Oral steroids for acute radiculopathy due to a herniated lumbar disk: a randomized clinical trial.
Oral steroids for acute radiculopathy due to a herniated lumbar disk: a randomized clinical trial.
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DOI：
10.1001/jama.2015.4468
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发表时间：
2015-05-19
期刊：
影响因子：
--
通讯作者：
Avins AL
中科院分区：
文献类型：
--
作者：
Goldberg H;Firtch W;Tyburski M;Pressman A;Ackerson L;Hamilton L;Smith W;Carver R;Maratukulam A;Won LA;Carragee E;Avins AL
口服类固醇通常用于治疗由椎间盘突出引起的急性坐骨神经痛，但尚未在适当的临床试验中进行评估。确定口服强的松在改善急性坐骨神经痛患者的功能和疼痛方面是否比安慰剂更有效。随机、双盲、安慰剂对照的临床试验，于2008年至2013年在北加州的一个大型综合医疗保健系统中进行。神经根疼痛持续3个月或更短，Oswestry残疾指数（ODI）评分为30或更高（范围0-100，分数越高表明功能障碍越严重），并经磁共振成像证实椎间盘突出的成人（n=269）符合条件。参与者以2:1的比例随机分配，接受逐渐递减的15天口服强的松疗程（60mg、40mg和20mg各5天；总累积剂量= 600mg; n = 181）或匹配的安慰剂（n = 88）。主要终点为3周时ODI变化；次要结果为1年ODI变化、下肢疼痛变化（0-10分，分数越高疼痛越重）、脊柱手术、36健康调查简表（SF-36）身体成分总结（PCS）和精神成分总结（MCS）评分（0-100分，分数越高越好）。观察到基线和3周平均ODI评分，强的松组分别为51.2和32.2，安慰剂组分别为51.1和37.5。强的松治疗组在3周时ODI评分的改善比安慰剂组高6.4点（95%CI, 1.9-10.9; P = 0.006），在52周时的改善比安慰剂组高7.4点（95%CI, 2.2-12.5; P = 0.005）。与安慰剂组相比，强的松组在3周时疼痛减轻的调整后平均为0.3点（95%CI, - 0.4至1.0;P = 0.34），在52周时疼痛减轻的平均为0.6点（95%CI, - 0.2至1.3;P = 0.15）。强的松组在3周时sf - 36pcs评分的调整后平均改善3.3点（95%CI, 1.3-5.2; P = 0.001）， 52周时sf - 36pcs评分无差异（平均值，2.5;95%CI, - 0.3至5.4;P = 0.08）， 3周时SF-36MCS评分无变化（平均值，2.2;95%CI, - 0.4至4.8;P = 0.10）， 52周时SF-36MCS评分的调整后3.6点（95%CI, 0.6-6.7; P = 0.02）改善。在52周的随访中，手术率没有差异。在3周的随访中，强的松组出现1个或更多不良事件的发生率高于安慰剂组（49.2% vs 23.9%; P < 0.001）。在腰椎间盘突出引起的急性神经根病患者中，与安慰剂相比，短期口服类固醇治疗可以适度改善功能，但疼痛没有改善。clinicaltrials.gov标识符：NCT00668434
Oral steroids are commonly used to treat acute sciatica due to a herniated disk but have not been evaluated in an appropriately powered clinical trial. To determine if oral prednisone is more effective than placebo in improving function and pain among patients with acute sciatica. Randomized, double-blind, placebo-controlled clinical trial conducted from 2008 to 2013 in a large integrated health care delivery system in Northern California. Adults (n=269) with radicular pain for 3 months or less, an Oswestry Disability Index (ODI) score of 30 or higher (range, 0-100; higher scores indicate greater dysfunction), and a herniated disk confirmed by magnetic resonance imaging were eligible. Participants were randomly assigned in a 2:1 ratio to receive a tapering 15-day course of oral prednisone (5 days each of 60mg, 40mg, and 20mg; total cumulative dose = 600mg; n = 181) or matching placebo (n = 88). The primary outcome was ODI change at 3 weeks; secondary outcomes were ODI change at 1 year, change in lower extremity pain (measured on a 0-10 scale; higher scores indicate more pain), spine surgery, and Short Form 36 Health Survey (SF-36) Physical Component Summary (PCS) and Mental Component Summary (MCS) scores (0-100 scale; higher scores better). Observed baseline and 3-week mean ODI scores were 51.2 and 32.2 for the prednisone group and 51.1 and 37.5 for the placebo group, respectively. The prednisone-treated group showed an adjusted mean 6.4-point (95%CI, 1.9-10.9; P = .006) greater improvement in ODI scores at 3 weeks than the placebo group and a mean 7.4-point (95%CI, 2.2-12.5; P = .005) greater improvement at 52 weeks. Compared with the placebo group, the prednisone group showed an adjusted mean 0.3-point (95%CI, −0.4 to 1.0; P = .34) greater reduction in pain at 3 weeks and a mean 0.6-point (95%CI, −0.2 to 1.3; P = .15) greater reduction at 52 weeks. The prednisone group showed an adjusted mean 3.3-point (95%CI, 1.3-5.2; P = .001) greater improvement in the SF-36 PCS score at 3 weeks, no difference in the SF-36 PCS score at 52 weeks (mean, 2.5; 95%CI, −0.3 to 5.4; P = .08), no change in the SF-36MCS score at 3 weeks (mean, 2.2; 95%CI, −0.4 to 4.8; P = .10), and an adjusted 3.6-point (95%CI, 0.6-6.7; P = .02) greater improvement in the SF-36MCS score at 52 weeks. There were no differences in surgery rates at 52-week follow-up. Having 1 or more adverse events at 3-week follow-up was more common in the prednisone group than in the placebo group (49.2% vs 23.9%; P < .001). Among patients with acute radiculopathy due to a herniated lumbar disk, a short course of oral steroids, compared with placebo, resulted in modestly improved function and no improvement in pain. clinicaltrials.gov Identifier: NCT00668434
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4.5
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