抗TNF-α联合甲氨蝶呤治疗皮肌炎的开放标签试验。
Open-label trial of anti-TNF-alpha in dermato- and polymyositis treated concomitantly with methotrexate.
作者信息
Hengstman G J D, De Bleecker J L, Feist E, Vissing J, Denton C P, Manoussakis M N, Slott Jensen H, van Engelen B G M, van den Hoogen F H J
机构信息
Neuromuscular Centre Nijmegen, Department of Neurology, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands.
出版信息
Eur Neurol. 2008;59(3-4):159-63. doi: 10.1159/000114036. Epub 2008 Jan 29.
BACKGROUND/AIMS: To determine the efficacy of infliximab combined with weekly methotrexate in drug-naive recent-onset dermatomyositis and polymyositis.
METHODS
A multicentre open-label controlled trial was conducted. Disease activity was assessed using patient's and physician's disease activity assessment, manual muscle testing (MMT), handheld dynamometry, and serum CK. The primary objective was to assess the efficacy using MMT after a period of 26 weeks.
RESULTS
The study was terminated prematurely because of a low inclusion rate and a high drop-out rate due to disease progression and the occurrence of an infusion reaction. The few patients who did reach the primary endpoint showed improvement in all aspects studied.
CONCLUSION
Infliximab combined with weekly methotrexate might be safe and well tolerated in a small subgroup of patients with drug-naive recent-onset myositis. At present, we do not advocate the use of this treatment because treatment response cannot be predicted beforehand.
背景/目的：确定英夫利昔单抗联合每周一次甲氨蝶呤治疗初治的近期发病皮肌炎和多发性肌炎的疗效。
方法
进行了一项多中心开放标签对照试验。使用患者和医生的疾病活动评估、徒手肌力测试（MMT）、手持测力计和血清肌酸激酶评估疾病活动度。主要目的是在26周后使用MMT评估疗效。
结果
由于纳入率低以及因疾病进展和输液反应的发生导致高脱落率，该研究提前终止。少数达到主要终点的患者在所有研究方面均有改善。
结论
英夫利昔单抗联合每周一次甲氨蝶呤在一小部分初治的近期发病肌炎患者中可能是安全且耐受性良好的。目前，我们不主张使用这种治疗方法，因为治疗反应无法预先预测。
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