Department of Anesthesiology, University of California, San Diego, La Jolla, CA 92037, USA.
Reg Anesth Pain Med. 2011 Nov-Dec;36(6):572-8. doi: 10.1097/AAP.0b013e318232e843.
Serious adverse events related to particulate steroids have curtailed the use of transforaminal epidural steroid injections for radicular pain. Dexamethasone has been proposed as an alternative. We investigated the efficacy, dose-response profile, and safety of 3 doses of epidural dexamethasone.
A prospective, randomized, double-blind, dose-ranging design was used. A total of 98 subjects were randomized to transforaminal epidural dexamethasone 4 mg (n = 33), 8 mg (n = 33), or 12 mg (n = 32). The primary outcome measure for this study was reduction in radicular pain according to the visual analog scale from baseline, with 30% reduction or higher considered clinically meaningful. Secondary measures included the Oswestry Low Back Disability Scale, Subject Global Impression of Change, Subject Global Satisfaction Scale, and adverse events. Outcomes were assessed at 1, 4, 8, and 12 weeks after injection. Outcome measures, sample size, and statistical analysis were defined before enrollment.
Mean radicular pain according to the visual analog scale compared with baseline was reduced 41.7%, 33.5%, and 26.6% at 4, 8, and 12 weeks, respectively, after injection. Oswestry disability ratings declined from "moderate" at baseline to "minimal" at 4, 8, and 12 weeks after injection. There was no statistical difference between groups for either measure (all P values < 0.05, Bonferroni-corrected). Parallel effects were observed in "impression of change" and "satisfaction" measures. No serious adverse events were noted.
Transforaminal epidural dexamethasone provides statistically significant and clinically meaningful improvement in radicular pain at 12 weeks after injection, with parallel improvements in disability, impression of change, and satisfaction measures. There was no difference in efficacy for dexamethasone 4 mg compared with 8 or 12 mg. The optimal dose of epidural dexamethasone may be lower than 4 mg, further increasing the long-term safety and tolerability of this treatment. Current data are reassuring with regard to the safety of dexamethasone for transforaminal epidural steroid injection.
与颗粒状类固醇相关的严重不良事件已经限制了经椎间孔硬膜外类固醇注射治疗神经根痛的使用。地塞米松已被提议作为替代药物。我们研究了硬膜外地塞米松 3 种剂量的疗效、剂量反应曲线和安全性。
采用前瞻性、随机、双盲、剂量范围设计。共 98 例患者随机分为经椎间孔硬膜外地塞米松 4mg（n=33）、8mg（n=33）或 12mg（n=32）。本研究的主要观察指标是根据视觉模拟量表（VAS）基线测量的神经根痛缓解情况，30%或更高的缓解率被认为具有临床意义。次要观察指标包括 Oswestry 下腰痛残疾量表、患者总体印象变化量表、患者总体满意度量表和不良事件。在注射后 1、4、8 和 12 周进行评估。在入组前确定了评估指标、样本量和统计分析方法。
与基线相比，注射后 4、8 和 12 周时，VAS 平均神经根痛分别降低 41.7%、33.5%和 26.6%。Oswestry 残疾评分从基线的“中度”降至注射后 4、8 和 12 周的“轻度”。两组之间这两个指标均无统计学差异（所有 P 值均<0.05，Bonferroni 校正）。“变化印象”和“满意度”测量也观察到了平行效果。未观察到严重不良事件。
经椎间孔硬膜外地塞米松可在注射后 12 周时显著改善神经根痛，且在残疾、印象改变和满意度方面也有显著改善。地塞米松 4mg 与 8mg 或 12mg 的疗效无差异。硬膜外地塞米松的最佳剂量可能低于 4mg，从而进一步提高该治疗的长期安全性和耐受性。目前的数据令人放心，表明地塞米松用于经椎间孔硬膜外类固醇注射是安全的。
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