Epidural Steroids, Etanercept, or Saline in Subacute Sciatica A Multicenter, Randomized Trial
Epidural Steroids, Etanercept, or Saline in Subacute Sciatica A Multicenter, Randomized Trial
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DOI：
10.7326/0003-4819-156-8-201204170-00397
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发表时间：
2012-04-17
影响因子：
39.2
通讯作者：
Nguyen, Conner
中科院分区：
文献类型：
--
作者：
Cohen, Steven P.;White, Ronald L.;Nguyen, Conner
背景资料：肿瘤坏死因子的神经周围抑制剂最近产生了浓厚的兴趣作为替代硬膜外类固醇注射lumbosacral radicalpathy.Objective：To评估硬膜外类固醇，依那西普，或生理盐水是否更好地改善疼痛和功能在成人lumbosacral radicalpathy.Design：一个多中心，3组，随机，安慰剂对照试验进行了2008年至2011年。随机化由计算机生成，并按研究中心分层。药剂师准备注射器。评估结果的患者、治疗医生和护士对治疗分配不知情。（ClinicalTrials.gov注册号：NCT 00733096）设置：军事和民用治疗中心。患者：84名患有腰骶神经根病的成年人，持续时间不到6个月。干预：2次硬膜外注射类固醇、依那西普或生理盐水，与布比卡因混合，间隔2周。测量：主要结果测量为第二次注射后1个月的腿部疼痛。所有患者均接受了1个月的随访;病情改善的患者在6个月的研究期内保持盲态。结果：接受硬膜外类固醇治疗的患者的主要结局指标比接受生理盐水治疗的患者下降更大（平均差异，-1.26 [95% CI，-2.79至0.27]; P = 0.11）或依那西普（平均差异，-1.01 [CI，-2.60至0.58]; P = 0.21）。对于背痛，与生理盐水（平均差异，-0.52 [CI，-1.85至0.81]; P = 0.44）和依那西普（平均差异，-0.92 [CI，-2.28至0.44]; P = 0.18）相比，观察到有利于类固醇的较小差异。最大的差异是功能能力，其中依那西普的表现比其他治疗差：类固醇vs.依那西普（平均差异，-16.16 [CI，-26.05至-6.27]; P = 0.002），类固醇与生理盐水（平均差异，-5.87 [CI，-15.59至3.85]; P = 0.23），依那西普与生理盐水（平均差异，10.29 [CI，0.55至20.04]; P = 0.04）。与接受生理盐水（50%）或依那西普（42%）的患者相比，接受硬膜外类固醇治疗的患者（75%）在1个月时报告了50%或更高的腿部疼痛缓解和积极的总体感知效果（P = 0.09）。局限性：短期随访，样本量小，依那西普的剂量可能低于治疗剂量。硬膜外类固醇注射可为某些腰骶神经根病成人患者提供适度的短期疼痛缓解，但需要更大规模的研究和更长时间的随访来证实其益处。
Background: Perineural inhibitors of tumor necrosis factor have recently generated intense interest as an alternative to epidural steroid injections for lumbosacral radiculopathy.Objective: To evaluate whether epidural steroids, etanercept, or saline better improves pain and function in adults with lumbosacral radiculopathy.Design: A multicenter, 3-group, randomized, placebo-controlled trial conducted from 2008 to 2011. Randomization was computer-generated and stratified by site. Pharmacists prepared the syringes. Patients, treating physicians, and nurses assessing outcomes were blinded to treatment assignment. (ClinicalTrials.gov registration number: NCT00733096)Setting: Military and civilian treatment centers.Patients: 84 adults with lumbosacral radiculopathy of less than 6 months' duration.Intervention: 2 epidural injections of steroids, etanercept, or saline, mixed with bupivacaine and separated by 2 weeks.Measurements: The primary outcome measure was leg pain 1 month after the second injection. All patients had 1-month follow-up visits; patients whose condition improved remained blinded for the 6-month study period.Results: The group that received epidural steroids had greater reductions in the primary outcome measure than those who received saline (mean difference, -1.26 [95% CI, -2.79 to 0.27]; P = 0.11) or etanercept (mean difference, -1.01 [CI, -2.60 to 0.58]; P = 0.21). For back pain, smaller differences favoring steroids compared with saline (mean difference, -0.52 [CI, -1.85 to 0.81]; P = 0.44) and etanercept (mean difference, -0.92 [CI, -2.28 to 0.44]; P = 0.18) were observed. The largest differences were noted for functional capacity, in which etanercept fared worse than the other treatments: steroids vs. etanercept (mean difference, -16.16 [CI, -26.05 to -6.27]; P = 0.002), steroids vs. saline (mean difference, -5.87 [CI, -15.59 to 3.85]; P = 0.23), and etanercept vs. saline (mean difference, 10.29 [CI, 0.55 to 20.04]; P = 0.04). More patients treated with epidural steroids (75%) reported 50% or greater leg pain relief and a positive global perceived effect at 1 month than those who received saline (50%) or etanercept (42%) (P = 0.09).Limitation: Short-term follow-up, small sample size, and a possibly subtherapeutic dose of etanercept.Conclusion: Epidural steroid injections may provide modest short-term pain relief for some adults with lumbosacral radiculopathy, but larger studies with longer follow-up are needed to confirm their benefits.