Randomized, Double-blind, Placebo-Controlled, Trial of Transforaminal Epidural Etanercept for the Treatment of Symptomatic Lumbar Disc Herniation
Randomized, Double-blind, Placebo-Controlled, Trial of Transforaminal Epidural Etanercept for the Treatment of Symptomatic Lumbar Disc Herniation
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DOI：
10.1097/01.brs.0000435140.61593.4c
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发表时间：
2013-11-01
期刊：
影响因子：
3
通讯作者：
Gorman, James R.
中科院分区：
文献类型：
--
作者：
Freeman, Brian J. C.;Ludbrook, Guy L.;Gorman, James R.
研究设计。多中心、随机、双盲、安慰剂对照试验。目的。旨在检查三种不同剂量的肿瘤坏死因子 α (TNF-α) 抑制剂依那西普与安慰剂治疗有症状的腰椎间盘突出症 (LDH) 的安全性和有效性。背景数据摘要。 TNF-α 被认为是与症状性 LDH 相关的根性腿痛的主要原因。 TNF-α 抑制剂的全身给药治疗坐骨神经痛已显示出疗效的趋势。方法。 49 名年龄在 18 岁至 70 岁之间、患有继发于 LDH 的持续性腰骶神经根性疼痛、平均腿部疼痛强度为 5/10 或以上的受试者被随机分为 4 组中的一组：0.5 mg、2.5 mg、12.5 mg 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。主要结果指标是平均每日最严重腿痛（WLP）的变化。次要结果包括平均腿痛、最严重背痛、平均背痛、诊所疼痛、Oswestry 残疾指数、患者对变化的整体印象和耐受性。 结果：49 名随机患者中有 43 名完成了研究。与安慰剂组相比，接受 0.5 mg 依那西普治疗的患者在 2 至 26 周期间，无论是按方案人群（-5.13 对比 -1.95；P = 0.066）还是意向治疗人群（-4.40 对比 -1.84；P = 0.058），平均每日 WLP 均出现临床和统计学显着性降低（P < 0.1）。其中 50% 的受试者报告治疗后 4 周 WLP 降低了 100%，而安慰剂组中这一比例为 0%。在 0.5 毫克依那西普队列中也观察到所有次要结局的改善。安慰剂和所有依那西普队列中不良事件的总体发生率相似。结论。对于有症状的 LDH 受试者，与安慰剂相比，两次经椎间孔注射依那西普可显着降低平均每日 WLP 和最严重背痛。硬膜外依那西普可以为坐骨神经痛患者提供安全有效的非手术治疗。
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-alpha) inhibitor etanercept versus placebo for the treatment of symptomatic lumbar disc herniation (LDH).Summary of Background Data. TNF-alpha is considered to be a major cause of radicular leg pain associated with symptomatic LDH. Systemic administration of TNF-alpha 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.