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Efficacy of infliximab for disc herniation-induced sciatica: one-year follow-up.

机译：英夫利昔单抗治疗椎间盘突出症坐骨神经痛的疗效：一年的随访。

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STUDY DESIGN: An open-label trial. OBJECTIVES: To test the long-term efficacy of infliximab, a monoclonal antibody against tumor necrosis factor-alpha (TNF-alpha), in disc herniation-induced sciatica. SUMMARY OF BACKGROUND DATA: Our recent trial indicated that a single infusion of 3 mg/weight-kg of infliximab produced a rapid curative effect in disc herniation-induced sciatica. Here, we describe the 1-year effect of a 3 mg/kg of infliximab in these 10 patients and our experience with a lower dose of 1 mg/kg of infliximab for the same indication in 2 additional patients. METHODS: Patients with severe sciatica were treated with a single infusion of infliximab, 3 mg/weight-kg in 10 patients and 1 mg/kg in 2 patients, intravenously over 2 hours. The outcomes (leg and back pain on a 100-mm visual scale, Oswestry disability, clinical signs) were assessed at 1 week, 2 weeks, 1 month, 3 months, 6 months, and 1 year after the infusion. The outcomes with 3 mg/kg of infliximab were compared to 62 patients who received periradicular saline for sciatica in a previous trial. The resorption rate of disc herniations from baseline to 1 year was compared between infliximab and control groups. RESULTS: The response to 1 mg/kg of infliximab for leg pain was good only in 1 of the 2 patients treated, whereas the response to 3 mg/kg of infliximab for leg pain was sustained in most patients over the 1-year follow-up. The 1-year response significantly favored 3 mg/kg of infliximab over periradicular saline in leg pain (P = 0.005) and disability (P = 0.003). Neurologic abnormalities normalized more comprehensively in the infliximab group (P = 0.001). Reduction in disc herniation volume did not differ between the infliximab-treated patients and controls. CONCLUSIONS: The results showed that the beneficial effect of a single infusion of 3 mg/kg of infliximab for herniation-induced sciatica is sustained in most patients over a 1-year follow-up period. Furthermore, infliximab does not seem to interfere with the spontaneous resorption of disc herniations.
机译：研究设计：开放性试验。目的：测试英夫利昔单抗（一种抗肿瘤坏死因子-α（TNF-alpha）的单克隆抗体）在椎间盘突出症引起的坐骨神经痛中的长期疗效。背景数据摘要：我们最近的试验表明，单次输注3 mg / kg体重的英夫利昔单抗可在椎间盘突出症引起的坐骨神经痛中产生快速的疗效。在这里，我们描述了3 mg / kg英夫利昔单抗在这10例患者中的1年疗效，以及我们在另外2名患者中针对相同适应症使用较低剂量1 mg / kg英夫利昔单抗的经验。方法：重度坐骨神经痛患者接受英夫利昔单抗单次输注，分别在10例患者中3 mg / kg / kg和2例患者1 mg / kg静脉输注2小时。在输注后1周，2周，1个月，3个月，6个月和1年时评估结局（以100毫米视觉评分的腿和背部疼痛，Oswestry残疾，临床体征）。在先前的研究中，将英夫利昔单抗3 mg / kg的结果与62例接受放射周围盐水治疗的坐骨神经痛患者进行了比较。比较了英夫利昔单抗和对照组从基线到1年的椎间盘突出症的吸收率。结果：仅在接受治疗的2例患者中，有1例对英夫利昔单抗腿痛的反应良好，而在1年随访期中，大多数患者对3 mg / kg英夫利昔单抗的腿痛反应持续。向上。在腿痛（P = 0.005）和残疾（P = 0.003）的情况下，一年的反应显着优于英夫利昔单抗3 mg / kg而不是根尖周盐水。英夫利昔单抗组神经系统异常更全面地标准化（P = 0.001）。在用英夫利昔单抗治疗的患者和对照组之间，椎间盘突出量的减少没有差异。结论：结果显示，在1年的随访期内，大多数患者单次输注3 mg / kg英夫利昔单抗对疝引起的坐骨神经痛的益处持续存在。此外，英夫利昔单抗似乎不干扰椎间盘突出症的自发吸收。

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