| | | | | Etanercept治疗未分化脊柱关节病患者的临床疗效和安全性初步研究 | | | 廖泽涛;古洁若;黄烽;余得恩;林曲;魏秋静 | | | 目的评价etanercept治疗未分化脊柱关节病(uSpA)患者的临床疗效以及安全性,并随访观察停药后患者复发的情况。方法研究共纳入30例活动性uSpA患者,前6周为随机双盲、安慰剂对照试验,后6周为开放性试验,受试者接受每周皮下注射etanercept或安慰剂2次,每次25mg。主要评价指标为第6和12周达到AS疗效评价标准(ASAS)20改善的比例,次要标准包括第6和12周达到ASAS50及ASAS70改善的比例,以及ASAS评价系统各单项指标的变化。用药结束后对患者进行定期随访,观察其复发时间。结果第6周安慰剂组所有指标较基线均无显著改善,而etanercept组除C反应蛋白(CRP)外其他指标均显著改善;两组间达到ASAS70改善的患者比例分别为33.3%和0,两组比较差异有统计学意义(P<0.05)。第12周两组间各个指标比较P>0.05。21例在12周达到ASAS20改善者在试验结束后随访满12个月,总计有11例(52.4%)患者复发,平均复发时间(5±4)个月;其中etanercept组7例,安慰剂组4例(两组比较P>0.05)。不良反应均为轻至中度,主要有注射部位皮肤反应、上呼吸道感染、转氨酶升高等。结论Etanercept治疗uSpA患者6或12周均能明显改善症状,且部分患者停药后能获得大于1年的良好控制症状效果,但能否真正控制病情进展和如何延续疗效尚待更多的临床研究和验证。
【作者单位】：中山大学附属第三医院风湿科;中山大学附属第三医院风湿科;解放军总医院风湿科;美国加州大学洛杉矶分校风湿病研究中心;中山大学附属第三医院风湿科;中山大学附属第三医院风湿科
【关键词】：脊柱疾病;治疗结果;Etanercept;复发
【基金】：国家杰出青年基金资助项目(30325019)
【分类号】：R593.2
【DOI】：CNKI:SUN:FSBZ.0.2007-10-009
【正文快照】：
在脊柱关节病(spondyloarthropathy,SpA)的欧洲脊柱关节病研究组(ESSG)分类标准中,未分化脊柱关节病(undifferentiated spondyloarthropathy,uSpA)被定义为临床提示SpA但又不符合任何一种分类已定的SpA亚型包括强直性脊柱炎(ankylosingspondylitis,AS)、Reiter综合征或反应性关 | | |  推荐 CAJ下载  PDF下载 | | | CAJViewer7.0阅读器支持所有CNKI文件格式，AdobeReader仅支持PDF格式 | | | | Study on the efficacy and safety of etanercept in patients with uSpA | | | LIAO Ze-tao;GU Jie-ruo;HUANG Feng;YU De-en;LIN Qu;WEI Qiu-jing. Department of Rheumatology;the Third Affiliated Hospital of Sun Yat-Sen University;Guangzhou 510630;China | | | Objective To determine the clinical efficacy and safety of etanercept in patients with uSpA. Method A 3 months,double-blind,placebo-controlled trial was conducted. Patients with active uSpA (n=30) were treated with either etanercept (n=15) or placebo (n=15) subcutaneously injection twice weekly for 6 weeks and followed by additional etanercept injection for 6 weeks. The primary outcome measures were the percentage of patients achieving the ASAS20 response at the sixth week and the twelfth week. Other outcome measures included the percentage of patients achieving the ASAS50 or ASAS70 response at the sixth week and twelfth week and the change of single parameter in the ASAS core sets. Patients were followed up until relapse or 1 year. Results At the 6th week,all parameters except BASDAI had no difference between the treatment and placebo group compared with the baseline. In the etanercept group,all parameters except CRP decreased significantly. But there was no difference between the two groups in all parameters. The percentage of patients achieving ASAS70 response was significantly different,but not in the percentage of patients achieving ASAS20 and ASAS50. After treated for 12 weeks,all parameters except CRP decreased significantly in both groups compared to the baseline. But no significant difference was found between the two groups. No significant difference could be detected in the percentage of patients achieving ASAS20/ASAS50/ASAS70 between the two groups. Among the 21 patients who achieved ASAS20 response,9 relapsed during the 1 year follow-up period. There was no significant difference between the two groups in the number of relapse. The adverse events included injection site reaction,upper respiratory tract infection and elevated liver transaminase. Conclusion Etanercept can relieve symptoms in uSpA patients. And some patients can get long-term relieve. However,whether it can delay the disease progression should be studied further.
【Keyword】：Spinal diseases;Efficacy;Etanercept;Relapse |
| | | | | | 1 | 黄烽,张莉芸,张江林,张奉春,梁东风,邓小虎,郭军华,朱剑,赵伟,李小峰,侯勇; 抗肿瘤坏死因子α单克隆抗体治疗强直性脊柱炎的短期临床观察 [J];中华内科杂志; 2006年02期 |
|
| | | | | | 1 | Dougados M, van der Linden S, Juhlin R, et al; The European spondyloarthropathy study group preliminary criteria for the classification of spondyloarthropathy [M];Arthritis & Rheumatism; 1991年 | | 2 | Braun J, Brandt J, Listing J, et al; Treatment of active ankylosing spondylitis with infliximab-a double blind placebo controlled multicenter trail [M];Lancet, The; 2002年 | | 3 | Baraliakos X,Brandt J,Listing J,et al; Clinical response to dis-continuation of anti-TNF therapy in patients with ankylosing spondylitis after3years of continuous treatment with Infliximab[J] [M];Arthritis Res Ther; 2005年 | | 4 | Garrett S, Jenkinson T, Kennedy LG, et al; A new approach to defining disease status in ankylosing spondylitis [M];Journal of Rheumatology, The; 1994年 | | 5 | Calin A, Garrett S, Whitelock H, et al; A new approach to defining functional ability in ankylosing spondylitis [M];Journal of Rheumatology, The; 1994年 | | 6 | Kumar A,,Bansal M,Srivastava DN,et al; Long-term outcome of undifferentiated spodyloarthropathy [M];Rheumatol Int; 2001年 | | 7 | Dougados M,van der Linden S,Leirisalo-Repo M et al; Sul-fasalazine in the treatment of spondylarthropathy:a randomized,multicenter,double-blind,placebo-controlled study [M];Arthritis Rheum; 1995年 | | 8 | Mease PJ,Goffe BS,Metz J,et al; Etanercept in the treatment of psoriatic arthritis and psoriasis:a randomised trial [M];Lancet; 2000年 | | 9 | Antoni C,Dechant C,Hanns-Martin Lorenz PD,et al; Open-la-bel study of infliximab treatment for psoriatic arthritis:clinical and magnetic resonance imaging measurements of reduction of inflammation [M];Arthritis Rheum; 2002年 | | 10 | Brandt J,Haibel H,Sieper J,et al; Successful treatment of pa-tients with severe undifferentiated spondyloarthropathy with theanti-TNF-alpha antibody infliximab [M];J Rheumatol; 2002年 |
|
| | | | | | 1 | 王莉莎,黄烽,张江林,邓小虎,张亚美,张莉芸,郭军华; 肿瘤坏死因子拮抗剂在治疗强直性脊柱炎中的安全性分析 [J];中国新药杂志; 2007年07期 | | 2 | 陈谦,邬明,程清,王忠强,李立军,陈忠庆; 骨肽辅助治疗强直性脊柱炎的临床观察 [J];中国医院药学杂志; 2007年09期 |
|
| | | | | | 1 | 刘可权; 异烟肼和山莨若碱联合治疗菌痢、肠炎80例 [J];新医学; 1987年06期; 51 | | 2 | 曾庆馀,肖征宇,许杰洲,黄少弼,王庆文,陈肃标,林玲; 未分化脊柱关节病的临床特点和骶髂关节病理观察 [J];实用医学杂志; 2003年01期; 28-30 | | 3 | 林增桃; ~(131)碘治疗甲亢疗效与甲状腺扫描特点的关系 [J];新医学; 1988年09期; 18-19 | | 4 | 张永勤; 硝苯吡啶治疗顽固性呃逆 [J];山东医药; 1991年03期; 60 | | 5 | 牟晓峰,王秀杰,刘淑云,崔林江,侯祖强; HLA-B_(27)和体液免疫与强直性脊柱炎关系的探讨 [J];青岛大学医学院学报; 1998年03期; 66 | | 6 | 纪卫政,吴兰华,包永星,艾力·吐尔逊,赵化荣,张华,王文然; Graves’眼病放射治疗的近期疗效观察 [J];新疆医科大学学报; 2006年03期; 70-71 | | 7 | 周伟; 干燥综合征的研究进展 [J];食品与药品; 2005年10期; 37-39 | | 8 | 范修云,张体华; 益肾汤联合西药治疗糖尿病肾病Ⅳ期45例疗效观察 [J];中国全科医学; 2006年18期; 78-80 | | 9 | 马成燕,高晶珍,刘洪香; 静脉注射丙种球蛋白治疗重症肌无力危象效果观察 [J];齐鲁医学杂志; 2007年02期; 72-73 | | 10 | 齐晓红; 中西医结合治疗系统性硬化症32例观察 [J];实用中医内科杂志; 2006年04期; 53 |
|
| | | | | | 1 | 陈翼,马黎明,杨洪文,洪愉,周平; ~(131)I固定计量法治疗甲亢近期疗效观察 [A];首届全国分子核医学暨分子影像学学术交流会资料汇编 [C]; 2006年 | | 2 | 张梅,姚群梅; 乐果中毒治疗结果161例分析 [A];中华医学会急诊医学学会第六次全国急诊医学学术会议论文汇编 [C]; 1996年 | | 3 | 陈翼,马黎明,杨洪文,洪愉,周平; ~(131)I固定计量法治疗甲亢近期疗效观察 [A];第三届全国核素显像暨核素治疗学术交流会论文汇编 [C]; 2006年 | | 4 | 田爱耕,张大正; 抢救有机磷农药中毒两组疗效对比 [A];中华医学会第七次全国内科学术会议论文汇编 [C]; 1995年 | | 5 | 李林,沈绍群; 碘-131固定计量法治疗甲亢近期疗效观察 [A];第二届全国核素显像及治疗学术会议论文摘要汇编 [C]; 2004年 | | 6 | 朱宝宽; 康尔秀减肥降脂胶囊临床观察 [A];第六届东南亚地区医学美容学术大会论文汇编 [C]; 2001年 | | 7 | 夏建锋,于国芳; 异病同治CTX小剂量冲击顽症风湿病治验例证 [A];第六届中国中西医结合风湿病学术会议论文汇编 [C]; 2006年 | | 8 | 陈锦平,李晓林,金永明,黄亚增; 气囊扩张椎体后凸成形术治疗骨质疏松性椎体压缩骨折的临床评价 [A];2006年浙江省骨质疏松与骨矿盐疾病防治学术年会论文汇编 [C]; 2006年 |
|
|
|
