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依那西普联合甲氨蝶呤治疗中国人群强直性脊柱炎髋关节病变的疗效。

Treatment efficacy of etanercept and MTX combination therapy for ankylosing spondylitis hip joint lesion in Chinese population.

机构信息

Department of Rheumatology & Clinical Immunology, The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.

出版信息

Rheumatol Int. 2012 Jun;32(6):1663-7. doi: 10.1007/s00296-011-1844-8. Epub 2011 Mar 9.

Abstract

To investigate the efficacy of etanercept and MTX (methotrexate) combination therapy in Chinese patients with ankylosing spondylitis hip joint lesion, the possible courses and maintenance protocol, altogether 97 ankylosing spondylitis patients fulfilling the modified New York criteria with hip joint lesion were enrolled in a 12-month trial treated with combined etanercept and MTX. All these patients were required to be poor responders to SSZ (Sulfasalazine) or MTX therapy for 6 consecutive months or the longer. Etanercept was administered subcutaneously twice a week at a fixed dosage of 25 mg for the first six months, followed by 25 mg once a week in patients with good control of both symptoms and radiological progression, or twice a week for another six months in patients with BASDAI > or = 4. Combined MTX was administered intravenously once a week at the dosage of 15 mg. Demographics, clinical and laboratory features, physical function and quality of life using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), the Bath Ankylosing Spondylitis Functional Index (BASFI), Harris hip score, and radiological assessment using the BASRI-hip index were recorded. Most patients achieved pain release at the end point of assessment. Significant improvement in Bath AS Disease Activity Index (BASDAI) (P < 0.05), Bath AS Functional Activity Index (BASFI) (P < 0.05), and Harris hip score (P < 0.05) was demonstrated. Radiographic progression was recorded as no exacerbation or alleviated. Larger interval between two etanercept administrations would provide similar advantages to standard method and possibly less adverse events if MTX was combined. Etanercept and MTX combination therapy was beneficial to ankylosing spondylitis patients with hip joint lesion, and staged dosage deduction in the long term proved to be effective as well as adverse event preventing.

摘要

为了研究依那西普联合甲氨蝶呤(MTX)治疗中国强直性脊柱炎髋关节病变患者的疗效、可能的疗程和维持方案,共纳入 97 例符合改良纽约标准且伴髋关节病变的强直性脊柱炎患者,进行了为期 12 个月的依那西普联合 MTX 治疗试验。所有患者均为 SSZ(柳氮磺胺吡啶)或 MTX 治疗连续 6 个月或更长时间无应答的难治性患者。前 6 个月,依那西普每周皮下注射 25mg,共 2 次;如果症状和放射学进展得到良好控制,此后改为每周 1 次;如果 BASDAI≥4,依那西普仍为每周 2 次。联合 MTX 方案为每周 1 次,静脉注射剂量为 15mg。记录患者的人口统计学、临床和实验室特征、躯体功能和生活质量(采用 Bath 强直性脊柱炎疾病活动指数(BASDAI)、Bath 强直性脊柱炎功能指数(BASFI)、Harris 髋关节评分以及 BASRI-髋关节指数进行放射学评估)。大多数患者在评估终点时达到疼痛缓解。BASDAI(P<0.05)、BASFI(P<0.05)和 Harris 髋关节评分(P<0.05)均显著改善。影像学进展记录为无加重或缓解。如果联合使用 MTX,延长两次依那西普给药之间的间隔时间会提供类似的优势,且可能会减少不良反应事件。依那西普联合 MTX 治疗对伴有髋关节病变的强直性脊柱炎患者有益,长期分阶段剂量减少不仅有效,还能预防不良反应。

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