*Royal Adelaide Hospital, Adelaide, Australia †University of Adelaide, Adelaide, Australia ‡Cabrini Medical Centre, Melbourne, Australia §Royal North Shore Hospital, Sydney, Australia ¶Metro Spinal Clinic, Melbourne, Australia ‖Summit Analytical, Chicago, IL; and **BioAssets Development Corporation, Wellesley, MA.
Spine (Phila Pa 1976). 2013 Nov 1;38(23):1986-94. doi: 10.1097/01.brs.0000435140.61593.4c.
STUDY DESIGN: Multicenter, randomized, double-blind, placebo-controlled trial. OBJECTIVE: To examine the safety and efficacy of three different doses of the tumor necrosis factor alpha (TNF-α) inhibitor etanercept versus placebo for the treatment of symptomatic lumbar disc herniation (LDH). SUMMARY OF BACKGROUND DATA: TNF-α is considered to be a major cause of radicular leg pain associated with symptomatic LDH. Systemic administration of TNF-α inhibitors for sciatica has indicated a trend toward efficacy. METHODS: Forty-nine subjects aged between 18 and 70 years, with persistent lumbosacral radicular pain secondary to LDH, and an average leg pain intensity of 5/10 or more were randomized to 1 of 4 groups: 0.5-mg, 2.5-mg, 12.5-mg etanercept, or placebo. Subjects received 2 transforaminal epidural injections, 2 weeks apart, and were assessed for efficacy up to 26 weeks after the second injection. The primary outcome measure was the change in mean daily worst leg pain (WLP). Secondary outcomes included average leg pain, worst back pain, average back pain, in-clinic pain, Oswestry Disability Index, patient global impression of change, and tolerability. RESULTS: Forty-three of the 49 randomized patients completed the study. Patients receiving 0.5-mg etanercept showed a clinically and statistically significant (P< 0.1) reduction in mean daily WLP compared with the placebo cohort from 2 to 26 weeks for both the per protocol population (-5.13 vs. -1.95; P= 0.066) and the intention-to-treat population (-4.40 vs. -1.84; P= 0.058). Fifty percent of these subjects reported a 100% reduction in WLP 4 weeks post-treatment compared with 0% of subjects in the placebo cohort. Improvements in all secondary outcomes were also observed in the 0.5-mg etanercept cohort. The overall incidence of adverse events was similar in placebo and all etanercept cohorts. CONCLUSION: Two transforaminal injections of etanercept provided clinically significant reductions in mean daily WLP and worst back pain compared with placebo for subjects with symptomatic LDH. Epidural etanercept may offer patients with sciatica a safe and effective nonoperative treatment.
研究设计：多中心、随机、双盲、安慰剂对照试验。 目的：研究肿瘤坏死因子-α（TNF-α）抑制剂依那西普治疗症状性腰椎间盘突出症（LDH）的安全性和有效性，比较三种不同剂量依那西普与安慰剂的疗效。 背景资料概要：TNF-α被认为是与症状性 LDH 相关神经根性腿痛的主要原因。全身给予 TNF-α 抑制剂治疗坐骨神经痛显示出一定的疗效趋势。 方法：49 名年龄在 18 至 70 岁之间的受试者，患有持续性腰骶神经根痛继发于 LDH，腿部疼痛平均强度为 5/10 或更高，随机分为 4 组：0.5mg、2.5mg、12.5mg 依那西普或安慰剂。受试者接受 2 次经椎间孔硬膜外注射，间隔 2 周，并在第二次注射后 26 周内评估疗效。主要结局指标为平均每日最差腿部疼痛（WLP）的变化。次要结局指标包括平均腿部疼痛、最严重背部疼痛、平均背部疼痛、门诊疼痛、Oswestry 残疾指数、患者总体印象变化和耐受性。 结果：49 名随机患者中有 43 名完成了研究。接受 0.5mg 依那西普治疗的患者与安慰剂组相比，在 2 至 26 周的时间内，在方案人群（-5.13 对-1.95；P=0.066）和意向治疗人群（-4.40 对-1.84；P=0.058）中，平均每日 WLP 均有临床和统计学显著（P<0.1）的降低。这些患者中有 50%在治疗后 4 周报告腿部疼痛完全缓解，而安慰剂组患者中无此比例。0.5mg 依那西普组的所有次要结局也均有改善。安慰剂和所有依那西普组的不良反应总发生率相似。 结论：与安慰剂相比，2 次经椎间孔硬膜外注射依那西普可使症状性 LDH 患者的平均每日 WLP 和最严重背痛显著降低。硬膜外依那西普可能为坐骨神经痛患者提供一种安全有效的非手术治疗方法。
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