Karppinen Jaro, Korhonen Timo, Malmivaara Antti, Paimela Leena, Kyllönen Eero, Lindgren Karl-August, Rantanen Pekka, Tervonen Osmo, Niinimäki Jaakko, Seitsalo Seppo, Hurri Heikki
Department of Physical Medicine and Rehabilitation, Oulu University Hospital, Finland.
Spine (Phila Pa 1976). 2003 Apr 15;28(8):750-3; discussion 753-4.
An open-label study was conducted.
To evaluate the efficacy and safety of infliximab, a monoclonal chimeric antibody, against tumor necrosis factor-alpha (TNFalpha) for the treatment of severe sciatica.
Evidence from animal studies indicates that TNFalpha plays a role in the pathophysiology of sciatica. Anti-TNFalpha therapy has not been previously evaluated in sciatic patients.
In this study, 10 patients with disc herniation-induced severe sciatica received infliximab (Remicade 3 mg/kg) intravenously over 2 hours. The outcome was assessed at 1 hour, 1 week, 2 weeks, 1 month, and 3 months after the infusion and compared to historical control subjects consisting of 62 patients who received saline in a trial of periradicular infiltration for sciatica. Leg pain was the primary outcome, with more than a 75% decrease from the baseline score constituting a painless state. Fisher's exact test and repeated measures analysis of variance were used for statistical analysis.
At 1 hour after the infusion, leg pain had decreased by 50%. At 2 weeks, 60% of the patients in the infliximab group were painless, as compared with 16% of the control patients (P = 0.006). The difference was sustained at 3 months (90% vs 46%; P = 0.014). Infliximab was superior over the whole follow-up period in terms of leg pain (P = 0.003) and back-related disability (P = 0.004). At 1 month, every patient in the infliximab group had returned to work, whereas 38% of the control subjects still were on sick leave (P = 0.02). None of the patients treated with infliximab underwent surgery during the follow-up period. No immediate or delayed adverse drug reactions and no adverse effects related to medication were observed.
Anti-TNFalpha therapy is a promising treatment option for sciatica. There is an urgent need for a randomized controlled trial to evaluate whether thesepromising early results can be confirmed.
进行了一项开放标签研究。
评估抗肿瘤坏死因子-α（TNFα）的嵌合单克隆抗体英夫利昔单抗治疗严重坐骨神经痛的疗效和安全性。
动物研究的证据表明TNFα在坐骨神经痛的病理生理学中起作用。抗TNFα疗法此前尚未在坐骨神经痛患者中进行评估。
在本研究中，10例因椎间盘突出导致严重坐骨神经痛的患者在2小时内静脉输注英夫利昔单抗（类克，3mg/kg）。在输注后1小时、1周、2周、1个月和3个月评估结果，并与历史对照受试者进行比较，历史对照受试者包括62例在坐骨神经痛的神经根周围浸润试验中接受生理盐水治疗的患者。腿痛是主要结局，与基线评分相比降低超过75%构成无痛状态。采用Fisher精确检验和重复测量方差分析进行统计分析。
输注后1小时，腿痛减轻了50%。在2周时，英夫利昔单抗组60%的患者无痛，而对照组为16%（P=0.006）。在3个月时差异仍然存在（90%对46%；P=0.014）。在整个随访期内，英夫利昔单抗在腿痛（P=0.003）和背部相关残疾方面（P=0.004）优于对照组。在1个月时，英夫利昔单抗组的每位患者都已恢复工作，而对照组38%的受试者仍在病假中（P=0.02）。在随访期间，接受英夫利昔单抗治疗的患者均未接受手术。未观察到立即或延迟的药物不良反应以及与药物相关的不良影响。
抗TNFα疗法是一种有前景的坐骨神经痛治疗选择。迫切需要进行一项随机对照试验，以评估这些有前景的早期结果是否能够得到证实。
