随机分为治疗组与对照组,每组16例患者。治疗组患者予以重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白(25 mg,2次/周皮下注射)联合益肾蠲脾丸治疗;对照组患者给予甲氨蝶呤(10~15 mg/周)和柳氮磺吡啶(1.5~2.0 g/d)联合治疗,两组均同时给予非甾体类抗炎药(NSAIDs)治疗。疗程12周后评价腰痛发生率、腰部晨僵时间、实验室炎症反应指标[红细胞沉降率(ESR)、C反应蛋白(CRP)、血小板计数(PLT)]及BASDAI、BASFI评分等,随时记录观察期间不良事件。结果两组治疗12周后与各自基线相比,腰痛发生率明显降低(P<0.05),腰部晨僵时间明显缩短(P<0.05),BASDAI、BASFI评分明显改善,ESR、CRP、PLT明显降低(P<0.05);治疗组各项临床指标改善程度均明显优于对照组(P<0.05);两组患者不良反应发生率比较差异无统计学意义(P>0.05)。随访过程中,治疗组患者降低重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白用药频率继续使用,病情维持稳定。不良反应均为轻度,未发现结核、病毒性肝炎感染等情况。结论重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白联合益肾蠲脾丸治疗强直性脊柱炎的临床疗效显著,且安全性较高。Objective To observe the effects of recombinant human II tumor necrosis factor receptor-antibody fusion protein combined with kidney reinforcing spleen pills in the treatment of ankylosing spondylitis（AS）.Methods 32 suf- ferers with AS activity admitted to Osteopathia Department, Institute of Occupational Disease Prevention and Treat- ment, Beidaihe, from July 2012 to June 2014 were randomly divided into treatment group and control group, with 16 sufferers in each group.The treatment group were given recombinant human II tumor necrosis factor receptor-antibody fusion protein（25 rag, 2 times/week subcutaneous injection） combined with kidney reinforcing spleen pills;The control group were given methotrexate（10 - 15 mg/week） and sulfasalazine（1.5 - 2.0 g/d）.Both groups at the same time were given non-steroidal anti-inflammatory drugs（NSAIDs）.After 12 weeks of treatment, the incidence of backache, the time of waist morning stiffness,the laboratory inflammatory reaction indicators （ESR, CRP,and PLT）, and BASDAI and BASFI scores were evaluated, and the adverse events during the observation period were recorded timely. Results Af- ter 12 weeks of treatment, compared with the respective baseline, the incidence of backache in both groups obviously decreased（P〈 0.05）,the duration of morning stiffness was significantly reduced（P 〈 0.05）,BASDAI and BASFI scores got improved significantly,and ESR,CRP,and PLT decreased significantly （P 〈 0.05）;The improving degrees of all clinical indexes in the treatment group were significantly better than those of the control group（P 〈 0.05）;The inci- dence of adverse reactions in both groups showed no difference of statistical significance （P 〉 0.05）.During the fol- low-up visit, the sufferers in the treatment group reduced the administration frequency of recombinant human II tumor necrosis factor receptor-antibody fusion protein for continuous use,to maintain the stable condition.Adverse reactions were mild, without infection of tuberc

关 键 词：强直性脊柱炎 重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白 益肾蠲脾丸 甲氨蝶呤 柳氮磺吡啶 

分 类 号：R593.23[医药卫生—内科学]