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

机译:依那西普和MTX联合治疗强直性脊柱炎髋关节病变的疗效

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摘要

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) (PP<0.05), Bath AS Functional Activity Index (BASFI) (PP<0.05), and Harris hip score (PP<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.
机译:为了研究依那西普和MTX(甲氨蝶呤)联合治疗在中国强直性脊柱炎髋关节病变患者中的疗效,可能的疗程和维持方案,共纳入符合标准的纽约标准的97名强直性脊柱炎患者并伴有髋关节病变依那西普和MTX联合治疗的为期一个月的试验。所有这些患者必须连续6个月或更长时间对SSZ(柳氮磺胺吡啶)或MTX治疗反应不良。在头六个月中,每周两次以固定剂量25 mg皮下注射Etanercept,然后在症状和放射学进展均得到良好控制的患者中每周25 mg一次,或在其他六个月中,每周两次再次给予Etanercept BASDAI≥4。合并的MTX以15mg的剂量每周一次静脉内施用。使用巴斯克强直性脊柱炎疾病活动指数(BASDAI),巴斯克强直性脊柱炎功能指数(BASFI),哈里斯髋关节评分以及使用BASRI-hip指数的放射学评估来记录人口统计学,临床和实验室特征,身体功能和生活质量。大多数患者在评估的终点都实现了疼痛缓解。证实了Bath AS疾病活动指数(BASDAI)(PP <0.05),Bath AS功能活动指数(BASFI)(PP <0.05)和哈里斯髋关节评分(PP <0.05)有显着改善。影像学进展被记录为未加重或缓解。两次依那西普给药之间的较大间隔将提供与标准方法相似的优势,并且如果将MTX合并使用,可能会减少不良事件。 Etanercept和MTX联合治疗对强直性脊柱炎合并髋关节病变的患者有益,并且长期分阶段降低剂量被证明是有效的,并且可以预防不良事件。

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