Wiland Piotr, Głowska Agnieszka, Chlebicki Arkadiusz, Szechiński Jacek
Oddział Chorób Wewnetrznych i Reumatologii Okregowego Szpitala Kolejowe, Wrocławiu.
Pol Arch Med Wewn. 2002 Nov;108(5):1055-63.
The objective of the paper was compare the effects and tolerability of combined therapy of multiple intravenous infusions of anti-tumour necrosis factor-alfa (TNF-alfa) monoclonal antibody (Remicade) with methotrexate versus treatment with sodium aurothiomalate and intramuscular depot methylprednisolone in rheumatoid arthritis (RA). We investigate also the interval necessary to obtain the improvement in both treatment groups. 36 patients commencing intramuscular sodium aurothiomalate therapy with intramuscular depot methylprednisolone acetate at weeks 0, 4, 8 and 12 in addition to chrysotherapy were compared in retrospective analysis with 32 patients starting with multiple intravenous infusions of infliximab, anti-TNF-alfa monoclonal antibody (Remicade) and methotrexate at a stable dose. Patients were assessed by composite clinical score (DAS 28) and C-reactive protein during 22 weeks of therapy. At week 2 and 6 a significantly greater percentage of infliximab-treated than gold-treated RA patients achieved improvement in each clinical measurement of disease activity. At 22 week of treatment moderate and good response according to EULAR criteria was achieved in 91% of infliximab-treated patients and 58% gold treated patients (p < 0.001). Adverse events were more frequently observed in infliximab-treated patients, but only gold-treated patients discontinued treatment because adverse events (2 patients due to proteinuria, 2 patients due to mucocutaneous changes and one patient due to leucopenia). The higher percentage of adverse events in infliximab-treated patients was caused mainly by the occurrence of infusion reactions (23 reactions out of 160 infusions); most of them were mild (somnolentia and headache) and transient. Viral infections (including herpes simplex and zoster) were more common in patients treated with infliximab and methotrexate. Combination therapy of infliximab and methotrexate is more effective in reducing clinical and biochemical disease activity than gold with methylprednisolone treatment in RA patients during 22 weeks of treatment, especially in the first 6 weeks.
本文的目的是比较多次静脉输注抗肿瘤坏死因子-α（TNF-α）单克隆抗体（类克）联合甲氨蝶呤与金硫代苹果酸钠和肌肉注射长效甲基强的松龙治疗类风湿关节炎（RA）的疗效和耐受性。我们还研究了两个治疗组获得病情改善所需的时间间隔。在回顾性分析中，将36例除金疗法外，在第0、4、8和12周开始接受金硫代苹果酸钠肌肉注射治疗并联合醋酸甲基强的松龙肌肉注射的患者，与32例开始接受稳定剂量的英夫利昔单抗（一种抗TNF-α单克隆抗体，类克）多次静脉输注及甲氨蝶呤治疗的患者进行比较。在22周的治疗期间，通过综合临床评分（DAS 28）和C反应蛋白对患者进行评估。在治疗的第2周和第6周，接受英夫利昔单抗治疗的RA患者在各项疾病活动度临床测量指标上实现改善的百分比显著高于接受金制剂治疗的患者。在治疗22周时，根据欧洲抗风湿病联盟（EULAR）标准，91%接受英夫利昔单抗治疗的患者达到中度和良好反应，而接受金制剂治疗的患者为58%（p<0.001）。在接受英夫利昔单抗治疗的患者中更频繁观察到不良事件，但只有接受金制剂治疗的患者因不良事件而停药（2例因蛋白尿、2例因皮肤黏膜改变、1例因白细胞减少）。接受英夫利昔单抗治疗的患者中不良事件百分比更高主要是由于输注反应的发生（160次输注中有23次反应）；其中大多数为轻度（嗜睡和头痛）且为短暂性。病毒感染（包括单纯疱疹和带状疱疹）在接受英夫利昔单抗和甲氨蝶呤治疗的患者中更为常见。在22周的治疗期间，尤其是在前6周，英夫利昔单抗和甲氨蝶呤联合治疗在降低RA患者临床和生化疾病活动度方面比金制剂联合甲基强的松龙治疗更有效。
