依那西普对难治眭强直性脊柱炎相关髋关节病变治疗的临床疗效观察

The therapeutic effect of etanercept on intractable ankylosing apondylitis related hip joint diseases

目的观察肿瘤坏死因子拮抗剂（依那西普）治疗难治性强直性脊柱炎（AS）相关髋关节病变的疗效。方法35例AS患者同时伴有单侧或双侧髋关节疼痛及活动受限，既往接受规范非甾体抗炎药及缓解病情抗风湿药治疗病情仍不能控制。我们采用前瞻性开放性临床研究，对35例患者给予依那西普治疗，即依那西普50mg皮下注射，每周1次，疗程12周；同时联合每周甲氨蝶呤（MTX）10mg治疗。评价指标有Harris髋关节评分、BathAS髋关节X线指数（BASRI—hip）、BathAS疾病活动指数（BASDAI）、BathAS功能指数（BASFI）、红细胞沉降率（ESR）、C反应蛋白（CRP），评价治疗前和治疗12周后以上指标的变化。结果35例患者中15例为单髋关节受累，20例为双侧髋关节受累，共有55个髋关节受累。Harris髋关节评分治疗后明显升高，治疗前和治疗后分别为（51±4）分和（86±5）分（P=0．000）；BASDAI治疗前后分别为6．4±1．2和4．4±0．8（P=-0．000）；BASFI治疗前后分别为6．3±1．1和3．4±0．8（P=0．000）；ESR治疗前后平均分别为（68±28）mm／l h和（25±6）mm／l h（P=0．001）；CRP治疗前后分别为（59．1±22．3）mg／L和（6．9±1．1）mg／L（P=0．000）；但BASRI—hip治疗前后改变不明显。本研究治疗和随访过程中患者未出现结核和其他严重感染。结论依那西普联合MTX治疗难治性AS髋关节病变能明显改善髋关节功能、很好控制疾病活动度，未见明显不良反应。

Objective To observe the therapeutic effect of tumor necrosis factor inhibitor （Etanercept） on intractable ankylosing spondylitis （AS） related hip joint lesion. Methods Thirty-five patients with AS with unilateral or bilateral hip joints pain and limitation of joint motion were included into this study. The patients＇ conditions were not controlled under standard treatment by non-steroidal anti- inflamma-tory drug and antirheumatic medications. The clinical trial was designed as a prospectiveopcn study, 35 pati-ents received Etanercept 50 mg once a week for 12 weeks, combined with methotrexate （MTX） 10 mg once a week. Parameters including Harris hip score, Bath ankylosing spondylitis radiologic index-hip （BASRI-hip）, Bath ankylosing spondylitis disease activity index （BASDAI）, Bath ankylosing spondylitis functional index （BASFI）, Erythrocyte sedimentation rate （ESR）, and C-reactive protein （CRP） were evaluated and side effects were observed before and after the treatment. Results Fifty-five hip joints were involved in 35 patients, in which unilateral hip involvement in 15 patients and bilateral in 20 patients. Harris score of the hips incr-eased significantly from 51±4 before treatment to 86±5 （P=0.000） after treatment ; Before and after treatment, BASDAI changed from 6.4±1.2 to 4.4±0.8 （P=0.000）, BASFI was changed from 6.3±1.1 to 3.4±0.8 （P=0.000）, before and after treatment ESR was changed from （68：1：28） mm/l h to （25±6） mm/l h （P=-0.001）, CRP changed from （59.1±22.3） mg/L to （6.9±1.1） mg/L （P=0.000） before and after treatment respectively, but BASRI-hip was not changed obviously before and after treatment. No tuberculosis and serious side effects was observed during the treatment and follow-up period. Conclusion Etanercept, when combined with methotrexate, could be used to treatintractable AS-related hip joint lesions. This regimen could improve the hip joint function and control the disease activity without serious side effects.